STRYKER STRI-SHIELD FLYTE TOGAS

K073017 · Stryker Instruments, Instruments Div. · FYA · Nov 30, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K073017
• Device Name: STRYKER STRI-SHIELD FLYTE TOGAS
• Applicant: Stryker Instruments, Instruments Div.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Nov 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Device Story

Steri-Shield Flyte Togas are surgical gowns worn over Stryker Flyte Helmets; provide barrier protection in operating room environments. Togas feature integrated hoods with attached lenses (including peel-away or UV options) and gown sections covering front, back, and arms. Available in pullover or zippered configurations. Barrier performance meets AAMI PB70:2003 standards; Level 4 critical zones resist liquid and viral penetration (tested per ASTM F1671:2003); Level 1 zones resist liquid penetration (tested per AATCC 42:2000). Protects patients and staff from fluid/microorganism transfer. Used by surgical teams during procedures.

Clinical Evidence

Bench testing only. Barrier performance validated against AAMI PB70:2003 guidelines. Viral penetration resistance tested per ASTM F1671:2003 (bacteriophage Phi-X174) with 4% AQL. Liquid penetration resistance tested per AATCC 42:2000 with 4% AQL.

Technological Characteristics

Materials: Polypropylene or polyester non-woven fabric, copolymer polyester film, 35g SMMS polypropylene. Barrier performance: AAMI PB70:2003 Level 1 and Level 4. Testing standards: ASTM F1671:2003, AATCC 42:2000. Form factor: Pullover or zippered gown with integrated hood and lens. Sizes: S/M to 3XL.

Indications for Use

Indicated for use by patients, health care personnel, and operating room personnel as a personal protection system component to prevent contamination, exposure to infectious bodily fluids, and transfer of microorganisms and particulate material.

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 T6 Hoods and Togas (K0063005)

Submission Summary (Full Text)

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K07 3017

4100 E. Milham Avenue
Kalamazoo, MI 49001
t: 269 323 7700 ff: 800 965 6505
www.stryker.com

NOV 3 0 2007

Image /page/0/Picture/3 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 upper right of the letter "r". The word is in black and the background is white.

Instruments

## 510(k) Summary

| Device Sponsor: | Stryker Instruments<br>4100 East Milham Avenue<br>Kalamazoo, Michigan 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
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| Registration No.: | 1811755 |
| Trade Name: | Stryker Steri-Shield Flyte Togas |
| Classification: | Sterile Surgical Gowns |
| Equivalent to: | K0063005-Stryker T6 Hoods and Togas |
| Device Description: | Device History |
| | Summary of Stryker Steri-Shield Flyte Togas |
| | The scope of this Special 510k material modification is limited<br>to material changes to the gown. The toga has a hood and gown<br>section. The hood covers the user's head. A lens is attached to the<br>front of the hood. The gown of the toga covers the user's front,<br>back and arms. The Stryker Steri-Shield Flyte Togas are tested to<br>meet applicable AAMI PB70:2003 standards. The AAMI standard<br>does not cover apparel for the head, face, and eyes. Therefore, the<br>hoods and lens (components of the togas) are exempt from<br>classification under the AAMI PB70:2003 standard. |
| | Stryker Steri-Shield Flyte Toga, Pullover |
| | The Stryker Steri-Shield Flyte Toga, Pullover is intended to be<br>worn over any Stryker Flyte Helmet. The Stryker Steri-Shield<br>Flyte Pullover togas provide Level 4 and Level 1 barrier protection<br>for the critical zones as set froth in the accompanying drafted IFUs<br>(Attachment 8 and as classified under the AAMI (Association for<br>the Advancement of Medical Instrumentation) guidelines for<br>barrier performance. This garment was tested for resistance to<br>bacteriophage Phi-X174 in accordance with ASTM F1671:2003 |

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KITT

per the AAMI Barrier Classification System and demonstrate a passing result with an AQL of 4% under Procedure A. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The barrier material for the Stryker Steri-Shield Flyte Toga Pullover is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Stryker Steri-Shield Flyte Toga, Pullover will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.

## Stryker Steri-Shield Flyte Toga, Zippered: Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; Stryker Steri-Shield Flyte Toga with UV Lens, Zippered.

The Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens. Zippered are intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Togas provide protection as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Barrier Classification System. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The Level 4 barrier material is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Level 1 material on the back of the zippered togas is constructed of 35 gram SMMS polypropylene. The Stryker Steri-Shield Flyte Toga. Zippered will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.

Indications for Use: The Stryker Steri-Shield Flyte Togas are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against

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| | | contamination, exposure of infectious bodily fluids, the transfer of<br>microorganisms and particulate material. |
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| | Substantial Equivalence<br>(SE) Rational: | The Stryker Steri-Shield Flyte Togas are substantially equivalent to<br>devices in commercial distribution. |
| | | Stryker Steri-Shield Flyte Togas have an equivalent intended use,<br>patient contact materials, operating principles and physical<br>specifications as compared to predicate devices. |
| | Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryke<br>Steri-Shield Flyte Togas are substantially equivalent to legally<br>marketed devices. The Stryker Steri-Shield Flyte Togas do not<br>raise any new safety or efficacy concerns. |
| | Submitted by: | Paulette D. Johnson<br>Regulatory Analyst<br>Stryker Instruments<br>4100 East Milham Avenue<br>Kalamazoo, MI 49009<br>p: 269-323-7700, ext 3084<br>f: 269-324-5412 |

tourities Signature

Date Submitted:

10-18-07

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2007

Ms. Paulette D. Johnson Regulatory Analyst Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K073017

Trade/Device Name: Stryker Steri-Shield Flyte Togas Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: November 19, 2007 Received: November 20, 2007

Dear Ms. Johnson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Johnson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Clue
Chia-Lin Pi, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K073017

Device Name: Stryker Steri-Shield Flyte Togas (Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered)

Indications for Use:

The Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

S. H. Murphy, Jr.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

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