(63 days)
A BARRIER surgical gown is a single use article of surgical apparel 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 new BARRIER surgical gowns have high repellency areas ( front and lower sleeves) constructed from new breathable repellent materials.
This document describes the acceptance criteria and the study conducted for the new BARRIER surgical gowns.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Safety/Biocompatibility | New materials meet ISO 10993-1 requirements. |
| Flammability | New gowns meet Class I flammability requirements of 16CFR1610. |
| Resistance to Penetration by Bloodborne Pathogens | New gowns pass ASTM Standard Test Method 1671 (Resistance of Protective Clothing Materials to Penetration by Bloodborne Pathogens Using Viral Penetration as a Test System). |
| Breathability (compared to predicate) | New materials have higher breathability. |
| Strength (compared to predicate) | New materials have equivalent strength. |
| Repellency (compared to predicate) | New materials have equivalent repellency. |
| Weight (compared to predicate) | New fabrics are lighter. |
| High Repellency Zone Area (compared to predicate) | High repellency zones are larger in area dimensionally. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each material test. It mentions that the "new materials were tested versus the predicate materials in the applicable standard material evaluations."
- Test Set Sample Size: Not specified.
- Data Provenance: The document implies that the testing was performed internally by the manufacturer (Johnson & Johnson Medical) or by third-party labs on behalf of the manufacturer, following established industry standards. The country of origin of the data is not specified, but the submission is to the US FDA, suggesting the data would comply with US regulatory standards. The testing is for a new product undergoing premarket notification, implying prospective testing for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This document describes performance testing of a physical product (surgical gowns) based on established material science standards. The "ground truth" is determined by objective measurements and compliance with these standards, not by expert interpretation in a clinical context. Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging or diagnostics is not directly relevant here. The experts involved would be material scientists, engineers, and technicians conducting the specified tests and interpreting results according to the standards. No specific number or qualifications of these testing personnel are provided.
4. Adjudication Method for the Test Set
Not applicable. The tests described are objective material performance tests, where results are measured against defined criteria within the standard. There is no subjective interpretation or adjudication process as would be seen in clinical or diagnostic studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a submission for a physical medical device (surgical gown) based on material performance, not a diagnostic or AI-assisted device that would involve human readers.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Performance Testing Summary" section describes the results of the new materials and gowns being tested against various standards (Class I flammability, ASTM 1671, ISO 10993-1) and compared to the predicate device for breathability, strength, and repellency. This represents the performance of the device itself (the surgical gown) without human interaction in a diagnostic or interpretive capacity.
7. Type of Ground Truth Used
The ground truth used is based on:
- Objective Material Performance Standards: Compliance with recognized international and national standards (e.g., ISO 10993-1, 16CFR1610 Class I flammability, ASTM Standard Test Method 1671).
- Direct Comparison to Predicate Device Performance: The new materials were compared to predicate materials for properties like breathability, strength, and repellency, where the predicate's established performance serves as a comparative benchmark.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The performance is based on the physical properties of the materials and production processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.