(275 days)
Surgical gowns 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.
The surgical gown is 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. It is made of soft, air permeable SMS non-woven fabric.
This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown (K141467). It reports the device's technical specifications and compares them to predicate devices to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices, where the proposed device's performance is expected to be similar or better than that of the predicates, specifically meeting or exceeding their reported values or "Met acceptance criteria."
| Specification | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| Material | SMS | SMS |
| Weight per square (g) | Predicate 1: 45; Predicate 2: 50 | 45 |
| Durability | Disposable | Disposable |
| Color | Predicate 1: Blue; Predicate 2: Various | Blue |
| Reinforced area | Predicate 1: PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs; Predicate 2: polypropylene/polyethylene protective reinforcement | air permeable membrane composite PE+ PP, double barrier non-woven fabric |
| Hydrostatic pressure: AATCC 127 | Predicate 1: >20 cm; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1) | >50 cm (This is significantly better than Predicate 1 and meets/exceeds the implied criteria for Predicate 2) |
| Impact penetration: AATCC 42 | Predicate 1: ≤1; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1) | ≤1 (Meets criteria) |
| Biocompatibility | Predicate 1: not an irritant, not a sensitizer, non-cytotoxic; Predicate 2: not an irritant, not a sensitizer, non-cytotoxic | not an irritant, not a sensitizer, non-cytotoxic (Meets criteria for both) |
| Tensile strength: ASTM D 5034 | Predicate 1: Length(lbf): 17.2, Width(lbf): 25.3; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1) | Length(lbf): 17.7, Width(lbf): 25.7 (Slightly better than Predicate 1 and meets/exceeds implied criteria for Predicate 2) |
| Tearing strength: ASTM D 5733 | Predicate 1: Length yarns torn(lbf): 4.5, Width yarns torn(lbf): 9.6; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1) | Length yarns torn(lbf): 4.7, Width yarns torn(lbf): 9.8 (Slightly better than Predicate 1 and meets/exceeds implied criteria for Predicate 2) |
| Seam strength: ASTM D 1683 | Predicate 1: Armhole seam (lbf) 17.4(F.B.), Shoulder seam (lbf) 9.4(F.B.); Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1) | Armhole seam (lbf) 17.6(F.B.), Shoulder seam (lbf) 9.5(F.B.) (Slightly better than Predicate 1 and meets/exceeds implied criteria for Predicate 2) |
| Flammability: 16 CFR Part 1610 | Predicate 1: Class 1; Predicate 2: Met acceptance criteria | Class 1 (Meets criteria) |
| Sterilization method | EO | EO |
| Resistance to blood and liquid penetration | Predicate 1: Level 4 per AAMI PB70; Predicate 2: Level 4 per AAMI PB70 | |
| (Note: The proposed device is Level 3, which is lower than the predicates. This could be a point of discussion for substantial equivalence, though the FDA cleared it.) | Level 3 per AAMI PB70 | |
| (This is lower than the predicate devices, which are Level 4. The FDA determines substantial equivalence based on the totality of the information, potentially considering if Level 3 is still sufficient for the intended use or if the predicate also had Level 3 models.) |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set used for each specific test (e.g., Hydrostatic pressure, Tensile strength). These are standardized tests, and the sample size would be defined by the relevant ASTM/AATCC standards.
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. However, given that XuChang ZhengDe Environstar Medical Products Co., Ltd is based in China, it is highly probable that the testing was conducted in China. The testing would be prospective for the purpose of demonstrating device performance to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the performance testing of a physical medical device (surgical gown) against established engineering and material standards. Therefore, the "ground truth" is established by the results of physical and chemical tests performed by qualified technicians in accredited laboratories using the specified methodologies (e.g., AATCC 127, ASTM D 5034). There is no "ground truth" established by human experts in the way that would apply to imaging or diagnostic AI devices.
4. Adjudication Method for the Test Set
Not applicable for a physical device performance test. The results are quantitative measurements or classifications (e.g., Class 1 for flammability).
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 a physical device (surgical gown), not a diagnostic or AI-driven decision support system. Therefore, MRMC studies involving human readers and AI are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth is established through:
- Performance against established industry standards: Such as AATCC 127 (Hydrostatic Pressure), AATCC 42 (Impact Penetration), ASTM D 5034 (Tensile Strength), ASTM D 5733 (Tearing Strength), ASTM D 1683 (Seam Strength), 16 CFR Part 1610 (Flammability), and AAMI PB70 (Resistance to blood and liquid penetration).
- Biocompatibility testing: To demonstrate non-irritancy, non-sensitization, and non-cytotoxicity.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of physical medical device performance testing, as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.