JOYKEY SURGICAL DRAPES (STERILE)

K062480 · Joykey Industryial , Ltd. · KKX · Mar 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062480
• Device Name: JOYKEY SURGICAL DRAPES (STERILE)
• Applicant: Joykey Industryial , Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: Mar 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

JOYKEY Surgical Drapes (Sterile) are single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

Device Story

JOYKEY Surgical Drapes are sterile, single-use protective coverings for patients undergoing surgery. Constructed from non-woven fabric, PE, and a reinforcement layer, the drapes function as a physical barrier to isolate the surgical incision site from microbial and other environmental contamination. The device is available in three configurations: split drape, thyroid sheet, and pediatric laparotomy drape. Used in clinical surgical settings, the drapes are applied by healthcare personnel to the patient to maintain a sterile field. The device provides a protective barrier, reducing the risk of surgical site contamination and potential infection.

Clinical Evidence

No clinical data. Bench testing only. Device conforms to ASTM F1670-03 (barrier properties), ASTM D1424, ASTM D5034, NFPA flammability standards, ISO 10993 (biological standards), and ISO 11137 (gamma sterilization).

Technological Characteristics

Materials: non-woven fabric, PE, and reinforcement layer. Barrier properties per ASTM F1670-03. Physical properties per ASTM D1424 and ASTM D5034. Flammability per NFPA standards. Biocompatibility per ISO 10993. Sterilization: Gamma radiation per ISO 11137. Configurations: split drape, thyroid sheet, pediatric laparotomy drape.

Indications for Use

Indicated for use as a protective patient covering to isolate surgical incision sites from microbial and other contamination during 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

• MASTER & FRANK SURGICAL DRAPES (STERILE) (K020393)

Submission Summary (Full Text)

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# 510(K) SUMMARY

K062480

. nis summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

MAR 0 5 2007

- JOYKEY INDUSTRYIAL LTD. Submitter's Name: 1. Address: Unit 7-8,230 Floor, No. 1, Hung To Road, Kwun Tong, KL , Hong Kong Phone: [phone] Fax: [phone] Ms. Ting-Yu Chang (President) Contact:
- 2. Device Name

JOYKEY Surgical Drapes (Sterile) Trade Name: Common Name: Sterile Surgical Drapes Classification name: Drape , SURGICAL

- 3. Classification: Class II
- MASTER & FRANK SURGICAL DRAPES (STERILE) Predicate Device: 4. (K020393) marketed by Master & Frank Enterprise Co., Ltd.
- 5. Device Description: JOYKEY Surgical Drapes (Sterile), are manufactured from non-woven fabric, PE & Reinforce layer. The Surgical Drapes include (3) basic configurations of SPLIT DRAPE, THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes are supplied sterile and for single use only.
- 6. Intended Use: JOYKEY Surgical Drapes (Sterile) are single use article intend to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

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7. Performance Summary: In terms of physical specification, the device conforms to ASTM F1670-03 Barrier properties against blood and body fluids & ASTM D1424, ASTM D5034 & NFPA Flammability standards --- etc. The device also conforms to Biological standards of ISO 10993 series, Gamma Sterilization standard of ISO 11137

#### Conclusions: 8.

The JOYKEY Surgical Drapes (Sterile) have the same intended use and similar technological characteristics as the MASTER & FRANK SURGICAL DRAPES (STERILE) (K020393). Moreover, bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the JOYKEY Surgical Drapes (Sterile) are substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 5 2007

JOYKEY Industryial Limited C/O Ms. Jennifer Reich 2904 N. Boldt Drive Flagstaff, Arizona 86001

Re: K062480

Trade/Device Name: JOYKEY Surgical Drapes (Sterile) Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: February 12, 2007 Received: February 16, 2007

Dear Ms. Reich:

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 - Ms. Reich

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/industry/support/index.html.

Sincerely yours,

Sytte Y. Michin 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

Enclosure

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## Indications for Use

510(k) Number (if known): K062480

Device Name: JOYKEY Surgical Drapes (Sterile) JOYKEY INDUSTRYIAL LTD.

Indications For Use:

Prescription Use

(Part 21 CFR 801 Subpart D)

JOYKEY Surgical Drapes (Sterile) are single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A. Murphy b

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(Dision sign-omm
Division of Anesthecology, General Hospital,
Infection Crintrol, Dental Devices

510(K) Number K042480