(401 days)
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 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.
Here's an analysis of the provided text regarding the MARS® system, focusing on acceptance criteria and supporting studies:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against predefined acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are implicitly linked to the performance claimed for the new indication, and the "study" is the information provided to support that new indication and equivalence.
Acceptance Criteria and Reported Device Performance
The core "acceptance criterion" in this 510(k) summary is the demonstration that for a new specific indication, the MARS® system performs at least as safely and effectively as the identified predicate devices, and achieves a specific clinical outcome.
| Acceptance Criterion (Implicit) | Reported Device Performance (for the new indication) |
|---|---|
| For Hepatic Encephalopathy (HE) due to decompensation of chronic liver disease: Demonstrate a significant decrease in HE scores. | "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)." Additionally, the device performs "at least as safe and effective as the identified predicate devices." |
Study Details
The document mentions "clinical trials" but provides very limited detail about their methodology. The primary purpose of this 510(k) is to extend the indications for use based on existing (or newly provided) clinical data, not to detail the full protocol of those trials.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the Hepatic Encephalopathy (HE) indication. The text only mentions "Clinical trials conducted with MARS® treatments in HE patients."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The wording "Clinical trials conducted" generally implies prospective studies, but this is not confirmed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. This document summarizes the device's regulatory submission, not the detailed clinical trial report.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a medical apparatus (Molecular Adsorbent Recirculating System), not an AI imaging or diagnostic algorithm that involves human "readers." The "comparative effectiveness" mentioned is between MARS® treatment and Standard Medical Therapy (SMT) for HE patients. The effect size stated is a "decrease [in] hepatic encephalopathy scores by at least 2 grades."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As noted above, this is a medical device for blood detoxification, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the HE indication appears to be the "hepatic encephalopathy scores" themselves. These scores are clinical assessments, typically made by medical experts (e.g., neurologists, hepatologists) based on standardized scales. So, it would likely involve expert clinical assessment and outcomes data (change in HE scores).
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The sample size for the training set:
- Not applicable. As this is not an AI/ML device, there isn't a "training set" in the conventional sense. The "clinical trials" mentioned would be considered the main data set used to demonstrate performance.
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How the ground truth for the training set was established:
- Not applicable due to the device type. The outcomes (HE scores) were established through clinical assessment during the trials.
§ 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.