Who is the manufacturer of MOLECULAR ADSORBENT RECIRCULATING(MARS)?

Gambro Renal Products, Inc. filed the 510(k) submission for MOLECULAR ADSORBENT RECIRCULATING(MARS) (K113313).

What is the FDA product code for MOLECULAR ADSORBENT RECIRCULATING(MARS)?

FLD. It is classified under 21 CFR 876.5870 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for MOLECULAR ADSORBENT RECIRCULATING(MARS)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MOLECULAR ADSORBENT RECIRCULATING(MARS)?

BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) (K984546); BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) (K992196); Molecular Adsorbent Recirculating System (MARS®) (K033262).

Who can help prepare an FDA 510(k) submission like MOLECULAR ADSORBENT RECIRCULATING(MARS)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MOLECULAR ADSORBENT RECIRCULATING(MARS)

K113313 · Gambro Renal Products, Inc. · FLD · Dec 14, 2012 · Gastroenterology, Urology

Device Facts

Record ID	K113313
Device Name	MOLECULAR ADSORBENT RECIRCULATING(MARS)
Applicant	Gambro Renal Products, Inc.
Product Code	FLD · Gastroenterology, Urology
Decision Date	Dec 14, 2012
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 indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathv scores bv at least 2 grades compared to standard medical therapy (SMT).

Device Story

MARS® is a blood detoxification system for removing water-soluble low/middle molecular weight substances and albumin-bound molecules. It utilizes a hollow-fiber dialyzer with a Polyamix (PAES) membrane, two sorbent columns (activated carbon and ion exchanger), tubing, and a monitor unit. The system performs albumin dialysis, where blood is dialyzed against an albumin-containing dialysate solution. Operated by clinicians in a clinical setting, the device uses a roller pump for sorbent/dialysate circulation and integrates with hemodialysis systems to control blood flow. The monitor unit allows manual/automatic operation, parameter adjustment, and status monitoring. Automated monitoring includes in-line pressure, dialysate temperature, blood leak, flow rates, and voltage. By removing toxins and albumin-bound substances, the device aims to provide a transient reduction in hepatic encephalopathy scores in patients with chronic liver disease decompensation, potentially benefiting patients by mitigating toxic accumulation.

Clinical Evidence

Clinical evidence consists of controlled, multi-center clinical trials evaluating MARS® in patients with hepatic encephalopathy (HE) due to decompensation of chronic liver disease. Results demonstrated a transient effect, significantly decreasing hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT).

Technological Characteristics

System includes hollow-fiber dialyzer (Polyamix/PAES membrane), two sorbent columns (activated charcoal, ion exchanger), tubing set, and monitor unit. Uses albumin in saline as a carrier. Features automated monitoring for pressure, temperature, blood leak, and flow rates. Operates via roller pump. Connectivity includes in-line sensors for device status. Sterilization and specific ASTM standards not detailed.

Indications for Use

Indicated for patients with drug overdose/poisoning (dialyzable/sorbent-bound substances) and patients with hepatic encephalopathy (HE) due to decompensated chronic liver disease. Contraindicated as a bridge to liver transplant; effectiveness in sedated patients is not established.

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® System (BioLogic-DT-1000 with DT-1000-TK) (K984546)
BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) (K992196)
Molecular Adsorbent Recirculating System (MARS®) (K033262)

Related Devices

K033262 — MOLECULAR ADSORBENT RECIRCULATING SYSTEM (MARS) · Gambro Renal Products · May 27, 2005
K133807 — MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT · Gambro Renal Products, Inc. · Mar 26, 2014
K992196 — BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) · Hemocleanse, Inc. · Sep 10, 1999
K984546 — BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK · Hemocleanse, Inc. · Aug 13, 1999
K122343 — PUREFLUX-H HEMODIALYZER · Nipro Medical Corporation · May 7, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ GAMBRO.Renal Products Traditional 510(k) for the Molecular Adsorbent Recirculating System (MARS®) DEC 1 4 2012 #### 5.0 510(k) SUMMARY This summary of 510(k) safety and effectiveness 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's knowledge. | Submitter's Name | Gambro Renal Products, Inc. | |----------------------------------|------------------------------------------------------------------| | Address | 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401 | | Establishment Registration No. | 2087532 | | Contact Person | Kae Miller, Regulatory Affairs Manager, Americas | | Telephone Number | 303.222.6724 | | Fax Number | 303.222.6916 | | Date of Summary | December 14, 2012 | | Device under clearance | | | Name of the Device | Molecular Adsorbent Recirculating System (MARS®) | | Common or Usual Name | Apparatus, Hemoerfusion, Sorbent | | Classification Name | Sorbent Hemoperfusion System | | Device Class | III | | Product Code | 78 FLD | | Regulation Number | 21 CFR 876.5870 | | Predicate Device Information (1) | | | Name of the Device | BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) | | 510(k) Number | K984546 (cleared on August 13, 1999) | | Classification Name | Sorbent Hemoperfusion System | | Device Class | III | | Product Code | 78 FLD | | Regulation Number | 21 CFR 876.5870 | | Predicate Device Information (2) | | | Name of the Device | BioLogic-DT® System (BioLogic-DT-1000 with DT-1000-TK) | | 510(k) Number | K99216 (cleared on September 10, 1999) | | Classification Name | Sorbent Hemoperfusion System | | Device Class | III | | Product Code | 78 FLD and FKT | | Regulation Number | 21 CFR 876.5870 | | Predicate Device Information (3) | | | Name of the Device | Molecular Adsorbent Recirculating System (MARS®) | | 510(k) Number | K033262 (cleared on May 27, 2005) | | Classification Name | Sorbent Hemoperfusion System | | Device Class | III | | Product Code | FLD and NKL | | Regulation Number | 21 CFR 876.5870 | {1}------------------------------------------------ # GAMBROsRenal Products Traditional 510(k) for the Molecular Adsorbent Recirculating System (MARS®) ### Additional Precaution: Patients treated with MARS® may experience a decrease in blood platelet counts during their treatment due to loss of platelets in the extracorporeal circuit, as with other extracorporeal blood treatments involving medical devices (i.e. acute and chronic hemodialysis, membrane plasmapheresis, continuous renal replacement therapy (CRRT), etc.). ### 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 indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathv scores bv at least 2 grades compared to standard medical therapy (SMT). ### Contraindication: The MARS® is not indicated as a bridge to liver transplant. Safety and efficacy has not been demonstrated for this indication in controlled, randomized clinical trials. The effectiveness of the MARS® device in patients that are sedated could not be established in clinical studies and therefore cannot be predicted in sedated patients. ### DEVICE DESCRIPTION The MARS® is a blood detoxification device comprised of dialyzers, adsorption columns, tubing connectors and a monitor unit. It is designed for the combined removal of watersoluble 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. {2}------------------------------------------------ Image /page/2/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 ".Renal Products" in a smaller font. There is a small, circular graphic to the left of the word "GAMBRO." Traditional 510(k) for the Molecular Adsorbent Recirculating System (MARS®) ### BRIEF DISCUSSION CLINICAL PERFORMANCE DATA: The presented data from controlled, multi-center clinical trials support the following new indication for use for MARS® and demonstrate that the device is performing at least as safe and effective as the identified predicate devices. The MARS® performs albumin dialysis to remove low molecular weight water-soluble solutes and albumin-bound solutes such as drugs and toxins, from the patient's blood. See Attachment 1. ### SUBSTANTIAL EQUIVALENCE The MARS® is substantially equivalent to the predicate devices since the basic features function and technologies are the same. The minor differences raise no new issues of safety and effectiveness. {3}------------------------------------------------ Ku3313 Image /page/3/Picture/1 description: The image shows the logo for Gambro Renal Products. The logo consists of a stylized letter "G" followed by the words "GAMBRO. Renal Products" in a sans-serif font. The word "GAMBRO" is larger and bolder than the words "Renal Products". Molecular Adsorbent Recirculating System (MARS®) #### DEVICE COMPARISION TABLE 5.1 | CATEGORY | DEVICE: MARS® | PREDICATE: MARS® K033262 | PREDICATE: BioLogic-DT System K984546 and K992196 | |--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT) | 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. | 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. 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. | | CATEGORY | DEVICE: MARS® | PREDICATE: MARS® K033262 | PREDICATE: BioLogic-DT System K984546 and K992196 | | Contraindications | The MARS® is not indicated as a bridge to liver transplant. Safety and efficacy has not been demonstrated for this indication in controlled, randomized clinical trials. The effectiveness of the MARS® device in patients that are sedated could not be established in clinical studies and therefore cannot be predicted in sedated patients. | 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. | The BioLogic DT is not indicated for the treatment of chronic liver conditions as a bridge to liver transplant. | | Treatment kit components | 2 dialyzers 2 sorbent columns Activated carbon Ion exchanger 1 tubing set consisting of tubing/ connectors/clamps/ hydrophobic and particle filters/heater bag/air traps | 2 dialyzers 2 sorbent columns Activated carbon Ion exchanger 1 tubing set consisting of tubing/connectors/clamps/ hydrophobic and particle filters/heater bag/air traps | 1 dialyzer Chemical sorbents Activated charcoal (carbon) Ion exchanger (powdered) Tubing set | | Dialyzer type/ membrane material (blood contacting) | Hollow fiber dialyzer/polyamix (PAES) | Hollow fiber dialyzer/polyamix (PAES) | Plate membrane dialyzer/ Cellulose acetate | | Sorbents | Activated Charcoal (contained in a column) Ion exchanger (contained in a column) | Activated Charcoal (contained in a column) Ion exchanger (contained in a column) | Finely powdered Activated Charcoal (in suspension) Powdered carbon exchanger (in suspension) | | Carrier | Albumin in saline | Albumin in saline | Polyvinylpyrrolidone (PVP) and Pluronic polyols in saline | | CATEGORY | DEVICE: MARS® | PREDICATE: MARS® K033262 | PREDICATE: BioLogic-DT System K984546 and K992196 | | Blood circulation method | None: hemodialysis system controls blood flow | None: hemodialysis system controls blood flow | Alternating pressure and vacuum ("push-pull" effect) to propel blood through circuit (positive pressure and vacuum pump) | | Sorbent/ dialysate circulation method | Roller pump | Roller pump | Alternating pressure and vacuum | | Operation modes | Preparation (priming) Treatment | Preparation (priming) Treatment | Preparation (priming) Treatment | | User interface control (display) | Select manual/automatic operation Review/change treatment parameters Monitor device status | Select manual/automatic operation Review/change treatment parameters Monitor device status | Automatic Operation only Monitor device status | | Automated monitoring | In-line pressure Albumin dialysate temperature Blood leak Albumin dialysate flow rate Pump door position Line voltage | In-line pressure Albumin dialysate temperature Blood leak Albumin dialysate flow rate Pump door position Line voltage | Sorbent temperature Blood leak Air bubble Blood flow rate | | Alarms | Blood leak Pressure Temperature | Blood leak Pressure Temperature | Blood leak Air detector | | Blood volume in circuit | 200-250mL | 200-250mL | 200-250mL | {4}------------------------------------------------ ## GAMBRO.Renal Products Molecular Adsorbent Recirculating S10(k) for the Molecular Adsorbent Recirculating System (MARS*) . {5}------------------------------------------------ Kizu 6Ko ### KII3313 ## GAMBRO.Renal Products Molecular Adsorbent Recirculating System (MARS®) {6}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/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 appears to be a scanned image. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2012 Gambro Renal Products, Inc. % Ms. Kae Miller RA Manager, Americas 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401 Re: K113313 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: December 5, 2012 Received: December 10, 2012 Dear Ms. Miller: 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 device 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. 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. {7}------------------------------------------------ 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, **Herbert R. Lerner** 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 {8}------------------------------------------------ ### GAMBRO Renal Products Traditional 510(k) for the Molecular Adsorbent Recirculating System (MARS®) ### Indications for Use K113313 510(k) Number (if known): Molecular Adsorbent Recirculating System (MARS®) Device Name: ### Indications for Use Statement 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 indicated in the treatment of Hepatic Encephalopathy (HE) due to a decompensation of a chronic liver disease. Clinical trials conducted with MARS® treatments in HE patients having a decompensation of chronic liver disease demonstrated a transient effect from MARS® treatments to significantly decrease their hepatic encephalopathy scores by at least 2 grades compared to standard medical therapy (SMT). ### Contraindication: The MARS® is not indicated as a bridge to liver transplant. Safety and efficacy has not been demonstrated for this indication in controlled, randomized clinical trials. The effectiveness of the MARS® device in patients that are sedated could not be established in clinical studies and therefore cannot be predicted in sedated patients. Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) RA 11-063 Revised (Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K113313 510(k) Number Page 18 of 69

MOLECULAR ADSORBENT RECIRCULATING(MARS)

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Device Story

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MOLECULAR ADSORBENT RECIRCULATING(MARS)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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