COMINED STANDARD SOLUTION

K130100 · Mesa Laboratories, Inc. · FKH · Apr 18, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130100
• Device Name: COMINED STANDARD SOLUTION
• Applicant: Mesa Laboratories, Inc.
• Product Code: FKH · Gastroenterology, Urology
• Decision Date: Apr 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient.

Device Story

Device is a secondary standard solution consisting of Sodium Chloride, Sodium Phosphate Dibasic, and Potassium Phosphate Monobasic in de-ionized water. Packaged in sealed HDPE bottles. Used by technicians or clinicians in clinical settings to calibrate or verify conductivity/TDS cells and pH measurement instruments associated with hemodialysis machines and water purification systems. Solution is used remotely from the equipment; no patient contact. Provides a stable reference (pH 7.0 ± 0.03; conductivity 14.00 mS/cm ± 0.03 mS/cm) to ensure accuracy of dialysis equipment measurement functions. Benefits patient by ensuring hemodialysis equipment operates within specified parameters.

Clinical Evidence

Bench testing only. Validations performed using N.I.S.T. Standard Reference Materials. Testing included manufacturing process validation, open-bottle stability (30 days), storage stability (18 months), and instrument independence. Results confirm the device maintains pH and conductivity specifications and performs consistently across different measurement instruments.

Technological Characteristics

Chemical solution: Sodium Chloride, Sodium Phosphate Dibasic, Potassium Phosphate Monobasic in de-ionized water. Conductivity: 14.00 mS/cm ± 0.03 mS/cm. pH: 7.0 ± 0.03. Packaging: HDPE bottles. Shelf life: 18 months sealed, 30 days opened/recapped. No preservatives. Non-electronic, non-software.

Indications for Use

Indicated for calibration and verification of conductivity/TDS cells and pH measurement instruments used in hemodialysis machines and water purification equipment. Not for patient contact.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Conductivity/TDS Calibrator Solution (K033330)

Submission Summary (Full Text)

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K130100 page 1 of 4

# MesaLabs

# 510(k) Summary

## APR 1 8 2013

سر

| Owner: | Mesa Laboratories, Inc.<br>12100 West 6 ^th Avenue<br>Lakewood, CO 80228<br>Phone: [phone] FAX: [phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Louie, Quality Manager |
| Date: | January 28, 2013 |
| Device Name: | Conductivity/pH Calibrator Solution |
| Common Name: | Combined Standard Solution |
| Device Classification: | Classification: II<br>Classification Panels: Gastroenterology<br>Regulation Number: 21 CFR § 876.5820,<br>Solution - Test Standard - Conductivity, Dialysis<br>Product Code FKH |
| Predicate Device(s): | Conductivity/TDS Calibrator Solution<br>Mesa Laboratories Inc<br>510(k) Number K033330<br>Cleared February 27, 2004 |
| Device Description: | The device consists of salts (Sodium Chloride, Sodium<br>Phosphate Dibasic, and Potassium Phosphate<br>Monobasic) dissolved in de-ionized water. The<br>proportion of total salt determines the solution's<br>conductivity. The proportions of Sodium Phosphate<br>Dibasic and Potassium Phosphate Monobasic<br>determine the solution's pH. The solution is packaged<br>into sealed polyethylene bottles.<br><br>The performance specifications of the device are a pH<br>value of pH 7.0 ± 0.03 pH units and a conductivity value<br>of 14.00 mS/cm ± 0.03 mS/cm. The solution should<br>maintain these values for 18 months stored in a sealed<br>bottle. The solution should also maintain these values |

Mesa Laboratories Inc - 510(k) submission for Combined Standard Solution Section 6 - 510(k) Summary (updated)

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for 30 days within an opened but recapped bottle. There will be two bottle sizes of this solution, a 32-oz bottle and a 16-oz bottle.

The solution is composed of the following:

| Component | CAS<br>Registry<br>Number | Suppliers |
|-------------------------------------|---------------------------|-----------------------------------------------------------------|
| Sodium Chloride | 7647-14-5 | Rocky Mountain Reagents<br>VWR Scientific |
| Sodium Phosphate<br>Dibasic | 7558-79-4 | Rocky Mountain Reagents<br>Sigma-Aldrich Inc.<br>VWR Scientific |
| Potassium<br>Phosphate<br>Monobasic | 7778-77-0 | Rocky Mountain Reagents<br>VWR Scientific |
| De-ionized Water | 7732-18-5 | In-House using<br>Water De-ionizer |

No components of the device come in contact with the patient.

Indications Conductivity/pH Calibrator Solutions are a secondary for Use: standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient. legion Charact

| Technological | The technological Characteristics are summarized in |
|------------------|-----------------------------------------------------|
| | the |
| Characteristics: | table below. |

Mesa Laboratories Inc – 510(k) submission for Combined Standard Solution Section 6 - 510(k) Summary (updated)

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## K130100

| Technological<br>Specification | Mesa Laboratories, Inc. Predicate Device<br>2004 510(k) K033330 | Mesa Laboratories, Inc.<br>New Device 2013 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conductivity<br>Value | 100.0 millisiemen<br>14.0 millisiemen<br>13.4 millisiemen<br>150 microsiemen<br>1.0 microsiemen | 14.0 millisiemen |
| pH Value | Not Specified*<br>*Measured values ranged 5.1 pH to 7.0 pH | 7.0 pH |
| Accuracy | 100.0 millisiemen ±0.2 millisiemen @ 25°C<br>14.0 millisiemen ±0.02 millisiemen @ 25°C<br>13.4 millisiemen ±0.02 millisiemen @ 25°C<br>150 microsiemen ±2 microsiemen @ 25°C<br>1.0 microsiemen ±2 microsiemen @ 25°C | ±0.03 millisiemen @ 25°C<br>±0.03 pH @ 25°C |
| Salt<br>Composition<br>(amount) | 70. 0g/l NaCl<br>7.799g/l NaCl<br>7.443g/l NaCl<br>48.90mg/l NaCl<br>0.4915g/l NaCl | 4.08g/l NaCl<br>5.34 g/l Sodium Phosphate Dibasic<br>2.87 g/l Potassium Phosphate<br>Monobasic |
| Salt<br>Composition<br>(chemical) | NaCl (Sodium Chloride) | NaCl (Sodium Chloride)<br>Sodium Phosphate Dibasic<br>Potassium Phosphate Monobasic |
| Ingredients | Sodium Chloride (CAS # 7647-14-5)<br>Water (CAS # 7732-18-5) | Sodium Chloride (CAS # 7647-14-5)<br>Sodium Phosphate Dibasic (CAS #<br>7558-79-4)<br>Potassium Phosphate<br>Monobasic (CAS # 7778-77-0) Water<br>(CAS # 7732-18-5) |
| Appearance<br>Properties | Clear, Colorless Liquid<br>Specific Gravity: Approx. 1-1.04 | Clear, Colorless Liquid<br>Specific Gravity: Approx. 1-1.04 |
| Chemical<br>Properties | Odor: Odorless<br>Boiling Point: Approx 100.1°C<br>Melting Point: Approx -0.6-0°C<br>Vapor Pressure: < 25mmHG @ 25°C<br>Solubility in water" Infinite | Odor: Odorless<br>Boiling Point: Approx 100.1°C<br>Melting Point: Approx -0.6-0°C<br>Vapor Pressure: < 25mmHG @ 25°C<br>Solubility in water" Infinite |
| Bottle Material | HDPE | HDPE |
| | 18 months* | 18 months |
| Shelf Life | *Tests conducted on samples of<br>microsiemen solutions stored over 18<br>months old showed the solution remained<br>within specification. The original 510(k)<br>submitted had an expiration date of 12-<br>months on microsiemen solutions | Testing of sealed samples showed that<br>pH and conductivity values will remain<br>within the specification after 18 months.<br>Test results were extrapolated from data<br>taken between 13 and 41 weeks. |
| Shelf Life once<br>bottle is<br>opened | 30 days | 30 days |
| Preservative | None | None |

Mesa Laboratories Inc – 510(k) submission for Combined Standard Solution
Section 6 – 510(k) Summary (updated)

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## Nonclinical Performance:

Validation of the performance of the device was performed on production lots using N.I.S.T. SRM's (Standard Reference Materials) produced in accordance with instructions provided by N.I.S.T. and used as primary calibration standards. The following is a list of the validations performed:

PQ-RM017 pH and Conductivity Solution Manufacturing Process The purpose of this test was to validate that the device could be produced to specification using the manufacturing process.

PQ-RM018 pH and Conductivity Solution Open Bottle Stability The purpose of this test was to validate that the device would meet specifications after bottles are opened, exposed to air and then recapped several times. The test results demonstrate that the new device, like the predicate device, is within specification after 30 days of the bottle has been opened and then tightly recapped several times.

PQ-RM019 pH and Conductivity Solution Storage Stability The purpose of this test was to validate that the device values remain within specification for 18 months. The test results demonstrate that the new device, like the predicate device, is projected to be within specification for 18 months.

PQ-RM020 pH and Conductivity Solution Instrument Independence The purpose of this test was to validate that the device values are independent upon the type of measurement instrument. The test results demonstrate that the new device, like the predicate, conductivity measurements are independent upon the type of measurement instrument.

Conclusions Drawn from Demonstrating Safety and Effectiveness:

The results of the validations show that the conductivity of the new device when manufacturered, prior to the expiration date, and after the bottle is opened and recapped for 30 days are the same as the predicate values. The tests also showed that different meters will measure the same conductivity values for the new device as the predicate.

The Conductivity/pH Calibrator Solution is substantially equivalent to the legally marketed Conductivity/TDS Calibrator Solution (predicate device) for the intended use as a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS measurement instruments.

Mesa Laboratories Inc - 510(k) submission for Combined Standard Solution Section 6 - 510(k) Summary (updated)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## April 18. 2013

Mesa Laboratories, Inc. % Ms. Jamie Louie Quality Manager 12100 West 6th Avenue LAKEWOOD CO 80228

Re: K130100

> Trade/Device Name: Conductivity/pH Calibrator Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKH Dated: February 1, 2013 Received: February 20, 2013

Dear Ms. Louie:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 - Ms. Jamie Louie

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

K130100 510(k) Number (if known):

Conductivity/pH Calibrator Solution Device Name:

Indications For Use:

Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the hemodialysis machine or water purification equipment, and does not come into contact with the patient.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|

Benjamin R. Fisher:=5. J.J.
2013.04.18 11:51:41:41:404.00

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130100 510(k) Number _

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Mesa Laboratories Inc -510(k) submission for Combined Standard Solution Section 5 - Indications for Use

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