(113 days)
VESTEX® Apparel ("VESTEX"), scrub tops, pants, skirts, and lab coats are apparel that provides fluid repellency and reduces the retention of Methicillin Resistant Staphylococcus aureus (MRSA) on the surface (outer layer) of the apparel.
The ability of VESTEX to reduce the retention of MRSA on the fabric surface has not been shown to correlate with the reduction of infections. Clinical studies to evaluate reduction in infection have not been performed for this device.
VESTEX Apparel is not intended to replace personal protective equipment.
VESTEX® Apparel is nonsterile, reusable, fluid repellant apparel containing an antimicrobial agent that is designed for continuous wear to provide protection to healthcare workers where intermittent or unexpected exposure to microorganisms from blood, body fluids and other potentially infectious material (OPIM) can occur.
VESTEX® does not replace PPE worn for specific use and during episodes of expected blood, body fluid and other potentially infectious material (OPIM) exposure.
VESTEX® has a dual mechanism of action that is fluid repellant and an antimicrobial agent. VESTEX® has a proprietary application method used to covalently bond a fluid repellent and an antimicrobial agent to the outer surface of the fabric.
The primary mechanism of action is a fluid repellant fabric surface which acts to resist bacteria acquisition on the fabric. As the fluids and pathogens are repelled, the numbers of microorganisms that remain on the fabric are significantly reduced.
The secondary mechanism of action is an antimicrobial agent. It has one of several possible modes of action, including disruption of the cell membrane, denaturation of cell surface and transmembrane proteins, and inactivation of bio-energetic systems to prevent the microorganisms from being retained on the fabric. This secondary mechanism of action reduces Methicillin Resistant Staphylococcus aureus (MRSA) on the surface (outer layer) of the apparel.
The document refers to a medical device called "VESTEX® Apparel". The "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in the "Performance Data" and "Summary of Substantial Equivalence" sections.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in a table format within the provided text. However, the performance data section lists the types of tests performed and implies that the device met these criteria to demonstrate substantial equivalence to its predicate. The "Performance Testing" table serves as a good summary of the tests conducted and "reported device performance" as simply "Yes" that the test was completed.
| Feature / Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Evaluation and testing for biological compatibility as per ISO 10993-1. | Yes (ISO 10993-1: Skin Sensitization, Irritation, Cytotoxicity) |
| Functional - Tearing Strength | Meet standards for tearing strength as per ASTM D1424-09:2013. | Yes (ASTM D1424-09:2013) |
| Functional - Fluid Repellency | Maintain fluid repellency after exposure (e.g., washes). | Yes (Simulated Worst Case Study (Variation of AATCC22) at 0 & 50 washes) |
| Functional - Splatter Testing (Reduction of MRSA Retention) | Demonstrate reduction of MRSA retention on the fabric surface. | Yes (Simulated Worst Case Study at 0 & 50 washes) |
| Functional - Cleaning Validation | Demonstrate effective cleaning. | Yes |
| Clinical Environment / Reuse - MRSA Reduction on HCW Clothing | Reduce accumulation of MRSA on healthcare worker (HCW) clothing compared to control clothing in a clinical setting. | Yes (Statistically significant MRSA reduction at the beginning and end of a 12-hour work shift) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Trial): Not explicitly stated in terms of the number of individuals or apparel items. The study is described as a "randomized, blinded, crossover trial."
- Data Provenance: The referenced clinical study is:
- Bearman, GML, et al. "A Crossover Trial of Antimicrobial Scrubs to Reduce Methicillin-Resistant Staphylococcus aureus Burden on Healthcare Worker Apparel." Infection Control and Hospital Epidemiology. Vol. 33, No. 3 (March 2012), pp. 268-275.
- This is a prospective study, indicated by its design as a "crossover trial."
- The document does not explicitly state the country of origin of the data, but Infection Control and Hospital Epidemiology is a US-based journal, suggesting a US context for the study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text, as the studies are mainly bench-top analyses and a clinical trial evaluating microbial load, not diagnostic interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable as the evaluation is not based on expert interpretation of results that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
- No, an MRMC comparative effectiveness study was not done. The device is apparel, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The "device" is a physical apparel item, not an algorithm. The performance tests are for the material properties and efficacy of the apparel itself.
7. The Type of Ground Truth Used
- For the bench testing (Biocompatibility, Fluid Repellency, Tearing Strength, Splatter Testing, Cleaning Validation): The ground truth is established by standardized laboratory testing procedures and protocols (e.g., ISO, ASTM, AATCC methods). The "truth" is the measured outcome against specified performance benchmarks (though the specific numerical benchmarks aren't provided in the summary).
- For the clinical trial: The ground truth was based on the measured accumulation of Methicillin Resistant Staphylococcus aureus (MRSA) burden on healthcare worker apparel, which likely involved quantitative microbial cultures.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
§ 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.