(84 days)
The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health are worker from the transfer of microorganisms, body fluids and particulate matter.
The MicroCool gown is manufactured from a breathable, repellent, non-woven, polypropylene fabric, The fabric is a three-layer lamination that resists tearing and penetration by liquids. This disposable gown is supplied sterile or non-sterile.
This document describes the acceptance criteria and study results for the Kimberly-Clark MicroCool™ Surgical Gown and Isolation Gown.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Meet USP XXIII requirements (no evidence of component sensitizer) | No evidence of component sensitizer (met USP XXIII requirements) |
| Skin Irritation | No evidence of dermal irritation | No evidence of dermal irritation |
| Sterilant Residues | Levels of EO, EC, and EG within proposed FDA limits for medical devices that contact skin | Levels of EO, EC, and EG were each within the proposed FDA limits for medical devices that contact skin |
| Flammability | Meet Class I flammability requirements per 16 CFR Part 1610 | Meets Class I flammability requirements per 16 CFR Part 1610 |
| Fluid Penetration | Resist visual penetration by blood and viral penetration fluids (meet ASTM 1670-97 & ASTM F 903-96 requirements) | Resists visual penetration by blood and viral penetration fluids (met ASTM 1670-97 & ASTM F 903-96 requirements) |
| Viral Penetration | Resist viral penetration (meet ASTM F 1671-97a requirements) | Resists viral penetration (met ASTM F 1671-97a requirements) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gowns tested for fluid penetration). The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin specified. It is implied that the testing was conducted by or for Kimberly-Clark Corporation for regulatory submission to the FDA (USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (surgical gown) does not typically involve "expert" assessment for establishing ground truth in the same way a diagnostic imaging device would. The ground truth for these tests is defined by established scientific standards, methods, and regulatory requirements (e.g., USP XXIII, ASTM standards, CFR regulations). No number of experts or their qualifications are mentioned for establishing these ground truths, as they are based on standardized laboratory protocols.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically relevant for subjective assessments, particularly in clinical studies or image interpretation. For the chemical and physical tests conducted on the surgical gown, the results are objective and determined by laboratory equipment and standardized procedures. Therefore, no adjudication method is indicated or required.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. This type of study is not applicable to the evaluation of surgical gowns, which are assessed based on their material properties and barrier performance rather than diagnostic accuracy or human interpretation.
6. Standalone Performance Testing
The performance data presented in the "Summary of Testing" table is standalone performance, as it measures the intrinsic properties of the device (gown material) against established standards and criteria, without human intervention in the loop for assessment (beyond conducting the standardized tests).
7. Type of Ground Truth Used
The ground truth used for these tests is objective standards and regulatory requirements. This includes:
- USP XXIII requirements (for cytotoxicity)
- 16 CFR Part 1610 (for flammability)
- ASTM 1670-97 & ASTM F 903-96 (for fluid penetration)
- ASTM F 1671-97a (for viral penetration)
- Proposed FDA limits (for sterilant residues)
8. Sample Size for the Training Set
Surgical gowns are not typically "trained" in the way an AI algorithm is. Therefore, there is no "training set" in this context. The manufacturing process and quality control would be analogous to a training process, ensuring the gown consistently meets specifications, but there isn't a data set used for iterative algorithm improvement.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, a ground truth for a training set was not established. The "ground truth" for the overall device performance relies on its ability to consistently meet the objective standards outlined in section 7 during manufacturing and quality assurance.
§ 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.