(87 days)
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No
The description focuses on standard sensor measurements and data storage, with no mention of AI/ML terms or functionalities like learning, prediction, or complex pattern recognition beyond basic temperature compensation.
No
This device is designed to measure characteristics of water and dialysate used in hemodialysis systems, not to directly treat a patient or disease.
No
This device is used to verify the characteristics of water and dialysate, and to independently verify the functioning of in-line monitors in hemodialysis systems. It measures properties like conductivity, pH, and ORP, but does not diagnose medical conditions in patients. While it is used in a medical context, its function is for equipment verification and quality control, not for patient diagnosis.
No
The device description explicitly states it is a "microprocessor-based, battery powered, handheld, device" that measures various parameters, indicating it is a physical hardware device, not software only.
Based on the provided information, the Myron L Company D-6 Dialysate Meter™ is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is specifically intended for use by trained hemodialysis professionals to "verify the characteristics of product water, dialysate and sodium bicarbonate dialysate used with hemodialysis systems". These are fluids that are used in vitro (outside the body) in the process of hemodialysis. The purpose is to ensure the quality and suitability of these fluids for use in a medical procedure.
- Nature of Measurements: The device measures parameters like conductivity, resistivity, TDS, pH, and ORP of these fluids. These measurements are performed on the fluids themselves, not on a patient's body.
- Verification of In-line Monitors: The intended use also mentions "independently verifying functioning of in-line monitors". This further reinforces that the device is used to assess the performance of equipment involved in the preparation or delivery of these fluids, rather than directly diagnosing a patient.
While the device doesn't directly diagnose a disease in a patient, its use in verifying the quality of fluids essential for a medical procedure like hemodialysis falls under the scope of IVD devices, which are used to examine specimens, including fluids, derived from the human body or used in conjunction with medical procedures.
The fact that it's used by trained professionals in a healthcare-related context and for quality control of materials used in a medical treatment strongly suggests its classification as an IVD.
N/A
Intended Use / 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 oxidizing or reducing agents in product water or treated wastewater.
Product codes (comma separated list FDA assigned to the subject device)
FLB
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.
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
trained hemodialysis professionals, water purification specialist
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)
Performance tests were carried out on the D-6 Dialysate Meter™ and the three predicate devices listed in Table 1, above. 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.
- Not all of the devices have the same measurement capabilities regarding number and types of parameters as well as range of values covered.
Clinical Testing was not performed on these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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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: | Date
Released: |
|--------------|------|----------|-------------------|
| DX-810 | B | Released | 1/20/10 |
Image /page/0/Picture/23 description: The image shows the text "Page" and "1 of 3". The word "Page" is at the top left of the image, and the text "1 of 3" is below the word "Page". The text is written in a simple, sans-serif font and appears to be part of a document or report.
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.
| Feature/Function | 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 | |
| Temperature | |||||
| Compensated | Automatic | ||||
| All Ranges | Automatic | ||||
| All Ranges | Automatic - | ||||
| Requires | |||||
| External | |||||
| Temp Sensor | Requires | ||||
| Programming | |||||
| Sensors Type | Built In: Field | ||||
| Replaceable | Built In: Not | ||||
| Replaceable | Separate | ||||
| Accessories | Separate | ||||
| Accessories | |||||
| Microprocessor Based | YES | YES | YES | YES | |
| Power supply | Battery | Battery | Rechargeable | ||
| Battery | Rechargeable | ||||
| Battery |
Table 1: D-6 Comparison to Predicate Devices
| Document P/N | Rev: | Status: | Date
Released: | |
|--------------|------|----------|-------------------|------|
| DX-810 | B | Released | 1/20/10 | Page |
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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 |
Image /page/2/Picture/20 description: The image shows the text "Page" with some scribbles next to it. Below that, the text "3 of 3" is written in a handwritten style. The text indicates that this is page 3 of a 3-page document.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and vigilance. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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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Image /page/5/Picture/0 description: The image shows the words "MYRON L COMPANY" stacked on top of each other. The words are in a bold, sans-serif font. The word "MYRON L" is 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 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