BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)

K992196 · Hemocleanse, Inc. · FLD · Sep 10, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992196
• Device Name: BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK)
• Applicant: Hemocleanse, Inc.
• Product Code: FLD · Gastroenterology, Urology
• Decision Date: Sep 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5870
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

1) Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd for the treatment of acute hepatic encephalopathy due to decompensation of chronic liver disease or fulminant hepatic failure. 2) Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable (in unbound form) and bound by charcoal, such as acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, and insecticides.

Device Story

BioLogic-DT System (BioLogic-DT-1000 with DT-1000-TK) is an extracorporeal blood purification device. It processes patient blood to remove toxins via charcoal adsorption and dialysis. Used in clinical settings for acute hepatic encephalopathy and drug overdose/poisoning. Operates by circulating blood through the system where unbound dialyzable substances and charcoal-bound toxins are removed. Provides clinicians with a method to manage acute toxicity and hepatic decompensation. Benefits patients by facilitating rapid clearance of specific toxins or metabolic byproducts associated with liver failure or poisoning.

Technological Characteristics

Extracorporeal blood purification system utilizing charcoal adsorption and dialysis. Components include BioLogic-DT-1000 unit and DT-1000-TK kit. System designed for removal of dialyzable and charcoal-bound substances from blood.

Indications for Use

Indicated for treatment of acute hepatic encephalopathy (decompensated chronic liver disease or fulminant hepatic failure) and treatment of dialyzable drug overdose/poisonings (e.g., acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents, antimicrobials, theophylline, herbicides, insecticides). Contraindicated for chronic liver conditions or as a bridge to liver transplant.

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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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

SEP 1 0 1999

Stephen R. Ash, M.D., FACP Chairman, Medical Director HemoCleanse, Inc. 2700 Kent Avenue West Lafayette, IN 47906

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K992196 BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) Dated: August 12, 1999 Received: August 13, 1999 Regulatory Class: III 21 CFR §876.5870/Procode: 78 FLD Regulatory Class: II 21 CFR §876.5600/Procode: 78 FKT

Dear Dr. Ash:

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 legally marketed predicate 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 regult 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 requlations.

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 diagnosic devices), piease contact the Office of Compiance 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/dsma/dsmamain.html"

Sincerely yours,

CAPT Daniel G. Schultz. M.D. Acting 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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## Attachment 1

| Ver/3 - 4/24/96 | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | HemoCleanse, Inc. |
| 510(k) Number: | to be assigned |
| Device Name: | BioLogic-DT ^® System (BioLogic-DT-1000 with DT-1000-TK) |
| Indications for Use: | |
| | 1) Acute Hepatic Encephalopathy: The BioLogic-DT System is indicatd for the<br>treatment of acute hepatic encephalopathy due to decompensation of chronic liver<br>disease or fulminant hepatic failure. |
| | 2) Drug Overdose and Poisonings: The BioLogic-DT System is indicated for the<br>treatment of drug overdose and poisonings. The only requirement is that the drug or<br>chemical be dialyzable (in unbound form) and bound by charcoal, such as<br>acetaminophen, tricyclics, barbiturates, tranquilizers, anticancer agents,<br>antimicrobials, theophylline, herbicides, and insecticides. |
| Contraindication: | The BioLogic-DT is not indicated for the treatment of chronic liver<br>conditions or as a bridge to liver transplant. |
| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
| | (Per 21 CFR 801.109) |
| | (Optional Format 1-2-96) |

## Indications for Use

**Prescription Use**
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
and Radiological Devices
11 And Radiological Devices
1 And Radiological Devices 1 0 1 510(k) Number. KYZ 146

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