GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS

K041501 · Guangzhou Fortunique , Ltd. · MMP · Nov 30, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041501
• Device Name: GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
• Applicant: Guangzhou Fortunique , Ltd.
• Product Code: MMP · General, Plastic Surgery
• Decision Date: Nov 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2

Intended Use

Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact. Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.

Device Story

Low density polyethylene film drapes, bags, and covers; used to shield surgical/medical equipment; maintains sterile field; aids in post-procedure cleanup. Offered in various sizes/shapes; available sterile (ready-to-use) or non-sterile (for inclusion in third-party convenience packages). Used in clinical settings (surgery/medical procedures); operated by healthcare staff. No patient contact; device does not interact with patient physiology.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Low density polyethylene film; various sizes and shapes; available sterile or non-sterile; manual application.

Indications for Use

Indicated for covering medical equipment to maintain a sterile field and assist in post-procedural cleanup. Not for use as patient drapes; no patient contact.

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

• Medline Band Bags and Equipment Covers (K032065)
• primaGARD Surgical Equipment Covers (K022868)
• Coverall All Equipment Covers Banded Bags & Dome Bags, Various Models, Sterile and Non-sterile (K023540)
• International MedSurge Connections Equipment Covers (K014239)
• United States Surgical Corporation Equipment Covers (K961699)
• Pinnacle Products Coverall All, Chair Sleeve, Drape-it-All, Tray Sleeve and related products (K962288)

Submission Summary (Full Text)

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K041501

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Page 48

| | Attachment 4: | 510 (k) Summary |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| | NOV 3 0 2004 | |
| | 510(k) Summary | |
| Manufacturer: | Guangzhou Fortunique Ltd.<br>Block B2 Zhou Shan Gang<br>Shi Bei Ind. Ave. Pan Yu District<br>Guangzhou<br>511410, China | |
| Contact: | Jane B. Campbell | |
| Address: | J. & D. Campbell Associates, Inc.<br>485 LaRoe Road<br>Chester, New York 10918 | |
| Telephone: | [phone] | |
| Fax: | 845-469-4212 | |
| Email: | [e-mail] | |
| Date Summary Prepared: | May 27, 2004 | |
| Product Trade Name: | Guangzhou Fortunique Drapes, Bags and Covers | |
| Common Name: | Equipment drapes, bags and covers | |
| Classification: | II | |
| Predicate Devices: | Medline Band Bags and Equipment Covers K032065<br>primaGARD Surgical Equipment Covers K022868<br>Coverall All Equipment Covers Banded Bags & Dome<br>Bags, Various Models, Sterile and Non-sterile K023540<br>International MedSurge Connections Equipment Covers -<br>K014239<br>United States Surgical Corporation Equipment Covers<br>K961699<br>Pinnacle Products Coverall All, Chair Sleeve, Drape-it-All,<br>Tray Sleeve and related products K962288 | |
| Description: | Guangzhou Fortunique Drapes, Bags and Covers are made of<br>low density polyethylene film ir various sizes and shapes for<br>use in covering equipment. These drapes, bags and covers are<br>offered non-sterile in bulk quantities and sterile in individual<br>packs. | |
| Intended Use: | Guangzhou Fortunique's Drapes, Bags and Covers are intended<br>to cover equipment, to maintain a sterile field and as an aid in<br>the clean up of equipment after surgery or other medical<br>procedures. These drapes, bags and covers are not intended to<br>be used as patient drapes and they have no patient contact. | |
| | Fortunique intends to manufacture and market Drapes, Bags<br>and Covers sterile in ready to use form and will also provide<br>them in non-sterile form to other companies for inclusion in<br>convenience packages which they will then sterilize. | |
| Substantial Equivalence: | The Fortunique Drapes, Bags and Covers are substantially<br>equivalent to the predicate devices listed above in that they<br>- have the same intended use<br>- are manufactured of the same polyethylene film<br>- they are offered in the same sizes and configurations<br>- they have the same physical characteristics | |

June 4, 2004

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2004

Guangzhou Fortunique, Limited C/O Ms. Jane B. Campbell US Agent/Official Correspondent J. & D. Campbell Associates, Incorporated 485 LaRoe Road Chester, New York 10918

Re: K041501

Trade/Device Name: Guangzhou Fortunique Drapes, Bags and Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX, MMP Dated: October 7, 2004 Received: October 8, 2004

Dear Ms. Campbell:

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. Campbell

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 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.

Susabunner
Sue Chin-Lin, 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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K641501

June 4, 2004

## Indications for Use Statement

510(k): 04150

Device Name: Guangzhou Fortunique Drapes, Bags and Covers

Intended Use: Guangzhou Fortunique's Drapes, Bags and Covers are intended to cover equipment, to maintain a sterile field and as an aid in the clean up of equipment after surgery or other medical procedures. These drapes, bags and covers are not intended to be used as patient drapes and they have no patient contact.

Fortunique intends to manufacture and market Drapes, Bags and Covers sterile in ready to use form and will also provide them in non-sterile form to other companies for inclusion in convenience packages which they will then sterilize.

Susan Runn

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

510(k) Number: KA1506

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 807 Subpart C) ✓

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

Concurrence of CDRH, Office of Device Evaluation (ODE)