K Number
K222214
Device Name
ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Date Cleared
2023-10-17

(449 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
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).
More Information

Not Found

No
The device description and performance studies focus on physical characteristics, air flow, and barrier protection, with no mention of AI/ML capabilities or data processing.

No
The device is described as a "Surgical Helmet System" intended to provide a barrier against contamination and exposure to infectious materials for surgical personnel, not for treating or diagnosing a disease or condition in a patient.

No
Explanation: The device is a protective barrier system for surgical personnel, designed to prevent contamination and exposure to infectious materials, not to diagnose medical conditions.

No

The device description clearly outlines multiple hardware components including a helmet, battery-powered fan, LED light, battery pack, battery holster, chargers, and foam pads. It is a physical system, not software only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to provide a physical barrier for surgical personnel to protect against contamination and exposure to infectious materials. This is a protective function for the user, not a diagnostic test performed on a sample from a patient.
  • Device Description: The description details a system of a hood and helmet designed for personal protection in a surgical environment. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
  • Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to assays, reagents, or any other elements typically associated with in vitro diagnostics.
  • Performance Studies: The performance studies focus on physical characteristics, air quality, safety, and operational aspects of the protective system, not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc.

In summary, the ViVi® Surgical Helmet System is a personal protective equipment (PPE) designed for surgical personnel, not a device used to perform diagnostic tests on patient samples.

N/A

Intended Use / Indications for Use

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.

Product codes

FXY

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgical personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

HELMET TESTING

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

HOOD TESTING

  • Tear Resistance: ASTM D5587, Acceptance Criteria: >10 N, Test Result: PASS
  • Tensile Strengh: ASTM D5034, Acceptance Criteria: >30 N, Test Result: PASS
  • Fire protection Flammability of Clothing Textiles: 16 CFR 1610, Acceptance Criteria: Fulfil requirements for Class 1, Test Result: PASS
  • Laser resistance: ISO 11810:2015, Acceptance Criteria: No ignition, Test Result: PASS
  • Ethylene Oxide residuals: ISO 10993-7:2008, Acceptance Criteria: EO:

§ 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.

0

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.

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

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

3

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
Gewerbestrasse 4
Feistritz im Rosental, 9181, Austria
Tel: +43 4228 30 100-14
Fax: +43 4228 30 100-20 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Albert Rego, Ph.D Inc. |
| Phone: | (949) 632-8126 |

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
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).

5

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

| Model/Reference
number (REF) | Description | Size
(if applicable) | Category name | Similarities / Differences |
|---------------------------------|------------------------------------------------------------------------|-------------------------|----------------------------------------|-------------------------------------------------------------------------------------|
| 80100 | ViVi® Helmet | One size | Surgical helmet | Design, materials and
manufacturing technologies
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
Li-Ion Battery for ViVi® system | N/A | Rechargeable
battery
(Accessory) | N/A |
| 60403 | Battery Holster for Battery Pack | N/A | Battery holster
(Accessory) | N/A |
| 60501 | 1-bay Battery Charger for
Battery Pack | N/A | Battery charger
(Accessory) | N/A |
| 60504 | 4-bay Battery Charger for
Battery Pack | N/A | Battery charger
(Accessory) | N/A |
| 60788 | ViVi® Muffle
(Foam pad set for ViVi® Helmet or
ViVi® Helmet HPL) | One size | Foam pads
(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

6

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 /PositionPart descriptionMaterial
Front panelSMS nonwoven fabric
Vent2-layer spunbond (PP)
Face ShieldClear Polycarbonate

SURGICAL HOOD SPECIFICATION

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

CharacteristicRequirementTest Method / Standard
Physical Specification
SizesHood: one sizeNA
Resistance to tears and
puncturesTear Resistance compliant with
ASTM D5587ASTM D5587
Finished hood material sealed in sterile packaging with
production equipment and procedure, double
Sterilized, three non-consecutive lots
Fire protectionCompliant with
16 CFR-1610 class 116 CFR 1610
Finished hood material sealed in sterile packaging with
production equipment and procedure, double sterilized.
Three non-consecutive lots
Laser resistanceNo ignition of SMS nowoven
fabricISO 11810:2015
Finished hood material sealed in sterile packaging with
production equipment and procedure, sterilized
Mechanical Specification
StrengthTensile Strength compliant with
ASTM D5034ASTM D5034
Finished hood material sealed in sterile packaging with
production equipment and procedure, double sterilized
DurabilityViVi® Hood is single use devicesLabeling single use
Biological Specification
Biocompatibility of material in
contact with intact skinNo noticeable/will not elicit
Irritation/ReactionISO 10993-10:2021 Test for skin sensitization
ISO 10993-23:2021 Test for irritation (Intracutaneous
reactivity)
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.

4 D

్ర

(14)

Picture 5: ViVi® Helmet components

| Serial number

/PositionPart descriptionMaterial
1Primary fan intakePlastic
2Exhausted air fan intakePlastic
3Air duct and structure to hold ViVi® HoodPlastic
4Exhausted air nozzlePlastic
5Frame for positioning face shield of ViVi® HoodPlastic
6Attachment points- Hook and Loop strip to fix face
shield of ViVi® HoodNylon
7Height adjustment strapPlastic
8Foam pads (ViVi® Muffle)Lycra (garment)
EVAC (foam)
9Headband adjustment knob and adjustable headbandPlastic
10Headlight- LED light
(ViVi® Helmet HPL only)Plastic, reinforced
Plastic, copper, aluminum
11Light housingPlastic
12Headlight adjustment handlePlastic
13Headlight control buttonPlastic
14Power cableCopper / Silicon

9

SURGICAL HELMET SPECIFICATION

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

CharacteristicRequirementTest Method/Standard
Physical Specification
Air Quality≤ 3°C temperature increase
≤5.000ppm CO2 concentration
(at ≤800ppm ambient concentration)
No fogging of face shieldInternal Test method
Temperature and CO2 measurement inside dressed
ViVi® Hood with ViVi® Helmet
Noise levelLess than predecessor productInternal Test method
Noise measurement with ViVi® Helmet and
dressed ViVi® Hood (inside)
Operational Runtime≥4 hours (without LED light)Internal Test method
Runtime test with ViVi® Helmet with Battery
pack
Mechanical Specification
Helmet weight≤500gInternal Test method
ViVi® Helmet on calibrated scale
Gesture ControlAverage score on five part rating
scale ≥4 (good)Internal usability study on dressed ViVi® System
Biological Specification
Biocompatibility of material in
contact with intact skinNo noticeable/will not elicit
Irritation/ReactionISO 10993-10:2021 Test for skin sensitization
ISO 10993-23:2021 Test for irritation
(Intracutaneous reactivity)
ISO 10993-5:2009 Test for in vitro
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 NUMBER604026050160504
Product DescriptionRechargeable Li-ion
Battery pack1-Bay Charger4-Bay Charger
Original ManufacturerRRC Power SolutionsRRC Power Solutions--
SpecificationFour cell Li-ion Battery packOne bay charging moduleFour bay charging module
Voltage/Capacity14,4V /49,7WhInput:100-240VAC
Output: 0-17,4VDC /
50W max.Input:100-240VAC
Output: 4x 0-17,4VDC /
4x 50W max.
Battery Life time>7 hours with ViVi® Helmet

4 hours with ViVi® Helmet HPL
(LED on) | N/A | N/A |
| Charging time | 2,5 hours | N/A | N/A |
| Certifications | IEC 62133-2:2017
UN38.3 | EN ISO 60601-1:2006/A1:2013
EN ISO 60601-1-2:2015
FCC 15 Class B
cULus | EN ISO 60601-1:2006/A1:2013
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 HoodParameter / Value
Personal Protective EquipmentEN 166:2011 Personal Eye Protection
  • High speed particles (45m/s) – low energy impact
  • Splashes of liquid |
    | Face Shield - Field of View | >180° |
    | Face Schield – Optical Quality
    (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

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
ViVi® Surgical Helmet System
K222214 | Predicate Device
TotalShield™
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
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 TotalShield Zippered Surgical Toga and/or TotalShield
Surgical Hood is for use with the TotalShield Surgical Helmet
and/or TotalShield Advanced Surgical Helmet with LED light
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. | Similar |
| Target user group | Surgical personnel | Surgical personnel | Same |
| Conditions of use
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
principle | The ViVi® Hood has been designed to properly fit
the ViVi® Helmet or ViVi® Helmet HPL in order to
be used together as the ViVi® Surgical Helmet
System. The ViVi® Hood is fastened to either the
ViVi® Helmet or ViVi® Helmet HPL with hook-and-
loop fasteners and a mechanical slot which ensures
also the position of the lens. The device acts as a
barrier between the operating environment and
the surgical personnel | The TotalShield Zippered Surgical Toga has been designed to
properly fit the TotalShield Surgical Helmet and Advanced
Surgical Helmet with LED Lighting in order to be used together
as the TotalShield Surgical Helmet System. The TotalShield
Zippered Surgical Toga or Surgical Hood is fastened to either
the TotalShield Surgical Helmet or Advanced Surgical Helmet
with LED Lighting with aid of hook-and-loop fasteners and
mechanical slot. The device acts as a barrier between the
operating environment and the surgical personnel | Similar |
| Category | Candidate Device
ViVi® Surgical Helmet System
K222214 | Predicate Device
TotalShield™
Surgical Helmet System , K132386 | Comparison result |
| Surgical gowns | | | |
| Sterilisation method Surgical
Hood | Ethylene oxide | Ethylene oxide | Same |
| Sterilisation Assurance Level
(SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Barrier Performance | Hood only
Hood and lens are exempt from classification under
AAMI PB70:2012 | ASTM 2407-06 (2013)
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
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
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
cable | External Lithium-Ion battery pack connected by
cable | Same |
| Light option | Yes / LED light
(ViVi Surgical Helmet HPL) | Yes / LED light
(TotalShield Advanced Surgical Helmet) | Same |
| Helmet material | Plastic | Plastic | Same |
| LED Components | Plastic, reinforced | Aluminium, Stainless Steel | Different |

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15

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

CharacteristicsTest Method /StandardAcceptance CriteriaTest Result
WeightInternal Test≤ 500g (helmet)PASS
Air QualityInternal Test≤ 3°C temperature increase
≤ 0% RH increase
Below 5000 ppm CO2 concentration
(at ≤ 800 ppm ambient concentration)
No fogging of face shieldPASS
System SizeInternal TestSignificant lower crown line profile than
predecessor productPASS
NoiseInternal TestNoise level ≤ predecessor productPASS
Operational
runtimeInternal TestBattery runtime ≥4 hours
(without LED light)PASS
Gesture ControlInternal Usability TestAverage score for 'ease of use': ≥ "4-good"
No score for 'ease of use' below "2-sufficient"
Score table: 5 ('very good') - 1 ('not sufficient')PASS

HOOD TESTING

CharacteristicsTest Method /StandardAcceptance CriteriaTest Result
Tear ResistanceASTM D5587>10 NPASS
Tensile StrenghASTM D5034>30 NPASS
Fire protection
Flammability of
Clothing Textiles16 CFR 1610Fulfil requirements for Class 1PASS
Laser resistanceISO 11810:2015No ignitionPASS
Ethylene Oxide
residualsISO 10993-7:2008EO: