(182 days)
The Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The proposed Surgical Isolation Gown is constructed of Polypropylene SMS non-woven material with the color in blue. The melt-blown nonwovens are made of polypropylene. The Surgical isolation gown is different in size. The size of surgical isolation gown is divided into seven groups: S(160), M(165), L(170), XL(175), XXL(180), 3XL(185), 4XL(190).
The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
The device description of the Surgical Isolation Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
The provided text describes the regulatory clearance for a medical device, a Surgical Isolation Gown, and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. This document is a 510(k) summary, not a study describing the development of an AI algorithm or its performance in a clinical setting. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" (non-clinical testing) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Surgical Isolation Gown are primarily based on established industry standards and regulatory guidance for barrier performance, physical properties, flammability, and biocompatibility. The reported device performance is compared against these standards.
Table of Acceptance Criteria and Device Performance
| Test/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Proposed Device K203415) | Equivalence to Predicate (K190306) |
|---|---|---|---|
| Barrier Performance (AAMI PB70:2012) | AAMI Level 3 barrier protection | Meets AAMI Level 3 requirements | Same |
| Water Resistance (AATCC 42-2017) | Meets requirements for Level 3 per AAMI PB70:2012 | Met Level 3 requirements | Not explicitly compared in table, but overall meets AAMI L3. |
| Water Resistance (AATCC 127-2018) | Meets requirements for Level 3 per AAMI PB70:2012 | Met Level 3 requirements | Not explicitly compared in table, but overall meets AAMI L3. |
| Basic Weight (ASTM D3776/D3776M-09) | No explicit acceptance criterion given, but compared to predicate. | 60.7 g/m² (1.79 oz/yd²) | Similar (Predicate: 39.97 ± 1.61 g/m²) |
| Flammability (16 CFR Part 1610.7) | Class 1 Flammability | Class 1 | Same |
| Breaking Strength (MD) (ASTM D5034-09) | No explicit acceptance criterion given, but compared to predicate. | Mean: 175.5 N | Similar (Predicate: 18.17 ± 0.31 lbf) |
| Breaking Strength (CD) (ASTM D5034-09) | No explicit acceptance criterion given, but compared to predicate. | Mean: 118.0 N | Similar (Predicate: 11.78 ± 0.33 lbf) |
| Tearing Strength (MD) (ASTM D5587-2015) | No explicit acceptance criterion given, but compared to predicate. | Mean: 63.5 N | Similar (Predicate: 11.01 ± 0.64 lbf) |
| Tearing Strength (CD) (ASTM D5587-2015) | No explicit acceptance criterion given, but compared to predicate. | Mean: 34.5 N | Similar (Predicate: 5.30 ± 0.35 lbf) |
| Linting (ISO 9073-10:2004) | No explicit acceptance criterion given, but compared to predicate. | Particulate size range (μm): 3 to 25; Coefficient of linting log10 Min:2.2, Max:2.8, Mean: 2.5 (Face A); Min:2.5, Max:2.9, Mean:2.74 (Face B) | Similar (Predicate values also provided) |
| Cytotoxicity (ISO 10993-5:2009) | Non-Cytotoxic | Non-Cytotoxic | Same |
| Irritation (ISO 10993-10:2010) | Non-Irritating and Non-Sensitizing | Non-Irritating | Same |
| Sensitization (ISO 10993-10:2010) | Non-Irritating and Non-Sensitizing | Non-Sensitizing | Same |
2. Sample sized 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 exact sample sizes (number of gowns or material samples) used for each non-clinical test. The tests were performed according to recognized ASTM, AATCC, ISO standards, and FDA guidances. The data provenance is described as non-clinical tests performed on the proposed device, manufactured by YANBIAN PACIFIC TEXTILE CO., LTD in China. These would be prospective tests specifically conducted for this submission.
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 question is not applicable. The device is a surgical isolation gown, not an AI or diagnostic device that requires expert ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis. The "ground truth" for this device's performance is derived from standardized physical, chemical, and biological testing methods as defined by the mentioned international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers provide interpretations (e.g., radiological reads) and disagreement needs to be resolved. This is a physical device subject to standard laboratory testing.
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 not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance described is for a physical product, the Surgical Isolation Gown, in a standalone testing environment (laboratory tests).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on the objective measurements and pass/fail criteria defined within the specified international standards (e.g., AAMI PB70:2012 for barrier performance, ISO 10993 for biocompatibility, ASTM for physical properties).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned or required 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.