(106 days)
Surgical gowns 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, the surgical gowns met the requirements for Level 3 classification.
The proposed devices 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 proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile two types. Both the sterile and non-sterile surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification.
This document is a 510(k) Summary for a Surgical Gown (Sterile) and Surgical Gown (Non-sterile). It describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a "Technological Characteristic Comparison Table" (Table 2) that lists various performance criteria and the performance of the Subject Device (K202706). It implies that the acceptance criteria are met if the device's performance is similar to or meets the standards of the predicate devices or specified test methods.
| Item | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device K202706) |
|---|---|---|
| Weight per square (g) | Similar to predicate (e.g., 50g/m², 45g/m², 68g/m² or 44g/m²) | 55g/m² |
| Size | Similar to predicate (e.g., M, L, XL, XXL, XXXL, XXXL-XLONG or XL) | S, M, L, XL, XXL, XXXL |
| Flammability | Class I (as per 16 CFR Part 1610) | Class I |
| Hydrostatic pressure | >50 cm (as per AATCC 127:2017) | >50 cm |
| Water impact | ≤1.0 g (as per AATCC 42:2017) | ≤1.0 g |
| Breaking strength | >20N (as per ASTM D5034:2017) | >20N |
| Tearing strength | >20N (as per ASTM D5587:2019) | >20N |
| Linting | Log1015cm³/s/cm² (29 ft³/min/ft²) or >30 ft³/min/ft² (as per ASTM D737:2018) | >30 ft³/min/ft² |
| Material | Similar to SMS polypropylene nonwoven | SMS polypropylene nonwoven + Polyester |
| Level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity (as per ISO 10993-5:2009) | No Cytotoxicity |
| Biocompatibility: Irritation | No Irritation (as per ISO 10993-10:2010) | No Irritation |
| Biocompatibility: Sensitization | No Sensitization (as per ISO 10993-10:2010) | No Sensitization |
| Sterile | Sterile/Non-sterile | Sterile/Non-sterile |
| Seal Strength | (Not explicitly stated in table, but ASTM F88/F88M:2015 implies a criterion) | (Test performed, results not explicitly shown in table) |
| Seal Leaks | (Not explicitly stated in table, but ASTM F1929:2015 implies a criterion) | (Test performed, results not explicitly shown in table) |
| EO Sterilization Residuals | (Not explicitly stated in table, but ISO 10993-7:2008 implies a criterion) | (Test performed, results not explicitly shown in table) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for each non-clinical test or the provenance of the data (e.g., country of origin, retrospective/prospective). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The study involved non-clinical performance testing of a medical device (surgical gown), not studies requiring expert interpretation or ground truth establishment in a medical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment.
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
This section is not applicable. No clinical studies, MRMC studies, or AI components are mentioned in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical gown; it does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests were established by the performance specifications outlined in recognized standards such as ANSI/AAMI PB70:2012, 16 CFR Part 1610, AATCC 127:2017, AATCC 42:2017, ISO 9073-10:2003, ASTM D1683/D1683M:2017/(R)2018, ASTM D5587:2019, ASTM D5034:2017, ASTM D737:2018, ASTM F88/F88M:2015, ASTM F1929:2015, ISO 10993-7:2008, ISO 10993-5:2009, and ISO 10993-10:2010.
8. The sample size for the training set
This section is not applicable. There is no mention of a "training set" as this is a non-clinical device performance study, not a machine learning or AI-based study.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for this type of device submission.
§ 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.