(212 days)
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
The provided text describes the 510(k) submission for the "Skypro, Surgical Gown 6021" and compares it to a predicate device. This document is a regulatory submission for a medical device (surgical gown), not a software-based AI/ML device. Therefore, the bulk of the questions, specifically those related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "number of experts for ground truth," or "sample size for training set"), are not applicable.
However, I can extract information related to the acceptance criteria and study proving the device meets those criteria, as well as the types of testing performed for this non-AI medical device.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical tests and their criteria, which serve as the acceptance criteria for the surgical gown.
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM F2407-20, Section 7.2 Tensile Strength (ASTM D5034-09(R17)) | To evaluate the tensile strength of the gown material | ≥ 30N | Pass (Warp yarns torn (MD): 179.7 N, Weft yarns torn (CD): 103.7 N) |
| ASTM F2407-20, Section 7.2 Seam Strength (ASTM D1683/D1683M-22) | To evaluate the tensile strength of the gown seam | ≥ 30N | Pass (Sleeve seam: 113.3 N, Armhole seam: 73.2 N, Shoulder seam: 111.1 N) |
| ASTM F2407-20, Section 7.2 Tearing Strength (ASTM D5733-99) | To evaluate the tear strength of the gown material | ≥ 10N | Pass (Warp yarns torn (MD): 53.9 N, Weft yarns torn (CD): 29.2 N) |
| ASTM F2407-20, Section 7.3 Lint Generation (ISO 9073-10:2003) | To evaluate the potential for linting of the gown | Documentation only | Pass (Side A (face): Total linting: 140.9, Coefficient of linting: 2.15; Side B (back): Total linting: 242.2, Coefficient of linting: 2.38) |
| ASTM F2407-20, Section 7.3 Evaporative Resistance (ASTM F1868-17) | To evaluate the evaporative resistance of the gown | Documentation only | Pass (0.00215 kPa·m²/W) |
| Water Resistance: Hydrostatic Pressure (AATCC 42:2017) | To evaluate the hydrostatic water resistance of the gown | ≥ 50cmH20 | Pass (Base material: > 50 cmH₂O, Sleeve Seam: > 50 cmH2O, Tie attachment with/without film: > 50 cmH₂O) |
| Water Resistance: Impact Penetration (AATCC 127:2018e) | To evaluate the water spray resistance of the gown | ≤ 1.0g | Pass (Base material: 0 g, Sleeve Seam: 0 g, Tie attachment with/without film: 0 g; No penetration can be observed) |
| ASTM F2407-20, Section 6.3 Flame Spread (16 CFR 1610) | To evaluate the flame resistance of the gown | Class 1 | Pass (Class 1) |
| Cytotoxicity Test: MEM Elution (ISO 10993-5:2009) | To evaluate the cytotoxic potential of the gown | Under conditions of the testing, non-cytotoxic | Pass (Under conditions of the testing, non-cytotoxic) |
| Sensitization Test: Kligman Maximization Test (ISO 10993-10:2021) | To evaluate the sensitization potential of the gown | Under conditions of the testing, not a sensitizer | Pass (Under conditions of the testing, not a sensitizer) |
| Primary Skin Irritation Test: Intracutaneous Injection Test (ISO 10993-10:2021) | To evaluate the skin irritation potential of the gown | Under conditions of the testing, not an irritant | Pass (Under conditions of the testing, not an irritant) |
| Sterilant Gas Residue Analysis (ISO 10993-7) | To verify low levels of residual ethylene oxide and ethylene chlorohydrin | 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.