(46 days)
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No
The summary does not mention AI, ML, or any related terms or concepts.
No
The device measures water quality parameters for hemodialysis and verifies other meters, but it does not directly treat or diagnose patients. Its function is to support the proper functioning of equipment used in a therapeutic process, not to be a therapeutic device itself.
No
The device measures properties of water, not human biological parameters or conditions. While the water is used in hemodialysis, the device itself is for water quality control, not directly for diagnosing a medical condition in a patient.
No
The device description explicitly states it is a "hand-held, multi-test instrument," indicating it is a physical hardware device, not software only.
Based on the provided information, the HYDRA Meter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to measure properties of water used in hemodialysis, not biological samples from a patient. IVDs are used to examine specimens derived from the human body.
- Device Description: It's a hand-held instrument for measuring water parameters.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, diagnosing conditions, or providing information about a patient's health status.
Therefore, the HYDRA Meter falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
78 FIP
Device Description
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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
water purification specialists
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
1
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