BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK

K984546 · Hemocleanse, Inc. · FLD · Aug 13, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K984546
• Device Name: BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
• Applicant: Hemocleanse, Inc.
• Product Code: FLD · Gastroenterology, Urology
• Decision Date: Aug 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5870
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Treatment of patients with (1) acute hepatic encephalopathy, or (2) serious drug overdose.

Device Story

BioLogic-DT System is a sorbent-regenerated detoxification system; removes toxins from blood via cellulosic dialyzer. System uses single-lumen catheter for alternating blood withdrawal/return. Unlike standard roller-pump dialysis, device applies alternating pressure/vacuum cycles to sorbent suspension, causing expansion/compression of dialyzer membranes to drive blood flow. System includes BioLogic-DT machine and single-use BioLogic-DT-1000-TK treatment kit. Software controls system functions, diagnostics, and automated sorbent mixing during prime phase (using air bubbling to prevent clogging). Safety features include bubble detectors, tubing occluders, membrane rupture detection, and automated electrolyte/saline infusion. Used in clinical settings for hepatic failure or overdose; operated by healthcare professionals. Benefits include efficient toxin removal via charcoal/cation exchangers while maintaining BCAA levels.

Clinical Evidence

Bench testing only. Seven repetitions of system setup with automatic mixing demonstrated 0% clogging during prime, compared to 25% clogging rate observed with manual shaking method. No clinical data provided.

Technological Characteristics

Sorbent-regenerated detoxification system. Components: BioLogic-DT machine and single-use cellulosic dialyzer kit. Principle: Alternating pressure/vacuum cycle for membrane-driven blood flow and sorbent mixing. Materials: Activated charcoal (primary sorbent), cation exchangers, cellulosic membranes. Connectivity: Embedded software for system control and diagnostics. Sterilization: Single-use disposable kit.

Indications for Use

Indicated for treatment of acute hepatic encephalopathy due to chronic liver disease decompensation or fulminant hepatic failure, and for treatment of drug overdose/poisonings involving dialyzable and charcoal-bound substances (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.

Predicate Devices

• BioLogic-DT-1000 Machine with BioLogic-DT-1000-TK Treatment Kit (K923046, K953751)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a date, "AUG 13 1993". The month is August, the day is the 13th, and the year is 1993. The text is in a simple, sans-serif font. The image is clear and easy to read.

K 984546

Image /page/0/Picture/2 description: The image is a logo for a company called "HEMOCLEANSE". The logo consists of the company name in bold, block letters, with a stylized graphic above it. The graphic appears to be an abstract representation of a medical or scientific concept, possibly related to blood or purification. The logo is simple, yet memorable, and conveys a sense of professionalism and expertise.

Page 1 of 3

## 510(k) Summary

Sorbent-based blood treatment systems

HemoCleanse Inc. 2700 Kent Avenue West Lafayette, IN 47906

Phone/765-463-9540, Fax/765-463-4129 Contact: Stephen R. Ash, M.D.

Date of Preparation: May 19, 1999

Trade Name: BioLogic-DT-1000 Machine with BioLogic-DT -1000-TK Treatment Kit

Common Name: BioLogic DT® System

### Classification Name:

Sorbent Regenerated Dialysate Delivery System (per 21 CFR 876.5600) and Sorbent Hemoperfusion Apparatus (per 21 CFR 876.5870)

### Device to which Substantial Equivalence is being Claimed:

Claiming equivalence to BioLogic-DT-1000 Machine with BioLogic-DT®-1000-TK Treatment Kit (K923046, K953751)

### Device Description:

The BioLogic-DT System is a sorbent regenerated detoxification system consisting of the BioLogic-DT Machine and the single use BioLogic-DT-1000-TK (Treatment Kit). In many ways, it is similar to a standard hemodialysis machine in that blood is removed from the body, passed through a cellulosic dialyzer, and returned to the body. Within the dialyzer, diffusion causes many chemicals and toxins to pass from the dialysate surrounding the membranes. Depending on the binding characteristics of the sorbents in suspension in the dialysate, some chemicals remain at low concentration in the dialysate, and are therefore efficiently removed from the blood, while others reach concentrations similar to blood, and are therefore not removed from the blood. Like existing single-access dialysis systems, the BioLogic-DT System alternately withdraws and returns blood through a single-lumen catheter. Unlike standard dialysis machines, which use roller pumps to pass blood through the membranes, the DT applies an alternating pressure/ vacuum cycle to the sorbent suspension causing the alternating expansion and compression of the dialyzer's parallel plate cellulosic membranes. This expansion and compression of the membranes is used to pump blood through the system.

An improvement in software of the DT-1000 System mixes the sorbents before prime, obviating the need for the operator to shake the bag.

Photographs and a detailed description of the DT System are provided in the BioLogic-DT System Technical Manual (modified, Appendix A).

2

{1}------------------------------------------------

K984546
Page 2 of 3

### Intended use of the Device

・

Treatment of patients with (1) acute hepatic encephalopathy, or (2) serious drug overdose.

| Comparison of Technological Characteristics: | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| BioLogic-DT System, DT-1000-TK | BioLogic-DT System (Rev. 1.05),<br>DT-1000-TK |
| Machine operation | |
| Combines the use of a long life machine fixture and<br>single use disposable kit to provide therapy | Same |
| All system functions and diagnostic features are<br>controlled through user interface and embedded software | Same |
| Vacuum/pressure cycle causes air to pass through the<br>sorbent to mix the sorbent components during the first<br>portion of Prime (obviating the need for shaking the bag) | New |
| Vacuum/pressure cycle causes dialyzer membrane to<br>expand and contract thus providing impetus for blood<br>flow, while monitoring positive transmembrane pressure<br>gradients | Same |
| Incorporates bubble detectors to prevent air embolism. | Same |
| Incorporates tubing occluders to immediately stop blood<br>flow in any situation that may compromise patient safety. | Same |
| Incorporates systems to detect membrane rupture and<br>limit potential patient blood loss. | Same |
| Automatically reinfuses electrolytes to counteract<br>depletion by sorbents | Same |
| Automatically infuses saline (prime fluid) to offset ultra-<br>filtration when desired goal has been met. | Same |
| Sorbent Components/Function | |
| Utilizes activated charcoal as primary sorbent for<br>removal of hepatic failure toxins. | Same |
| Contains cation exchangers for removal of potassium,<br>manganese, etc. | Same |
| Contains flow-inducing agents | Same |
| Removes aromatic amino acids strongly. | Same |
| Increases or maintains constant BCAA levels in blood<br>(due to limited binding of BCAA to charcoal). | Same |

{2}------------------------------------------------

K984546
Page 3 of 3

#### Studies Supporting Changes:

#### Sorbent Mixing in Prime

Non-clinical Performance Data - The method for automatically mixing the sorbent suspension is bubbling air through the Sorbent Bag after saline is added to the dry powder. Air is alternately bubbled through the Sorbent Bag for 15 seconds, then removed from the bag for 10 seconds, for 4 cycles. To perform this required only a software change, to direct air from the accumulator through the Sorbent Bag before priming begins.

Studies showed that 4 cycles of bubbling air through the sorbent results in a well mixed suspension that will flow freely through the dialyzer. Bubbling the sorbent for more than the normal 4 cycles does not appreciably change the sorbent concentration profile.

Seven repetitions of the DT System setup with automatic mixing resulted in swift sorbent flow through the dialyzer (0% clogging) during Prime. The previous method of mixing by user shaking resulted in sorbent clogging, thus no sorbent flow through the dialyzer, in 1 out of 4 (25%) setups.

Clinical Performance Data - N/A. Sorbent mixing occurs during setup of the BioLogic-DT System. If the sorbent clogs, the system will not Prime and the user must begin setting up with a new treatment kit.

Conclusions - Using the pneumatic system to automatically mix the sorbent at the beginning of Prime prevents clogging and assures an optimum sorbent flow during Prime. Automatic mixing simplifies setup for the user.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 13 1999

Stephen R. Ash, M.D., FACP Chairman and Director of Research and Development HemoCleanse, Inc. 2700 Kent Avenue West Lafayette, IN 47906

Re: K984546 BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) Dated: May 18, 1999 Received: May 21, 1999 Requiatory Class: Ill 21 CFR §876.5870/Procode: 78 FLD

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). 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.

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), piease 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/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

{4}------------------------------------------------

# Indications for Use

| Ver/3 - 4/24/96 |
|-----------------|
|-----------------|

| Applicant: | HemoCleanse, Inc. |
|----------------------|--------------------------------------------------------------------|
| 510(k) Number: | K984546 |
| Device Name: | BioLogic-DT ^® System (BioLogic-DT-1000 with DT-1000-TK) |
| Indications for Use: | |

1. Acute Hepatic Encephalopathy: The BioLogic-DT System is indicated 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.

| Contraindication: | The BioLogic-DT is not indicated for the treatment of chronic liver 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)

Prescription Use
(Per 21 CFR 801.109)

Javid C. Sejmon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number

Revised 8/6/99 – Page 2