(401 days)
Not Found
No
The document describes a blood detoxification device and its mechanism of action, focusing on dialysis and adsorption. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies summary.
Yes
The device is indicated for the treatment of drug overdose and poisonings, and Hepatic Encephalopathy, which are medical conditions, and it performs blood detoxification to remove harmful substances from the patient's blood.
No
The device description clearly states it is a "blood detoxification device" designed for the "combined removal of water-soluble low and middle molecular weight substances and albumin bound molecules." Its intended use is for "treatment of drug overdose and poisonings" and "treatment of Hepatic Encephalopathy." These descriptions indicate a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the MARS® is comprised of physical components like dialyzers, adsorption columns, tubing connectors, and a monitor unit, indicating it is a hardware-based device.
Based on the provided text, the MARS® device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes the treatment of drug overdose, poisonings, and Hepatic Encephalopathy. These are all conditions treated within the patient's body by directly processing their blood.
- Device Description: The description details a blood detoxification device comprised of dialyzers, adsorption columns, tubing, and a monitor unit. It describes the process of dialysis of blood against an albumin-containing dialysate solution. This is a therapeutic intervention performed on the patient's blood outside the body but as part of a treatment process, not for diagnostic purposes.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. The device's function is to remove substances from the blood, which is a therapeutic action.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. The MARS® device's function is to treat the patient by directly processing their blood, not to analyze a sample for diagnostic information.
N/A
Intended Use / 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).
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.
Product codes (comma separated list FDA assigned to the subject device)
78 FLD
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5870 Sorbent hemoperfusion system.
(a)
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.(b)
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.
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