STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
Device Facts
| Record ID | K141095 |
|---|---|
| Device Name | STRYKER STERI-SHIELD FLYTE HYBRID TOGAS |
| Applicant | Stryker Corporation |
| Product Code | FYA · General, Plastic Surgery |
| Decision Date | Aug 26, 2014 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Indications for Use
The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material. The togas are sterile and single use only.
Device Story
Steri-Shield Flyte Hybrid Togas are single-use, sterile surgical apparel components of a personal protection system. Worn by operating room personnel to provide a barrier against contamination, infectious bodily fluids, microorganisms, and particulate material. Modifications from predicate include more breathable hood material, improved barrier material grade for manufacturing efficiency, and minor design/fit changes. Device is terminally sterilized via ethylene oxide. Healthcare providers wear the toga as part of a protective system; output is the physical barrier itself, which reduces risk of cross-contamination between patient and staff. Benefits include maintained sterile field and protection of personnel from exposure.
Clinical Evidence
Bench testing only. Performance testing included biocompatibility (ISO 10993-1), lint level (ISO 9073-10), tensile strength (BS EN 29073-3), tear resistance (ASTM D5587-08), evaporative resistance (ASTM F1868), bacterial filtration efficiency (ASTM F2101-07), particulate filtration efficiency (ASTM F2299-03), viral penetration (ASTM F1671), and impact penetration (AATCC 42). Results demonstrate compliance with requirements for intended use.
Technological Characteristics
Single-use surgical apparel. Materials: Polypropylene (hood), Polypropylene/Acrylic (filter), Polycarbonate/PET (lens), Polypropylene/Polyester (barrier). Sterilization: Ethylene oxide (SAL 10^-6). Standards: ANSI/AAMI/ISO 10993-1, ISO 11135-1, ASTM F2101, ASTM F2299, AATCC 42. Form factor: Zippered or pullover toga.
Indications for Use
Indicated for operating room personnel to protect patient and staff against contamination, infectious bodily fluids, microorganisms, and particulate material. Single-use only.
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
- Stryker Steri-Shield Flyte Togas (K073017)
Submission Summary (Full Text)
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
August 26, 2014
Stryker Instruments Ms. Julia L. Helgeson Senior Regulatory Representative 4100 E. Milham Ave Kalamazoo, MI 49001
Re: K141095
Trade/Device Name: Stryker Steri-Shield Flyte Hybrid Togas Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: July 30, 2014 Received: July 31, 2014
Dear Ms. Helgeson.
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 mav publish further announcements concerning your device in the Federal Register. 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
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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
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Section 4 Indications for Use Statement
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# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
### 510(k) Number (if known) K141095
Device Name Styker Steri-Shield Flyte Hybrid Togas
Indications for Use (Describe)
The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The togas are sterile and single use only.
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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4100 E. Milham Ave.
Kalamazoo, MI 49001
t: 269 329 7000 f: 269 389 5412 www.stryker.com
# 510(k) Summary
| 510(k) Owner: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-329-7000<br>(f) 269-389-5412 | | | | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|----------------------|-------|---------------------------------|
| Contact Person: | Julia L. Helgeson<br>Sr. Regulatory Affairs Representative | | | | |
| Registration Number: | 1811755 | | | | |
| Date Summary Prepared: | June 25, 2014 | | | | |
| Trade Name(s): | Stryker Steri-Shield Flyte Hybrid Togas | | | | |
| Common Name: | Surgical Apparel | | | | |
| Classification Data: | Product Code | Device | Regulation<br>Number | Class | Review<br>Panel |
| | FYA | Gown, Surgical | 21 CFR 878.4040 | ll | General &<br>Plastic<br>Surgery |
| Reason for 510(k)<br>Submission: | Special 510(k): Device Modifications with no change to fundamental scientific<br>technology or intended use. | | | | |
| Device Modification: | Stryker submits this Special 510(k): Device Modification for our Steri-Shield Flyte<br>Togas. The modifications are as follows: | | | | |
| | Change in material utilized in hood region of toga<br>●<br>Change in material formulation of barrier material<br>●<br>Dimensional changes for user fit<br>●<br>Minor design modifications to component attachment methods<br>● | | | | |
| | The modification changes neither the intended use, the indications for use, nor the<br>fundamental scientific technology. | | | | |
| Predicate SE Device(s): | Stryker Steri-Shield Flyte Togas (K073017) | | | | |
| Indications for Use: | The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal<br>protection system and are intended to protect the patient, healthcare personnel,<br>and operating room personnel against contamination, exposure of infectious bodily<br>fluids, and the transfer of microorganisms and particulate material. The togas are<br>sterile and single-use only. | | | | |
| Device Description: | The Steri-Shield Flyte Hybrid Togas are single use, sterile, disposable devices that<br>comprise part of the Steri-Shield Flyte Hybrid Personal Protection System. They are<br>intended to be worn by healthcare personnel to protect the patient and healthcare | | | | |
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4100 E. Milham Ave. Kalamazoo, MI 49001 t: 269 329 7000 f: 269 389 5412 www.stryker.com
Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The word is in black and the background is white.
personnel against contamination, exposure of infectious bodily fluids and the transfer of microorganisms and particulate material. The devices are prescription use.
#### Device Models:
| Description | Part Numbers |
|---------------------------------------------------------------------|---------------------|
| Stryker Steri-Shield Flyte Hybrid Zippered Togas,<br>Standard Lens | 0408-8X1-000 Series |
| Stryker Steri-Shield Flyte Hybrid Zippered Togas, Peel<br>Away Lens | 0408-8X1-100 Series |
| Stryker Steri-Shield Flyte Hybrid Pullover Togas | 0408-7X1-000 Series |
Results of performance testing demonstrate that the functionality, integrity, and Performance Data (Non safety and effectiveness of the Steri-Shield Flyte Hybrid Togas are sufficient for Clinical Tests): their intended use and support a determination of substantial equivalence.
#### Summary of Performance Testing
Biocompatibility testing was performed on the subject device in accordance with ANSI/AAMI/ISO 10993-1:2009: Biological Evaluation of Medical Devices-Part 1: Evaluation and AAMI Standards and Recommended Practices, Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices. Results of testing validate the subject device is non-cytotoxic, non-sensitizing, and a negligible irritant.
Stryker Steri-Shield Flyte Hybrid Togas will be available only in sterile packaged form. The sterile product will be terminally sterilized using ethylene oxide (EO). The sterilization method was validated and performed in accordance with ANSI/AAMI/ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide. A sterility assurance level of 10 ° has been validated for this product.
#### Comparison to Predicate Device:
| Description | Stryker Steri-Shield Flyte<br>Togas (K073017)<br>(Predicate) | Stryker Steri-Shield Flyte<br>Hybrid Togas<br>(Subject) | Explanation of Difference |
|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification/<br>Regulation | Class II | Class II | Identical |
| Regulation | 21 CFR 878.4040 Surgical<br>Apparel | 21 CFR 878.4040 Surgical<br>Apparel | Identical |
| Product Code | FYA | FYA | Identical |
| Description | Stryker Steri-Shield Flyte<br>Togas (K073017)<br>(Predicate) | Stryker Steri-Shield Flyte<br>Hybrid Togas<br>(Subject) | Explanation of Difference |
| Intended Use | The Stryker Steri-Shield Flyte<br>Togas are components of a<br>personal protection system<br>and are intended to protect<br>the patient, health care<br>personnel and operating<br>room personnel against<br>contamination, exposure of<br>infectious bodily fluids, the<br>transfer of microorganisms<br>and particulate materials. | The Stryker Steri-Shield Flyte<br>Hybrid Togas are components<br>of a personal protection<br>system and are intended to<br>protect the patient, health care<br>personnel and operating room<br>personnel against<br>contamination, exposure of<br>infectious bodily fluids, the<br>transfer of microorganisms and<br>particulate materials.<br>The togas are sterile and single<br>use only. | Identical |
| Target Population | Operating room personnel | Operating room personnel | Identical |
| Conditions for Use | Single Use/Disposable | Single Use/Disposable | Identical |
| Materials | | | |
| Hood Region | Polypropylene and polyester | Polypropylene | Steri-Shield Flyte Hybrid<br>products utilizes a more<br>breathable material in<br>the hood region. |
| Filter | Polypropylene and Acrylic | Polypropylene and Acrylic | Identical |
| Lens: Standard<br>(Non-Peelaway) | Clear Polycarbonate | Clear Polycarbonate | Identical |
| Lens: Peelaway | Clear PET Laminate | Clear PET Laminate | Identical |
| Front and Sleeves<br>(Barrier Material) | Polypropylene and polyester | Polypropylene and polyester | Similar. Steri-Shield Flyte<br>Hybrid front and sleeves<br>use an improved grade of<br>the material, which<br>increases manufacturing<br>efficiencies. |
| Back and Shoulder<br>Ties | polypropylene | polypropylene | Identical |
| Waist Ties | Polypropylene and polyester | Polypropylene and polyester | Identical |
| Cuffs | Polyester | Polyester | Identical |
| Zipper | Polyester, Nylon, and Vinyl | Polyester, Nylon, and Vinyl | Identical |
| Zipper Guard | polypropylene | polypropylene | Identical |
| Color | Hood region material: Blue<br>Front/Sleeve material: Blue | Hood region material: Light<br>blue<br>Front/Sleeve material: Blue | Similar. Steri-Shield Flyte<br>Hybrid hood region<br>material is light blue in<br>color instead of blue. |
| | Back material: Blue<br>Filter material: White | Back material: Blue<br>Filter material: White | |
| Physical/ Mechanical Specifications | Cuffs: White | Cuffs: White | |
| Description | Stryker Steri-Shield Flyte<br>Togas (K073017)<br>(Predicate) | Stryker Steri-Shield Flyte<br>Hybrid Togas<br>(Subject) | Explanation of Difference |
| Lint Level (ISO 9073<br>part 10 ) | Compliant - Pass | Compliant - Pass | Specification met. Steri-<br>Shield Flyte Hybrid Togas<br>use a different hood<br>region material. The filter<br>material was not tested<br>as part of the initial 510k<br>but was tested for the<br>Steri-Shield Flyte Hybrid<br>510k. |
| Tensile Strength (BS<br>EN 29073-3) | Compliant - Pass | Compliant - Pass | Specification met. Steri-<br>Shield Flyte Hybrid hood<br>region material has a<br>lower tensile strength,<br>but it still meets the<br>specification. The filter<br>material was not tested<br>as part of the initial 510k<br>but was tested for the<br>Steri-Shield Flyte Hybrid<br>510k. |
| Tear Resistance<br>(Flyte Hybrid: ASTM<br>D 5587-08; Flyte:<br>ASTM D 5733) | Compliant - Pass | Compliant - Pass | Specification met. ASTM<br>D5733 was withdrawn in<br>2008; therefore, a<br>different test standards<br>were followed. The filter<br>material was not tested<br>as part of the initial 510k,<br>but was tested for the<br>Steri-Shield Flyte Hybrid<br>510k. |
| Evaporative<br>resistance (ASTM F<br>1868 ) | Not Previously Tested | Compliant - Pass | Specifications met.<br>Evaporative Resistance<br>was not previously tested<br>as part of the initial Steri-<br>Shield Flyte 510k. |
| Bacterial Filtration<br>Efficiency<br>per ASTM F2101-07 | Compliant - Pass | Compliant - Pass | Specifications met. |
| Particulate Filtration<br>Efficiency<br>per ASTM F2299-03 | Compliant - Pass | Compliant - Pass | Specifications met. |
| | | | |
| Description | Stryker Steri-Shield Flyte<br>Togas (K073017)<br>(Predicate) | Stryker Steri-Shield Flyte<br>Hybrid Togas<br>(Subject) | Explanation of Difference |
| Viral Penetration<br>(per ASTM F1671)<br>Level 4 Critical Zone<br>as defined in<br>AAMI/ANSI PB70 | Hood region material: Pass<br>requirements for Level 4<br>Protection. | Hood region material: Material<br>not designed to meet Level 4<br>protection and was not tested<br>for viral penetration | Specifications met. |
| | Front/Sleeve material: Pass<br>requirements for Level 4<br>Protection. | Front/Sleeve material: Pass<br>requirements for Level 4<br>Protection. | |
| | Sleeve Seam: Pass<br>requirements for Level 4<br>Protection. | Sleeve Seam: Pass<br>requirements for Level 4<br>Protection. | |
| Water Resistance:<br>Impact Penetration<br>(per AATCC 42)<br>Level 1 Critical Zone | Hood region Material: Pass<br>requirements for Level 1<br>Protection. | Hood region Material: Pass<br>requirements for Level 1<br>Protection. | Specifications met. |
| as defined in<br>AAMI/ANSI PB70 | Back material: Pass<br>requirements for Level 1<br>Protection. | Back material: Pass<br>requirements for Level 1<br>Protection. | |
| | All other protective seams:<br>Pass requirements for Level 1<br>Protection. | All other protective seams:<br>Pass requirements for Level 1<br>Protection. | |
| General Safety and Performance | | | |
| Biocompatibility | | | |
| in vitro cytotoxicity | Under the conditions of the<br>study, non-cytotoxic | Under the conditions of the<br>study, non-cytotoxic | Identical |
| primary skin<br>irritation | Under the conditions of the<br>study, not an irritant | Under the conditions of the<br>study, not an irritant | Identical |
| skin sensitization | Under the conditions of the<br>study, not a sensitizer | Under the conditions of the<br>study, not a sensitizer | Identical |
| Flammability | No Flame Spread per 16 CFR<br>Part 1610 | No Flame Spread per 16 CFR<br>Part 1610 | Identical |
| Shelf Life | 3 years | 1 year | Similar – the intent is to<br>extend the shelf life for<br>the subject device upon<br>successful completion of<br>aging studies |
| Finished (Terminal)<br>Product Sterilization<br>Method | SAL 10-6<br>Terminally sterilized via<br>Ethylene Oxide in accordance<br>with ISO 11135-1 | SAL 10-6<br>Terminally sterilized via<br>Ethylene Oxide in accordance<br>with ISO 11135-1 | Identical |
| Packaging | Individually packaged in a<br>Poly-Tyvek pouch | Individually packaged in a Poly-Tyvek pouch | Identical |
| Description | Stryker Steri-Shield Flyte<br>Togas (K073017)<br>(Predicate) | Stryker Steri-Shield Flyte<br>Hybrid Togas<br>(Subject) | Explanation of Difference |
| Labeling | Adhesive backed label placed<br>on carton and pouch label<br>printed directly onto the<br>Tyvek.<br>Label specified part<br>description, quantity,<br>sterilization method, lot<br>number, expiration date, and<br>contact information.<br>No known contraindications. | Adhesive backed label placed<br>on carton and pouch label<br>printed directly onto the Tyvek.<br>Label specified part<br>description, quantity,<br>sterilization method, lot<br>number, expiration date, and<br>contact information.<br>No known contraindications. | Identical |
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Image /page/6/Picture/1 description: The image shows the word "Stryker" in a bold, sans-serif font. The word is all in lowercase letters except for the first letter, which is capitalized. A small registered trademark symbol is located to the upper right of the letter "r" at the end of the word. The word is in black and the background is white.
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Image /page/7/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase except for the first letter, which is uppercase. A small registered trademark symbol is located to the upper right of the letter "r".
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Image /page/8/Picture/1 description: The image shows the Stryker logo in black and white. The logo is a stylized wordmark with a distinctive font. The word "Stryker" is written in all lowercase letters, with the "r" having a unique curved shape. A registered trademark symbol is located to the upper right of the "r".
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Image /page/9/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all connected, and the word is in black. There is a registered trademark symbol to the right of the letter "r". The logo is simple and modern.
# Conclusion/ Substantial Equivalence (SE) Rationale:
The Stryker Steri-Shield Flyte Hybrid Togas are substantially equivalent in intended use, technological characteristics, safety, and effectiveness to the previously cleared Stryker Steri-Shield Flyte Togas. The products have the same fundamental scientific technology, basic design, functional characteristics and applications. The modifications introduced raise no new issues of safety and effectiveness. Therefore, the Stryker Steri-Shield Flyte Hybrid Togas are substantially equivalent to the existing predicate devices.
