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.

Device Description

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.

AI/ML Overview

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."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 18, 2018

Vestagen Protective Technologies, Inc. Scott Pease Sr. Vice President of Regulatory and Quality 1301 W. Colonial Dr. Orlando, Florida 32804

Re: K180217

Trade/Device Name: VESTEX Apparel ("VESTEX") Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: QBW Dated: April 16, 2018 Received: April 17, 2018

Dear Scott Pease:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180217

Device Name VESTEX® Apparel ("VESTEX")

Indications for Use (Describe)

VESTEX Apparel is not intended to replace personal protective equipment.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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VESTEX® Apparel "Vestex"

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Vestagen Protective Technologies, Inc. 1301 W. Colonial Dr. Orlando. FL 32804

(o) 407.781.2572 (m) 678.689.8010

Contact Person: Scott Pease, Sr. Vice President of Regulatory and Quality (scott.pease@vestagen.com)

Date Prepared: May 3, 2018

Name of Device	VESTEX® Apparel
Common or Usual Name	Healthcare Practitioner Apparel (Scrub)
Classification Name	Suit, Surgical
Product Code / RegulationClassification	QBW / 21 CFR § 878.4040 Class II
Predicate Devices	K891212 (Aprons, Scrub Slacks & Tops, Patient Drape) -Pro-Safe Professional Linens. Inc.

Indications for Use

VESTEX Apparel is not intended to replace personal protective equipment.

Device Description / Technological Characteristics

VESTEX® does not replace PPE worn for specific use and during episodes of expected blood, body fluid and other potentially infectious material (OPIM) exposure.

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Performance Data

Biocompatibility and functional bench testing performed by Vestagen Protective Technologies, Inc. demonstrates VESTEX® Apparel substantial equivalence, in terms of the safety and effectiveness, to the referenced predicate device. In vitro bench testing included an assessment of all design input requirements and confirmation that the output of the design process met all design input requirements was completed, including those relating to appropriate standards and guidance's, as follows:

Biocompatibility

ISO 10993-1:2009 Biological Evaluation of Medical Devices- Part I: ● Evaluation and Testing
- Skin Sensitization O
- Irritation O
- Cytotoxicity O

Functional

ASTM D1424-09:2013 Tearing Strength of Fabrics by Falling-Pendulum ● (Elemdorf-Type) Apparatus
. Fabric Clinical Environment / Reuse
- Pre-Conditioning o
- O Fluid Repellency: Spray Test
- Splatter Testing (Reduction of MRSA Retention) O
- Cleaning Validation O

Additionally, in a randomized, blinded, crossover trial within a medical ICU, VESTEX® apparel demonstrated its effectiveness in reducing accumulation of Methicillin Resistant Staphylococcus aureus (MRSA) on health care workers (HCW) clothing 1 compared to control clothing. The MRSA reduction as statically significant both at the beginning and end of a 12 hour work shift.

1. 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.

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Feature	Subject Device (K180217)	Predicate Device(K891212)
Intended Use /Indications	VESTEX® Apparel (“VESTEX”),scrub tops, pants, skirts, and lab coatsare apparel that provides fluidrepellency and reduces the retention ofMethicillin Resistant Staphylococcusaureus (MRSA) on the surface (outerlayer) of the apparel.The ability of VESTEX to reduce theretention of MRSA on the fabricsurface has not been shown tocorrelate with the reduction ofinfections. Clinical studies to evaluatereduction in infection have not beenperformed for this device.	Protective apparel fordentists to prevent themigration of bacteria andliquids.
	VESTEX Apparel is not intended toreplace personal protective equipment.
Materials ofConstruction	79% Polyester, 18% Rayon, 3%Spandex	65% polyester, 35% cottonback with Barrier Supreme®50% cotton 50% polyesterfront.
Design Features	One layer of fabric constructed as anactive barrier. Exterior has a dualmechanism of action to include a fluidbarrier and antimicrobial agent.Interior has moisture wicking on theskin touching side of the fabric.	One layer of fabric ScrubTop and Slacks constructedwith a fluid resistant fabric infront of the garment.
PerformanceTesting	Biocompatibility:Yes - ISO 10993-1	Biocompatibility:Not available
	Fluid Repellency (@ 0 & 50 washes):Yes - Simulated Worst Case Study(Variation of AATCC22)	Fluid Repellency (@ 0 & 50washes):Yes - AATCC22
	Durability & Tear Strength:Yes - ASTM D1424	Durability & Tear Strength:Yes - ASTM D2261
	Splatter Challenge (Reduction ofMRSA Retention @ 0 & 50 Washes):Yes - Simulated Worst Case Study	Reduction of MSRARetention:No
	Clinical TrialYes - Bearman, GML, et al. ACrossover Trial of AntimicrobialScrubs to Reduce Methicillin-Resistant Staphylococcus aureusBurden on Healthcare Worker Apparel	Clinical TrialNo

Summary of Substantial Equivalence

Based upon the device description, technical characteristics and test data provided within this submission, VESTEX® Apparel is substantially equivalent to the referenced predicate devices.

Regulation Number and Section

§ 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.