ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

K222214 · Thi Total Healthcare Innovation GmbH · FXY · Oct 17, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K222214
• Device Name: ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
• Applicant: Thi Total Healthcare Innovation GmbH
• Product Code: FXY · General, Plastic Surgery
• Decision Date: Oct 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The ViVi® Surgical Helmet System 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® Surgical Helmet System provides a protective barrier for surgical personnel in the operating room. The system consists of a reusable, battery-powered helmet (with or without LED light) and a sterile, single-use hood. The helmet features dual fans: a primary fan to intake fresh air and a secondary fan to exhaust air away from the patient, preventing recirculation and managing heat/humidity. The hood, made of SMS nonwoven fabric with a polycarbonate face shield, attaches to the helmet via mechanical slots and hook-and-loop fasteners. The system is powered by a rechargeable Li-ion battery pack worn by the user. The device is operated by surgical personnel. The helmet provides a support structure for the hood and ensures proper positioning of the face shield. By maintaining airflow and providing a physical barrier, the system protects the wearer from infectious fluids and microorganisms while maintaining comfort during surgical procedures.

Clinical Evidence

No clinical data. The device was evaluated through non-clinical bench testing, including physical specifications (weight, noise, runtime), air quality (CO2 concentration, temperature, fogging), mechanical strength (tear/tensile), flammability (16 CFR 1610), laser resistance (ISO 11810), and biocompatibility (ISO 10993-5, -10, -23).

Technological Characteristics

System includes reusable plastic helmet (≤500g) and sterile SMS nonwoven hood with polycarbonate face shield. Powered by 14.4V Li-ion battery. Features dual-fan air circulation (3925–4775 rpm). Biocompatible materials (Lycra/EVAC foam pads). Complies with EN 166:2011 for eye protection. Sterilization of hood via Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for surgical personnel to provide a barrier between the operating environment and the user to protect against contamination and/or exposure to infectious body fluids and harmful microorganisms. Used with ViVi® Helmet or ViVi® Helmet HPL and ViVi® Hood.

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

• Zimmer TotalShield™ Surgical Helmet System (K132386)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

October 17, 2023

THI Total Healthcare Innovation GmbH % Albert Rego Consultant Albert Rego, Ph.D. Consulting 25401 Cabot Road. Suite 122 Laguna Hills, California 92653

Re: K222214

Trade/Device Name: ViVi® Surgical Helmet System (ViVi® Helmet HPL, ViVi® Hood) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXY Dated: September 21, 2022 Received: September 25, 2022

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.

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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" (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 (OS) 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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).

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Sincerely,

# Bifeng Qian -S

Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K222214

Device Name

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

Indications for Use (Describe)

The ViVi® Hood is used with the ViVi® Helmet and/or ViVi® Helmet HPL as the ViVi® Surgical Helmet System 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® Helmet and ViVi® Helmet HPL has a battery powered fan, which provides a continuous flow of air in the the ViVi® Hood.

The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood, must be worn over a ViVi® Helmet or ViVi® Helmet HPL.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## K222214 510(k) SUMMARY

(As required by 21 CFR 807.92)

| I. SUBMITTER: | Total Healthcare Innovation GmbH<br>Gewerbestrasse 4<br>Feistritz im Rosental, 9181, Austria<br>Tel: [phone]<br>Fax: [phone] |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Albert Rego, Ph.D Inc. |
| Phone: | [phone] |

SUBMISSION DATE: October 15, 2023

#### II. DEVICE

| TRADE NAME: | ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) |
|-------------|---------------------------------------------------------------------------|
|-------------|---------------------------------------------------------------------------|

| COMMON NAME: | Surgical Helmet System |
|-------------------------|------------------------------------------------------------------------------------------------------|
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | FXY |
| III. PREDICATE DEVICES: | Zimmer TotalShield™ Surgical Helmet System<br>510(k) Nr: K132386, Clearance date December 23rd, 2013 |

#### IV. DEVICE DESCRIPTION:

The ViVi" Surgical Helmet System is intended to be worn by surgical personnel to provide a barrier between the operating environment and the surgical personnel to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The ViVi" Surgical Helmet System is composed of sterile ViVi" Hood, which is used with the unsterile ViVi" Helmet or the unsterile 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. The components include a top-covering sterile surgical hood (ViVi" Hood), an air-exchanging surgical helmet (ViVi" Helmet), and an air-exchanging surgical helmet with LED light (ViVi" Helmet HPL). The surgical hood is sterilized with Ethylene Oxide (EO). The surgical hood is worn over the helmets. The unsterile accessories include a rechargeable Lithium lon battery pack, a battery holster, a 1-bay battery charger, a 4-bay battery charger, and a non-sterile set of three foam pads (ViVi® Muffle).

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Following table lists all reference numbers of the ViVi® Surgical Helmet System, including model, size dimensions, similarities, and differences.

| Model/Reference<br>number (REF) | Description | Size<br>(if applicable) | Category name | Similarities / Differences |
|---------------------------------|------------------------------------------------------------------------|-------------------------|----------------------------------------|-------------------------------------------------------------------------------------|
| 80100 | ViVi® Helmet | One size | Surgical helmet | Design, materials and<br>manufacturing technologies<br>are similar. ViVi Helmet HPL |
| 80130 | ViVi® Helmet HPL | One size | Surgical helmet | includes a LED light |
| 80200V | ViVi® Hood | One size | Surgical hood | N/A |
| 60402 | Battery Pack HW rechargeable<br>Li-Ion Battery for ViVi® system | N/A | Rechargeable<br>battery<br>(Accessory) | N/A |
| 60403 | Battery Holster for Battery Pack | N/A | Battery holster<br>(Accessory) | N/A |
| 60501 | 1-bay Battery Charger for<br>Battery Pack | N/A | Battery charger<br>(Accessory) | N/A |
| 60504 | 4-bay Battery Charger for<br>Battery Pack | N/A | Battery charger<br>(Accessory) | N/A |
| 60788 | ViVi® Muffle<br>(Foam pad set for ViVi® Helmet or<br>ViVi® Helmet HPL) | One size | Foam pads<br>(Accessory) | N/A |

#### SURGICAL HOOD

The ViVi" Hood is a one-piece head cover that is worn with a separate surgical gown, as shown in Picture 1. ViVi" Hood covers head and shoulders only. The blue SMS (Spunbond-Meltblown-Spunbond) nonwoven fabric is utilized throughout the hood.

The AAMI PB70 standard does not cover apparel from the head, face, and eyes. Therefore, the hoods and lens are exempt from classification under the AAMI PB70:2012 standard and contain no critical zones.

Image /page/5/Picture/5 description: In the image, a woman is wearing a blue surgical hood with a clear face shield. The hood covers her head and neck, and the face shield protects her face from splashes and sprays. The woman is looking to the side, and her expression is neutral. The background is white.

Picture 1: ViVi® Hood worn over ViVi® helmet without a surgical gown

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#### SURGICAL HOOD PARTS AND MATERIALS

Picture 2 illustrates the parts of the ViVi" Hood. In the table materials corresponding to the positions are listed.

Image /page/6/Figure/2 description: The image shows three different views of a head covering, possibly a balaclava or hijab. The first image shows a side view of the head covering, with the front part in blue and the back part in yellow, labeled with the numbers 1 and 2 respectively. The second image shows a front view of the head covering in blue, with the face opening labeled with the number 3. The third image shows a back view of the head covering in yellow, labeled with the number 2.

Picture 2: Illustration of positions and parts of ViVi® Hood

| Serial number /Position | Part description | Material |
|-------------------------|------------------|-----------------------|
| ① | Front panel | SMS nonwoven fabric |
| ② | Vent | 2-layer spunbond (PP) |
| ③ | Face Shield | Clear Polycarbonate |

#### SURGICAL HOOD SPECIFICATION

The table shown below provides an overview of the ViVi® Hood specification.

| Characteristic | Requirement | Test Method / Standard |
|-------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Specification | | |
| Sizes | Hood: one size | NA |
| Resistance to tears and<br>punctures | Tear Resistance compliant with<br>ASTM D5587 | ASTM D5587<br>Finished hood material sealed in sterile packaging with<br>production equipment and procedure, double<br>Sterilized, three non-consecutive lots |
| Fire protection | Compliant with<br>16 CFR-1610 class 1 | 16 CFR 1610<br>Finished hood material sealed in sterile packaging with<br>production equipment and procedure, double sterilized.<br>Three non-consecutive lots |
| Laser resistance | No ignition of SMS nowoven<br>fabric | ISO 11810:2015<br>Finished hood material sealed in sterile packaging with<br>production equipment and procedure, sterilized |
| Mechanical Specification | | |
| Strength | Tensile Strength compliant with<br>ASTM D5034 | ASTM D5034<br>Finished hood material sealed in sterile packaging with<br>production equipment and procedure, double sterilized |
| Durability | ViVi® Hood is single use devices | Labeling single use |
| Biological Specification | | |
| Biocompatibility of material in<br>contact with intact skin | No noticeable/will not elicit<br>Irritation/Reaction | ISO 10993-10:2021 Test for skin sensitization<br>ISO 10993-23:2021 Test for irritation (Intracutaneous<br>reactivity)<br>ISO 10993-5:2009 Test for in vitro cytotoxicity |

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#### SURGICAL HELMET

ViVi® Helmet is a non-sterile reusable surgical helmet covered with a sterile, single use surgical hood and is worn by healthcare professionals in the operating room during surgery. In addition, ViVi" Helmet also provides a support structure for ViVi" Hood and ensures positioning and fixation ViVi" Hood face shield on ViVi" Helmet. The ViVi" Helmet is also available with a battery-powered Light Emitting Diode (LED), ViVi Helmet HPL.

Wearing ViVi" Hood in combination with a separate surgical gown will cause hot and humid exhaust air to get trapped in the suit. This effect is promoted by the high barrier performance of the textiles in use, which has the downside of high resistance against free airflow through the textile. Therefore, the ViVi" Helmet has a built-in battery-operated primary fan to push fresh air into the suit. A second integrated battery-operated air fan actively pushes air through a vent out of the suit avoiding recirculation of air. The air leaves the suit at the back of the healthcare professional, away from the patient (see Picture 3).

Image /page/7/Picture/3 description: In the image, a man is wearing a medical helmet. The helmet is black and has a clear visor. The man is wearing a surgical cap under the helmet. Blue arrows are showing the airflow through the helmet. The man is wearing a green surgical gown.

Picture 3: Airflow provided by ViVi® Helmet

#### FOAM PADS (ViVi® Muffle)

ViVi" Helmet or ViVi" Helmet HPL contains three non-sterile foam pads named ViVi" Muffle (REF 50788) that are attached to the headband of the ViVi® helmet to increase user comfort. ViVi® Muffle consist of the garment (Lycra) and the foam (EVAC). The fabric encloses the foam. ViVi® Muffle consists of three components. The three components are identical in material, construct, and form, with the exception of the physical dimensions of these otherwise identical components They are replaceable if they are worn out or have to be changed due to hygienic reasons (e.g. sweating)

Image /page/7/Picture/7 description: The image shows a head-mounted device, possibly a VR headset or a similar wearable technology, placed on a mannequin head. The device has multiple components, including a top-head (crest-pad), forehead/temples (brow pad), and a neck (neck pad). The device is black and red, and the mannequin head is clear.

Picture 4: Position and contact areas of foam pads

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#### SURGICAL HELMET PARTS AND MATERIALS

Picture 5 illustrates the parts of the ViVi® Helmet HPL. In the following table materials corresponding to the positions are listed.

Image /page/8/Figure/2 description: The image shows a technical drawing of a product, with different views labeled as 'Front REF 80100', 'Front REF 80130', and 'Back REF 80100/80130'. The drawing includes numbered annotations pointing to specific parts of the product, such as 1, 2, 3, 5, 6, 8, 10, 11, 12, and 13. These numbers likely correspond to a parts list or a detailed explanation of the product's features. The drawing provides a comprehensive view of the product's design from different angles.

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| Picture 5: ViVi® Helmet components | |
|------------------------------------|--|
| | |

| Serial number<br>/Position | Part description | Material |
|----------------------------|----------------------------------------------------------------------------|--------------------------------|
| 1 | Primary fan intake | Plastic |
| 2 | Exhausted air fan intake | Plastic |
| 3 | Air duct and structure to hold ViVi® Hood | Plastic |
| 4 | Exhausted air nozzle | Plastic |
| 5 | Frame for positioning face shield of ViVi® Hood | Plastic |
| 6 | Attachment points- Hook and Loop strip to fix face<br>shield of ViVi® Hood | Nylon |
| 7 | Height adjustment strap | Plastic |
| 8 | Foam pads (ViVi® Muffle) | Lycra (garment)<br>EVAC (foam) |
| 9 | Headband adjustment knob and adjustable headband | Plastic |
| 10 | Headlight- LED light<br>(ViVi® Helmet HPL only) | Plastic, reinforced |
| | | Plastic, copper, aluminum |
| 11 | Light housing | Plastic |
| 12 | Headlight adjustment handle | Plastic |
| 13 | Headlight control button | Plastic |
| 14 | Power cable | Copper / Silicon |

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#### SURGICAL HELMET SPECIFICATION

The table shown below provides an overview of the ViVi® Helmet / ViVi® Helmet HPL specification.

| Characteristic | Requirement | Test Method/Standard |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Specification | | |
| Air Quality | ≤ 3°C temperature increase<br>≤5.000ppm CO2 concentration<br>(at ≤800ppm ambient concentration)<br>No fogging of face shield | Internal Test method<br>Temperature and CO2 measurement inside dressed<br>ViVi® Hood with ViVi® Helmet |
| Noise level | Less than predecessor product | Internal Test method<br>Noise measurement with ViVi® Helmet and<br>dressed ViVi® Hood (inside) |
| Operational Runtime | ≥4 hours (without LED light) | Internal Test method<br>Runtime test with ViVi® Helmet with Battery<br>pack |
| Mechanical Specification | | |
| Helmet weight | ≤500g | Internal Test method<br>ViVi® Helmet on calibrated scale |
| Gesture Control | Average score on five part rating<br>scale ≥4 (good) | Internal usability study on dressed ViVi® System |
| Biological Specification | | |
| Biocompatibility of material in<br>contact with intact skin | No noticeable/will not elicit<br>Irritation/Reaction | ISO 10993-10:2021 Test for skin sensitization<br>ISO 10993-23:2021 Test for irritation<br>(Intracutaneous reactivity)<br>ISO 10993-5:2009 Test for in vitro<br>cytotoxicity |

#### POWER SYSTEM

#### BATTERY PACK AND BATTERY HOLSTER

A rechargeable Lithium-ion (Li-ion) Battery pack provides the ViVi® Helmets with low voltage Direct Current (DC) electrical energy. The rechargeable Li-ion Battery pack is connected to the battery holster and the helmet power cord (see Picture 5). The rechargeable Li-ion Battery pack is purchased offthe-shelf by THI and provided for use with ViVi® Surgical Helmet System

Image /page/9/Picture/6 description: The image shows a head-mounted device with a battery pack. The device is black and red and is mounted on a clear plastic head. The battery pack is black and is connected to the device by a white power cord. The battery pack is labeled with the words "Battery pack" and "Battery holster".

Picture 6: Power connection to helmet

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The Battery holster serves as a receptacle for the Battery pack (see Picture 7). Additionally, the battery holster is used to fix the battery pack on users clothing (e.g. belt)

Image /page/10/Picture/1 description: The image shows a battery pack and a battery holster. The battery pack is labeled REF 60402, and the battery holster is labeled REF 60403. An orange arrow points from the battery pack to the battery holster, indicating that the battery pack is being inserted into the holster. The battery pack is gray and the battery holster is black.

Picture 7: Battery pack and battery holster

#### CHARGING OF BATTERY PACK

To recharge and store the rechargeable Li-ion Batteries Pack two types of battery chargers are available as accessories to the ViVi system. The charger is typically located in the scrub room of the operating theater and connected to the mains using a power plug

- . Bay Charger (REF 60501)
The 1- Bay Charger is intended to recharge one Battery pack. The charging bay is connected to a power supply which is connected to the mains with a power plug. The 1-Bay Charger is purchased off-the-shelf by THI and provided to charge Battery pack REF 60402

Image /page/10/Picture/7 description: The image shows a charging bay, a power supply, and a power plug. The charging bay is black and has a cradle-like shape. The power supply is also black and has a cable that connects to the charging bay. The power plug is black and has a country-specific design.

Picture 8: 1- Bay Charger

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- 4- Bay Charger (REF 60504) ●
The 4-Bay charger is intended to recharge four battery packs in parallel. The 4-Bay charger consists of four 1-Bay chargers (purchased off-the-shelf by THI as described above) which are built in a steel case. The 4-Bay charger is directly connected to the mains using a power plug.

Image /page/11/Picture/2 description: The image shows a black charging station with four charging docks. The charging station has a red stripe on the side and the word "Vivi" printed in red on the top. The charging station also has the letters "THI" printed on the bottom.

Picture 9: 4- Bay Charger

#### BATTERY PACK AND CHARGER SPECIFICATION

The table below provides a summary of the battery and charger specification

| REFERENCE NUMBER | 60402 | 60501 | 60504 |
|-----------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------|
| Product Description | Rechargeable Li-ion<br>Battery pack | 1-Bay Charger | 4-Bay Charger |
| Original Manufacturer | RRC Power Solutions | RRC Power Solutions | -- |
| Specification | Four cell Li-ion Battery pack | One bay charging module | Four bay charging module |
| Voltage/Capacity | 14,4V /49,7Wh | Input:100-240VAC<br>Output: 0-17,4VDC /<br>50W max. | Input:100-240VAC<br>Output: 4x 0-17,4VDC /<br>4x 50W max. |
| Battery Life time | >7 hours with ViVi® Helmet<br>>4 hours with ViVi® Helmet HPL<br>(LED on) | N/A | N/A |
| Charging time | 2,5 hours | N/A | N/A |
| Certifications | IEC 62133-2:2017<br>UN38.3 | EN ISO 60601-1:2006/A1:2013<br>EN ISO 60601-1-2:2015<br>FCC 15 Class B<br>cULus | EN ISO 60601-1:2006/A1:2013<br>EN ISO 60601-1-2:2015 |

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#### V. INDICATIONS FOR USE:

The ViVi® Hood is used with the ViV® Helmet and/or ViVi® Helmet HPL as the ViVi® Surgical Helmet System 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® Helmet and ViVi® Helmet HPL has a battery-powered fan, which provide a continuous flow of air in the ViVi® Hood.

The ViVi® Hood is a stand-alone head covers that may be worn with a separate surgical gown. The ViVi® Hood must be worn over a ViVi® Helmet or ViVi® Helmet HPL.

#### VI. INTENDED USE:

The ViVi® Surgical Helmet System 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.

#### VII. TECHNOLOGICAL CHARACTERISTICS:

| Characteristic Hood | Parameter / Value |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Personal Protective Equipment | EN 166:2011 Personal Eye Protection<br>- High speed particles (45m/s) – low energy impact<br>- Splashes of liquid |
| Face Shield - Field of View | >180° |
| Face Schield – Optical Quality<br>(acc. EN166 cl. 7.1.2.1) | Class 1 |
| Characteristic Helmet | Parameter / Value |
| Mass | 13,1 [oz] / 370 [g] |
| Fanspeed (primary fan) | variable 3925 – 4775 rpm |
| Accessories – Battery/ Charger | Parameter / Value |
| Voltage (nominal) | 14,4 [V] (DC) |
| Capacity (rated) | 3.450[mAh] |
| Weight | 8,1 [oz] / 230 [g] |
| Battery life | >7 [h] with ViVi® Helmet<br>>4 [h] with ViVi® Helmet HPL |
| Charging time (typical) | 2,5 [h] |

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#### VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

| Category | Candidate Device<br>ViVi® Surgical Helmet System<br>K222214 | Predicate Device<br>TotalShield™<br>Surgical Helmet System , K132386 | Comparison results |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Common Name | ViVi® Surgical Helmet System | TotalShield™ Surgical Helmet System | |
| Manufacturer | THI Total Healthcare Innovation Gmbh | Zimmer Surgical Inc. | |
| 510(k) Number | K222214 | K132386 | |
| Indication For Use | The ViVi® Hood is used with the ViVi® Helmet<br>and/or ViVi® Helmet HPL as the ViVi® Surgical<br>Helmet System to provide a barrier between the<br>operating environment and the surgical personnel<br>in order to protect against contamination and/or<br>exposure of infectious body fluids and harmful<br>microorganisms. | The TotalShield Zippered Surgical Toga and/or TotalShield<br>Surgical Hood is for use with the TotalShield Surgical Helmet<br>and/or TotalShield Advanced Surgical Helmet with LED light<br>as the TotalShield Surgical Helmet System that is intended<br>to be worn by surgical personnel to provide a barrier<br>between the operating environment and the surgical<br>personnel in order to protect against contamination and/or<br>exposure of infectious body fluids and harmful<br>microorganisms. | Similar |
| Target user group | Surgical personnel | Surgical personnel | Same |
| Conditions of use<br>Surgical Helmet | Non-sterile / reusable | Non-sterile / reusable | Same |
| Condition of use Surgical Hood | Sterile / Disposable / Single Use | Sterile / Disposable / Single Use | Same |
| System design / Operating<br>principle | The ViVi® Hood has been designed to properly fit<br>the ViVi® Helmet or ViVi® Helmet HPL in order to<br>be used together as the ViVi® Surgical Helmet<br>System. The ViVi® Hood is fastened to either the<br>ViVi® Helmet or ViVi® Helmet HPL with hook-and-<br>loop fasteners and a mechanical slot which ensures<br>also the position of the lens. The device acts as a<br>barrier between the operating environment and<br>the surgical personnel | The TotalShield Zippered Surgical Toga has been designed to<br>properly fit the TotalShield Surgical Helmet and Advanced<br>Surgical Helmet with LED Lighting in order to be used together<br>as the TotalShield Surgical Helmet System. The TotalShield<br>Zippered Surgical Toga or Surgical Hood is fastened to either<br>the TotalShield Surgical Helmet or Advanced Surgical Helmet<br>with LED Lighting with aid of hook-and-loop fasteners and<br>mechanical slot. The device acts as a barrier between the<br>operating environment and the surgical personnel | Similar |
| Category | Candidate Device<br>ViVi® Surgical Helmet System<br>K222214 | Predicate Device<br>TotalShield™<br>Surgical Helmet System , K132386 | Comparison result |
| Surgical gowns | | | |
| Sterilisation method Surgical<br>Hood | Ethylene oxide | Ethylene oxide | Same |
| Sterilisation Assurance Level<br>(SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Barrier Performance | Hood only<br>Hood and lens are exempt from classification under<br>AAMI PB70:2012 | ASTM 2407-06 (2013)<br>AAMI PB70 Level 3 compliant | Different |
| Material Front layer | SMS nonwoven with PE film | Single layer SMS nonwoven | Similar |
| Lens/Face Shield | Clear polycarbonate | PETG clear copolyester | Similar |
| Vent/Filter | Blended Synthetic Fiber Spunbound Polypropylene | Two-layer spunbond (Polypropylene) | Similar |
| Method of Hood attachment to<br>Surgical Helmet | Mechanical slot and hook and loop | Mechanical slot and hook and loop | Same |
| Color | Blue | Blue | Same |
| Sizes | Hood: single size | Hood: single size<br>Toga: 3 sizes (regular, large, extra large) | Same (for hood) |
| Surgical Helmet | | | |
| Air flow/conditioning | Air circulation provided by two integrated fans | Air circulation provided by integrated fan | Similar |
| Power supply | External Lithium-Ion battery pack connected by<br>cable | External Lithium-Ion battery pack connected by<br>cable | Same |
| Light option | Yes / LED light<br>(ViVi Surgical Helmet HPL) | Yes / LED light<br>(TotalShield Advanced Surgical Helmet) | Same |
| Helmet material | Plastic | Plastic | Same |
| LED Components | Plastic, reinforced | Aluminium, Stainless Steel | Different |

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#### IX. SUMMARY OF NON-CLINICAL TESTING

Laboratory testing regarding characteristics was performed on the ViVi® Surgical Helmet System to verify its safety and performance.

#### HELMET TESTING

| Characteristics | Test Method /Standard | Acceptance Criteria | Test Result |
|------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Weight | Internal Test | ≤ 500g (helmet) | PASS |
| Air Quality | Internal Test | ≤ 3°C temperature increase<br>≤ 0% RH increase<br>Below 5000 ppm CO2 concentration<br>(at ≤ 800 ppm ambient concentration)<br>No fogging of face shield | PASS |
| System Size | Internal Test | Significant lower crown line profile than<br>predecessor product | PASS |
| Noise | Internal Test | Noise level ≤ predecessor product | PASS |
| Operational<br>runtime | Internal Test | Battery runtime ≥4 hours<br>(without LED light) | PASS |
| Gesture Control | Internal Usability Test | Average score for 'ease of use': ≥ "4-good"<br>No score for 'ease of use' below "2-sufficient"<br>Score table: 5 ('very good') - 1 ('not sufficient') | PASS |

#### HOOD TESTING

| Characteristics | Test Method /Standard | Acceptance Criteria | Test Result |
|---------------------------------------------------------|-----------------------|---------------------------------------|-------------|
| Tear Resistance | ASTM D5587 | >10 N | PASS |
| Tensile Strengh | ASTM D5034 | >30 N | PASS |
| Fire protection<br>Flammability of<br>Clothing Textiles | 16 CFR 1610 | Fulfil requirements for Class 1 | PASS |
| Laser resistance | ISO 11810:2015 | No ignition | PASS |
| Ethylene Oxide<br>residuals | ISO 10993-7:2008 | EO: < 4mg/device<br>ECH: < 9mg/device | PASS |

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#### X. BIOCOMPATIBILITY EVALUATION

As shown in the table below, the user contact with the system is isolated to the foam pads (ViVi® Muffle) and the hood material. All non-contacting devices and their materials are exempt from the requirements of ISO 10993-1 and will not be further evaluated due to the lack of contact to the user or patient. This includes the ViVi Helmets with the exception of the foam pads (ViVi® Muffle) and the hood material.

| Characteristics | Test Method /Standard | Acceptance Criteria | Test<br>Result |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Biocompatibility<br>Foam Pads<br>(ViVi® Muffle) | ISO 10993-10:2021 Test for skin sensitization<br>ISO 10993-23:2021 Test for irritation<br>(Intracutaneous reactivity)<br>ISO 10993-5:2009 Test for in vitro cytotoxicity | Test for skin sensitization: Not sensitizing<br>Test for irritation: No irritation<br>Test for in vitro cytotoxicity: < grade2 (mild reactivity) | PASS |
| Biocompatibility<br>Hood material<br>(SMS nonwoven fabric) | ISO 10993-10:2021 Test for skin sensitization<br>ISO 10993-23:2021 Test for irritation<br>(Intracutaneous reactivity)<br>ISO 10993-5:2009 Test for in vitro cytotoxicity | Test for skin sensitization: Not sensitizing<br>Test for irritation: No irritation<br>Test for in vitro cytotoxicity: <grade2 (mild<br>reactivity) | PASS |

#### XI. Summary of CLINICAL STUDY

The ViVi® Surgical Helmet System composed of VIVi® Helmet HPL and ViVi® Hood was not subjected to clinical testing.

#### XII. CONCLUSIONS

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device Zimmer TotalShield™ Surgical Helmet System (K132386)