(311 days)
The surgical gown is 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, the Surgical Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
The proposed devices have a SMS design that provides a PB70:2012 level 3 Liquid Barrier Performance Barrier.
The proposed devices are single use, disposable medical devices and can be provided in nonsterile. These surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL.
This document is a 510(k) summary for a surgical gown, not an AI/ML device. Therefore, the requested information regarding AI/ML device performance criteria, study design, expert involvement, and ground truth establishment is not applicable.
The document describes the acceptance criteria and the study proving the device meets these criteria for a Surgical Gown (Model: surgical gown-hp-3).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria (Predicate Device K202706 or Standard) | Reported Device Performance (surgical gown-hp-3) | Remark (for comparison to predicate) |
|---|---|---|---|---|
| Performance | ||||
| Water Resistance (Imp. Pen.) | AATCC TM42-2017e | ≤1.0g | ≤1.0g (Pass) | Same / Meet standard requirement |
| Water Resistance (Hydro. Res.) | AATCC 127 - 2017 (2018) | ≥50cm | ≥50m (Pass, Meet level 3 requirement) | Same / Meet standard requirement |
| Tensile Strength | ASTM D5034-09(2017) | ≥30N(7 lbf) | Pass (≥30N(7 lbf)) | Meet standard requirement (See Note 2) |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | Pass (≥10N(2.3 lbf)) | Meet standard requirement (See Note 2) |
| Seam Strength | ASTM D1683/D1683M-2011 | ≥30N(7 lbf) | Pass (≥30N(7 lbf)) | Meet standard requirement (See Note 2) |
| Flammability | 16 CFR Part 1610 | Class 1 | Class 1 (Pass) | Same |
| Biocompatibility | ||||
| Cytotoxicity | ISO 10993-5:2009 | No Cytotoxicity (under conditions of study) | Pass - Non-toxic | Same |
| Skin Sensitization | ISO 10993-10:2010 | No Irritation / Non-sensitizing (under conditions of study) | Pass - No Irritation / Non-sensitizing | Same |
| Skin Irritation | ISO 10993-10:2010 | No Sensitization / Non-irritating (under conditions of study) | Pass - No Sensitization / Non-irritating | Same |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to compliance with standards like ANSI/AAMI PB70:2012, ASTM F2407-20, ISO 10993-5, and ISO 10993-10, which would dictate the number of test samples required by those standards.
The data provenance is not explicitly stated as "country of origin," but the submitter (Weihai Dishang Medical Technology Co., Ltd) is located in Weihai, Shandong, China. The studies are non-clinical (laboratory tests), not patient-based data. These are prospective tests conducted on the device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device (surgical gown), not an AI/ML diagnostic or predictive device requiring expert review for ground truth. The "ground truth" here is established by the specifications and measurement methodologies defined in the referenced standards (e.g., AATCC, ASTM, ISO).
4. Adjudication method for the test set
Not applicable. This refers to laboratory testing against defined standards, not clinical assessment requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML system.
7. The type of ground truth used
The "ground truth" is defined by the acceptance criteria specified in internationally recognized performance standards for surgical gowns. These include:
- ANSI/AAMI PB70:2012 (Liquid barrier performance and classification of protective apparel and drapes)
- ASTM F2407-20 (Standard Specification for Surgical Gowns)
- AATCC TM42-2017e (Water Resistance: Impact Penetration Test)
- AATCC 127 - 2017 (2018) (Water Resistance: Hydrostatic Pressure Test)
- ASTM D5034-09(2017) (Tensile Strength)
- ASTM D5733-1999 (Tearing Strength)
- ASTM D1683/D1683M-2011 (Seam Strength)
- 16 CFR Part 1610 (Flammability)
- ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)
- ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)
8. The sample size for the training set
Not applicable. This is not an AI/ML product that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML product.
§ 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.