STERILE DISPOSABLE EQUIPMENT MAGNET COVER

K970185 · Contour Fabricators, Inc. · KKX · Apr 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970185
• Device Name: STERILE DISPOSABLE EQUIPMENT MAGNET COVER
• Applicant: Contour Fabricators, Inc.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Apr 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination. This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.

Device Story

Sterile, disposable drape designed for use with General Electric Medical Systems Signa SP MRI system during surgical procedures. Device consists of Dexter nonwoven fabric coated with 0.5 mil linear low-density polyethylene. Applied to clean, dry surfaces via pressure-sensitive adhesive tape. Functions as physical barrier to prevent gross contamination of MRI magnet walls and maintain sterile field integrity. Used in clinical/surgical environments by healthcare personnel. Benefits include protection of sensitive imaging equipment and maintenance of sterile conditions during intraoperative MRI.

Clinical Evidence

Bench testing only. Flammability tested per 16 CFR 1610 (Class I compliant). Physical properties tested: grammage (69.4 g/m²), tensile strength (MD 3500 g/25mm, CD 2100 g/25mm), and absorbency (2.5 sec). Fluid penetration resistance tested at 0.22 psi for 6 hours with no penetration observed.

Technological Characteristics

Material: Dexter nonwoven fabric with 0.5 mil linear low-density polyethylene coating. Dimensions: 114" x 54", 5 mils thick. Attachment: Pressure-sensitive adhesive tape. Flammability: Class I (16 CFR 1610). Fluid resistance: 0.22 psi for 6 hours.

Indications for Use

Indicated for use in surgical procedures involving the General Electric Medical Systems Signa SP MRI system to protect magnet walls from contamination and isolate the sterile field.

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

• Contour Fabricators, Inc. Bandbag, Wrap, Sterile, Disposable Flouroscope and General Equipment Cover (K782155)
• Bemiss-Jason Corporation (originally Triad Medical Division), E-Z Fit Cover (K831287)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
OCT 26 2004
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Michael Czop
Contour Fabricators, Incorporated
4100 E. Baldwin Road
Grand Blanc, Michigan 48439

Re: K970185
Trade/Device Name: Sterile Disposable Equipment Magnet Cover
Regulation Number: 21 CFR 878.4370
Regulation Name: Surgical Drape and Drape Accessories
Regulatory Class: II
Product Code: KKX
Dated: March 27, 1997
Received: March 28, 1997

Dear Mr. Czop:

This letter corrects our substantially equivalent letter of April 10, 1997 regarding the product code.

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 (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 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 – Mr. Czop

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 continue 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/dsma/dsmamain.html

Sincerely yours,


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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K970185
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# 510(K) SUMMARY
(as required by 807.92(c))

## Submitter of 510(k):
Contour Fabricators, Inc.
4100 East Baldwin Rd.
Grand Blanc, MI 48439

Phone: [phone]
Fax: [phone]
APR 10 1997

## Contact Person:
Michael W. Czop

## Date of Summary:
April 3, 1997

## Trade Name:
Sterile, Disposable Magnet Cover

## Classification Name:
Sterile, Disposable Equipment Cover

## Predicate Device:
Contour Fabricators, Inc. Bandbag, Wrap, Sterile, Disposable Flouroscope and General Equipment Cover. K782155
Bemiss-Jason Corporation (originally Triad Medical Division), E-Z Fit Cover. K831287

## Device Description:
The sterile, disposable magnet cover utilizes a Dexter Nonwoven: a soft, strong absorbent pinhole resistant base fabric, which has been coated with .5 mil of linear low density polyethylene extrusion. The material is blue in color, cut to an overall length and width of 114" x 54", and is 5 mils thick.

Through the use of pressure sensitive adhesive tape, the cover can be attached to a clean, dry surface to establish a barrier.

## Performance Standards:
Flammability:

Material was tested for flammability in accordance with 16 CFR 1610. Because the material is disposable in nature and would not withstand the rigors of washing and dry cleaning specified by the standard, the material was tested in its “as received condition.” The average rate of burn for the material was 7.3 seconds, compliant with Class I flammability standards.

Grammage (Basis Weight): g/m² 69.4
Tensile Strength, Dry: g/25mm MD 3500
CD 2100
Absorbency (Water Drop): sec 2.5

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K970185
PZ:12

# 510(K) SUMMARY
(as required by 807.92(c))

## Performance Standards: (Continued)

Resistance to fluid penetration:

An engineering test was prepared to determine the ability of the material to resist fluid penetration. Material was subjected to fluid-depth-related pressure of .22 psi for 6 hours, visual and tactile inspection revealed no fluid penetration through the material.

## Intended Use:

Magnetic Resonance Imaging (MRI) technology requires the use of large magnets for image generation. This technology is now being tested for use in surgical procedures. The sterile, disposable magnet cover is intended to protect the walls of a magnet from gross contamination and also to isolate the sterile field from microbial contamination.

This particular cover is specifically intended for use with the General Electric Medical Systems Signa SP MRI system.

TOTAL P.03