(216 days)
Blood detoxification and drug removal/retention
AHCS Hemoperfusion System
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (AHCS Hemoperfusion System with heparin/hydrogel coated charcoal). This document focuses on regulatory approval and substantial equivalence to a predicate device.
It does not contain information on the acceptance criteria, study details, or performance metrics of the device itself. The letter confirms the device can be marketed based on its substantial equivalence to previously approved devices, subject to general controls and good manufacturing practices.
Therefore, I cannot extract the requested information like:
- A table of acceptance criteria and the reported device performance: This document doesn't provide performance data or specific acceptance criteria for a validation study.
- Sample sized used for the test set and the data provenance: Not available in this regulatory letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided.
- Adjudication method: Not applicable or provided.
- Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not applicable or provided for this type of regulatory submission.
- Sample size for the training set: Not applicable or provided.
- How the ground truth for the training set was established: Not applicable or provided.
§ 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.