(449 days)
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.
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).
The provided document is a 510(k) Premarket Notification from the FDA regarding the ViVi® Surgical Helmet System. It details the device's characteristics, indications for use, and a summary of non-clinical testing. It is crucial to understand that this document describes a medical device, specifically surgical apparel, and not an AI/ML powered device or a diagnostic/imaging device. Therefore, many of the typical acceptance criteria and study methodologies applicable to AI/ML or diagnostic devices (e.g., ground truth establishment, expert adjudication, MRMC studies, standalone performance of an algorithm) are not relevant to this product.
The "study" described herein refers to non-clinical laboratory testing to ensure the safety and performance of the surgical helmet system, rather than typical clinical studies for diagnostic accuracy or treatment efficacy.
Here's an attempt to answer your questions based on the provided text, highlighting the differences where your questions pertain to AI/ML or diagnostic devices:
1. A table of acceptance criteria and the reported device performance
The document provides two tables outlining acceptance criteria and test results for the Helmet and Hood components.
Table 1: ViVi® Surgical Helmet System - Acceptance Criteria and Performance (Non-Clinical Testing)
| Characteristic (Component) | Requirement (Acceptance Criteria) | Reported Performance (Test Result) |
|---|---|---|
| HELMET TESTING | ||
| Weight | ≤ 500g (helmet) | PASS |
| Air Quality | ≤ 3°C temperature increase | PASS |
| ≤ 0% RH increase | PASS | |
| Below 5000 ppm CO2 concentration (at ≤ 800 ppm ambient concentration) | PASS | |
| No fogging of face shield | PASS | |
| System Size | Significant lower crown line profile than predecessor product | PASS |
| Noise | Noise level ≤ predecessor product | PASS |
| Operational runtime | Battery runtime ≥4 hours (without LED light) | PASS |
| Gesture Control | Average score for 'ease of use': ≥ "4-good" (Score table: 5 'very good' - 1 'not sufficient') | PASS |
| No score for 'ease of use' below "2-sufficient" | PASS | |
| HOOD TESTING | ||
| Tear Resistance | >10 N | PASS |
| Tensile Strength | >30 N | PASS |
| Fire protection Flammability of Clothing Textiles | Fulfil requirements for Class 1 | PASS |
| Laser resistance | No ignition | PASS |
| Ethylene Oxide residuals | EO: < 4mg/device | PASS |
| ECH: < 9mg/device | PASS | |
| BIOCOMPATIBILITY EVALUATION | ||
| Foam Pads (ViVi® Muffle) - Skin sensitization | Not sensitizing | PASS |
| Foam Pads (ViVi® Muffle) - Irritation | No irritation | PASS |
| Foam Pads (ViVi® Muffle) - In vitro cytotoxicity | < grade2 (mild reactivity) | PASS |
| Hood material (SMS nonwoven fabric) - Skin sensitization | Not sensitizing | PASS |
| Hood material (SMS nonwoven fabric) - Irritation | No irritation | PASS |
| Hood material (SMS nonwoven fabric) - In vitro cytotoxicity | <grade2 (mild reactivity) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI/ML model. The testing described is non-clinical laboratory testing of physical and functional characteristics of the device.
- Sample Size: For "Tear Resistance," "Fire protection," and "Ethylene Oxide residuals" of the hood, it states "three non-consecutive lots." Other tests do not specify exact sample sizes, often referring to "Internal Test" or simply stating "PASS" without detailing the number of units tested.
- Data Provenance: Not applicable in the context of AI/ML data sets. The tests are conducted on manufactured units of the device. There is no information about the country of origin of the data as the tests are physical/mechanical/biological performance tests, not data collection from individuals or medical records. The tests are non-clinical, so "retrospective or prospective" doesn't apply in the typical sense of clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML or diagnostic device where "ground truth" for a test set would be established by experts interpreting medical data (e.g., radiologists interpreting images). The "ground truth" for this device is established by objective physical, mechanical, and biological standards (e.g., specific thresholds for tear resistance, CO2 concentration, or biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no expert interpretation or labeling of data for model training/testing is involved, adjudication methods are not relevant. The "ground truth" is determined by predefined, measurable physical and safety standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study is designed for diagnostic tools, typically those involving human interpretation of medical images or data, with or without AI assistance. This device is surgical apparel with a fan system; it does not involve human "readers" or AI assistance for diagnostic tasks. The closest is a "Gesture Control" test with an average score for 'ease of use', which is a usability assessment, not an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an AI algorithm independent of human intervention. It is not applicable to a physical surgical helmet system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on predefined engineering specifications, international standards (e.g., ASTM, ISO), and regulatory requirements (e.g., 16 CFR 1610, biocompatibility standards). For example:
- Physical specifications: Measured weight, temperature/CO2 levels, noise levels.
- Mechanical specifications: Measured tensile strength, tear resistance.
- Biological specifications: Laboratory tests for biocompatibility (skin sensitization, irritation, cytotoxicity) against established thresholds.
- Usage: Battery runtime, usability scores.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 GmbHGewerbestrasse 4Feistritz im Rosental, 9181, AustriaTel: +43 4228 30 100-14Fax: +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 System510(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/Referencenumber (REF) | Description | Size(if applicable) | Category name | Similarities / Differences |
|---|---|---|---|---|
| 80100 | ViVi® Helmet | One size | Surgical helmet | Design, materials andmanufacturing technologiesare 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 rechargeableLi-Ion Battery for ViVi® system | N/A | Rechargeablebattery(Accessory) | N/A |
| 60403 | Battery Holster for Battery Pack | N/A | Battery holster(Accessory) | N/A |
| 60501 | 1-bay Battery Charger forBattery Pack | N/A | Battery charger(Accessory) | N/A |
| 60504 | 4-bay Battery Charger forBattery Pack | N/A | Battery charger(Accessory) | N/A |
| 60788 | ViVi® Muffle(Foam pad set for ViVi® Helmet orViVi® 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
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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 andpunctures | Tear Resistance compliant withASTM D5587 | ASTM D5587Finished hood material sealed in sterile packaging withproduction equipment and procedure, doubleSterilized, three non-consecutive lots |
| Fire protection | Compliant with16 CFR-1610 class 1 | 16 CFR 1610Finished hood material sealed in sterile packaging withproduction equipment and procedure, double sterilized.Three non-consecutive lots |
| Laser resistance | No ignition of SMS nowovenfabric | ISO 11810:2015Finished hood material sealed in sterile packaging withproduction equipment and procedure, sterilized |
| Mechanical Specification | ||
| Strength | Tensile Strength compliant withASTM D5034 | ASTM D5034Finished hood material sealed in sterile packaging withproduction equipment and procedure, double sterilized |
| Durability | ViVi® Hood is single use devices | Labeling single use |
| Biological Specification | ||
| Biocompatibility of material incontact with intact skin | No noticeable/will not elicitIrritation/Reaction | ISO 10993-10:2021 Test for skin sensitizationISO 10993-23:2021 Test for irritation (Intracutaneousreactivity)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
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(14)
| Picture 5: ViVi® Helmet components | |
|---|---|
| Serial number/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 faceshield of ViVi® Hood | Nylon |
| 7 | Height adjustment strap | Plastic |
| 8 | Foam pads (ViVi® Muffle) | Lycra (garment)EVAC (foam) |
| 9 | Headband adjustment knob and adjustable headband | Plastic |
| 10 | Headlight- LED light(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≤5.000ppm CO2 concentration(at ≤800ppm ambient concentration)No fogging of face shield | Internal Test methodTemperature and CO2 measurement inside dressedViVi® Hood with ViVi® Helmet |
| Noise level | Less than predecessor product | Internal Test methodNoise measurement with ViVi® Helmet anddressed ViVi® Hood (inside) |
| Operational Runtime | ≥4 hours (without LED light) | Internal Test methodRuntime test with ViVi® Helmet with Batterypack |
| Mechanical Specification | ||
| Helmet weight | ≤500g | Internal Test methodViVi® Helmet on calibrated scale |
| Gesture Control | Average score on five part ratingscale ≥4 (good) | Internal usability study on dressed ViVi® System |
| Biological Specification | ||
| Biocompatibility of material incontact with intact skin | No noticeable/will not elicitIrritation/Reaction | ISO 10993-10:2021 Test for skin sensitizationISO 10993-23:2021 Test for irritation(Intracutaneous reactivity)ISO 10993-5:2009 Test for in vitrocytotoxicity |
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-ionBattery 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:100-240VACOutput: 0-17,4VDC /50W max. | Input:100-240VACOutput: 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 62133-2:2017UN38.3 | EN ISO 60601-1:2006/A1:2013EN ISO 60601-1-2:2015FCC 15 Class BcULus | EN ISO 60601-1:2006/A1:2013EN 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- 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 DeviceViVi® Surgical Helmet SystemK222214 | Predicate DeviceTotalShield™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® Helmetand/or ViVi® Helmet HPL as the ViVi® SurgicalHelmet System to provide a barrier between theoperating environment and the surgical personnelin order to protect against contamination and/orexposure of infectious body fluids and harmfulmicroorganisms. | The TotalShield Zippered Surgical Toga and/or TotalShieldSurgical Hood is for use with the TotalShield Surgical Helmetand/or TotalShield Advanced Surgical Helmet with LED lightas the TotalShield Surgical Helmet System that is intendedto be worn by surgical personnel to provide a barrierbetween the operating environment and the surgicalpersonnel in order to protect against contamination and/orexposure of infectious body fluids and harmfulmicroorganisms. | Similar |
| Target user group | Surgical personnel | Surgical personnel | Same |
| Conditions of useSurgical Helmet | Non-sterile / reusable | Non-sterile / reusable | Same |
| Condition of use Surgical Hood | Sterile / Disposable / Single Use | Sterile / Disposable / Single Use | Same |
| System design / Operatingprinciple | The ViVi® Hood has been designed to properly fitthe ViVi® Helmet or ViVi® Helmet HPL in order tobe used together as the ViVi® Surgical HelmetSystem. The ViVi® Hood is fastened to either theViVi® Helmet or ViVi® Helmet HPL with hook-and-loop fasteners and a mechanical slot which ensuresalso the position of the lens. The device acts as abarrier between the operating environment andthe surgical personnel | The TotalShield Zippered Surgical Toga has been designed toproperly fit the TotalShield Surgical Helmet and AdvancedSurgical Helmet with LED Lighting in order to be used togetheras the TotalShield Surgical Helmet System. The TotalShieldZippered Surgical Toga or Surgical Hood is fastened to eitherthe TotalShield Surgical Helmet or Advanced Surgical Helmetwith LED Lighting with aid of hook-and-loop fasteners andmechanical slot. The device acts as a barrier between theoperating environment and the surgical personnel | Similar |
| Category | Candidate DeviceViVi® Surgical Helmet SystemK222214 | Predicate DeviceTotalShield™Surgical Helmet System , K132386 | Comparison result |
| Surgical gowns | |||
| Sterilisation method SurgicalHood | Ethylene oxide | Ethylene oxide | Same |
| Sterilisation Assurance Level(SAL) | $10^{-6}$ | $10^{-6}$ | Same |
| Barrier Performance | Hood onlyHood and lens are exempt from classification underAAMI 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 toSurgical Helmet | Mechanical slot and hook and loop | Mechanical slot and hook and loop | Same |
| Color | Blue | Blue | Same |
| Sizes | Hood: single size | Hood: single sizeToga: 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 bycable | External Lithium-Ion battery pack connected bycable | 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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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≤ 0% RH increaseBelow 5000 ppm CO2 concentration(at ≤ 800 ppm ambient concentration)No fogging of face shield | PASS |
| System Size | Internal Test | Significant lower crown line profile thanpredecessor product | PASS |
| Noise | Internal Test | Noise level ≤ predecessor product | PASS |
| Operationalruntime | Internal Test | Battery runtime ≥4 hours(without LED light) | PASS |
| Gesture Control | Internal Usability Test | 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') | 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 protectionFlammability ofClothing Textiles | 16 CFR 1610 | Fulfil requirements for Class 1 | PASS |
| Laser resistance | ISO 11810:2015 | No ignition | PASS |
| Ethylene Oxideresiduals | ISO 10993-7:2008 | EO: < 4mg/deviceECH: < 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 | TestResult |
|---|---|---|---|
| BiocompatibilityFoam Pads(ViVi® Muffle) | ISO 10993-10:2021 Test for skin sensitizationISO 10993-23:2021 Test for irritation(Intracutaneous reactivity)ISO 10993-5:2009 Test for in vitro cytotoxicity | Test for skin sensitization: Not sensitizingTest for irritation: No irritationTest for in vitro cytotoxicity: < grade2 (mild reactivity) | PASS |
| BiocompatibilityHood material(SMS nonwoven fabric) | ISO 10993-10:2021 Test for skin sensitizationISO 10993-23:2021 Test for irritation(Intracutaneous reactivity)ISO 10993-5:2009 Test for in vitro cytotoxicity | Test for skin sensitization: Not sensitizingTest for irritation: No irritationTest for in vitro cytotoxicity: <grade2 (mildreactivity) | 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)
§ 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.