(15 days)
The Convertors® Breathable Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The gowns are comprised of a single layer of spunlaced nonwoven fabric laminated to a breathable impervious film.
This document does not contain the requested information regarding acceptance criteria and a study proving device performance against those criteria.
The provided text is a 510(k) summary for a medical device (Convertors® Breathable Gowns). It focuses on:
- Device identification and classification.
- Statement of substantial equivalence to a predicate device based on similar intended use and performance attributes.
- Summary of biological qualification safety tests (cytotoxicity, sensitization, irritation/intracutaneous reactivity) conducted according to ISO 10993 Part-1. It states these materials were "found to be acceptable for the intended use" but does not define specific acceptance criteria or provide detailed performance data.
- FDA's response letter, confirming substantial equivalence and allowing the device to be marketed.
Missing Information:
The document lacks the following details typically expected for describing acceptance criteria and a study showing performance:
- A table of acceptance criteria and reported device performance: While it mentions biological qualification tests, it doesn't specify numerical or qualitative acceptance criteria (e.g., "cytotoxicity level must be below X" or "no irritation observed in Y% of subjects") nor does it provide the results of these tests in a comparative format.
- Sample size used for the test set and data provenance: No details on the number of samples or subjects used in the biological qualification tests, or the origin of this data (e.g., country, retrospective/prospective).
- Number of experts and their qualifications for ground truth: Not applicable for biological safety tests.
- Adjudication method: Not applicable for biological safety tests.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for this type of device (surgical gown) and the described tests.
- Standalone (algorithm only) performance: Not applicable as this is not an AI-powered device.
- Type of ground truth used: Not explicitly defined beyond the "biological qualification safety tests" and "industry recognized test methods."
- Sample size for the training set: Not applicable as this is not an AI-powered device.
- How ground truth for the training set was established: Not applicable.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.