(664 days)
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No
The provided 510(k) summary describes a fiber hemofilter, a physical device for blood filtration, and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is described as a "hemofilter," which is a component used in hemodialysis to filter blood. While hemodialysis is a therapeutic procedure, the hemofilter itself is a single-use component of the system rather than a standalone therapeutic device or a device capable of performing a therapeutic function on its own.
No
A hemofilter is used for treatment (e.g., in hemodialysis or hemofiltration) to remove waste products and excess fluid from the blood, not strictly for diagnosing a condition.
No
The device description clearly states "Gambro FH 22H Fiber Hemofilter," which is a physical medical device used in hemodialysis, not a software-only product.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: The description "Gambro FH 22H Fiber Hemofilter" strongly suggests a device used for filtering blood, likely in a procedure like hemodialysis or hemofiltration. These are procedures performed on the patient's blood outside the body, but the device itself is not used for diagnosing a condition based on analyzing a sample.
- Lack of IVD Indicators: The document is missing key information typically found in descriptions of IVD devices, such as:
- Intended Use/Indications for Use: This section is crucial for defining what the device is used to diagnose or measure.
- Anatomical Site: While not always present for IVDs, it can sometimes indicate the type of sample being analyzed.
- Input Imaging Modality: This is irrelevant for a hemofilter.
- Mentions of image processing, AI, DNN, or ML: These are not typically associated with basic hemofilters.
- Information about training/test sets, performance studies, and key metrics: These are essential for demonstrating the analytical and clinical performance of an IVD.
In summary, a hemofilter is a therapeutic device used to treat a condition by filtering blood, not a diagnostic device used to identify or measure substances in a sample to diagnose a condition.
Therefore, based on the available information, this device is not an IVD.
N/A
Intended Use / Indications for Use
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Product codes
78 KDL
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
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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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§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 5 1997
Jeffrey R. Shideman, Ph.D. Cobe Renal Care 1185 Oak Street Lakewood, Colorado 80215-4407 Re: K955497 Gambro FH 22H Fiber Hemofilter Dated: July 10, 1997 Received: July 15, 1997 Regulatory class: III 21 CFR §876.5860/Product code: 78 KDL
Dear Dr. Shideman:
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 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 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/cdrh/dsmamain.html".
Sincerely yours
Kilian 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