(63 days)
Dental Barrier and Sleeves are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.
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The provided text is a 510(k) clearance letter from the FDA for a device named "Dental Barrier and Sleeves." It explicitly states that the device is a physical barrier and not an AI/software device. Therefore, the questions related to AI/software performance acceptance criteria, test sets, ground truth, expert opinions, and training sets are not applicable to this document.
The document discusses regulatory aspects of a Class II medical device, including:
- Trade/Device Name: Dental Barrier and Sleeves
- Regulation Number/Name: 21 CFR 878.4370, Surgical Drape And Drape Accessories
- Regulatory Class: Class II
- Product Code: PEM, PUI
- Indications for Use: Intended to be used as a disposable barrier for dental instruments and equipment. Non-sterile and intended for single patient use only.
Since the device is a physical product and not an AI or software-based system, the acceptance criteria would relate to its physical properties, material safety, effectiveness as a barrier, and manufacturing quality, rather than algorithms or data performance. Such tests would typically involve:
- Material Biocompatibility: Testing to ensure the materials are not toxic or irritating when in contact with patients or users.
- Barrier Integrity/Effectiveness: Physical testing to confirm its ability to prevent the passage of fluids, microorganisms, or other contaminants.
- Physical Properties: Tensile strength, tear resistance, and dimensions to ensure it performs as intended under typical dental use conditions.
- Sterility (if applicable, though this device is noted as non-sterile): If it were a sterile barrier, testing would confirm the absence of viable microorganisms.
- Shelf Life: Stability testing to ensure the product remains effective and safe over its intended storage period.
- Manufacturing Quality Control: Adherence to Good Manufacturing Practices (GMP) to ensure consistent quality.
None of this information is detailed in the provided FDA clearance letter, as the letter primarily serves to confirm substantial equivalence to a predicate device and outlines regulatory obligations, not to present detailed study results for a non-AI/software device.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.