(29 days)
Not Found
No
The device description and performance studies focus on physical barrier properties, airflow, battery life, and safety standards. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is described as providing a barrier to protect against contamination and exposure to infectious materials for surgical personnel, rather than directly treating or diagnosing a medical condition.
No
The device is described as a system of protective garments (helmet, toga, hood) worn by surgical personnel to provide a barrier against contamination and exposure to infectious materials, fulfilling a protective rather than a diagnostic function.
No
The device description clearly outlines physical components such as a helmet, toga, hood, battery-powered fan, and LED lighting, indicating it is a hardware-based medical device.
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 body fluids and microorganisms. 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 protective clothing (toga, hood) and a helmet with a fan for airflow. This is consistent with personal protective equipment (PPE) used in a surgical setting.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on aspects like electrical safety, usability, sterilization, shipping, biocompatibility, airflow, noise, battery life, and liquid barrier properties. These are all relevant to the function of protective equipment, not diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The TotalShieldTM Surgical Helmet System is comprised of the TotalShieldTM Zippered Surgical Toga, TotalShieldTM Surgical Hood, TotalShieldTM Surgical Helmet and Advanced Surgical Helmet with LED lighting and various accessories.
The TotalShieldTM Zippered Surgical Toga and/or TotalShieldTM Surgical Hood are used with the TotalShieldTM Helmet and/or TotalShieldTM Advanced Surgical Helmet with LED lighting as the TotalShieldTM 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 TotalShieldTM Surgical Helmet and Advanced Surgical Helmet with LED lighting have a battery powered fan, which provides a continuous flow of air in the TotalShieldTM Surgical Hood or Zippered Surgical Toga.
The TotalShieldTM Surgical Hood is a stand-alone head cover that may be worn with a separate surgical gown, while the TotalShieldTM Zippered Surgical Toga is a one-piece head and body cover.
The stand-alone TotalShieldTM Surgical Hood is identical to the hood that is incorporated into the TotalShieldTM Zippered Surgical Toga. The TotalShieldTM Surgical Hood or Zippered Surgical Toga must be worn over a TotalShieldTM Surgical Helmet or Advanced Surgical Helmet with LED lighting.
The TotalShieldTM Zippered Surgical Toga has been tested to meet the applicable AAMI PB70 standards for level 4 compliance. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens are exempt from classification under the AAMI PB70:2003 standard.
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
Operating Room Personnel / Operating environment
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Description: During the design and development of the TotalShieldTM Surgical Helmet System, the following tests were completed:
- Electrical safety and Environmental testing (IEC 60601-1 and IEC 60601-1-2) Device Usability testing was conducted in accordance with requirements of IEC 60601-1-6 and IEC 62366:2007.
- Sterilization Validation testing was conducted in accordance with AAMI/ANSI/ISO 11607-1, 11607- 2 and AAMI/ANSI/ISO 11135-1. Shipping Validation was conducted according to ASTM D4169-09.
- Biocompatibility Testing was conducted on skin contact material in accordance with ISO 10993-1, ISO 10993-10, ISO 10993-5 and ISO 10993-7.
- Non-Clinical testing was conducted to demonstrate that the subject device performed as intended and met all acceptance criteria, including:
- Airflow Testing
- Helmet Noise Testing
- Battery Life Testing
- Liquid Barrier testing (per AAMI/ANSI PB70 Level 4, for Surgical Zippered Toga only)
The TotalShieldTM Surgical Helmet System adheres to the specifications for requirements for performance, documentation, and labeling per ASTM F2407-06.
Clinical Performance: No Clinical evaluations necessary for this device
Conclusion: All tests passed according to predetermined acceptance criteria, thus demonstrating equivalent performance of the subject device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flammability of Clothing Textiles: Class 1 Compliant- pass
Biological Evaluation on Skin Contact: Compliant- pass
Sterility Method: Compliant- pass
Tear Resistance: Compliant- pass
Tensile Strength: Compliant- pass
Seam Strength: Compliant- passed seam test
Lint: Compliant- pass
Water Vapor Transmission Rate: Compliant- pass
Water resistance: Impact penetration, Hydrostatic pressure: Compliant Level 4
Airflow Testing: Pass Acceptance Criteria
Helmet Noise Testing: Pass Acceptance Criteria
Battery Life Testing: Pass Acceptance Criteria
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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/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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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)
Summary | Sponsor: | Zimmer Surgical, Inc.
200 West Ohio Avenue
Dover, OH 44622
Phone: (330) 343-8801 | |
|-------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Contact: | Michael T. Wolford
Regulatory Affairs Specialist
Phone: (330) 364-9411 | |
| | Date: | July 17, 2014 | |
| | Trade Name: | TotalShield™ Surgical Helmet System | |
| | Product Code/Device: | FYA - Gown, Surgical | |
| | Regulation Number and
Description: | 21 CFR 878.4040 – Surgical Apparel | |
| | Predicate Device | TotalShield™ Surgical Helmet System K132386, cleared
December 23, 2013. | |
| | Device Description | The TotalShield™ Surgical Helmet System is comprised
of the TotalShield™ Zippered Surgical Toga,
TotalShield™ Surgical Hood, TotalShield™ Surgical
Helmet and Advanced Surgical Helmet with LED
lighting and various accessories. | |
| | | The TotalShield™ Zippered Surgical Toga and/or
TotalShield™ Surgical Hood are used with the
TotalShield™ Helmet and/or TotalShield™ Advanced
Surgical Helmet with LED lighting as the TotalShield™
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™ Surgical Helmet and Advanced | |
510(k) Summary of Safety and Effectiveness
4
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
powered fan, which provides a continuous flow of air in
the TotalShield™ Surgical Hood or Zippered Surgical
Toga. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The TotalShield™ Surgical Hood is a stand-alone head
cover that may be worn with a separate surgical gown,
while the TotalShield™ Zippered Surgical Toga is a one-
piece head and body cover. |
| | The stand-alone TotalShield™ Surgical Hood is identical
to the hood that is incorporated into the TotalShield™
Zippered Surgical Toga. The TotalShield™ Surgical
Hood or Zippered Surgical Toga must be worn over a
TotalShield™ Surgical Helmet or Advanced Surgical
Helmet with LED lighting. |
| | The TotalShield™ Zippered Surgical Toga has been
tested to meet the applicable AAMI PB70 standards for
level 4 compliance. The AAMI standard does not cover
apparel for the head, face, and eyes. Therefore, the hoods
and lens are exempt from classification under the AAMI
PB70:2003 standard. |
| Intended Use: | 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 lighting as the
TotalShield™ Surgical Helmet System that is intended to
be worn by surgical personnel to provide a barrier
between the operating environment and the surgical
personnel in order to protect against contamination and/or
exposure of infectious body fluids and harmful
microorganisms. |
| Technological
Characteristics | The TotalShield Surgical Helmet System is substantially
equivalent to the predicate device in that the devices have
the same technological characteristics, including:
Has the same intended use, target population and
indications for use as the predicate Uses the same operating principles Incorporates the same basic design of durable
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 |
5
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
System | Modified Device: TotalShield™
Surgical Helmet System |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | 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 Lighting as the
TotalShield™ Surgical Helmet System that
is intended to be worn by surgical
personnel to provide a barrier between
the operation environment and the
surgical personnel in order to protect
against contamination and/or exposure of
infectious body fluids and harmful
microorganisms. | Same |
| Target
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
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
Polypropylene | Same |
| Helmet | Plastic | Same |
| LED Components | Aluminum, Stainless Steel | Same |
Technology and Product Features
| Property | Predicate: TotalShield™ Surgical
Helmet System | Modified Device: TotalShield™ Surgical
Helmet System |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| TotalShield™ Zippered Surgical Toga and Hood | | |
| Operating
Principle | 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. | Same |
| Adjustable
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
Standards | Level 3 Barrier Performance AAMI/ANSI
PB70:2003/(R)2009
ASTM F2407-06 Standard Specification
for Surgical Gowns Intended for Use in
Healthcare Facilities | Level 4 Barrier Performance AAMI/ANSI
PB70:2003/(R)2009
ASTM F2407-06 Standard Specification
for Surgical Gowns Intended for Use in
Healthcare Facilities |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility
Assurance Level | $10^{-6}$ | Same |
| Condition of Use | Single Use/Disposable | Same |
| Closure | Toga Neck tie/waist tie
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
Attachment | Mechanical slot and hook-and-loop | Same |
| Lighting Option | LED | Same |
Performance Comparison
| Property or
Characteristic | Testing Method | Predicate:
TotalShield™
Surgical Helmet
System | Modified Device:
TotalShield™
Surgical Helmet
System |
|-------------------------------------------------------|------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------|
| TotalShield™ Zippered Surgical Toga and Surgical Hood | | | |
| Flammability of
Clothing Textiles | ASTM F2100-07 reference 16
CFR-1610.4 | Class 1 Compliant-
pass | Class 1 Compliant-
pass |
8
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
Evaluation
on Skin Contact | ISO-10993-10 Intracutaneous
Reactivity Test
ISO-10993-5 MEM Elution Assay
with L-929 Mouse
Fibroblast Cells
ISO-10993-10 Guinea Pig
Maximization Sensitization Test | Compliant- pass | Compliant- pass |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--------------------------------|
| Sterility Method | ISO 11607-2 Packaging
Validation
ISO 11135-1 EO Validation
ISO 10993-7 EO Residual Test | Compliant- pass | Compliant- pass |
| Tear Resistance | ASTM D5733 MD Trap Tear
Compliant- pass AAMI Level 3 | Compliant- pass | Compliant- pass |
| Tensile Strength | ASTM D5034 Grab Tensile
Strength | Compliant- pass | Compliant- pass |
| Seam Strength | ASTM D1683 | Compliant- passed
seam test | Compliant- passed
seam test |
| Lint | ISO 9073; EN 13795-2 Test
methods for surgical
drapes, gowns and clean air
suits, used as medical
devices for patients, clinical
staff and equipment | Compliant- pass | Compliant- pass |
| Water Vapor
Transmission Rate | ASTM E96 with Water | Compliant- pass | Compliant- pass |
| Water resistance:
Impact
penetration
Hydrostatic
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
Method | Pass Acceptance
Criteria | Pass Acceptance
Criteria |
|-------------------------|---------------------------------------------|-----------------------------|-----------------------------|
| Helmet Noise
Testing | Internal Noise Measurement
Test Method | Pass Acceptance
Criteria | Pass Acceptance
Criteria |
| Battery Life
Testing | Internal Battery Performance
Test Method | Pass Acceptance
Criteria | Pass Acceptance
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
Description: | During the design and development of the TotalShield™
Surgical Helmet System, the following tests were
completed: |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electrical safety and Environmental testing (IEC
60601-1 and IEC 60601-1-2) Device Usability testing
was conducted in accordance with requirements of IEC
60601-1-6 and IEC 62366:2007. |
| | Sterilization Validation testing was conducted in
accordance with AAMI/ANSI/ISO 11607-1, 11607- 2
and AAMI/ANSI/ISO 11135-1. Shipping Validation was
conducted according to ASTM D4169-09. |
| | Biocompatibility Testing was conducted on skin contact
material in accordance with ISO 10993-1, ISO 10993-10,
ISO 10993-5 and ISO 10993-7. |
| | Non-Clinical testing was conducted to demonstrate that
the subject device performed as intended and met all
acceptance criteria, including:
• Airflow Testing
• Helmet Noise Testing
• Battery Life Testing
• Liquid Barrier testing (per AAMI/ANSI
PB70 Level 4, for Surgical Zippered Toga only) |
| | The TotalShield™ Surgical Helmet System adheres to the
specifications for requirements for performance,
documentation, and labeling per ASTM F2407-06. |
| Clinical Performance | No Clinical evaluations necessary for this device |
| Conclusion | All tests passed according to predetermined acceptance
criteria, thus demonstrating equivalent performance of the
subject device to the predicate device. |