TDS Standard Solution

K191496 · Mesa Laboratories, Inc. · FKH · Aug 5, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K191496
• Device Name: TDS Standard Solution
• Applicant: Mesa Laboratories, Inc.
• Product Code: FKH · Gastroenterology, Urology
• Decision Date: Aug 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.

Device Story

TDS Standard Solution is a chemical calibration standard consisting of sodium bicarbonate, sodium sulfate, and sodium chloride in de-ionized water. Packaged in HDPE bottles. Used in hemodialysis clinics to verify and calibrate conductivity/TDS meters prior to their use in monitoring water purification systems. The user draws the solution into the meter or dips the sensor into the solution; if the meter reading deviates from the known value, the user performs a manual calibration. The device is used remotely from water purification equipment; no patient contact occurs. Benefits include ensuring accurate water quality monitoring for hemodialysis, which is critical for patient safety.

Clinical Evidence

Bench testing only. Validation protocols (VP-00020, VP-00021, VP-00022) confirmed accuracy of 15 ppm, 150 ppm, and 1500 ppm TDS solutions against reference conductivity meters. Shelf-life studies (VP-00030, VP-00073, VP-00074, VP-00075) confirmed stability for 18 months in sealed bottles and 60 days after opening. No clinical data.

Technological Characteristics

Solution of sodium bicarbonate, sodium sulfate, and sodium chloride in de-ionized water. Packaged in HDPE bottles. Conductivity values: 23.8, 229, and 2060 µS/cm. Shelf life: 18 months sealed, 60 days open. No energy source; non-electronic; no software.

Indications for Use

Indicated for verifying the accuracy (calibration) of TDS meters used to determine the conductivity of water in hemodialysis water purification systems. No patient population specified; device does not contact patients.

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)

Reference Devices

• Conductivity/TDS Calibrator Solution (K955298)

Submission Summary (Full Text)

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August 5, 2019

Mesa Laboratories, Inc. Jamie Louie Senior Manager - Quality 12100 West 6th Avenue Lakewood. CO 80228

Re: K191496

Trade/Device Name: TDS Standard Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKH Dated: June 5, 2019 Received: June 5, 2019

Dear Jamie 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Carolyn Y. Neuland, Ph.D. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastro-Renal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191496

Device Name TDS Standard Solution

#### Indications for Use (Describe)

This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <div style="display:inline-flex; align-items:center;"><span style="font-size:20px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-flex; align-items:center;"><span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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Image /page/3/Picture/1 description: The image contains the logo for MesaLabs. The logo consists of a teal square with a white trapezoid-like shape inside. Below the square is the text "MesaLabs" in a bold, sans-serif font. The text is black.

# 510(k) Summary K191496

| Owner: | Mesa Laboratories, Inc.<br>12100 West 6th Avenue<br>Lakewood, CO 80228<br>Phone: [phone] FAX: [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Louie, Director of Quality |
| Date: | July 11, 2019 |
| Device Name: | TDS Standard Solution |
| Trade Name: | TDS Standard Solution |
| Common Name: | Conductivity/TDS Calibrator Solution |
| Classification<br>Name: | Solution-Test Standard-Conductivity, Dialysis |
| Device<br>Classification: | Classification: II<br>Classification Panels: Gastroenterology/Urology<br>Regulation Number: 21 CFR § 876.5820,<br>Solution-Test Standard-Conductivity, Dialysis<br>Product Code 78 FKH |
| Predicate<br>Device(s): | Conductivity/TDS Calibrator Solution<br>Mesa Laboratories Inc<br>510(k) Number K033330<br>Cleared February 4, 2004 |
| Device<br>Description: | The device consists of salts (Sodium Chloride, Sodium<br>Bicarbonate and Sodium Sulfate) dissolved in de-ionized<br>water. The solution is packaged into sealed polyethylene<br>bottles. |
| Indications<br>for Use: | This TDS Standard Solution is indicated for verifying the<br>accuracy (calibration) of TDS (Total Dissolved Solids)<br>meters. This standard solution should be used<br>immediately before conductivity meters are used to<br>determine the conductivity of water obtained from water<br>purification systems used in hemodialysis. This solution is<br>prepared from a mixture of salts comprised of 40% Sodium<br>Bicarbonate, 40% Sodium Sulfate, and 20% Sodium<br>Chloride which is intended to mimic natural water systems. |

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These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.

- The population requiring disalysis requires that the solutions General Description of used in the dialysis machine and during the preparation of solutions used in the hemodialysis setting be verified for the Diseases or Conditions proper conductivity. The hemodialysis industry uses conductivity meters to verify the proper conductivity. The Device will treat: new device is used to verify and calibrate these meters at conductivities near the new values of the device.
- Operational Use: Prior to operating the conductivity meter, the user draws the Conductivity/TDS Calibrator Solution into the meter or dips the meter sensor into the solution to verify the meter is reading the value of the solution. If meter does not read the correct value (within the tolerances of the solution and the meter), the user will calibrate the meter to read the correct value.

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

The conductivity of the fluid is determined by the amount of Scientific Concepts that electrical current flow within the solution. The dissolved form the basis salts separate into positive and negative ions. The ions are of the Device: free to move and the movement resulting from a voltage difference will result in an electrical current.

Modifications to Predicate:

The following modifications were made from the predicate to the new device:

- 1. Additional Values
- 2. Use of two different salts
- 1. Additional Values

The new device has conductivity values of 23.8 µS/cm. 229 µS/cm and 2060 uS/cm are added to the original seven values of the predicate.

# 2. Use of two additional salts

The new device uses sodium bicarbonate and sodium sulfate in addition to the sodium chloride used in the predicate device.

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

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| Technological<br>Characteristic | Mesa Laboratories, Inc. Predicate<br>Device 2004 510(k) K033330 | Mesa Laboratories, Inc.<br>New Device 2019 510(k) K191496 |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Conductivity/TDS Calibrator Solutions<br>are a secondary standard solution used<br>for the calibration of conductivity/TDS<br>cells together with conductivity/TDS<br>measurement instruments. The<br>conductivity/TDS cells and instruments<br>may be indicated for calibrating the<br>conductivity measurement function of<br>hemodialysis machines and water<br>purification equipment for hemodialysis,<br>or for verifying proper function of<br>hemodialysis machine or water<br>purification equipment measurement<br>functions. These solutions are used<br>remotely from the hemodialysis machine<br>or water purification equipment, and doot come into contact with the patient. | This TDS Standard Solution is indicated<br>for verifying the accuracy (calibration) of<br>TDS (Total Dissolved Solids) meters.<br>This standard solution should be used<br>immediately before conductivity meters<br>are used to determine the conductivity<br>of water obtained from water purification<br>systems used in hemodialysis. This<br>solution is prepared from a mixture of<br>salts comprised of 40% Sodium<br>Bicarbonate, 40% Sodium Sulfate, and<br>20% Sodium Chloride which is intended<br>to mimic natural water systems. These<br>solutions are used remotely from the<br>water purification equipment, and do not<br>come into contact with the patient. |
| User<br>Instructions | See attached label | See attached label |
| 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℃<br>Melting Point: Approx. -0.6-0ºC<br>Vapor Pressure: <25mmHg @ 25°C<br>Solubility in water: Infinite | Odor: Odorless<br>Boiling Point: Approx. 100.1ºC<br>Melting Point: Approx. -0.6-0ºC<br>Vapor Pressure: <25mmHg @ 25°C<br>Solubility in water: Infinite |
| Conductivity<br>Values and<br>Specifications<br>at 25ºC | 150 ± 2 microsiemen/cm<br>1.0 ± 0.002 millisiemen/cm<br>3.9 ± 0.02 millisiemen/cm<br>12.5 ± 0.02 millisiemen/cm<br>13.4 ± 0.02 millisiemen/cm<br>14.0 ± 0.02 millisiemen/cm<br>100.0 ± 0.2 millisiemen/cm | 23.8 ± 0.2 microsiemen/cm<br>229 ± 2 microsiemen/cm<br>2060 ± 0.02 microsiemen/cm |
| TDS Values<br>and<br>Specifications<br>at 25ºC | Not specified | 15 ppm ± 1%<br>150 ppm ± 1%<br>1500 ppm ± 1% |
| Salt<br>Composition | NaCl (Sodium Chloride) | NaCl (Sodium Chloride)<br>Sodium Bicarbonate<br>Sodium Sulfate |
| Disinfectant | None | None |
| Bottle | High-density Polyethylene (HDPE) | High-density Polyethylene (HDPE) |
| Shelf Life | 18 months | 18 months |
| Open Bottle<br>Shelf Life | 30 Days | 60 Days |

The new device is similar to the predicate device in that it is drawn into the conductivity meter or the conductivity meter is exposed to the solution. The conductivity meter displays the value it measures for the conductivity.

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The new device is different in that there are three additional conductivity values. The new device is using additional two salts (Sodium Bicarbonate and Sodium Sulfate) to the single salt (Sodium Chloride) used in the predicate.

The new device and the predicate provide a secondary standard to be used in verifying or calibrating conductivity cells or instruments. For the purposes of verifying or calibrating Conductivity, the new device is substantially equivalent to the predicate device.

# Materials Used in the New Device

The following materials are used in the new device. None of these materials contact the patient or any patient fluids.

| Material | Where used | Common<br>Name | CAS Registry<br>Number | Manufacturer | Patient or Patient<br>Fluid Contact |
|------------------------------|------------|----------------|------------------------|----------------------------|-------------------------------------|
| De-lonized<br>Water | Solution | DI Water | 7732-18-5 | Produced<br>in-house | No |
| Sodium<br>Chloride | Solution | NaCl | 7440-23-5 | Rocky Mountain<br>Reagents | No |
| Sodium<br>Bicarbonate | Solution | Baking<br>Soda | 144-55-8 | Rocky Mountain<br>Reagents | No |
| Sodium<br>Sulfate | Solution | Thenardite | 7757-82-6 | Sigma-Aldrich | No |
| High-density<br>Polyethylene | Bottle | HDPE | 9002-88-4 | Silgan | No |

# Comparison of material use between the predicate and the new device.

| Where Used | Mesa Laboratories, Inc.<br>Predicate Device 1996<br>510(k) K955298 | Mesa Laboratories, Inc.<br>New Device 2019<br>510(k) K191496 |
|------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------|
| De-lonized Water | Solution | Solution |
| Sodium Chloride | Solution | Solution |
| Sodium Bicarbonate | - | Solution |
| Sodium<br>Sulfate | - | Solution |
| High-density<br>Polyethylene | Bottle | Bottle |

Validations were performed to to demonstrate that the materials performed equivalently for their required function.

# Performance Testing

The following validations were performed:

# VP-00020 Conductivity Values of 15ppm TDS Solutions

The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 15.063 ppm, 15.032 ppm, 15.007 ppm, 14.988 ppm and 14.994

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ppm. The value of the 15ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.

# VP-00021 Conductivity Values of 150ppm TDS Solutions

The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 150.546 ppm, 150.480 ppm, 150.546 ppm, 150.876 ppm and 150.744 ppm. The value of the 150ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.

# VP-00022 Conductivity Values of 1500ppm TDS Solutions

The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 1508.18 ppm, 1505.99 ppm, 1505.99 ppm, 1506.72 ppm and 14.994 ppm. The value of the 1500ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.

# VP-00030 Open Bottle Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 60 days after the bottle was opened and tightly recapped. The three values 23.8 µS/cm, 229 µS/cm, and 2060 µS/cm were all found to be within tolerance after the bottle was opened for 60 days and then tightly resealed. This was considered acceptable as per the Validation Protocol.

# VP-00073 Sealed Bottle Storage Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 23.8 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. The results showed that the solution remained in tolerance for 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. This was considered acceptable as per the Validation Protocol.

# VP-00074 Sealed Bottle Storage Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 229 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. The results showed that the solution remained in tolerance for 18 months. This was used to demonstrate that the

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batch had uniform properties thourghout the production. This was considered acceptable as per the Validation Protocol.

# VP-00075 Sealed Bottle Storage Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 2060 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. The results showed that the solution remained in tolerance for 18 months. This was considered acceptable as per the Validation Protocol.

Additional batches of TDS Solutions were manufactured to demonstrate that the new device would remain within specification during the 18 months in sealed bottle storage. . The goal was to produce the solution with a value within the lower 10% range of the specification range for each TDS solution. This was done to ensure that the value after 18 months of sealed bottle storage remained with specification.

| TDS Solution | 15 ppm<br>Tank<br>(uS/cm) | 150 ppm<br>Tank<br>(uS/cm) | 1500 ppm<br>Tank<br>(uS/cm) |
|---------------------|---------------------------|----------------------------|-----------------------------|
| Batch | | | |
| 1 | 23.56 | 226.8 | 2040.0 |
| 2 | 23.57 | 227.3 | 2040.0 |
| 3 | 23.56 | 226.8 | 2040.0 |
| 4 | 23.57 | 227.2 | 2042.0 |
| 5 | 23.56 | 226.9 | 2042.0 |
| Lower Specification | 23.324 | 226.7 | 2039.4 |
| Upper Specification | 24.276 | 231.3 | 2080.6 |

The table below shows the conductivity value of each batch of solution in the mixing tank. The lower specification and the upper specification for each TDS Solution are given in the last two rows of the table.

Nonclinical Performance: Validation of the performance of the device was performed on units equivalent to production.

Conclusions Demonstrating Safety and Effectiveness:

The results of the validations show that the new device is equivalent to the Conductivity/TDS Calibrator Solutions. The new device is substantially equivalent to the leqally marketed Conductivity/TDS Calibrator Solutions (predicate device).