MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)

K033262 · Gambro Renal Products · FLD · May 27, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K033262
• Device Name: MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS)
• Applicant: Gambro Renal Products
• Product Code: FLD · Gastroenterology, Urology
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5870
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The MARS® 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 and/or ion exchange resins. The MARS® is not indicated for the treatment of chronic liver disease conditions or as a bridge to liver transplant. Safety and efficacy has not been demonstrated for these indications in controlled, randomized clinical trials.

Device Story

MARS® is a blood detoxification system; components include dialyzers, adsorption columns, tubing connectors, and a control unit. Principle of operation involves dialysis of blood against an albumin-containing dialysate solution to remove water-soluble low/middle molecular weight substances and albumin-bound molecules. Used in clinical settings for extracorporeal blood purification. Healthcare providers operate the system to facilitate toxin removal, aiding in the management of acute poisoning or overdose cases.

Clinical Evidence

No clinical data provided; safety and efficacy for liver-related indications have not been demonstrated in controlled, randomized clinical trials.

Technological Characteristics

System includes dialyzers, adsorption columns, tubing connectors, and a control unit. Operates via dialysis against albumin-containing dialysate. Removes water-soluble and albumin-bound substances.

Indications for Use

Indicated for patients requiring treatment for drug overdose and poisonings, provided the substance is dialyzable and bound by charcoal/ion exchange resins. Contraindicated for chronic liver disease 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/1 description: The image shows the logo for Gambro Renal Products. The logo consists of the word "GAMBRO" in a bold, sans-serif font, followed by the words "Renal Products" in a smaller, italicized font. There is a small graphic to the left of the word "GAMBRO". The logo is simple and professional, and it is likely used to identify the company's products and services.

# 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectivencss has been submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of Gambro Renal Product's knowledge.

SPONSOR GAMBRO RENAL PRODUCTS REGULATORY AFFAIRS 14143 DENVER WEST PARKWAY, SUITE 400 LAKEWOOD, CO 80401

CONTACT Kae Miller 303.222.6724

### DEVICE NAME INFORMATION

Molecular Adsorbent Recirculating System (MARS®) Proprietary Name: Apparatus, Hemoperfusion, Sorbet Common/Usual Name: Sorbent Hemoperfusion System Classification Name:

## INDICATION

The MARS is indicated for the treatment of drug overdose and poisonings. The only requirement is that the drug or chemical be dialyzable and bound by charcoal. The MARS® is not indicated for the treatment of chronic liver conditions or as a bridge to liver transplant. Safety and efficacy has not been demonstrated for these indications in controlled, randomized clinical trials.

#### DEVICE DESCRIPTION

The MARS® is a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a control unit. It is designed for the combined removal of water-soluble low and middle molecular weight substances and albumin bound molecules. The treatment is based on the dialysis of blood against an albumin-containing dialysate solution.

#### SUBSTANTIAL EQUIVALENCE

The MARS® is substantially equivalent to the predicate devices since the basic features and technologies are similar. The minor differences between the MARS® and the predicate devices raise no new issues of safety and effectiveness.

Signed:

Kaa Miller

Kae Miller Regulatory Affairs Manager Gambro Renal Products

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2014

Gambro Renal Products, Inc. Kae Miller Regulatory Affairs Manager, Americas 10810 W. Collins Avenue Lakewood. CO 80215

Re: K033262

> Trade/Device Name: Molecular Adsorbent Recirculating System (MARS®) Regulation Number: 21 CFR§ 876.5870 Regulation Name: Sorbent hemoperfusion system Regulatory Class: III Product Code: FLD Dated (Date on orig SE Itr): March 2, 2005 Received (Date on orig SE Itr): March 3, 2005

Dear Kae Miller,

This letter corrects our substantially equivalent letter of May 27, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your devir (can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 – Kae Miller

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Molecular Adsorbent Recirculating System (MARS®)

Indications for Use:

The MARS® 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 and/or ion exchange resins.

Contraindication for Use:

The MARS® is not indicated for the treatment of chronic liver disease conditions or as a bridge to liver transplant. Safety and efficacy has not been demonstrated for these indications in controlled, randomized clinical trials.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Herbert P. Lerner -S 2014.01.16 11:43:21 -05'00'

Prescription Use __ X

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

vi

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