SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE

K081476 · Surgical Concept Designs · KKX · Aug 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081476
• Device Name: SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
• Applicant: Surgical Concept Designs
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

The Surgical Concept Designs Surgical Drape, Model #01001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.

Device Story

Surgical drape device consisting of a tubular polyethylene film sleeve; features integrated equipment attachment mechanism composed of polycarbonate, stainless steel pegs, and butyl rubber gasket. Used in surgical settings to cover medical equipment during general surgery. Protects equipment from contamination; maintains sterile field. Operated by surgical staff.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Polyethylene film, polycarbonate, stainless steel, butyl rubber. Form factor: Tubular sleeve with integrated attachment feature. Energy source: None (passive device).

Indications for Use

Indicated for use as a protective cover for medical equipment during general surgical procedures.

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

• Advance Medical Designs Slush Drapes (K053594)
• Microtek Medical, Inc. Equipment Drapes (K050322)

Submission Summary (Full Text)

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K081476

## Summary of Safety and Effectiveness

AUG - 8 2008

- Submitter: Christopher Scott Surgical Concept Designs 307 Prospect Ave - 2G Hackensack, NJ 07601
- Date Prepared: May 15, 2008

Surgical Concept Designs Surgical Drape Device:

- Classification: 79 KKX - Surgical drape and drape accessories, 21 CFR 878.4370 Class 11
- Predicate Device: Advance Medical Designs Slush Drapes - K053594 Microtek Medical, Inc. Equipment Drapes - K050322
- Device Description: The Surgical Concept Designs Surgical Drape is a generally tubular sleeve of polyethylene film with an integrated equipment attachment feature at one end made from polycarbonate, with stainless steel pegs and a butyl rubber gasket.
- Intended Use: The Surgical Concept Designs Surgical Drape is an equipment cover used to cover medical equipment in a surgical setting. It is to be used in general surgery.

## Comparison to Predicates:

The Surgical Concept Designs Surgical Drape consists of a polyethylene drape cut and configured to a specification with an integrated equipment attachment feature. The device is equivalent to the Microtek Medical Equipment Drape and Advance Medical Designs Slush Drapes which are also surgical drapes manufactured from polymer film cut and configured to a specification.

Surgical Concept Designs has determined that any differences in the proposed device will not impact the safety or effectiveness of the surgical drape for its intended use. Testing has shown that the proposed device meets the applicable requirements of the standards for surgical drapes.

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Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2008

Mr. Christopher Scott President Surgical Concept Designs 307 Prospect Avenue, Suite 2G Hackensack, New Jersey 07601

Re: K081476

Trade/Device Name: Surgical Concept Designs Surgical Drape Regulation Number: 878.4370 Regulation Name: Surgical drape and drape Accessories Regulatory Class: II Product Code: KKX Dated: July 30, 2008 Received: August 4, 2008

Dear Mr. Scott:

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 - Mr. Scott

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 équivalence 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

H.Sommerler. Send und foe. //

Chiu S. Lin. Ph. D Division 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 Form

510(k) Number (if known):

Device Name: __Surgical Concept Designs Surgical Drape

Indications for Use:

The Surgical Concept Designs Surgical Drape, Model #01001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.

Prescription Use X (Per 21 CFR 801.109)

-

OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy, M.D.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K08142/

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