(95 days)
Disposable Surgical Gown and Disposable Reinforced Surgical Gown are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile. There are two types of surgical gown: Disposable Surgical Gown and Disposable Reinforced Surgical Gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. Disposable Surgical Gown have two models: ML515M45U and GD524ME65. Disposable Reinforced Surgical Gown have one model: PA528ME45R. Disposable Surgical Gown ML515M45U met the requirements for Level 3 classification, Disposable Surgical Gown GD524ME65 and Disposable Reinforced Surgical Gown met the requirements of Level 4 classification.
The provided FDA 510(k) summary document (K212869) pertains to Disposable Surgical Gowns. This document describes the acceptance criteria and the study that proves the device meets those criteria, specifically through non-clinical performance testing and biocompatibility assessment rather than studies involving AI algorithms or human readers.
Therefore, many of the requested points regarding AI/human reader studies, ground truth establishment for such studies, and multi-reader multi-case analyses are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides extensive tables (Table 3 and Table 4) detailing the acceptance criteria and results for various non-clinical performance and biocompatibility tests.
Table 1: Summary of Performance Testing - Categorized for clarity
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Flammability | Evaluate flammability of the test sample. | Meets Class 1 requirements | Pass |
| Hydrostatic Pressure | Determine hydrostatic pressure. | >50 cm | Level 3 Standard Surgical Gown: Average 67cm; Level 4 Standard Surgical Gown: Average 196cm; Level 4 Reinforced Surgical Gown: Average 162cm |
| Water Impact | Determine hydrostatic pressure. (Note: Description seems to be a typo, likely measuring water penetration/impact resistance) | ≤1.0 g | Level 3 Standard Surgical Gown: Average 0.011g; Level 4 Standard Surgical Gown: Average 0.014g; Level 4 Reinforced Surgical Gown: Average 0.017g |
| Breaking Strength | Evaluate breaking strength. | >20N | Level 3 Standard Surgical Gown: Lat. Avg 96N, Long. Avg 116N; Level 4 Standard Surgical Gown: Lat. Avg 111N, Long. Avg 184N; Level 4 Reinforced Surgical Gown: Lat. Avg 109N, Long. Avg 122N |
| Tearing Strength | Evaluate tearing strength. | >20N | Level 3 Standard Surgical Gown: Lat. Avg 77N, Long. Avg 128N; Level 4 Standard Surgical Gown: Lat. Avg 90N, Long. Avg 137N; Level 4 Reinforced Surgical Gown: Lat. Avg 80N, Long. Avg 137N |
| Linting | Evaluate linting. | Log10(particle count) 30 ft³/min/ft² | Level 3 Standard Surgical Gown: Average 40 ft³/min/ft² (Note: Only Level 3 reported, but acceptance criteria imply all gowns with this spec meet it) |
| EO/ECH Residue | Evaluate level of sterilant residues. | EO: |
§ 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.