TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES

K142166 · Zimmer, Inc. · FYA · Aug 28, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142166
• Device Name: TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES
• Applicant: Zimmer, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Aug 28, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood is for use with the TotalShieldTM Surgical Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM 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.

Device Story

TotalShield 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 lighting) and single-use disposable hoods or zippered togas. The helmet features an internal fan that provides a continuous flow of air into the hood or toga, maintaining a protective environment for the wearer. The hood/toga attaches to the helmet via mechanical slots and hook-and-loop fasteners. The device protects the wearer from contamination and exposure to infectious body fluids and microorganisms. Healthcare providers wear the system during surgical procedures to maintain a sterile field and protect themselves. The system is designed to meet AAMI PB70 Level 4 barrier performance standards.

Clinical Evidence

No clinical data. Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366), sterilization validation (ISO 11135-1, ISO 11607), biocompatibility (ISO 10993), and performance testing (airflow, noise, battery life, and AAMI PB70 Level 4 liquid barrier testing).

Technological Characteristics

System includes reusable helmet (plastic) with battery-powered fan and LED lighting (aluminum/stainless steel). Single-use hoods/togas made of BVB nonwoven fabric with PETG clear copolyester lens and blended synthetic fiber polypropylene filter. Sterilization via EO to SAL 10^-6. Complies with AAMI/ANSI PB70 Level 4, ASTM F2407-06, and ISO 10993 standards.

Indications for Use

Indicated for surgical personnel in the operating room to provide a barrier against infectious body fluids and microorganisms.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• TotalShield Surgical Helmet System (K132386)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 28, 2014

Zimmer Surgical, Incorporated C/O Mr. Michael T. Wolford Regulatory Affairs Specialist 200 West Ohio Avenue Dover, OH 44622

Re: K142166

Trade/Device Name: TotalShield Surgical Helmet System Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 17, 2014 Received: July 30, 2014

Dear Mr. Wolford:

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

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

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Page 2 - Mr. Wolford

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the

Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K142166

Device Name TotalShield Surgical Helmet System

## Indications for Use (Describe)

The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood is for use with the TotalShieldTM Surgical Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM 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.

#### Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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

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

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a bold, sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller, lighter font.

200 West Ohio Avenue Dover, Ohio 44622 330.343.8801

| 510(k)<br>Summary | Sponsor: | Zimmer Surgical, Inc.<br>200 West Ohio Avenue<br>Dover, OH 44622<br>Phone: [phone] | |
|-------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact: | Michael T. Wolford<br>Regulatory Affairs Specialist<br>Phone: [phone] | |
| | Date: | July 17, 2014 | |
| | Trade Name: | TotalShield™ Surgical Helmet System | |
| | Product Code/Device: | FYA - Gown, Surgical | |
| | Regulation Number and<br>Description: | 21 CFR 878.4040 – Surgical Apparel | |
| | Predicate Device | TotalShield™ Surgical Helmet System K132386, cleared<br>December 23, 2013. | |
| | Device Description | The TotalShield™ Surgical Helmet System is comprised<br>of the TotalShield™ Zippered Surgical Toga,<br>TotalShield™ Surgical Hood, TotalShield™ Surgical<br>Helmet and Advanced Surgical Helmet with LED<br>lighting and various accessories. | |
| | | The TotalShield™ Zippered Surgical Toga and/or<br>TotalShield™ Surgical Hood are used with the<br>TotalShield™ Helmet and/or TotalShield™ Advanced<br>Surgical Helmet with LED lighting as the TotalShield™<br>Surgical Helmet System to provide a barrier between the<br>operating environment and the surgical personnel in order<br>to protect against contamination and/or exposure of<br>infectious body fluids and harmful microorganisms. | |
| | | The TotalShield™ Surgical Helmet and Advanced | |

# 510(k) Summary of Safety and Effectiveness

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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a white "Z" inside. Below the circle, the word "zimmer" is written in lowercase letters, with a line underneath. Below the line, the word "surgical" is written in smaller lowercase letters.

| | Surgical Helmet with LED lighting have a battery<br>powered fan, which provides a continuous flow of air in<br>the TotalShield™ Surgical Hood or Zippered Surgical<br>Toga. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The TotalShield™ Surgical Hood is a stand-alone head<br>cover that may be worn with a separate surgical gown,<br>while the TotalShield™ Zippered Surgical Toga is a one-<br>piece head and body cover. |
| | The stand-alone TotalShield™ Surgical Hood is identical<br>to the hood that is incorporated into the TotalShield™<br>Zippered Surgical Toga. The TotalShield™ Surgical<br>Hood or Zippered Surgical Toga must be worn over a<br>TotalShield™ Surgical Helmet or Advanced Surgical<br>Helmet with LED lighting. |
| | The TotalShield™ Zippered Surgical Toga has been<br>tested to meet the applicable AAMI PB70 standards for<br>level 4 compliance. The AAMI standard does not cover<br>apparel for the head, face, and eyes. Therefore, the hoods<br>and lens are exempt from classification under the AAMI<br>PB70:2003 standard. |
| Intended Use: | The TotalShield™ Zippered Surgical Toga and/or<br>TotalShield™ Surgical Hood is for use with the<br>TotalShield™ Surgical Helmet and/or TotalShield™<br>Advanced Surgical Helmet with LED lighting as the<br>TotalShield™ Surgical Helmet System that is intended to<br>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. |
| Technological<br>Characteristics | The TotalShield Surgical Helmet System is substantially<br>equivalent to the predicate device in that the devices have<br>the same technological characteristics, including:<br>Has the same intended use, target population and<br>indications for use as the predicate Uses the same operating principles Incorporates the same basic design of durable<br>helmet and single-use hoods and togas Hood and toga are sterilized using the same mode Both are sterilized to SAL 10-6 Reusable helmets are provided non-sterile Is manufactured of similar materials |

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Image /page/5/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue letter Z inside of a blue circle. Below the circle, the word "zimmer" is written in a blue, sans-serif font. Below the word "zimmer", the word "surgical" is written in a smaller, sans-serif font.

### The TotalShield™ Surgical Helmet System is Comparison to Predicate: substantially equivalent to the legally marketed predicate device, TotalShield™ Surgical Helmet System, in that these devices have the same intended use and are similar in design. The following tables provide a comparison between the predicate device and modified device:

| Property | Predicate: TotalShield™ Surgical Helmet<br>System | Modified Device: TotalShield™<br>Surgical Helmet System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | The TotalShield™ Zippered Surgical Toga<br>and /or TotalShield™ Surgical Hood is for<br>use with the TotalShield™ Surgical Helmet<br>and/or TotalShield™ Advanced Surgical<br>Helmet with LED Lighting as the<br>TotalShield™ Surgical Helmet System that<br>is intended to be worn by surgical<br>personnel to provide a barrier between<br>the operation environment and the<br>surgical personnel in order to protect<br>against contamination and/or exposure of<br>infectious body fluids and harmful<br>microorganisms. | Same |
| Target<br>Population | Operating Room Personnel | Same |

Materials of Construction

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Image /page/6/Picture/0 description: The image contains the logo for Zimmer Surgical. The logo features a stylized blue letter "Z" enclosed in a circle. Below the circle, the word "zimmer" is written in a sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller font size.

| Property | Predicate: TotalShield TM Surgical Helmet<br>System K132386 | Modified Device: TotalShield TM Surgical Helmet System |
|------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------|
| Toga and Hood | SMS nonwoven fabric | BVB nonwoven fabric |
| Lens/Face Shield | PETG Clear Copolyester | Same |
| Filter | Blended Synthetic Fiber Spunbound<br>Polypropylene | Same |
| Helmet | Plastic | Same |
| LED Components | Aluminum, Stainless Steel | Same |

# Technology and Product Features

| Property | Predicate: TotalShield™ Surgical<br>Helmet System | Modified Device: TotalShield™ Surgical<br>Helmet System |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| TotalShield™ Zippered Surgical Toga and Hood | | |
| Operating<br>Principle | The TotalShield™ Zippered Surgical Toga<br>has been designed to properly fit the<br>TotalShield™ Surgical Helmet and<br>Advanced Surgical Helmet with LED<br>Lighting in order to be used together as<br>the TotalShield™ Surgical Helmet<br>System. The TotalShield™ Zippered<br>Surgical Toga or Surgical Hood is<br>fastened to either the TotalShield™<br>Surgical Helmet or Advanced Surgical<br>Helmet with LED Lighting with aid of<br>hook-and-loop fasteners and mechanical<br>slot. The device acts as a barrier<br>between the operating environment and<br>the surgical personnel. | Same |
| Adjustable<br>Length (Toga) | Tear away feature (12" from length) | Same |

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Image /page/7/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a lowercase, sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller font size.

| Consensus<br>Standards | Level 3 Barrier Performance AAMI/ANSI<br>PB70:2003/(R)2009<br>ASTM F2407-06 Standard Specification<br>for Surgical Gowns Intended for Use in<br>Healthcare Facilities | Level 4 Barrier Performance AAMI/ANSI<br>PB70:2003/(R)2009<br>ASTM F2407-06 Standard Specification<br>for Surgical Gowns Intended for Use in<br>Healthcare Facilities |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility<br>Assurance Level | $10^{-6}$ | Same |
| Condition of Use | Single Use/Disposable | Same |
| Closure | Toga Neck tie/waist tie<br>Hood pull over | Same |
| Toga Sizes | Regular, Large, Extra Large | Same |
| Color | Blue | Same |
| TotalShield™ Surgical Helmet and Advanced Surgical Helmet with LED Lighting | | |
| Method of Hood<br>Attachment | Mechanical slot and hook-and-loop | Same |
| Lighting Option | LED | Same |

# Performance Comparison

| Property or<br>Characteristic | Testing Method | Predicate:<br>TotalShield™<br>Surgical Helmet<br>System | Modified Device:<br>TotalShield™<br>Surgical Helmet<br>System |
|-------------------------------------------------------|------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------|
| TotalShield™ Zippered Surgical Toga and Surgical Hood | | | |
| Flammability of<br>Clothing Textiles | ASTM F2100-07 reference 16<br>CFR-1610.4 | Class 1 Compliant-<br>pass | Class 1 Compliant-<br>pass |

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Image /page/8/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue circle with a stylized "Z" inside. Below the circle, the word "zimmer" is written in a sans-serif font, also in blue. Underneath "zimmer", the word "surgical" is written in a smaller font size.

| Biological<br>Evaluation<br>on Skin Contact | ISO-10993-10 Intracutaneous<br>Reactivity Test<br>ISO-10993-5 MEM Elution Assay<br>with L-929 Mouse<br>Fibroblast Cells<br>ISO-10993-10 Guinea Pig<br>Maximization Sensitization Test | Compliant- pass | Compliant- pass |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------|
| Sterility Method | ISO 11607-2 Packaging<br>Validation<br>ISO 11135-1 EO Validation<br>ISO 10993-7 EO Residual Test | Compliant- pass | Compliant- pass |
| Tear Resistance | ASTM D5733 MD Trap Tear<br>Compliant- pass AAMI Level 3 | Compliant- pass | Compliant- pass |
| Tensile Strength | ASTM D5034 Grab Tensile<br>Strength | Compliant- pass | Compliant- pass |
| Seam Strength | ASTM D1683 | Compliant- passed<br>seam test | Compliant- passed<br>seam test |
| Lint | ISO 9073; EN 13795-2 Test<br>methods for surgical<br>drapes, gowns and clean air<br>suits, used as medical<br>devices for patients, clinical<br>staff and equipment | Compliant- pass | Compliant- pass |
| Water Vapor<br>Transmission Rate | ASTM E96 with Water | Compliant- pass | Compliant- pass |
| Water resistance:<br>Impact<br>penetration<br>Hydrostatic<br>pressure | AAMI/ANSI PB70 | Compliant Level 3 | Compliant Level 4 |
| TotalShield Surgical Helmet and Advanced Surgical Helmet with LED Lighting | | | |

| Airflow Testing | Internal Fan Performance Test<br>Method | Pass Acceptance<br>Criteria | Pass Acceptance<br>Criteria |
|-------------------------|---------------------------------------------|-----------------------------|-----------------------------|
| Helmet Noise<br>Testing | Internal Noise Measurement<br>Test Method | Pass Acceptance<br>Criteria | Pass Acceptance<br>Criteria |
| Battery Life<br>Testing | Internal Battery Performance<br>Test Method | Pass Acceptance<br>Criteria | Pass Acceptance<br>Criteria |

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Image /page/9/Picture/0 description: The image shows the logo for Zimmer Surgical. The logo features a blue letter Z inside of a circle. Below the circle is the word "zimmer" in blue, and below that is the word "surgical" in gray.

| Non-Clinical Performance<br>Description: | During the design and development of the TotalShield™<br>Surgical Helmet System, the following tests were<br>completed: |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrical safety and Environmental testing (IEC<br>60601-1 and IEC 60601-1-2) Device Usability testing<br>was conducted in accordance with requirements of IEC<br>60601-1-6 and IEC 62366:2007. |
| | Sterilization Validation testing was conducted in<br>accordance with AAMI/ANSI/ISO 11607-1, 11607- 2<br>and AAMI/ANSI/ISO 11135-1. Shipping Validation was<br>conducted according to ASTM D4169-09. |
| | Biocompatibility Testing was conducted on skin contact<br>material in accordance with ISO 10993-1, ISO 10993-10,<br>ISO 10993-5 and ISO 10993-7. |
| | Non-Clinical testing was conducted to demonstrate that<br>the subject device performed as intended and met all<br>acceptance criteria, including:<br>• Airflow Testing<br>• Helmet Noise Testing<br>• Battery Life Testing<br>• Liquid Barrier testing (per AAMI/ANSI<br>PB70 Level 4, for Surgical Zippered Toga only) |
| | The TotalShield™ Surgical Helmet System adheres to the<br>specifications for requirements for performance,<br>documentation, and labeling per ASTM F2407-06. |
| Clinical Performance | No Clinical evaluations necessary for this device |
| Conclusion | All tests passed according to predetermined acceptance<br>criteria, thus demonstrating equivalent performance of the<br>subject device to the predicate device. |