(54 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device is described as a water treatment system for hemodialysis, which is a standard medical device category not inherently requiring AI/ML.
No
The device purifies water for hemodialysis, which is a supportive function, not a direct therapeutic intervention on a patient. It does not treat a disease or condition itself.
No
The device is described as a water purification system for hemodialysis, not a device used to diagnose medical conditions.
No
The intended use describes a "Water Treatment System," which strongly implies a physical device for purifying water, not a software-only solution.
Based on the provided information, the Gambro® Water Treatment System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the purification of water used in hemodialysis procedures (diluting dialysate concentrate and reprocessing dialyzers). This is a process that prepares materials for use in a medical procedure, but it does not involve testing a sample taken from the human body to diagnose, monitor, or treat a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. The Gambro® Water Treatment System is a device that processes water, which is then used in a medical procedure, but it doesn't perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.
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
hemodialysis clinics
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
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Key Metrics
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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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN..." is arranged in a circular pattern around the left side of the emblem, while "...USA" is positioned on the right side.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 1998
Mr. William M. Townsend Senior Regulatory Specialist GAMBRO Healthcare 1185 Oak Street Lakewood, CO 80215-4498 Re: K981085
Gambro® Water Purification System Dated: March 23, 1998 Received: March 25, 1998 Regulatory Class: II 21 CFR 876.5665/Procode: 78 FIP
Dear Mr. Townsend:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 substantialion assumes compliance with the Current Good Manufacturing Practice requirements. as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product 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 questions on the promotion 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/cdrb/dsmaldsmam.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director. Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Indications for Use Statement 10.0
MBRO Healthcare Renal Care Products 1185 Oak Street Lakewood, CO 80215.498
The Gambro® Water Treatment System is intended to be used by hemodialysis clinics for the purification of water to be used for the dilution of dialysate concentrate and in the reprocessing of dialyzers for reuse.
Robert R. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number 108
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use_