STRYKER T4 HYTREL ZIPPER TOGA

K040764 · Stryker Corp. · FYA · Apr 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040764
• Device Name: STRYKER T4 HYTREL ZIPPER TOGA
• Applicant: Stryker Corp.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Device Story

The Stryker T4 Hytrel Zipper Toga is a component of the Stryker Personal Protection System, which includes a ventilation helmet, hood, toga, and rechargeable battery. The toga serves as a protective barrier for surgical team members in the operating room. It is designed to prevent contact with infectious body fluids and microorganisms. The device functions as a physical shield; it does not involve electronic processing or clinical decision-making outputs.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence was established through laboratory testing of material properties including viral penetration, synthetic blood penetration, water resistance (impact penetration and hydrostatic pressure), flammability, and tear resistance.

Technological Characteristics

The device is a surgical gown (toga) constructed from Hytrel material. It functions as a physical barrier component of a personal protection system. It does not utilize energy sources, software, or connectivity. Sterilization and specific ASTM standards are not detailed in the provided text.

Indications for Use

Indicated for members of the surgical team to provide a barrier against contamination and exposure to infectious body fluids and microorganisms in the operating environment.

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 Personal Protection System (K944393)
• Stryker Steri-shield Personal Protection System (K011755)

Submission Summary (Full Text)

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# 510(k) Summary ______________________________________________________________________________________________________________________________________________________________________________

Ko40764

| Trade Name: | Stryker T4 Hytrel Zipper Toga | | | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Common Name: | Surgical gown and hood | | | | | |
| Classification Name: | Surgical Apparel (per 21 CFR section 878.4040) | | | | | |
| Equivalent to: | The Stryker T4 Hytrel Zipper Toga is equivalent to the zipper<br>toga of the Stryker Steri-shield Personal Protection System<br>(K944393, K011755). The material used on the front and<br>sleeves of the Stryker T4 Hytrel Zipper Toga was shown to be<br>equivalent to or better than the material used on the front and<br>sleeves of the Stryker Steri-Shield Personal Protection System<br>(K944393, K011755), as is detailed in Tab 4. Equivalence was<br>based on the results of the following tests: Viral Penetration,<br>Synthetic Blood Pentration, Water Resistance: Impact<br>Penetration, Water Resistance: Hydrostatic Pressure,<br>Flammability, and Tear Resistance | | | | | |
| Device Description: | The Stryker Personal Protection Systems include a self-contained<br>ventilation helmet, a hood, a toga, rechargeable battery, and<br>accessories. | | | | | |
| Intended Use: | The Stryker T4 Hytrel Zipper Toga is a component of a personal<br>protection system that is intended to provide a barrier between<br>the operating environment and the members of the surgical team<br>in order to help protect against contamination and/or exposure of<br>infectious body fluids and harmful microorganisms. | | | | | |
| Technological | Technological characteristics are the same as previously cleared<br>for the Stryker Steri-Shield | | | | | |
| Comparison: | Personal Protection System (K944393, K011755). | | | | | |
| Submitted by: | Jennifer Mars, Regulatory Affairs Representative<br>Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>Phone- 269-323-7700 ext. 3808<br>Fax- 269-324-5412 | | | | | |
| Date Submitted: | March 17, 2004 | | | | | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes and a stylized body.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Stryker Instruments Corporation Ms. Jennifer Mars Regulatory Affairs Representative Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K040764

Trade/Device Name: The Stryker T4 Personal Protection System: Stryker T4 Hytrel Zipper Toga Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 16, 2004 Received: April 19, 2004

Dear Ms. Mars:

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. Mars

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 vour device to proceed to the market.

If vou 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/dsma/dsmamain.html

Sincerely yours.

ChrLs

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 Statement

| 510(k) Number | K040764 |
|---------------|--------------------------------------------------------------------------|
| Device Name | The Stryker T4 Personal Protection System: Stryker T4 Hytrel Zipper Toga |

Indications For Use The Stryker T4 Hytrel Zipper Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

Prescription Use (Pcr 21 CFR 801 Subpart D) OR Over-The-Counter Use (21 CFR 807 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Morley

(Division Sign-Off) (Division Sign-On/) ----------------------------------------------------------------------------------------------------------------------------------------------------------Infection Control, Dental Devices

510(k) Number: K040764