STRYKER T4 HYTREL TOGA

K070078 · Stryker Instruments, Instruments Div. · FYA · Feb 2, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K070078
• Device Name: STRYKER T4 HYTREL TOGA
• Applicant: Stryker Instruments, Instruments Div.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Stryker T4 Hytrel 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

Stryker T4 Hytrel Toga is a single-use, sterile surgical gown component of a personal protection system. Device acts as a physical barrier between the surgical team and the operating environment to prevent cross-contamination and exposure to infectious body fluids or microorganisms. Used in surgical settings by surgical team members. Provides protection through material barrier properties; no electronic or algorithmic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-use sterile surgical gown made of Hytrel material. Functions as a passive physical barrier. No energy source, software, or electronic connectivity.

Indications for Use

Indicated for members of the surgical team as a barrier against contamination and exposure to infectious body fluids and harmful 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 T4 Hytrel Zipper Toga (K040764)
• Stryker Steri-Shield T4 Hytrel Toga (K011755)
• Stryker Steri-Shield Protection System (K944393)

Submission Summary (Full Text)

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Instruments

stry er

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

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## 510(k) Summary

510(k) Summary

| Device Sponsor: | Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001 (p) 269-323-7700 (f) 269-324-5412 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 1811755 |
| Trade Name: | Stryker T4 Hytrel Toga |
| Common Name: | Surgical gown |
| Equivalent to: | K040764-Stryker Steri-Shield T4 Hytrel Zipper Toga K011755-Stryker Steri-Shield T4 Hytrel Toga K944393-Stryker Steri-Shield Protection System |
| Device Description: | The Stryker T4 Hytrel Toga is a single use sterile product that covers the user to minimize potentially hazardous contact between the user and patient. |
| Intended Use: | The Stryker T4 Hytrel 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. |
| Substantial Equivalence Rational: | The Stryker T4 Hytrel Toga is substantially equivalent to (SE) devices in commercial distribution. The Stryker T4 Hytrel Togas have the same intended use, similar patient contact materials, same operating principles and physical specifications as compared to predicate devices. There are no new safety or efficacy concerns. |

Submitted by: Paulette D. Johnson

Regulatory Affairs Analyst

Date Submitted:

।।

1-23-07

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB - 2 2007

Re: K070078

Trade/Device Name: Stryker T4 Hytrel Toga Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA, FXY Dated: January 3, 2007 Received: January 9, 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 vour 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.

Chris Lee, 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):

Stryker T4 Hytrel Toga Device Name:

Indications for Use:

The Stryker T4 Hytrel 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 X (Part 21 CFR 801 Subpart D)

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

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula A Murphy, KD

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(Director) Sign Off) I tivision of Anesthesiology, General Hospital, Infaction Control, Dental Devices

1. 10.6.1 Paul