(216 days)
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Not Found
No
The summary explicitly states "Not Found" for mentions of AI, DNN, or ML, and the device description is for a hemoperfusion system, which typically does not involve AI/ML.
Yes
The intended use of "Blood detoxification and drug removal/retention" clearly indicates that the device is designed to treat a medical condition or perform a medical function, classifying it as a therapeutic device.
No
The "Intended Use / Indications for Use" describes "Blood detoxification and drug removal/retention," which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states "AHCS Hemoperfusion System," which is a hardware-based blood purification system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Blood detoxification and drug removal/retention." This describes a therapeutic procedure performed on the patient's blood outside the body, but the purpose is to treat the patient directly, not to diagnose a condition.
- Device Description: The device is described as a "Hemoperfusion System." Hemoperfusion is a process where blood is passed through an adsorbent material to remove toxins or drugs. This is a treatment method, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing blood or other biological samples to determine the presence of a disease, condition, or marker. IVDs are designed to provide information for diagnosis, monitoring, or screening.
Therefore, the AHCS Hemoperfusion System, as described, falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Blood detoxification and drug removal/retention
Product codes
78 FLD
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): 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).
Not Found
§ 876.5870 Sorbent hemoperfusion system.
(a)
Identification. A sorbent hemoperfusion system is a prescription device that consists of an extracorporeal blood system similar to that identified in the hemodialysis system and accessories (§ 876.5820) and a container filled with adsorbent material that removes a wide range of substances, both toxic and normal, from blood flowing through it. The adsorbent materials are usually activated-carbon or resins which may be coated or immobilized to prevent fine particles entering the patient's blood. The generic type of device may include lines and filters specifically designed to connect the device to the extracorporeal blood system. The device is used in the treatment of poisoning, drug overdose, hepatic coma, or metabolic disturbances.(b)
Classification. (1) Class II (special controls) when the device is intended for the treatment of poisoning and drug overdose. The special controls for this device are:(i) The device must be demonstrated to be biocompatible;
(ii) Performance data must demonstrate the mechanical integrity of the device (e.g., tensile, flexural, and structural strength), including testing for the possibility of leaks, ruptures, release of particles, and/or disconnections under anticipated conditions of use;
(iii) Performance data must demonstrate device sterility and shelf life;
(iv) Bench performance testing must demonstrate device functionality in terms of substances, toxins, and drugs removed by the device, and the extent that these are removed when the device is used according to its labeling, and to validate the device's safeguards;
(v) A summary of clinical experience with the device that discusses and analyzes device safety and performance, including a list of adverse events observed during the testing, must be provided;
(vi) Labeling must include the following:
(A) A detailed summary of the device-related and procedure-related complications pertinent to the use of the device;
(B) A summary of the performance data provided for the device, including a list of the drugs and/or poisons the device has been demonstrated to remove, and the extent for removal/depletion; and
(vii) For those devices that incorporate electrical components, appropriate analysis and testing must be conducted to verify electrical safety and electromagnetic compatibility of the device.
(2) Class III (premarket approval) when the device is intended for the treatment of hepatic coma and metabolic disturbances.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA by April 17, 2014, for any sorbent hemoperfusion system indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution before May 28, 1976, or that has, by April 17, 2014, been found to be substantially equivalent to any sorbent hemoperfusion device indicated for treatment of hepatic coma or metabolic disturbances that was in commercial distribution before May 28, 1976. Any other sorbent hemoperfusion system device indicated for treatment of hepatic coma or metabolic disturbances shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Earl G. Schmit Official Correspondent American Health Care Systems, Inc. P.O. Box 791120 New Orleans, Louisiana 70179-1120
0CT 2 2 1997
Re: K971015 American Health Care System Hemoperfusion system with heparin/hydrogel coated charcoal Regulatory Class: III 21 CFR §876.5870/Product Code: 78 FLD Dated: July 8, 1997 Received: July 9, 1997
Dear Mr. Schmit:
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 You may, therefore, market the device, subject to the general controls (Act). 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Reqister. 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.
1
Page 2 - Mr. Earl G. Schmit
Please be aware that the finding of substantial equivalence applies only to the American Healthcare Systems Hemoperfusion system with heparin/hydroqel coated charcoal, as described in this 510(k). Any hemoperfusion system containing any other specific chelating agent or adsorbent will require premarket clearance/approval prior to marketing.
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) 594-4616. 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,
Roher R. Sathing//
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
Enclosure
2
510(k) Number (if known): . . K97-1015 . . .
Device Name: AHCS Hemoperfusion System
Indications For Use:
Blood detoxification and drug removal/retention
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rolar R. Ratliff
(Division Sign-Off) ivision of Reproductive, Abdominal, ENT, nd Radiological Devices 97101 10(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)