Myron L Company D-6 Dialysate Meter™ is a hand-held, multi-test instruments that is intended for use by trained hemodialysis professionals to verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems as a means of independently verifying functioning of in-line monitors. It may also be used by water purification specialist to verify the suitability of feed water used with hemodialysis systems and to test wastewater created by hemodialysis systems. D-6 Dialysate Meter is intended for the above uses where: a. The measurement of conductivity, resistivity, TDS, pH is needed and; b. The measurement of Oxidation Reduction Potential (ORP) is needed to determine the presence and level of oxidizing or reducing agents in product water or treated wastewater.

Device Description

The D-6 Dialysate Meter™ is a microprocessor-based, battery powered, handheld, device that measures conductivity, resistivity total dissolved solids (TDS), pH, Temperature, and oxidation-reduction potential (ORP) of water and dialysate fluids associated with hemodialysis delivery systems. It measures and reports multiple ranges of conductivity, resistivity, TDS, pH and ORP. All measurement functions are automatically compensated for temperature. Up to 100 measurements can be stored in the devices memory, including the measured value, temperature and the date/time the measurement was taken. The device comes in a waterproof, chemically resistant case.

AI/ML Overview

The D-6 Dialysate Meter is a medical device intended for use by trained hemodialysis professionals to verify the characteristics of water and dialysate fluids associated with hemodialysis systems. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for each measurement type (conductivity, pH, temperature, resistivity, TDS, ORP). Instead, the performance testing describes a comparative approach against published specifications of the device itself and against predicate devices. The implicit acceptance criterion is that the D-6 Dialysate Meter performs consistently with its own published specifications and comparably to predicate devices.

Feature/Parameter	Acceptance Criterion (Implicit)	Reported Device Performance
General	Substantial equivalence to predicate devices regarding safety and effectiveness.	"The D-6 Dialysate Meter™ is substantially equivalent regarding safety and effectivity to other devices already on the market that have the same intended uses." "The D-6 Dialysate Meter™ does not pose any new safety risks or effectivity issues."
Measurements	Consistent performance with published specifications and predicate devices for: Conductivity, pH, Temperature, Resistivity, TDS, ORP.	Performance tests were carried out on the D-6 Dialysate Meter™ and three predicate devices (Hydra, 90XL, HDM97). These tests: Were performed on side-by-side using identical solutions and test set-ups.Compared each device to its published specs.Where possible, compared each device to all of the other devices.
Temperature Compensation	Automatic temperature compensation for all ranges.	Confirmed: "Automatic All Ranges"
Sensors	Built-in, field-replaceable sensors.	Confirmed: "Built In: Field Replaceable"
Microprocessor	Microprocessor-based functionality.	Confirmed: "YES"
Power Supply	Battery powered.	Confirmed: "Battery"

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for the test solutions or the number of measurements taken during performance testing. It simply states "identical solutions and test set-ups" were used.
Data Provenance: The data was generated by the manufacturer, Myron L Company, through "performance tests... carried out on the D-6 Dialysate Meter™ and the three predicate devices listed in Table 1". The tests were conducted "side-by-side" using "identical solutions and test set-ups." The document does not specify a country of origin for the data beyond being generated by a US-based company. The study appears to be prospective as it involves actively performing tests on the new device and predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The performance tests appear to have been conducted under controlled laboratory conditions, comparing the device's readings against its own specifications and those of predicate devices. There is no mention of experts establishing a ground truth for the test set in the clinical sense (e.g., radiologists interpreting images). The ground truth for the performance testing is implicitly the design specifications of the devices being tested and the known properties of the test solutions.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As performance testing involved comparing meter readings against established specifications and other meters, there would be no need for an adjudication method in the context of expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. The D-6 Dialysate Meter is a measurement device, not an AI-assisted diagnostic tool that requires human interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. While the device is "microprocessor-based", it is a physical measurement tool. "Standalone" performance testing refers to the device's ability to accurately measure the specified parameters. The performance tests ("side-by-side using identical solutions and test set-ups") serve as the standalone performance evaluation for this type of device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for the performance testing of the D-6 Dialysate Meter was:

Published specifications of the D-6 Dialysate Meter itself.
Published specifications of the predicate devices.
Known properties of the "identical solutions" used in the test set-ups. This implies a reliance on calibrated standards or reference measurements.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The D-6 Dialysate Meter is a hardware-based measurement device, not a machine learning or AI model that requires a "training set" in the traditional sense. Its design and calibration would be based on engineering principles and established measurement standards.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for this type of device. The accuracy and calibration of the device are established through manufacturing processes, quality control, and adherence to measurement standards, rather than a data-driven training paradigm.

Summary

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K100237

D-6 Dialysate Meter 510(K) Summary

MPA

OWNERMANUFACTURER 1.

1.1. Myron L Company 2450 Impala Drive Carlsbad, CA 92010-7226 USA
1.2. Phone: (760) 438-2021
1.3. Fax: (760) 931-9189
1.4. Website" www.myronl.com

2. CONTACT INFORMATION

2.1. Mr. Richard Spahl Quality Manager (760) 438-2021 x 1303 rspahl@myronl.com

3. DEVICE NAME

3.1. Trade Name: D-6 Dialysate Meter. TM
3.2. Common Name: Digital, handheld, multi-function dialysis meter.
3.3. Classification Name: Meter, Conductivity, Induction, Remote Type.
3.4. Classification Code: FLB.

DEVICE DESCRIPTION 4.

4.1. The D-6 Dialysate Meter™ is a microprocessor-based, battery powered, handheld, device that measures conductivity, resistivity total dissolved solids (TDS), pH, Temperature, and oxidation-reduction potential (ORP) of water and dialysate fluids associated with hemodialysis delivery systems.
4.2. It measures and reports multiple ranges of conductivity, resistivity, TDS, pH and ORP.
4.3. All measurement functions are automatically compensated for temperature.
4.4. Up to 100 measurements can be stored in the devices memory, including the measured value, temperature and the date/time the measurement was taken. The device comes in a waterproof, chemically resistant case.

INDICATIONS OF USE ડી

5.1. Myron L Company D-6 Dialysate Meter™ is a hand-held, multi-test instruments that is intended for use by trained hemodialysis professionals to verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems as a means of independently verifying functioning of in-line monitors.
5.2. It may also be used by water purification specialist to verify the suitability of feed water used with hemodialysis systems and to test wastewater created by hemodialysis systems.

Document P/N	Rev:	Status:	DateReleased:
DX-810	B	Released	1/20/10

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APR 2 3 2010

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K10023.7

D-6 Dialysate Meter 510(K) Summary

5.3. D-6 Dialysate Meter is intended for the above uses where:
- a. The measurement of conductivity, resistivity, TDS, pH is needed and;
- b. The measurement of Oxidation Reduction Potential (ORP) is needed to determine the presence and level of oxidizing or reducing agents in product water or treated wastewater.

COMPARISON TO PREDICATE DEVICES 6.

DEVICE	D-6	Hydra	90XL	HDM97
Measurement Type	Remote	In-Line or Remote	In-Line or Remote	In-Line
Conductivity	YES	YES	YES	YES
pH	YES	YES	YES	YES
Temperature	YES	YES	No	YES
Resistivity1	YES	YES	No	No
TDS1	YES	YES	No	No
ORP1	YES	No	No	No
Pressure	No	No	YES	YES
TemperatureCompensated	AutomaticAll Ranges	AutomaticAll Ranges	Automatic -RequiresExternalTemp Sensor	RequiresProgramming
Sensors Type	Built In: FieldReplaceable	Built In: NotReplaceable	SeparateAccessories	SeparateAccessories
Microprocessor Based	YES	YES	YES	YES
Power supply	Battery	Battery	RechargeableBattery	RechargeableBattery

Table 1: D-6 Comparison to Predicate Devices

Document P/N	Rev:	Status:	DateReleased:
DX-810	B	Released	1/20/10	Page

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K100237

Image /page/2/Picture/1 description: The image shows the logo for Myron L Company. The logo is in black and white and features the company name in bold, sans-serif font. The words "MYRON L" are on the top line, and the word "COMPANY" is on the bottom line. There is a vertical line to the right of the word "COMPANY".

D-6 Dialysate Meter 510(K) Summary

RESULTS OF PERFORMANCE TESTING 7.

7.1. Performance tests were carried out on the D-6 Dialysate Meter™ and the three predicate devices listed in Table 1, above. These tests:
- 7.1.1. Were performed on side-by-side using identical solutions and test set-ups.
- 7.1.2. Compared each device to its published specs.
- 7.1.3. Where possible, compared each device to all of the other devices.
  - a. Not all of the devices have the same measurement capabilities regarding number and types of parameters as well as range of values covered.

7.2. Clinical Testing:

7.2.1. Clinical Testing was not performed on these devices.
7.3. Biocompatibility:
- 7.3.1. This type of device does not require biocompatibility testing.

8. SAFETY

8.1. A Risk Analysis and Failure Modes Effects and Criticality Analysis (FMECA) was performed to identify possible sources of hazards to the user or patient related to the use of the device.
8.1.1. All potential risks were found to be acceptable and/or mitigate-able.

9. CONCLUSION:

9.1. The D-6 Dialysate Meter™ is substantially equivalent regarding safety and effectivity to other devices already on the market that have the same intended uses.
The D-6 Dialysate Meter™ does not pose any new safety risks or effectivity 9.2. issues.

Document P/N	DX-810
Rev:	B
Status:	Released
Date Released:	1/20/10

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G61 Silver Spring, MD 20993-0002

Mr. Richard James Spahl Quality Manager Myron L Company 2450 Impala Drive CARLSBAD CA 92010-7226

APR 2 3 2010

· Re: K100237

Trade/Device Name: Dialysate Meter, Model D-6 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FLB Dated: January 22, 2010 Received: January 26, 2010

Dear Mr. Spahl:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related

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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/Report.aProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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D-6 Dialysate Meter Traditional 510(K) Submission

INDICATIONS FOR USE: III.

510(k) Number (if known): K100237

Device Name: Dialysate Meter, Model D-6

Indications for Use:

Myron L Company D-6 Dialysate Meter™ is a hand-held, multi-test instrument that is intended for use by trained hemodialysis professionals to verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems as a means of independently verifying functioning of in-line monitors.

It may also be used by water purification specialist to verify the suitability of feed water used with hemodialysis systems and to test wastewater created by hemodialysis systems.

D-6 Dialysate Meter is intended for the above uses where:

· The measurement of conductivity, resistivity, TDS, pH is needed and;
· The measurement of Oxidation Reduction Potential (ORP) is needed to determine the presence and level of reducing agents in source water, product water and/or treated wastewater

Prescription Use X (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)

Hulas Kumar

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.