IVD-GE02
Device Facts
| Record ID | K101947 |
|---|---|
| Device Name | IVD-GE02 |
| Applicant | Sphere Medical , Ltd. |
| Product Code | CGA · Clinical Chemistry |
| Decision Date | Mar 16, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurements of pH, pCO₂, pO₂, potassium, and glucose. Measurements of blood gases (pCO₂, pO₂) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances. Measurement of potassium is used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by high or low potassium levels. Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO₂, pO₂, potassium and glucose.
Device Story
Modular blood gas analyzer; processes whole blood samples via disposable cartridge containing multi-analyte sensor array. System includes instrument with fluid management (pumps, valves), PC/touchscreen monitor, and printer. Sensors utilize electrochemical (potentiometric/amperometric) principles to generate electrical signals proportional to analyte concentration. ASIC on cartridge processes signals. Operator manually injects samples and calibration/QC solutions via injection port. Output displayed on monitor; used by clinicians to monitor acid-base status, electrolytes, and glucose levels. Benefits include rapid diagnostic information for life-threatening conditions.
Clinical Evidence
Bench testing only. Precision studies (CLSI EP5-A2) performed with control materials and heparinized whole blood. Linearity (CLSI EP6-A) confirmed across specified ranges. Interference testing (CLSI EP7-A2) identified specific substances (e.g., acetyl salicylic acid, halothane, sodium pentothal) affecting measurements. Method comparison (CLSI EP9-A2) against predicate using 98-111 patient samples showed high correlation (R² 0.95-0.99).
Technological Characteristics
Multi-analyte sensor chip with array of individual sensors. Transducer technologies: potentiometric (ISFET) and amperometric. Components: dedicated PC/monitor, disposable cartridge with ASIC, fluid management system (pumps, valves). Connectivity: cables between monitor and instrument. Calibration: aqueous solutions. Analyte range: pH, pCO2, pO2, K+, glucose.
Indications for Use
Indicated for quantitative measurement of whole blood samples in clinical laboratories to diagnose/treat acid-base disturbances, monitor electrolyte balance, and manage carbohydrate metabolism disorders (e.g., diabetes, hypoglycemia, pancreatic islet cell carcinoma).
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
- Siemens Rapidlab 865 analyzer (k934907)
Related Devices
- K160412 — GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) · Instrumentation Laboratory CO · Dec 14, 2016
- K151978 — EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control · Edan Instruments, Inc. · Jul 15, 2016
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the word "SPHERE" in large, bold letters. Below the word "SPHERE" is the phrase "RAISING THE STANDARD OF CRITICAL CARE" in smaller letters. The letter "H" in "SPHERE" is stylized to look like a cross.
# IVD-GE02 510(k) Submission
Image /page/0/Picture/2 description: The image shows the text "K101947" in a handwritten style at the top. Below this, the word "Reference" is printed in a simple font. Underneath "Reference", the text "REP059" is printed, also in a simple font.
# 510(k) SUMMARY
MAR 1 6 20i1
As requested by 21 CFR 807.92, the following 510(k) summary is provided:
## SUBMITTER'S INFORMATION
Submitter's Name and Address:
Sphere Medical Ltd. Harston Mill Harston Cambridge UK CB22 7GG
Tel: +44 1223 875222
Contact Person:
Mary Hutchens Regulatory Affairs Manager
Device Information
Proprietary Name: IVD-GE02
Common Name:
Classification:
| NAME | CLASS | REGULATION<br>NUMBER | PANEL | PRODUCT<br>CODE |
|------------------------------------------------------------------------|-------|----------------------|-----------------------|-----------------|
| Electrode, Measurement of<br>Blood Gasses (pO2, pCO2 )<br>and Blood pH | II | 862.1120 | Clinical<br>Chemistry | CHL |
| Electrode, Ion Specific<br>Potassium | II | 862.1600 | Clinical<br>Chemistry | CEM |
| Glucose oxidase, Glucose | II | 862.1345 | Clinical<br>Chemistry | CGA |
| Calibrators | II | 862.1150 | Clinical<br>Chemistry | JIX |
Blood Analyser
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### PREDICATE DEVICE INFORMATION
| NAME | Rapidlab 865 |
|---------------|-----------------------------------|
| MANUFACTURER | Siemens Healthcare<br>Diagnostics |
| 510(k) NUMBER | K934907 |
#### DESCRIPTION OF DEVICE
The IVD-GE02 system is an in-vitro diagnostic device for the determination of specified analytes in blood using electrochemical principles. The IVD-GE02 is essentially a modular system consists of the following components .-
- A dedicated combined PC and monitor with a touch screen .
- · A disposable cartridge containing
- o Sensor
- o Electronic circuitry, including an ASIC (Application Specific Integrated Circuit), to process sensor signals and drive the fluid management system.
- ◆ An instrument containing
- o Fluid management components (tubing, pumps and valves)
- o The cartridge (see above)
- o An injection port for samples, calibration solutions and QC solutions
- o Wiring to connect the cartridge to the fluid management components
- Syringes with calibration solutions packed in sealed foil bags .
- Containers with flush solutions ◆ ◆
- A waste container �
- A dedicated printer and associated cables �
- An ambient temperature and pressure sensor �
- Cables to connect the monitor to the instrument and a power supply unit �
- Packaging � �
.
- Label Copy �
#### INTENDED USE OF THE DEVICE
Indications for Use:
The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of pH, pCO2, pQ2, potassium and glucose.
pH, pCO2, pO2 Measurement of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
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Potassium. Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels.
Glucose. Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathetic hypoglycaemia and of pancreatic islet cell carcinoma.
IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, pO2, potassium and glucose.
| CHARACTERISTIC | IVD-GE02 | RAPIDLAB 865<br>K934907 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use by trained<br>healthcare professionals in<br>a clinical laboratory | For use by trained healthcare<br>professionals in a clinical<br>laboratory |
| Measured<br>Parameters | pH, pCO2, pO2, K+, Glucose | pH, pCO2, pO2, Na+, K+, Ca++,<br>Glucose, Lactate, Cl-, tHb,<br>FHHb, FO₂Hb, FMetHb, FCOHb |
| Sample Type | Whole blood | Whole blood |
| Sensor Array | Multi-analyte chip | Individual sensors |
| Test principle | Electrochemical<br>(potentiometric,<br>amperometric) | Electrochemical (potentiometric,<br>amperometric), biochemical,<br>optical |
| Individual test<br>sensor type | | |
| pH | Potentiometric ISFET | Potentiometric<br>ISE |
| pCO2 | Potentiometric<br>ISFET | Potentiometric<br>ISE |
| pO2 | Amperometric | Amperometric |
| K+ | Potentiometric<br>ISFET | Potentiometric<br>ISE |
| Glucose | Amperometric | Amperometric |
| Calibrators | Aqueous solutions<br>Two level target calibration<br>Contains sodium,<br>potassium, calcium,<br>surfactant, buffer<br>(phosphate), glucose and<br>dissolved, O2, CO2.. | Aqueous solutions<br>Two level target calibration<br>Contains sodium, potassium,<br>chloride, surfactant, buffer,<br>glucose. O2, CO2 gas. |
| | Stored at 15°C - 25°C | Stored at 4°C - 25°C |
SIMILARITIES AND DIFFERENCES TO PREDICATE DEVICES
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## Technological Characteristics
The IVD-GE02 system is contained on a single multi-analyte sensor chip that has an arrav of individual sensors, each of which measures a different analyte. The sensors produce electrical signals in response to the analytes in the blood. The signal from each sensor is proportional to the concentration of analyte.
The individual sensors use one of two transducer technologies: potentiometric (a field effect transistor structure to measure the potential generated), and amperometric (measuring the current generated).
Many of the transducers on the sensor chip require a covering membrane so that thev can respond to a specific analyte. The membranes used by Sphere on the IVD- GE02 sensor array are based on those already used in other commercially available blood analysers.
#### Performance Data Summary
#### Linearity
The study design was based on CSLI document EP6-A "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach: Approved Guideline"
The study used human whole blood as the test material and was conducted for the analytes pH. pCO2. pO2. K+. and glucose.
7 levels of each analyte were read in duplicate on each of three IVD-GE02 systems and the predicate device (Rapidlab 865 blood gas analyser).
| Analyte | Test Range | Units | R2 |
|---------|--------------|-------|-------|
| pH | 6.8 – 7.8 | N/A | >0.99 |
| pO2 | 28 - 498 | mmHg | >0.99 |
| pCO2 | 21.8 - 101.9 | mmHg | >0.99 |
| K+ | 2.1 - 9.7 | mM | >0.99 |
| Glucose | 10.8 - 445.3 | m/dL | >0.99 |
#### Aqueous Precision
#### Method
The study design is based on CLSI document EP5-A2. Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline-Second Edition. On each day the outlier test was applied to the duplicate readings, as described in EP5-A2. Data was analysed as specified in CLSI quideline EP5-A2.
The mean, the repeatability (within run precision), the between-day standard deviation, the between-run standard deviation and the total precision were calculated from the raw data with all calculations beinq performed as recommended in CLSI quideline EP5-A2.
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The precision data collected for the IVD-GE02 shows comparable performance to published precision data for other blood analysers within the reference range.
## Precision in Blood
#### Method.
The study was conducted for the analytes pH, pCO2, pO2, K*, and glucose and for each analyte, human blood samples were prepared at two different levels of analyte. Ten readings of the analyte level in human blood were taken at each analyte level. After each replicate of a blood sample was read on the IVD-GE02 system the same sample was read on the predicate device (Rapidlab 865 blood gas analyser).
Human whole blood was used for the "Precision Study in Blood". Blood was drawn into heparinised vacutainers by trained phlebotomists. All blood was used within 24 hours of donation.
### Results
#### Summary of pH precision in blood data
| | Blood 1 | Blood 2 |
|--------------------------------|-----------------------|-----------------------|
| | IVD-GE02<br>Monitor 2 | IVD-GE02<br>Monitor 4 |
| Mean (pH units) | 7.355 | 7.242 |
| Standard deviation | 0.018 | 0.014 |
| Coefficient of variation (%CV) | 0.242 | 0.200 |
#### Summary of K+ precision in blood data
| | Blood 1 | Blood 2 |
|--------------------------------|-----------------------|-----------------------|
| | IVD-GE02<br>Monitor 2 | IVD-GE02<br>Monitor 5 |
| Mean (mM K+) | 4.10 | 6.65 |
| Standard deviation | 0.08 | 0.21 |
| Coefficient of variation (%CV) | 1.99 | 3.17 |
#### Summary of oxygen precision in blood data
| 100 Blood 1 Blood 1 8 Stock 1 1 Blood 1 2 Blood 1 2 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> | | |
| | | |
| tandard deviation | | |
| Coefficient of variation | | |
#### Summary of glucose precision in blood data (mM)
| | Blood 1 | Blood 2 |
|--------------------------------|-----------------------|-----------------------|
| | IVD-GE02<br>Monitor 2 | IVD-GE02<br>Monitor 5 |
| Mean (mM glucose) | 4.9 | 11.9 |
| Standard deviation | 0.19 | 0.26 |
| Coefficient of variation (%CV) | 3.9 | 2.2 |
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Summary of glucose precision in blood data (mg/dL)
| | Blood 1<br>IVD-GE02<br>Monitor 2 | Blood 2<br>IVD-GE02<br>Monitor 5 |
|--------------------------------|----------------------------------|----------------------------------|
| Mean (mM glucose) | 88.4 | 215.0 |
| Standard deviation | 3.44 | 4.75 |
| Coefficient of variation (%CV) | 3.9 | 2.2 |
#### Summary of CO2 precision in blood data.
| | Blood 1 | Blood 2 |
|--------------------------------|-----------|-----------|
| | IVD-GE02 | IVD-GE02 |
| | Monitor 4 | Monitor 7 |
| Mean (mmHg CO2) | 39.3 | 68.3 |
| Standard deviation | 2.60 | 1.66 |
| Coefficient of variation (%CV) | 6.61 | 2.42 |
#### METHOD COMPARISON
The Method Comparison study compared the IVD-GE02 with the Rapidlab 865 predicate device. The study was conducted in a clinical setting with human blood samples. Data from the linearity study was also included to extend the analyte range used.
#### Method
The objective of the study was to compare the IVD-GE02 system and the Rapidlab 865 blood gas analyser for measurements on human blood of pH, potassium, oxygen, glucose and carbon dioxide.
The study design is based on the CSLI guideline EP9A-2 and a review of similar 510(k) submissions.
#### Summary Results Table
| Analyte | N | Slope<br>(calculated<br>by Deming<br>regression) | Intercept<br>(calculated by<br>Deming<br>regression) | R2 (calculated<br>using least<br>squares linear<br>regression) | Sample range<br>tested |
|--------------------|-----|--------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------|------------------------|
| pH (pH units) | 104 | 1.04 | -0.26 | 0.9954 | 6.815-7.797 |
| pCO2 (mmHg) | 102 | 1.03 | -1.00 | 0.9501 | 20.8-100 |
| pO2 (mmHg) | 105 | 0.97 | 3.66 | 0.9917 | 38.7-496.9 |
| K+ (mmol/L) | 111 | 1.00 | 0.29 | 0.9523 | 2.5-8.9 |
| Glucose<br>(mg/dL) | 98 | 0.96 | 8.69 | 0.9559 | 48.6-397.8 |
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### Interferent Study
The study design is based on CLSI document EP7-A2: Interference Testing in Clinical Chemistry; Approved Guideline Second Edition and was designed to ascertain the effect of potential interfering substances of the performance of the IVD-GE02
| Analyte | Interferent | Concentration of<br>Interferent Tested |
|-----------------------|-----------------------|----------------------------------------|
| pH | Acetyl salicylic acid | 2170μΜ |
| pO2 (levels < 22mmHg) | Halothane | >253 μΜ |
| pCO2 | Sodium pentothal | 20.6 μΜ |
| Potassium | Sodium pentothal | >248 μΜ |
| Glucose | Acetaminophen | 662 μΜ |
| | O2 | ≤ 30mmHg |
| | Triglyceride | >15mM |
## Compounds showing an interferent effect on IVD-GE02 readings
## Conclusions
7
For all analytes the observed precision, linearity and method comparison of the IVD-GE02 system is substantially equivalent to that seen for the predicate device (Rapidlab 865).
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
**MAR 1 6 2011**
Sphere Medical Ltd. c/o Ms. Mary Hutchens Regulatory Affairs Manager Harston Mill. Harston Cambridge, CB22 7GG, United Kingdom
> k101947 Trade Name: IVD-GE02 Regulation Number: 21 CFR §862.1120 Regulation Name: Blood Gases (pCO2, pO2) and Blood pH Test System. Regulatory Class: Class II Product Codes: CHL, CEM, CGA, JIX Dated: February 4, 2011 Received: February 7, 2011
Dear Ms. Hutchens:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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# Indications for Use Form
510(k) Number (if known): __K101947___________________________________________________________________________________________________________________________________________
Device Name: _______IVD-GE02 _________________________________________________________________________________________________________________________________________________
Indications for Use:
The IVD-GE02 system is a blood gases analyzer intended as an in vitro diagnostic device for the quantitative measurement of whole blood samples in a clinical laboratory. The IVD-GE02 system includes sensors for the measurement of pH, pCO2, pO2, potassium and glucose.
pH, pCO2, pO2: Measurement of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Potassium: Measurement of potassium are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by high or low potassium levels.
Glucose: Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathetic hypoglycaemia and of pancreatic islet cell carcinoma.
IVD-GE02 calibration solutions are in vitro diagnostic products for the calibration of the IVD-GE02 test system for the measurements of pH, pCO2, pO2, potassium and glucose.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Co
(21 CFR 801
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101947
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