AHCS HEMOPERFUSION SYSTEM

K971015 · American Health Care Systems, Inc. · FLD · Oct 22, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971015
• Device Name: AHCS HEMOPERFUSION SYSTEM
• Applicant: American Health Care Systems, Inc.
• Product Code: FLD · Gastroenterology, Urology
• Decision Date: Oct 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5870
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Blood detoxification and drug removal/retention

Device Story

AHCS Hemoperfusion System utilizes heparin/hydrogel coated charcoal for extracorporeal blood detoxification and drug removal. Device operates by circulating patient blood through a cartridge containing adsorbent material to sequester toxins or drugs. Used in clinical settings by trained medical personnel. Output is purified blood returned to patient circulation. Benefits include rapid reduction of circulating toxins or drugs in acute poisoning or overdose scenarios.

Technological Characteristics

Hemoperfusion cartridge containing charcoal adsorbent coated with heparin and hydrogel. Extracorporeal circuit configuration. Class III device.

Indications for Use

Indicated for blood detoxification and drug removal/retention in patients requiring hemoperfusion therapy.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

OCT 22 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 (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 (Special Controls) or 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 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 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.

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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/hydrogel 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

[Signature]

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

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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)

Blow & Putting
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971011

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)