(46 days)
The HYDRA Meter is a hand-held, multi-test instrument intended for use by water purification specialists to measure the conductivity, resistivity, total dissolved solids (TDS), pH, and temperature of water used in hemodialysis.
The HYDRA Meter may also be used to verify proper functioning of the water system's in-line conductivity, resistivity and pH meters.
The HYDRA Meter is a hand-held, multi-test instrument.
This FDA letter and associated Indications for Use statement do not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance. This document is a 510(k) clearance letter, which means the device (HYDRA Meter) was determined to be substantially equivalent to an already marketed predicate device, rather than requiring extensive clinical trials for approval.
Therefore, the requested information, which would typically be found in a comprehensive clinical study report or a detailed 510(k) submission summary, is not available in the provided text.
Based on the provided text, here's what can be stated about the device and the lack of study information:
1. A table of acceptance criteria and the reported device performance
- Not available. The document does not specify any performance acceptance criteria or report specific performance metrics for the HYDRA Meter. As a 510(k) clearance, the primary focus is on substantial equivalence to a predicate device rather than presenting detailed performance data against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance
- Not available. There is no mention of a test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not available. Since no test set or ground truth establishment process is described, this information is not present.
4. Adjudication method for the test set
- Not applicable/Not available. No information on adjudication is provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The HYDRA Meter is described as a "hand-held, multi-test instrument" for measuring water parameters (conductivity, resistivity, TDS, pH, temperature). It is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an instrumentation device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The type of ground truth used
- Not available. No ground truth for device performance is discussed in this document. For devices measuring physical parameters, the "ground truth" would typically refer to highly accurate reference measurements against which the device's accuracy is assessed, but no such assessment is detailed here.
8. The sample size for the training set
- Not applicable/Not available. This is a physical instrument, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not available. As above, no training set concept applies.
Summary based on available information:
The provided document is a 510(k) clearance letter for the HYDRA Meter. This type of clearance relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than requiring the extensive clinical trial data typically found in a PMA (Premarket Approval) or for a novel device. Therefore, the details requested about acceptance criteria, study design, sample sizes, expert ground truth, and specific performance metrics are not typically included in a 510(k) clearance letter itself. These details would likely be part of the full 510(k) submission, which is not provided here.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 1997
Ms. Linda V. Masano President Automata Instrumentation, Inc. 15600 North 78th Street Scottsdale, Arizona 85260-1735 Re: K974127 HYDRA Meter Dated: October 30, 1997 Received: November 3, 1997 Regulatory Class: II 21 CFR §876.5665/Product Code: 78 FIP
Dear Ms. Masano:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT G.
Indications for Use Statement
510(k) Number (if known):
Device Name: The HYDRA Meter
Indications for Use:
The HYDRA Meter is a hand-held, multi-test instrument intended for use by water purification specialists to measure the conductivity, resistivity, total dissolved solids (TDS), pH, and temperature of water used in hemodialysis.
The HYDRA Meter may also be used to verify proper functioning of the water system's in-line conductivity, resistivity and pH meters.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sattler/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K97412
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _ (
AUTOMATA Instrumentation, Inc. 10/27/97
§ 876.5665 Water purification system for hemodialysis.
(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.