IRMA BLOOD ANALYSIS SYSTEM

K981270 · Diametrics Medical, Inc. · CGZ · May 1, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981270
• Device Name: IRMA BLOOD ANALYSIS SYSTEM
• Applicant: Diametrics Medical, Inc.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Intended Use

The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na , K , iCa BUN. CI'. and Hct. in whole blood are performed such as the clinical laboratory or the patient bedside. The pH, pCO2, pO2 measurements, and their associated calculated values are used to assess acid-base status and state of oxygenation. Common causes of acid-base disturbances include: cardiopulmonary disease, metabolic abnormalities, drugs and poisons, and fluid imbalance. The electrolyte measurements (Na . K . Cl) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states which utilize these measurements for diagnosis are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities. The measurement of ionized calcium is used to assess disease states such as thyroid abnormalities, renal failure or transplant, and to monitor dialysis patients. The measurement of blood urea nitrogen is used to monitor renal disease, dialysis --patients, and hyperalimentation. The measurement of hematocrit is used to assess anemia, blood loss such as in an accident or during surgical procedures, and polycythemia. With the addition of BUN and Cr, the IRMA Blood Analysis System will measure: blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit. The sensor arravs of the cartridge will also be packaged in various combinations.

Device Story

IRMA Blood Analysis System is a portable, battery or AC-powered analyzer using disposable cartridges for point-of-care blood analysis. Input: whole blood samples (syringe or capillary) injected into cartridges. Operation: cartridges contain microelectrodes (potentiometric for pH, pCO2, Na+, K+, iCa++, BUN, Cl-; amperometric for pO2; conductivity for hematocrit). Microprocessor-controlled system performs automated calibration using prepackaged NIST-traceable standards, executes sample analysis, and manages diagnostics. Output: measured and calculated values displayed on screen and printed; data exportable via RS232 to LIS/IDMS. Used by clinicians at bedside or in labs to monitor acid-base, electrolyte, and renal status, enabling rapid clinical decision-making for critical care, dialysis, and trauma patients.

Clinical Evidence

Bench testing only. Accuracy evaluated via split-sample studies comparing IRMA results to reference methods (n=99 for Cl-, n=97 for BUN). Correlation coefficients (r) were 0.9976 for Cl- and 0.9996 for BUN. Precision assessed using aqueous controls over two days across three levels; CVs ranged from 0.3% to 3.1% for Cl- and 2.1% to 13.7% for BUN. Linearity ranges established: 10.6-146.8 mM for Cl- and 7.3-124.5 mg/dL for BUN.

Technological Characteristics

System uses disposable cartridges with microelectrode technology. Sensing principles: ion-selective potentiometric (pH, pCO2, Na+, K+, iCa++, BUN, Cl-), amperometric (pO2), and conductivity (hematocrit). Power: 7.2V NiCAD battery or AC adapter. Connectivity: RS232 serial port for LIS/IDMS. Software: microprocessor-controlled with automated calibration and diagnostic checks. Form factor: portable, 5 lbs.

Indications for Use

Indicated for professional use in clinical laboratories or patient bedside settings for the measurement of blood gases (pCO2, pO2), pH, electrolytes (Na+, K+, Cl-, iCa++), BUN, and hematocrit in whole blood to assess acid-base status, oxygenation, hydration, renal function, and anemia/blood loss in patients with conditions such as cardiopulmonary disease, metabolic abnormalities, renal failure, or trauma.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• Johnson and Johnson Vitros Chemistry System DT6011 (BUN)
• Buchler Digital Chloridometer (Cl-)

Submission Summary (Full Text)

{0}------------------------------------------------

K981270

MAY 1 1998

## 510(k) Summary

| 1. Submitter | Diametrics Medical, Inc. |
|---------------------------------------|----------------------------|
| | 2658 Patton Road |
| | Roseville, MN 55113 |
| 2. Establishment Registration Number: | 2183953 |
| 3. Device Names | |
| Proprietary Name: | IRMA Blood Analysis System |

Common Name:

Blood Gas/Electrolyte/Hematocrit Analyzer

Classification Name:

Blood gases (pCO2, pO2), pH, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit test systems

- 4. Device Classification
The blood gases (pCO2 and pO2), pH, sodium, potassium, ionized calcium, chloride, blood urea nitrogen and hematocrit systems have been classified under Clinical Chemistry Test Systems 21 CFR 862.1120, 862.1665, 862.1600, 862.1145, 862.1170, 862.1770 and under Hematology and Pathology Devices, 864.6400. All are Class II devices.

- 5. Compliance to Classification Requirements No performance standards have been established for the above referenced systems. Diametrics Medical intends to comply with any standards applicable to this product developed in the future.
- 6. Proposed labels, labeling, and advertisements The proposed labeling appears in Appendix B (Pouch and cartridge label), Appendix C (Package insert) and Appendix D (User manual). There are no required changes to the current device label. Diametrics Medical, Inc. does not intend to advertise the product at this time.

{1}------------------------------------------------

## 7 . System Description and Statement of Substantial Equivalence

#### System Description

The current IRMA Blood Analysis System comprises a system of an electronic instrument and disposable cartridges (single-use or multi-use) intended for the measurement of blood gases (pCO2 and pO2), pH, potassium, sodium, ionized calcium, and hematocrit in blood.

The new system will measure the above mentioned analytes plus blood urea nitrogen (BUN) and chloride (Cl) in blood on the single-use cartridge. Except for the addition of these two analytes and their associated changes, the system will remain the same as the current system. A description of the new system follows.

The IRMA analyzer can use either battery or AC power. The system's operation utilizes a microprocessor which is controlled by internal electronics and diagnostics. The microprocessor controls the touch screen, analog electronics which collect the digital signals from the sensors and the controls the printer. The printer provides a hard copy of the measured and calculated values.

Samples are introduced via syringe or capillary injections with the IRMA Capillary Collection Device. The minimum sample volumes are 200uL from a syringe injection and 125uL from a Capillary Collection Device injection. Other capillary collection devices which require aspiration are not compatible with the system.

The cartridges utilize microelectrode technology for the measurement of the following blood analytes: pH, pCO2, pO2, sodium, potassium, ionized calcium, blood urea nitrogen, chloride, and hematocrit.

The principles of measurement are similar to traditional electrode methodologies for blood gas and electrolyte measurements. The pH, pCO2, Na*, K*, iCa**, BUN, and Cli utilize ion-selective potentiometric electrodes including a reference electrode. The pO2 electrode is an amperometric Clark electrode. The hematocrit sensor utilizes a conductivity electrode. Further description of the principles of operation for the electrodes can be found in the draft labeling of the user manual.

#### Calibration

The IRMA sensors are calibrated prior to each test using a calibrant prepackaged over the sensors. The calibrant is manufactured and tested with NIST traceable gases and salt standards. Calibration of the cartridge is completed when information determined at the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.

Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

The user may also output the stored data via a RS232 serial port to IDMS ( IRMA Data Management System) or to a LIS.

{2}------------------------------------------------

#### Cartridge operation

Upon insertion of the cartridge, the user will enter a calibration code and the software's checksums will determine whether the code is appropriate for that cartridge type. Screen prompts will guide the user through the calibration process and sample analysis

For a more detailed description of the sample sequence refer to Section 2 of the User Manual Draft Labeling which is located in Appendix D.

### Intended Use Comparison

The IRMA Blood Analysis System is intended for professional use in those settings where direct measurement of blood such as blood gases (pCO2 and pO2), pH, Na* , K* , iCa* , Cl; BUN, and Hct in whole blood are performed such as the clinical laboratory or the patient bedside.

#### Substantial Equivalence

This notification demonstrates that the IRMA Blood Analysis System's BUN and Cl sensors are substantially equivalent to several other commercially cleared products: Johnson and Johnson Vitros Chemistry System DT6011 (BUN) and the Buchler Digital Chloridometer (CI).

The IRMA and Vitros analysis systems are similar in that both systems are intended for the measurement of blood urea nitrogen (BUN) by enzymatic methods which utilize an urease reaction. The IRMA and Buchler Digital Chloridometer systems are similar in that both systems are intended for the measurement of chloride by electrochemical methods.

The predicate systems and proposed IRMA Blood Analysis System are compared in Tables #1-2.

{3}------------------------------------------------

| | IRMA | Vitros |
|--------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detection Method | enzymatic electrochemical<br>urease reaction | enzymatic colorimetric<br>urease reaction |
| Analytes measured | pH, pCO2, pO2, Na+, K+, iCa++,<br>BUN, CI-, Hct<br>*BUN and Cl- not available on<br>multi-use | BUN, ammonia, amylase,<br>cholesterol, creatinine,<br>glucose, HDL cholesterol,<br>hemoglobin, lactate,<br>magnesium, neonatal bilirubin,<br>phosphorus, total bilirubin,<br>total protein, triglycerides,<br>uric acid |
| Measuring Range | BUN 0 - 150 mg/dL | BUN 1 - 100 mg/dL |
| Operating Temp. | 15-30°C (59-86°F) | 15.5-29.4℃ (60-85°F) |
| Operating Humidity | 0-80% | 15-75%*<br>*Upper RH value dependent of<br>temperature. |
| Sample | Whole blood<br>0.2 - 3.0 mL, syringe<br>0.125 mL from capillary<br>collection device | Serum/plasma<br>10 µL per test |
| Power | 7.2 V NiCAD rechargeable<br>battery<br>or<br>AC adapter | 120 VAC 1 amp<br>240 VAC 0.5 amp |
| Reagents | Supplied in self-contained<br>disposable cartridge | Supplied in self-contained<br>disposable slide |
| Weight | 5 lbs. | 19 lbs. |
| Results | Display and printer on board | Display and printer on board |
| Calibration | Automatic with each sample | User initiated process upon<br>installation, changing of slide<br>lots, when QC is out, or as<br>needed for system verification. |
| Sensors | disposable single-use<br>or<br>multi-use | disposable single-use |

# Table #1 Comparison of IRMA to Vitros System Features

ﺰ ﺳﻴﺒﻴﺎ

:

:

{4}------------------------------------------------

| | IRMA | Buchler Chloridometer |
|--------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Detection Method | electrochemical | electrochemical |
| Analytes measured | pH, pCO2, pO2, Na+, K+, iCa++,<br>BUN, Cl-, Hct<br>*BUN and Cl- not available on<br>multi-use | Cl- |
| Measuring Range | Cl- 30-150 mM or mEq/L | Cl- 1.0-999.9 mEq/L |
| Operating Temp. | 15-30°C (59-86°F) | Room temperature (range not<br>specifically defined) |
| Operating Humidity | 0-80% | Not defined |
| Blood Sample | Whole blood<br>0.2 - 3.0 mL, syringe<br>0.125 mL from capillary<br>collection device | serum/plasma<br>10 μL on low range<br>100 μL on high range |
| Power | 7.2 V NICAD rechargeable<br>battery<br>or<br>AC adapter | 115 VAC, 60 Hz<br>230 VAC, 50 Hz |
| Reagents | Supplied in self-contained<br>disposable cartridge | Chloridometer acid reagent<br>which is manually measured |
| Weight | 5 lbs. | 10 lbs. |
| Results | Display and printer on board | Display on board |
| Calibration | Automatic with each sample | Manual blank adjustment of<br>reagents and check with<br>chloride standard |
| Sensors | disposable single-use<br>or<br>multi-use | reusable silver wire |

1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

Table, #2, Comparison of IRMA to Buchler Chloridometer System Features

:

{5}------------------------------------------------

## 8 . Performance Characteristics: Supporting data for Substantial Equivalence

This section provides blood and aqueous data generated in-house using the IRMA Blood Analysis System's chloride and BUN sensors. The samples used in the study were spiked heparinized blood and prepared aqueous standards.

- A. Accuracy Data
To determine chloride and BUN accuracy of the IRMA Blood Analysis, split sample studies were conducted using whole blood samples measured by both the IRMA system and a reference method (refer to Table #3). The method of least squares was used to determine the best fit line. Testing was conducted by three laboratory personnel. The IRMA system was cleared in a previous 510k submission for use by non-laboratory personnel therefore this submission does not include data by non-laboratory personnel such as nurses. The heparinized whole blood samples were prepared by spiking with varying concentrations of electrolytes to allow testing throughout the reportable range.

The data shown below in Table #4 and the x-y plots located in Appendix A indicate substantial equivalence between CI- and BUN sensors on the IRMA Blood Analysis System and the predicate devices.

#### Table #3 Reference methods

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>Company of the company of the clife of the closed to the closed to the closes of the children the collection of the children the collection of the children the collection of<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Comments of the program and the program and the many of the many of the many of the many of the<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>---------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----------------<br>. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Comments of the Research and Concession Comes of the Comments of Concession of Concession Come of Concession Come of Concession Come of Concession Come of Concession Come of<br>A case a manage controllation and manufacturer and consisted<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>--------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>---------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Company<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br><br><br>A LEW SHOW HOME AND CONSULT A LE REAL<br>SHIP SHEATERS CHARACT CHARACT LAND CONSULTER COLLECTION COLLECTION COLLECTION COLLECTION COLLEGION COLLECTION COLLEGION COLLEGION COLLECTION COLLECTION CONNOMER COLLECTION CO |
| Complete of Children Company of the commend and any and well and with a program and any and any and the comments of the comments of the comments of the comments of the commen<br>------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>10.00 000 000 000 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>LE R. R. BE LEW LEASE .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1 |

Table #4 Blood Accuracy: The method of least squares was used to determine the best fit line.

| .<br>of the control of the closed of the closed on the consideration of the consisted<br>соданного всего в составления с в ставетского с своемника с седание с продобращие содательного в собставляется в собставляется в собство на свъем в об объем в об объем в об о | -------------------------------------------------------------------------------<br>100 CONSULT LINERAL LINE SECTION CONSULTION ALL CONTRACT ALL CONTRACT ALL CONTRACT ALL CONTRACT ALL CONTRACT AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A | .<br>Comprehensive and Children and Children and Children Children Children Children Children Children Children Children Children Children Children Children Children Children Chil<br>No. of Recommens and Commens and Canada and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>AN AND A CR IN LE AND LEVEL FOR CONSULTION FOR LEARNER LE CONSULE<br>----------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>---------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | I a proposant I a picture and any and the manager<br>IN LEARNELIES MIT | Company of Children Comments of Children<br>Standard States and<br>Commend of a c the Children assessment consisted as any and the different of the commend and the different of the commend and the different of the commend and the different o |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | A LEA BE COLORIES | We was and the commend of the commend of the commend of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of th<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>LELE FREE LE SELECTRANCIAL LULL FRIEN (SELECTRICAL LULL LIGHTS COLLECTION CONSULTER<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-----------------------------------<br>1 | on the most of the state of the first and the first and the contributed to the country of<br>Company of Concession in a consideration of the contribution of the comments of the comments of the comments of the comments of the comments of the comments of the comments o<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CONSULT CONSULT CONSULTER CONSULTERS OF THE LES CLOUDS OF<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Annual described for a former of the commend to the commend to the commend to the commend to the commend to the commend to the commend to the commend to the commend to the co<br>Market on the cases of the called to the called to the children the<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>---------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>I I I I l t t l t t t t a see a separate and second and second and the second of the second of the second of the second of the second of the second the second the second the<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br> |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-----------------------------------------------------------------------------------------------------------------------<br>Comments of Concession of Concession of Concession of Children of Children of Children of Children of Children of Children of Children of Children of Children of Children of<br>Children annual considered the re a more considered as a manufacture as a manufacturer and considered as a commend | I SURNER IN ------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Canada Call Annual Property of<br>Commens of the consisted in the consideration of the first<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>---------------------------------------------------------------------------------------------------------------<br>Commenss of the Resident of the Children of Children of Children of Children of Children of Children of Children of Children of Children of Children of Children of Children o<br>Status of Canadian Company of<br>1<br>Complete of the first and consistence of consumers of the first the programments of the first | - House of the program and the management on and the comments of the first for the first and the first and the first and the first and<br>Commend on the country of can and control of cannot of can | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------<br>-------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | BBC C C EXE EXPLOSE<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

r = correlation coefficient

{6}------------------------------------------------

## B. Precision Data

r recision Data
To determine precision of the Cl' and BUN sensors of the IRMA system, samples at a given level ro determine problem of the samples used in the study consisted of three levels of aqueous were testion reportionly. The our problement of the control materials. Each day of testing, each solutions similar to commercially a familians from each of the three levels. Data from this study are shown in Tables #5-6.

| Day | Operator | n | Level | Mean | SD | CV |
|-------|----------|----|-------|------|------|-----|
| Day 1 | 1 | 5 | 1 | 30.6 | 0.76 | 2.5 |
| | 2 | 5 | 1 | 30.2 | 0.27 | 0.9 |
| | 3 | 5 | 1 | 30.8 | 0.94 | 3.0 |
| | Combined | 15 | 1 | 30.5 | 0.72 | 2.4 |
| Day 2 | 1 | 5 | 1 | 30.5 | 0.94 | 3.1 |
| | 2 | 5 | 1 | 30.2 | 0.63 | 2.1 |
| | 3 | 4 | 1 | 30.5 | 0.17 | 0.6 |
| | Combined | 14 | 1 | 30.4 | 0.65 | 2.1 |
| Day 1 | 1 | 5 | 2 | 56.6 | 0.22 | 0.4 |
| | 2 | 5 | 2 | 57.1 | 0.28 | 0.5 |
| | 3 | 5 | 2 | 57.0 | 0.43 | 0.8 |
| | Combined | 15 | 2 | 56.9 | 0.36 | 0.6 |
| Day 2 | 1 | 5 | 2 | 57.0 | 0.30 | 0.5 |
| | 2 | 5 | 2 | 57.1 | 0.15 | 0.3 |
| | 3 | 5 | 2 | 57.1 | 0.30 | 0.5 |
| | Combined | 15 | 2 | 57.1 | 0.24 | 0.4 |
| Day 1 | 1 | 5 | 3 | 85.9 | 1.78 | 2.1 |
| | 2 | 5 | 3 | 87.1 | 0.61 | 0.7 |
| | 3 | 4 | 3 | 87.0 | 0.42 | 0.5 |
| | Combined | 14 | 3 | 86.6 | 1.20 | 1.4 |
| Day 2 | 1 | 4 | 3 | 86.0 | 1.59 | 1.9 |
| | 2 | 5 | 3 | 86.2 | 1.45 | 1.7 |
| | 3 | 5 | 3 | 85.2 | 1.90 | 2.2 |
| | Combined | 14 | 3 | 85.8 | 1.60 | 1.9 |

Table #5 Cl Aqueous Precision

Combined = Results from all users combined for a day of testing.

{7}------------------------------------------------

| Table #6 BUN Aqueous Precision | | | |
|--------------------------------|--|--|--|
|--------------------------------|--|--|--|

| Day | Operator | n | Level | Mean | SD | CV |
|-------|----------|----|-------|------|------|------|
| Day 1 | 1 | 5 | 1 | 17.5 | 2.40 | 13.7 |
| | 2 | 5 | 1 | 18.0 | 1.72 | 9.6 |
| | 3 | 5 | 1 | 17.4 | 1.36 | 7.8 |
| | Combined | 15 | 1 | 17.6 | 1.76 | 10.0 |
| Day 2 | 1 | 5 | 1 | 17.7 | 0.96 | 5.4 |
| | 2 | 5 | 1 | 16.3 | 1.43 | 8.8 |
| | 3 | 5 | 1 | 17.3 | 1.06 | 6.1 |
| | Combined | 15 | 1 | 17.1 | 1.25 | 7.3 |
| Day 1 | 1 | 5 | 2 | 33.8 | 1.40 | 4.1 |
| | 2 | 5 | 2 | 34.8 | 2.98 | 8.6 |
| | 3 | 5 | 2 | 34.2 | 3.93 | 11.5 |
| | Combined | 15 | 2 | 34.3 | 2.77 | 8.1 |
| Day 2 | 1 | 5 | 2 | 33.3 | 2.19 | 6.6 |
| | 2 | 5 | 2 | 33.7 | 1.29 | 3.8 |
| | 3 | 5 | 2 | 34.5 | 2.84 | 8.2 |
| | Combined | 15 | 2 | 33.8 | 2.09 | 6.2 |
| Day 1 | 1 | 5 | 3 | 64.1 | 4.56 | 7.1 |
| | 2 | 4 | 3 | 64.8 | 1.81 | 2.8 |
| | 3 | 5 | 3 | 65.4 | 4.81 | 7.4 |
| | Combined | 14 | 3 | 64.7 | 3.82 | 5.9 |
| Day 2 | 1 | 5 | 3 | 68.7 | 1.46 | 2.1 |
| | 2 | 5 | 3 | 67.4 | 3.79 | 5.6 |
| | 3 | 5 | 3 | 67.6 | 2.55 | 3.8 |
| | Combined | 15 | 3 | 67.9 | 2.63 | 3.9 |

Combined = Results from all users combined for a day of testing.

{8}------------------------------------------------

- D. Display range
Graphs #1-2 show the tested linear range of the product. This data along with the blood accuracy data which were shown earlier justify the display ranges shown in Table #8.

| Table #8 IRMA Blood Analysis System Display Range<br>and and the commend of the commend of the many and any and any and the many of the may |
|---------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------------------------------------------------|

| THE RESEARCE A RESEARCE LA CONSULT LA CONSULTION COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION COL<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>The program and a superior of the program and any and the provinced and the commend of the comments of the contribution of the contribution of the contribution of the contrib<br><br>------------------------------------------------------------------------------------------------<br><br>A CONTRACTOR COLLECTION COLLEGION OF CHILIP OF CLEASE OF CHEARTH OF CHEARTH OF CHEARTH AND THE CHARGE OF CHEARTH AND THE CHARGE OF CHEARTH AND THE CHARGE OF CHEARTH AND THE C<br>N.J. BREAK REVENUES & A Company of the Children Comments<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>I<br>------------<br>-------- | The first and the first of the control of the control of the control of the commend of the commend of the many of the many of the may be any and the many of the many of the m<br><br><br>----------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and a first program court procession in of experience in an any and<br><br>Collection of the later the station of the control of the promote of the program and interesting of any a<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-----------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----- |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| -----------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>. I . I . LE LEASINGLE AREA A MILIE . IN MINISTER LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAS<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------<br>-<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Comment of Children and Children and Children and Children and Children<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>of the may be and the world of the times and in the bigger will be the first and<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----<br> | <br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-<br>been and and the complex would with a provinced and a film the film the<br>LA & LEALERS COLLEGE COLLECTION COLLECTION COLLECTION COLLECTION COLLEGION<br>A<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CONNECT & CAR COLLECTION CONSULTION COLLECTION COLLECTION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CONTRACT COLLEGION CO<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>---------------------------------------------------<br>Acres of the are a comments<br><br><br>100 100 |
| -<br>--------<br>1<br>Annual Property of<br>11 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>-----------------------------------<br>-----<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>LENGINEER I BARRENER A LA BERTAIN AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------<br>--------------------------------------<br>Company of the contract and the many of promote of procession for program and the management of the | Company of the program and consideration and<br>I I a loss possibles i concession i consistent consistent in consistent in controlled in the contribution in the contribution in the contribution in<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br><br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>CA READING . I<br>L BREAK ----------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |

Graph #1

Image /page/8/Figure/5 description: The image is a graph titled "Mean(IRMA Cl- mM) By Mean(Cl- conc (mM))". The graph shows a linear relationship between the mean concentration of chloride (Cl-) and the mean IRMA Cl- mM. The x-axis represents the Mean(Cl- conc (mM)) and ranges from 0 to 200, while the y-axis represents the Mean(IRMA Cl- mM) and ranges from 0 to 200. A linear fit line is plotted on the graph, showing a positive correlation between the two variables.

IRMA CI- Linear Range

IRMA Cl = 0.9262 Cl- conc (mM) -22.43 n = 99 samples - with mean of each level shown r = 0.9976 Sy.x =4.0 Range evaluated = 10.6 - 146.8 mM

{9}------------------------------------------------

Graph #2

Image /page/9/Figure/1 description: The image is a graph titled "Mean IRMA BUN (mg/dL) By Mean BUN conc (mg/dL)". The graph shows a linear relationship between Mean IRMA BUN and Mean BUN concentration. The x-axis represents Mean BUN concentration in mg/dL, ranging from 0 to 150, while the y-axis represents Mean IRMA BUN in mg/dL, also ranging from 0 to 150. A line of best fit, labeled as "Linear Fit", is plotted on the graph.

## I RMA BUN Linear Range

IRMA BUN= 1.0831 BUN conc (mg/ dL) + 3.7837 N = 97 samples - with mean of each level shown r = 0.9996 Sv.x = 1.5 Range evalutated = 7.3 - 124.5 mg/ dL

#### 11. Safety and Effectiveness

The addition of the CI- and BUN sensors to the IRMA Blood Analysis System has not been found to interfere or cause any adverse effects with the operation of the IRMA instrument or other nearby equipment. There are no additional risks to the patient or user when cartridges containing these sensors are utilized with the IRMA system.

The IRMA Blood Analysis System has already been certified to the required electrical and EMI safety specifications of medical equipment such as UL 2601-1 and UL 2601-2 (or equivalent).

{10}------------------------------------------------

#### 11. Software Information

The IRMA Blood Analysis System's software has been developed, tested and will be validated in accordance with Diametrics' software development procedures and where applicable, the FDA's Reviewer's Guide to Computer Controlled Medical Devices (August, 1991). Based on the criteria of this document, our product is perceived to be of a low level of concern. Below is a description of the software development process.

Software requirements are developed based on approved product design requirements. All design specifications are reviewed for consistency and accuracy with respect to one another and a software hazard analysis is performed. The software hazard analysis for this product is located in Table #9. The software code is developed from the approved software requirements. Software revisions are maintained under a software version control system.

Software test plans and procedures are developed based on the software requirements specifications. Related software requirements are grouped to form the basis of test procedures. Each functional requirement (or group of requirements) is translated into a functional test and is included in a test procedure. These procedures are designed to ensure that functional requirements are met, software related system specifications fulfilled and software safety features adequately tested.

Code inspections and walk-throughs are performed by software engineers not involved in the code development in order to detect design flaws and validate software logic where functional testing is insufficient.

Written test procedures are executed and the results are reviewed to ensure that acceptance criteria have been met.

Software testing is also conducted in a less structured environment (free-form testing) by technicians and users under a variety of conditions in an attempt to "break" the software,

Considerable attention is applied to system safety throughout the verification. validation and testing of the software. A system hazard analysis which is done in the early development phase of the product is reviewed and updated as required. Safety requirements are identified in the hazard analysis and incorporated into the design specifications and tests via functional procedures. Potential error and exception conditions are also identified and tested. Stress conditions are also tested during the verification and validation phase.

All events identified as potential hazards for the IRMA Blood Analysis System have been addressed through hardware, software, or product labeling.

Changes to software requirements are documented, reviewed and approved. Each revision of the software is reviewed and evaluated for complete functionality and impact to the hazard analysis. New revisions are subjected to the same tests as the previous version. Revisions to areas that do not affect calculations may be regression tested. Each version of the software released to manufacturing will be archived with a list of the changes and validation data.

{11}------------------------------------------------

Table #9 Software Hazard Analysis

ﺍ ﺗﻮﺻﻌﻬﺎ ﻭﺍﻟﺘﻲ ﺗﻪ ﺍﻟ

| Potential Hazard:<br>Inaccurate Algorithms | Action to Minimize<br>Hazard | Add'I<br>Information | Likelihood | Severity |
|--------------------------------------------|-------------------------------------------------|----------------------|------------|----------|
| Calibration | Test & Validation<br>plans<br>Development Phase | QC check | Improbable | Marginal |
| Sample Calculations | Test & Validation<br>plans<br>Development Phase | QC check | Improbable | Marginal |
| System operation | Test & Validation<br>plans<br>Development Phase | QC check | Improbable | Marginal |
| Incorrect IR reading | Test & Validation<br>plans<br>Development Phase | QC check | Improbable | Marginal |
| Temperature &<br>Barometric checks | Test & Validation<br>plans<br>Development Phase | QC check | Improbable | Marginal |

Table #10 Categories

| Table #10 Categories | |
|----------------------|--------------|
| Likelihood | Severity |
| Frequent | Negligible |
| Probable | Marginal |
| Occasional | Critical |
| Remote | Catastrophic |
| Improbable | |
| Incredible | |

{12}------------------------------------------------

## Software Certification

I certify that, in my capacity as Director of Quality Assurance and Regulatory Affairs of Diametrics Medical, Inc., prior to market release of the product, the software development process will be completed. The final documentation will include official signoff of the software requirements specifications, test plans and test completion criteria, and their results which demonstrate the system specifications and functional requirements were met along with release of the software revision.

We have shown substantial equivalence between the IRMA Blood Analysis System utilizing the multi-use cartridge and the predicate devices even though the software development process has not yet been completed.

Name of Company Official Correspondent: Steve Boeh

Signature:

e: Steve Burch

Title: Director of QA/RA

Company Name: Diametrics Medical Inc.

Date of Signature: Month/Day/Year

{13}------------------------------------------------

## 13. Attachments

The proposed labeling appears in Appendix B (Pouch and Cartridge Labels), Appendix C (Cartridge Package Insert) and Appendix D (User Manual). There are no required changes to the IRMA Blood Analysis System's device label. The draft user manual which is shown contains the information which is pertinent to the addition of the new CI and BUN sensors. Any screen changes associated with these new sensors will also be made to the pictures in the user manual. This information will either be incorporated into the current IRMA SL Series 2000 User Manual or it will become an addendum to it. Diametrics Medical, Inc. does not intend to advertise the product at this time.

{14}------------------------------------------------

Image /page/14/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three stylized human profiles incorporated into its design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 1998 MAY

Steve Boeh . Director, Quality Assurance and Regulatory Affairs Diametrics Medical, Inc. 2658 Patton Road Saint Paul, Minneapolis 55113 Minnesota K981270 Re :

IRMA® Blood Analysis System Regulatory Class: II Product Code: CGZ, CDS, GKG, JFP, JGS, CHL, CEM Dated: April 2, 1998 Received: April 7, 1998

Dear Mr. Boeh:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions…