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(a) Identification. A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Evaluation of improvement of shoulder function and reduction of symptoms (e.g., pain and function) for the indications for use; and
(ii) Evaluation of relevant adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Integrity testing of the device, including mechanical and chemical stability; and
(ii) Characterization of the device degradation profile.
(3) Animal performance testing must include evaluation of the following:
(i) Adverse effects, including gross necropsy and histopathology; and
(ii) Device degradation to verify in vitro versus in vivo degradation correlation.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Instruction for use, including specific instructions regarding device selection and placement;
(ii) A detailed summary of the clinical performance testing with the device, including procedure- and device-related complications or adverse events; and
(iii) A shelf life.
[87 FR 981, Jan. 6, 2023]
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