STERILE EQUIPMENT COVERS

K052395 · Volcano Corporation · KKX · Dec 1, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052395
• Device Name: STERILE EQUIPMENT COVERS
• Applicant: Volcano Corporation
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Dec 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

Device Story

Sterile Equipment Covers function as protective barriers for medical equipment; used to maintain sterile field during procedures. Device is a passive cover; no active inputs, processing, or outputs. Used in clinical environments (e.g., OR) by healthcare staff to prevent contamination of equipment. Benefits include maintenance of sterile environment and protection of equipment from fluids/particulates.

Clinical Evidence

Bench testing only. Sterilization validation performed per ANSI/AAMI/ISO 11135:1994; all requirements met.

Technological Characteristics

Sterile, passive equipment covers. Sterilization via ethylene oxide per ANSI/AAMI/ISO 11135:1994.

Indications for Use

Indicated for covering medical equipment to maintain a sterile field in clinical settings. Not for patient contact or use as patient drapes.

Regulatory Classification

Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• MicroTek Equipment Drapes (K050322)
• Medline Band Bags and Equipment Covers (K032065)
• United States Surgical Corporation (K961699)

Submission Summary (Full Text)

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Submitter: Volcano Corp.

2005 DEC 1

Sterile Equipment Covers 510(k) Premarket Notification

# 510 (k) Summary Sterile Equipment Covers

| Date Prepared: | August 30, 2005 |
|------------------------------------|---------------------------------------------------------------|
| Submitted by: | Volcano Corp.<br>2870 Kilgore Rd.<br>Rancho Cordova, CA 95670 |
| Contact person: | Michelle J. Badal, RAC<br>Regulatory Affairs Manager |
| Phone number:<br>Facsimile number: | [phone] or [phone] ext. 287<br>[phone] |
| Device Name: | Sterile Equipment Covers |

# Classification name:

878.4370 Surgical drape and drape accessories

Class II

# Predicate Device:

The Sterile Equipment Covers are substantially equivalent to the MicroTek Equipment Drapes cleared under K050322 on May 17, 2005, Medline Band Bags and Equipment Covers cleared under K032065 on September 22, 2003, and United States Surgical Corporation cleared under K961699 on August 23, 1996. The Volcano Sterife Equipment Covers have the same Intended Use and utilizes the same fundamental scientific technology as that of the predicate devices.

# Device Description:

Sterile Equipment Covers

# Intended Use:

The Sterile Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field. These covers are not intended to be used as patient drapes and have no patient contact.

# Device Technological Characteristics and Comparison to Predicate Device:

The Sterile Equipment Covers uses the same fundamental scientific technology and has the same intended use and clinical applications as that of the predicate device.

# Performance Data:

Sterilization validation testing was performed according to ANSI/AAMI/ISO 11135:1994. All requirements were met.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 resembling an eagle or bird in flight, composed of three curved lines.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 2005

Ms. Michelle J. Badal, RAC Manager, Regulatory Volcano Corporation 2870 Kilgore Road Rancho Cordova, California 95670

Re: K052395

Trade/Device Name: Sterile Equipment Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: November 23, 2005 Received: November 28, 2005

Dear Ms. Badal:

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 rortions 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 appear and 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. Badal

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 Incall that I DA mas made a assossions administered by other Federal agencies. of the Act of ally I ouchar backs requirements, including, but not limited to: registration 1 od interest comply with and 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 er reverts 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) This letter will anon you to began finding of substantial equivalence of your device to a premarket notified bevice 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), If you desire specific at 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 may obtain 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 vours,

Sarette Y. Michael Oms

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

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# Indications for Use

510(k) Number (if known): K052395

Sterile Equipment Covers Device Name:

Indications For Use:

The Sterile Equipment Covers are intended to be used to cover medical

equipment in order to maintain the sterile field. These covers are not

intended to be used as patient drapes and have no patient contact.

Prescription Use x AND/OR CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use ________(Part 21

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hale P. Murphy, MD 11/30/05

Sign-Off)
ision of Anesthesiology, General Hospital,
ection Control, Dental Devices
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- Number: K 052 593