ViVi® Toga Premium

K243522 · Thi Total Healthcare Innovation GmbH · FYA · May 30, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K243522
• Device Name: ViVi® Toga Premium
• Applicant: Thi Total Healthcare Innovation GmbH
• Product Code: FYA · General, Plastic Surgery
• Decision Date: May 30, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Indications for Use

The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Device Story

ViVi® Toga Premium is a one-piece, sterile, single-use head and body cover worn by surgical personnel. It functions as a component of the ViVi® Surgical Helmet System, worn over an air-exchanging helmet (ViVi® Helmet or Helmet HPL). The device provides a physical barrier against infectious body fluids and microorganisms in the operating room. It attaches to the helmet via a mechanical slot and hook-and-loop fasteners. The device is constructed from SMS nonwoven material with PE film. It is intended to protect the wearer from the surgical environment; it does not provide active diagnostic or therapeutic functions.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ANSI/AAMI PB70:2012 (Level 4 barrier), ASTM F1671 (blood-borne pathogen resistance), ISO 10993 (biocompatibility: cytotoxicity, sensitization, irritation, systemic toxicity), ISO 11810 (laser resistance), ASTM D5587 (tear resistance), ASTM D5034 (tensile strength), ASTM F88/F88M (seam strength), ISO 9073-10 (linting), and ASTM E96 (water vapor transmission).

Technological Characteristics

Materials: SMS nonwoven with PE film. Barrier: ANSI/AAMI PB70:2012 Level 4. Biocompatibility: ISO 10993-5, -10, -11, -23. Mechanical: ASTM D5587, D5034, F88/F88M. Laser resistance: ISO 11810. Sterilization: Ethylene oxide (SAL 10^-6). Form factor: One-piece head/body cover, 3 sizes. Connectivity: None (mechanical attachment to helmet).

Indications for Use

Indicated for surgical personnel to provide a barrier between the operating environment and the user to protect against contamination and exposure to infectious body fluids and microorganisms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TotalShield™ II Zippered Surgical Toga and Hood (K192194)

Reference Devices

• ViVi® Surgical Helmet System (K222214)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 30, 2025

THI Total Healthcare Innovation GmbH
% Albert Rego
Consultant
Albert Rego PhD, Inc (d.b.a Rego Associates)
25401 Cabot Road, # 122
Laguna Hills, California 92653

Re: K243522
Trade/Device Name: ViVi® Toga Premium
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical apparel
Regulatory Class: Class II
Product Code: FYA
Dated: April 30, 2025
Received: April 30, 2025

Dear Albert Rego:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K243522 - Albert Rego
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

{2}

K243522 - Albert Rego
Page 3

Sincerely,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

Submission Number (if known)

K243522

Device Name

ViVi® Toga Premium;

ViVi® Toga Premium XL-XXL (82220);

ViVi® Toga Premium M-L (82221);

ViVi® Toga Premium XXS-S (82222);

ViVi® Toga Premium XL-XXL (including customer logo) (82220V);

ViVi® Toga Premium M-L (including customer logo) (82221V);

ViVi® Toga Premium XXS-S (including customer logo) (82222V)

Indications for Use (Describe)

The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}

THI

Total Healthcare Innovation GmbH

THI Total Healthcare Innovation GmbH

Gewerbestrasse 4

A-9181 Feistritz im Rosental

Tel: [phone]

Fax: [phone]

E-Mail: [e-mail]

# K243522 510(k) SUMMARY

## SUBMITTER:
THI Total Healthcare Innovation GmbH
Gewerbestrasse 4
9181 Feistritz
Austria
Tel.: [phone]

## SUBMITTER CONTACT:
Albert Rego, Ph.D. Inc.
25401 Cabot Road
Suite 122
Laguna Hills, CA 92653
Phone [phone]

## DATE:
May 30th, 2025

## TRADE NAME:
ViVi® Toga Premium

## PRODUCT CODE / DEVICE:
FYA – Gown, Surgical

## REGULATION NUMBER AND DESCRIPTION:
21 CFR 878.4040 – Surgical Apparel

## PREDICATE DEVICE:
TotalShield™ II Zippered Surgical Toga and Hood (K192194 cleared on October 15th, 2019)

## Reference Device:
ViVi® Surgical Helmet System (K222214 cleared on October 17th, 2024)

## DEVICE DESCRIPTION:
The ViVi® Toga Premium is a one-piece head and body cover that is worn by healthcare professionals.
The ViVi® Toga Premium is a component of the ViVi® Surgical Helmet System and worn over the air-exchanging surgical helmet. The ViVi® Toga Premium is used with the ViVi® Helmet or the ViVi® Helmet HPL (High Power LED) with Light Emitting Diode (LED) light to provide a barrier between the operating environment and the surgical personnel to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

ViVi® Toga Premium is designed and has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hood area and the lens are exempt from classification under this standard.

Page 1 of 5

{5}

THI

Total Healthcare Innovation GmbH

THI Total Healthcare Innovation GmbH

Gewerbestrasse 4

A-9181 Feistritz im Rosental

Tel: [phone]

Fax: [phone]

E-Mail: [e-mail]

# STATEMENT OF INTENDED USE:

The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

# COMPARISON TO PREDICATE:

The comparison of features and operation principles between ViVi® Toga Premium and predicate device TotalShieldTM II Zippered Surgical Toga and Hood (K192194) and reference device ViVi® Hood as part of the ViVi® Surgical Helmet System (Surgical Gown) (K222214) is listed as follows:

| Category | Subject Device
ViVi® Toga Premium
(Surgical Gown) | Predicate Device
TotalShield Surgical Helmet System
(Surgical Gown) | Reference Device
ViVi® Surgical Helmet System (Surgical Hood) | Comparison |
| --- | --- | --- | --- | --- |
| Common Name | ViVi® Toga Premium | TotalShieldTM II Zippered Surgical Toga and Hood | ViVi® Surgical Helmet System | |
| Manufacturer | THI Total Healthcare Innovation GmbH | Zimmer Surgical, Inc. | THI Total Healthcare Innovation GmbH | |
| 510(k) Number | K243522 | K192194 | K222214 | |
| Registration Number | 21 CFR 878.4040 | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Device Class | Class II | Class II | Class II | Same |
| Product Code | FYA | FYA | FXY | Same as predicate device |
| Classification Panel | General Hospital | General Hospital | General Hospital | Same |
| Indication For Use^{1} | The ViVi® Toga Premium is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. | The TotalShield II Zippered Surgical Toga and/or TotalShield II Surgical Hood is for use with the TotalShield II Surgical Helmet and/or TotalShield Surgical Helmet with LED lighting as the TotalShield Surgical Helmet System that is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. | The ViVi® Hood is a component of the ViVi® System and is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. | Same |
| Target user group | Surgical personnel | Operating Room Personnel | Surgical personnel | Similar |
| Condition of use
Surgical Hood or Toga | Sterile / Disposable / Single Use | Sterile / Disposable / Single Use (Gowns) | Sterile / Disposable / Single Use (Gowns) | Same |

Page 2 of 5

{6}

THI

Total Healthcare Innovation GmbH

THI Total Healthcare Innovation GmbH

Gewerbestrasse 4

A-9181 Feistritz im Rosental

Tel: [phone]

Fax: [phone]

E-Mail: [e-mail]

| Category | Subject Device
ViVi® Toga Premium
(Surgical Gown) | Predicate Device
TotalShield Surgical Helmet
System
(Surgical Gown) | Reference Device
ViVi® Surgical Helmet
System (Surgical Hood) | Similarities/Differences |
| --- | --- | --- | --- | --- |
| Materials Technology Product Features | | | | |
| Sterilization of Gown | Yes | Yes | Yes | Same |
| Sterilization method Surgical Hood or Toga | Ethylene oxide | Ethylene oxide | Ethylene oxide | Same |
| Sterilization Assurance Level (SAL) | 10^{6} | 10^{6} | 10^{6} | Same |
| Barrier Performance | ANSI/AAMI PB70:2012 Level 4 compliant
ASTM F2407-06 (2013) | AAMI/ANSI PB70:2012 Level 4 compliant
ASTM F2407-06 (Reapproved 2013) Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | ASTM F2407-06 (2013) | Same |
| Method of Hood/Toga attachment to Surgical Helmet | Mechanical slot and hook and loop (Velcros®) | Hook-and-loop | Mechanical slot and hook and loop (Velcros®) | Similar |
| Material | SMS nonwoven with PE film | Base material SMS Nonwoven with PE Film reinforcement in critical zones | SMS nonwoven with PE film | Similar |
| Biocompatibility | ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization
ISO 10993-23 Irritation | ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization
ISO 10993-23 Irritation | ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization
ISO 10993-23 Irritation | Same |
| Sizes | Toga: 3 sizes
(XXL-XL; L-M; S-XXS) | Large, X-Large, 2X-Large, 3X-Large | Hood: single size | Similar |

Page 3 of 5

{7}

THI

Total Healthcare Innovation GmbH

THI Total Healthcare Innovation GmbH

Gewerbestrasse 4

A-9181 Feistritz im Rosental

Tel: [phone]

Fax: [phone]

E-Mail: [e-mail]

# NON-CLINICAL PERFORMANCE DESCRIPTION:

During the design and development of the ViVi® Toga Premium, the following tests were conducted and completed.

## Level 4 liquid barrier performance according to:

ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities

ASTM Method F1671/F1671M Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

## Biocompatibility according to:

ISO 10993-1 Biological evaluation of medical devices Evaluation and testing within a risk management process

ISO 10993-5 Biological Evaluation of Medical Devices - Part 5(2009): Tests for In Vitro Cytotoxicity

ISO 10993-10 Biological Evaluation of Medical Devices – Part 10(2021) Test for Skin Sensitization

ISO 10993-11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

ISO 10993-23 Biological Evaluation of Medical Devices – Part 23(2021): Tests for Irritation)

## Laser Resistance of surgical drapes according to:

ISO 11810 Lasers and laser-related equipment — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers — Primary ignition, penetration, flame spread and secondary ignition

## Tear Resistance according to:

ASTM D5587 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure

## Tensile test according to:

ASTM D5034 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)

## Seam Strength according to:

ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials

## Lint and other particle generation according to:

ISO 9073-10:2005 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state

## Water Vapor Transmission according to:

ASTM E96/E96M-24A Standard Test Methods for Water Vapor Transmission of Materials

Page 4 of 5

{8}

THI

Total Healthcare Innovation GmbH

THI Total Healthcare Innovation GmbH

Gewerbestrasse 4

A-9181 Feistritz im Rosental

Tel: [phone]

Fax: [phone]

E-Mail: [e-mail]

# PERFORMANCE COMPARISON TO PREDICATE

| Property or Characteristics | Test Method | Predicate Device TotalShield Surgical Helmet System (Surgical Gown) K192194 | Subject Device ViVi® Toga Premium (Surgical Gown) K243522 |
| --- | --- | --- | --- |
| Flammability of clothing textiles | 16 CFR 1610 | Class 1 compliant PASS | Class 1 compliant PASS |
| Biological evaluation | ISO 10993-5 Cytotoxicity
ISO 10993-10 Sensitization
ISO 10993-23 Irritation | Compliant PASS | Compliant PASS |
| Tear Resistance | ASTM D5587 | Compliant PASS | Compliant PASS |
| Tensile Strength | ASTM D5034 | Compliant PASS | Compliant PASS |
| Seam Strength | ASTM F88/F88M | Compliant PASS | Compliant PASS |
| Laser Resistance | ISO 11810:2015 | Compliant PASS | Compliant PASS |
| Linting | ISO 9073-10:2005 | Compliant PASS | Compliant PASS |
| Water Vapor Transmission rate | ASTM E96 | Compliant PASS | Compliant PASS |
| Barrier Performance | ANSI/AAMI PB70:2012 | Compliant Level 4 PASS | Compliant Level 4 PASS |

# CLINICAL PERFORMANCE:

No clinical evaluation is necessary for this device.

# CONCLUSION:

The conclusions drawn from the nonclinical tests demonstrate that the ViVi® Toga Premium is as safe, as effective, and performs as well as or better than the predicate device.

Page 5 of 5