DHS DISPOSABLE HOOD SYSTEM

K021992 · Biomet, Inc. · FYA · Jan 14, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K021992
• Device Name: DHS DISPOSABLE HOOD SYSTEM
• Applicant: Biomet, Inc.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Jan 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous bloodborne pathogens that may be present in the operation room environment. The device also offers the patient additional protection from potential deep wound infection by preventing skin, hair and other debris entry into the wound from surgical team members

Device Story

Disposable surgical hood system; worn by surgical team members. Components include drape material enclosure, adjustable headband, clear viewing window, and battery-powered air delivery system (fan) worn on waistband. Provides physical barrier against bloodborne pathogens; prevents shedding of skin/hair into surgical site. Used in operating room. Benefits include reduced risk of cross-contamination between surgical team and patient.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing.

Technological Characteristics

Sterile, single-use surgical hood. Materials: drape fabric. Components: adjustable headband, clear viewing window, battery-powered fan/air delivery system. Mechanical design for personal protection. No software or electronic processing.

Indications for Use

Indicated for surgical team members in an operating room environment to provide a barrier against bloodborne pathogens and to protect patients from surgical site contamination by preventing the shedding of skin, hair, and debris.

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 Device
• DePuy Sterile View Disposable Hood / Gown

Submission Summary (Full Text)

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BIOMET

K621992

JAN 1 4 2003

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant/Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
|----------------------|--------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN. MBA<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | DHS Disposable Hood System |
| Common Name: | Disposable Surgical Hood |
| Classification Name: | Surgical Apparel (21 CFR 878.4040) |

## Legally Marketed Devices to Which Substantial Equivalence is Claimed:

- Stryker Steri-Shield Personal Protection Device .
- DePuy Sterile View Disposable Hood / Gown .

Device Description: The device consists of an enclosure of drape material that is worn by members of a surgical team and is fitted to the head with an adjustable headband. A clear viewing window is provided along with an air delivery system to supply cool air under the enclosure via a fan powered by a battery pack worn on the waistband.

Intended Use: The device is a sterile, sinqle-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous body fluids that may be present in the operation room environment.

Summary of Technologies: The disposable sterile surgical hood components (materials, design, sizes and indications) are similar or identical to the predicate devices.

Non-Clinical Testing: Non-clinical testing demonstrated the device performed as well as or better than currently marketed devices. Substantial equivalence was determined based on a comparison of technological characterizes with the predicate device. This comparison included fabric weight, grab strength, grab elongation, trap tear, hydrohead test, spray impact, alcohol (repellency), permeability and static decay.

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

.

SHIPPING ADDRESS 56 E. Bell Drive
Warsaw, IN 46582

E-MAIL [e-mail]

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2003

Mr. Kacy Arnold Regulatory Affairs Specialist Biomet Orthopedics, Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K021992

Trade/Device Name: DHS Disposable Surgical Hood System Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: January 2, 2003 Received: January 7, 2003

Dear Mr. Arnold:

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 vour 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 - Mr. Arnold

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 (OS) 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]. Additionally, for questions on the promotion and advertising of your device, 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 vour responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. Ulatowski 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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K021992 510 (k) Number (if known) : __________________________________________________________________________________________________________________________________________________

Device Name: DHS Disposable Hood System

Indications for Use:

The device is a sterile, single-use, personal protective system designed to provide a barrier between the surgical team and potentially hazardous bloodborne pathogens that may be present in the operation room environment. The device also offers the patient additional protection from potential deep wound infection by preventing skin, hair and other debris entry into the wound from surgical team members

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |
| ( | |

Over-The-Counter-Use (Optional Format 1-2-96)

Anesthesiology, General Hospital Control. Denta

510(k) Number: K021992