(266 days)
The Surgical Isolation Gown is intended to protect 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 nonsterile.
The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to 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. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.
This document is a 510(k) premarket notification for a Surgical Isolation Gown. It aims to demonstrate substantial equivalence to a predicate device. Here's an extraction of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the device are largely based on meeting AAMI Level 3 barrier protection requirements as per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, and demonstrating biocompatibility.
| Acceptance Criteria (Set by ANSI/AAMI PB70:2012 Level 3 & ISO 10993) | Reported Device Performance (K171535) |
|---|---|
| Liquid Barrier Performance (AAMI Level 3) | |
| - Hydrostatic Head (AATCC 127) | CHEST/BACK/SLEEVE: Mean = 69 cm (Ind Min = 54, Ind Max = 84) - Meets Level 3 requirements, comparing favorably to predicate (Body/Sleeve: Mean = 69, Ind Min = 56, Ind Max = 84). |
| - Water Impact (AATCC-42) | Sleeve Seams: Mean = 0.04 g (Ind Min = 0.02, Ind Max = 0.08) |
| CHEST: Mean = 0.04 g (Ind Min = 0.02, Ind Max = 0.05) | |
| Back: Mean = 0.05 g (Ind Min = 0.04, Ind Max = 0.07) - Meets Level 3 requirements, comparing favorably to predicate (Body/Sleeve: Mean = 0.08, Ind Min = 0.05, Ind Max = 0.13). | |
| - Overall Liquid Barrier Classification | Device was tested in accordance with ANSI/AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. The critical zone areas tested were the chest, the back, the sleeve seam, the belt seam, and side seam. |
| Physical Properties | |
| - Grab tensile MD (ASTM D5034) | Mean = 20.71 lb (Ind Min = 19.73, Ind Max = 21.87) - Similar to predicate (Mean = 24.38, Ind Min = 21.94, Ind Max = 26.28). |
| - Grab tensile CD (ASTM D5034) | Mean = 12.21 lb (Ind Min = 11.20, Ind Max = 14.11) - Similar to predicate (Mean = 14.54, Ind Min = 12.70, Ind Max = 16.45). |
| - Trap Tear MD (ASTM D5587-15 Highest Peak) | Mean = 3.48 lbs (Ind Min = 2.82, Ind Max = 3.93) - Similar to predicate (Mean = 4.74, Ind Min = 3.67, Ind Max = 5.47). |
| - Trap Tear CD (ASTM D5587-15 Highest Peak) | Mean = 7.15 lbs (Ind Min = 6.20, Ind Max = 7.70) - Similar to predicate (Mean = 9.24, Ind Min = 7.54, Ind Max = 12.98). |
| - Flammability (CPSC, Part 1610) | Class I - Same as predicate. |
| Biocompatibility (ISO10993-5 and ISO10993-10) | Noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1. - Same as predicate. |
| Lint and other particles generated in dry state | SIDE A: OUTSIDE: TOTAL >0.3 1024, TOTAL >0.5 658 |
| SIDE B: INSIDE: TOTAL >0.3 1066, TOTAL >0.5 697 - Performance values not available for predicate, but provided for the new device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each performance test. However, for "Liquid Barrier Performance Classification Properties" for the proposed device, it mentions that "The critical zone areas tested were the chest, the back, the sleeve seam, the belt seam and side seam."
The data provenance is from non-clinical testing performed by Jingzhou Haixin Green Cross Medical Products Co., Ltd in China, as indicated by the applicant's address. The data is retrospective in the sense that these tests were conducted to support the 510(k) submission, not as a prospective clinical study involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes a medical device (surgical gown) and its physical and barrier properties. It relies on standardized testing protocols (like ANSI/AAMI PB70:2012, AATCC, ASTM, ISO) rather than expert-derived ground truth from imaging or clinical data. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic algorithms is not applicable here. The "ground truth" is established by the specified test methods and their performance criteria.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective physical and chemical measurements based on industry standards, not subjective interpretations requiring 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 a submission for a physical medical device (surgical gown), not an AI/software as a medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a submission for a physical medical device (surgical gown), not an AI/software as a medical device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is defined by the standardized test methods and their predetermined acceptance criteria (e.g., AAMI Level 3 specifications for barrier performance, Class I for flammability, non-cytotoxic/non-irritating/non-sensitizing for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. 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.