Phoenix XL Dialysate Meter

K150657 · Mesa Laboratories, Inc. · FIZ · Sep 21, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150657
• Device Name: Phoenix XL Dialysate Meter
• Applicant: Mesa Laboratories, Inc.
• Product Code: FIZ · Gastroenterology, Urology
• Decision Date: Sep 21, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting.

Device Story

Hand-held, battery-powered meter for hemodialysis professionals; verifies dialysate solution quality. Input: dialysate solution drawn through internal conductivity cell via vacuum created by attached syringe. Sensing: conductivity electrodes, thermistor, and pH electrode. Processing: electronic circuitry converts sensor signals to digital measurements. Output: digital display of conductivity, temperature, and pH. Usage: point-of-care in hemodialysis clinics. Clinical impact: ensures dialysate solution meets required parameters for safe dialysis treatment.

Clinical Evidence

Bench testing only. Performance validation conducted on production-equivalent units demonstrated that the Phoenix XL Dialysate Meter provides equivalent measurements for conductivity, pH, and temperature compared to the predicate device.

Technological Characteristics

Hand-held, battery-powered (3.6 VDC Lithium) meter. Sensing: conductivity electrodes, thermistor, and pH electrode. Dimensions: 11" x 2.9" x 1.7"; Weight: 10.6 oz. Connectivity: None (standalone). User interface: digital display. Luer connector for syringe-based sample aspiration.

Indications for Use

Indicated for hemodialysis professionals to verify conductivity, temperature, and pH of dialysate solutions in a hemodialysis setting.

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

• Phoenix Dialysate Meter (K955298)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.

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

September 21, 2015

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

Re: K150657

> Trade/Device Name: Phoenix XL Dialysate Meter Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIZ Dated: August 20, 2015 Received: August 21, 2015

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. 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.

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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerelv vours.

for Benjamin 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

510(k) Number (if known): K 150657

Phoenix XL Dialysate Meter Device Name:

Indications For Use:

This device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting.

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)

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Image /page/3/Picture/0 description: The image shows the logo for MesaLabs. The logo consists of a blue square with a white trapezoid inside, stacked on top of the text "MesaLabs". The word "Mesa" is in black, and the word "Labs" is in blue.

## 510(k) Summary

| Owner: | Mesa Laboratories, Inc.<br>12100 West 6th Avenue<br>Lakewood, CO 80228<br>Phone: [phone] FAX: [phone] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Louie, Quality Manager |
| Date: | March 11, 2015 |
| Device Name: | Phoenix XL Dialysate Meter |
| Common Name: | Meter, Conductivity, Non-Remote |
| Device<br>Classification: | Classification: II<br>Classification Panels: Gastroenterology<br>Regulation Number: 21 CFR § 876.5820,<br>Meter, Conductivity, Non-Remote<br>Product Code FIZ |
| Predicate<br>Device(s): | Phoenix Dialysate Meter<br>Mesa Laboratories Inc<br>510(k) Number K955298<br>Cleared February 29, 1996 |
| Device<br>Description: | This device is a hand-held battery powered, multi-test<br>meter designed for use by hemodialysis professionals<br>to measure the conductivity, temperature and pH of<br>Dialysate solutions associated with the dialysis<br>treatment. The unit houses the conductivity cell,<br>electronic circuitry and digital display. A syringe<br>attaches to the unit with luer connectors. When pulled,<br>the syringe creates a vacuum and draws solution<br>through the conductivity cell for measurement. The<br>conductivity cell contains the conductivity electrodes, a<br>thermistor, and a pH electrode. A 3.6 volt battery<br>provides power. |
| Indications<br>for Use: | This device is designed for use by hemodialysis<br>professionals to verify the conductivity, temperature<br>and pH of solutions in the hemodialysis setting |

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

| Technological<br>Characteristic | Mesa Laboratories, Inc. Predicate<br>Device 1996 510(k) K955298 | Mesa Laboratories, Inc.<br>New Device 2013 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Phoenix Dialysate Meter is designed<br>for use by hemodialysis professionals to<br>verify proper conductivity, temperature<br>and pH of solution in the hemodialysis<br>setting. | The Phoenix XL Dialysate Meter is<br>designed for use by hemodialysis<br>professionals to verify proper conductivity,<br>temperature and pH of solution in the<br>hemodialysis setting. |
| User<br>Instructions | See attached User Manual | See attached User Manual |
| Conductivity<br>Accuracy | ±0.01 mS/cm from 0.10 to 1.99 mS/cm<br>±0.1 mS/cm from 2.0 to 19.9 mS/cm<br>±2.0 mS/cm from 20.0 to 119.9 mS/cm<br>±30.0 mS/cm from 120.0 to 200.0 mS/cm | ±0.01 mS/cm from 0.10 to 1.99 mS/cm<br>±0.1 mS/cm from 2.0 to 19.9 mS/cm<br>±2.0 mS/cm from 20.0 to 119.9 mS/cm<br>±5.0 mS/cm from 120.0 to 200.0 mS/cm |
| Conductivity<br>Resolution | 0.01 mS/cm from 0.10 to 1.99 mS/cm<br>0.1 mS/cm from 2.0 to 19.9 mS/cm<br>1 mS/cm from 20.0 to 200.0 mS/cm | 0.01 mS/cm from 0.10 to 1.99 mS/cm<br>0.1 mS/cm from 2.0 to 19.9 mS/cm<br>1 mS/cm from 20.0 to 200.0 mS/cm |
| Conductivity<br>Temperature<br>Compensation | 15°C to 45°C | 15°C to 45°C |
| Temperature<br>Range | 15°C to 90°C | 15°C to 90°C |
| Temperature<br>Accuracy | ±1°C from 15°C to 90°C | ±1°C from 15°C to 90°C |
| Temperature<br>Resolution | 1°C from 15°C to 90°C | 1°C from 15°C to 90°C |
| pH Range | 2.0 to 10.0 pH | 2.0 to 10.0 pH |
| pH Accuracy | ±0.1 from 2.0 to 10.0 pH | ±0.1 from 2.0 to 10.0 pH |
| pH Resolution | 0.1 from 2.0 to 10.0 pH | 0.1 from 2.0 to 10.0 pH |
| Battery Type | 522 9VDC Alkaline | 3.6 VDC Lithium |
| Dimensions | H 10" x W 3.3" x T 1" | H 11" x W 2.9" x T 1.7" |
| Weight | 7.33 oz. | 10.6 oz. (300q) |

Mesa Laboratories Inc – 510(k) submission for pHoenix XL Dialysate Meter Section 6 – 510(k) Summary – Rev. A

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The Phoenix XL Dialysate Meter is similar to the predicate device in that they are both hand-held meters, measuring Conductivity, pH, and temperature. Both devices use conductivity cells using electrodes to measure the conductivity, a thermistor to measure temperature and a pH electrode to measure pH. Both devices are battery powered. Nonclinical Validation of the performance of the device was Performance: performed on units equivalent to production. The results of the validations show that the pHoenix XL Conclusions Drawn from Dialysate Meter is equivalent to the pHoenix Dialysate Meter for measuring Conductivity,pH, and temperature. Demonstrating Safety and Effectiveness:

> The Phoenix XL Dialysate Meter is substantially equivalent to the legally marketed Phoenix Dialysate Meter (predicate device).