(192 days)
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No
The description focuses on standard electronic measurement of physical properties (conductivity, temperature, pH) using electrodes and circuitry. There is no mention of AI, ML, or any form of data processing that would suggest learning or complex algorithmic decision-making beyond basic measurement and display.
No
Explanation: This device is for verifying the conductivity, temperature, and pH of solutions in hemodialysis. It measures and analyzes the Dialysate solution, but does not provide direct therapy to a patient.
No
This device is used to verify the properties (conductivity, temperature, pH) of solutions (dialysate) used in hemodialysis, not to diagnose a patient's medical condition. It's for quality control of the treatment solution.
No
The device description explicitly states it is a "hand-held battery powered, multi-test meter" that houses hardware components like a conductivity cell, electronic circuitry, digital display, syringe attachment, conductivity electrodes, thermistor, and pH electrode. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to "verify the conductivity, temperature, and pH of solutions in the hemodialysis setting." These solutions (Dialysate) are used in the treatment of patients, and measuring their properties is crucial for ensuring the safety and effectiveness of the dialysis process.
- Device Description: The device measures parameters (conductivity, temperature, and pH) of a solution (Dialysate) outside of the human body. This is a key characteristic of an in vitro diagnostic device.
- Target: The device is used to analyze a sample (Dialysate solution) to provide information relevant to a medical treatment.
While the device doesn't directly diagnose a disease in a patient, it provides critical information about a solution used in a medical procedure, which falls under the scope of IVD regulation. The measurements it provides are essential for ensuring the quality and safety of the Dialysate, which directly impacts patient care.
N/A
Intended Use / 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.
Product codes
FIZ
Device Description
This device is a hand-held battery powered, multi-test meter designed for use by hemodialysis professionals to measure the conductivity, temperature and pH of Dialysate solutions associated with the dialysis treatment. The unit houses the conductivity cell, electronic circuitry and digital display. A syringe attaches to the unit with luer connectors. When pulled, the syringe creates a vacuum and draws solution through the conductivity cell for measurement. The conductivity cell contains the conductivity electrodes, a thermistor, and a pH electrode. A 3.6 volt battery provides power.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hemodialysis professionals / hemodialysis setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Validation of the performance of the device was performed on units equivalent to production. The results of the validations show that the pHoenix XL Dialysate Meter is equivalent to the pHoenix Dialysate Meter for measuring Conductivity, pH, and temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.5820 Hemodialysis system and accessories.
(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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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 (800) 638-2041 or (301) 796-7100 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)
Page 1 of _ 1 ___
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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.
12100 West 6th Avenue
Lakewood, CO 80228
Phone: (303) 987-8000 FAX: (303) 987-8989 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Louie, Quality Manager |
| Date: | March 11, 2015 |
| Device Name: | Phoenix XL Dialysate Meter |
| Common Name: | Meter, Conductivity, Non-Remote |
| Device
Classification: | Classification: II
Classification Panels: Gastroenterology
Regulation Number: 21 CFR § 876.5820,
Meter, Conductivity, Non-Remote
Product Code FIZ |
| Predicate
Device(s): | Phoenix Dialysate Meter
Mesa Laboratories Inc
510(k) Number K955298
Cleared February 29, 1996 |
| Device
Description: | This device is a hand-held battery powered, multi-test
meter designed for use by hemodialysis professionals
to measure the conductivity, temperature and pH of
Dialysate solutions associated with the dialysis
treatment. The unit houses the conductivity cell,
electronic circuitry and digital display. A syringe
attaches to the unit with luer connectors. When pulled,
the syringe creates a vacuum and draws solution
through the conductivity cell for measurement. The
conductivity cell contains the conductivity electrodes, a
thermistor, and a pH electrode. A 3.6 volt battery
provides power. |
| 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 |
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Technological Characteristics: The technological Characteristics are summarized in the table below.
| Technological
Characteristic | Mesa Laboratories, Inc. Predicate
Device 1996 510(k) K955298 | Mesa Laboratories, Inc.
New Device 2013 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Phoenix Dialysate Meter is designed
for use by hemodialysis professionals to
verify proper conductivity, temperature
and pH of solution in the hemodialysis
setting. | The Phoenix XL Dialysate Meter is
designed for use by hemodialysis
professionals to verify proper conductivity,
temperature and pH of solution in the
hemodialysis setting. |
| User
Instructions | See attached User Manual | See attached User Manual |
| Conductivity
Accuracy | ±0.01 mS/cm from 0.10 to 1.99 mS/cm
±0.1 mS/cm from 2.0 to 19.9 mS/cm
±2.0 mS/cm from 20.0 to 119.9 mS/cm
±30.0 mS/cm from 120.0 to 200.0 mS/cm | ±0.01 mS/cm from 0.10 to 1.99 mS/cm
±0.1 mS/cm from 2.0 to 19.9 mS/cm
±2.0 mS/cm from 20.0 to 119.9 mS/cm
±5.0 mS/cm from 120.0 to 200.0 mS/cm |
| Conductivity
Resolution | 0.01 mS/cm from 0.10 to 1.99 mS/cm
0.1 mS/cm from 2.0 to 19.9 mS/cm
1 mS/cm from 20.0 to 200.0 mS/cm | 0.01 mS/cm from 0.10 to 1.99 mS/cm
0.1 mS/cm from 2.0 to 19.9 mS/cm
1 mS/cm from 20.0 to 200.0 mS/cm |
| Conductivity
Temperature
Compensation | 15°C to 45°C | 15°C to 45°C |
| Temperature
Range | 15°C to 90°C | 15°C to 90°C |
| Temperature
Accuracy | ±1°C from 15°C to 90°C | ±1°C from 15°C to 90°C |
| Temperature
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).