MASTER & FRANK SURGICAL DRAPES (STERILE)

K020393 · Master & Frank Enterprses Co., Ltd. · KKX · May 3, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020393
• Device Name: MASTER & FRANK SURGICAL DRAPES (STERILE)
• Applicant: Master & Frank Enterprses Co., Ltd.
• Product Code: KKX · General, Plastic Surgery
• Decision Date: May 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4370
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..

Device Story

Master & Frank Surgical Drapes are sterile, single-use protective coverings for patients. Configurations include split drape, thyroid sheet, and pediatric laparotomy drape. Used in clinical surgical settings to isolate incision sites, preventing microbial and other contamination. Device acts as a physical barrier between the patient and the surgical environment. Healthcare providers apply the drapes to the patient prior to surgery.

Clinical Evidence

Bench testing only. Device performance verified against physical specifications (ASTM D1424, ASTM D5034, NFPA flammability), biological safety (ISO 10993 series), and sterilization standards (ISO 11137, ISO 11607-1).

Technological Characteristics

Constructed from nonwoven fabric, PE, and reinforcement layers. Designed to meet ASTM D1424, ASTM D5034, and NFPA flammability standards. Biocompatibility per ISO 10993; sterilization per ISO 11137 and ISO 11607-1. Single-use, sterile, non-powered.

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

• Medline Disposable Surgical Drapes & Gowns (K964142)

Submission Summary (Full Text)

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MAR 1 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Master & Frank Enterprises Company Limited C/O Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail Flaggstaff, Arizona 86001

Re: K020393

Trade/Device Name: Master & Frank Surgical Drapes (Sterile) Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 30, 2004 Received: February 17, 2004

Dear Ms. Reich:

This letter corrects our substantially equivalent letter of April 19, 2002, regarding the incorrect 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 - 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 Acts 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Chris Lins, 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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## 510(K) SUMMARY

02020293

## MAY 0 3 2002

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

| 1. | Submitter's Name: | Master & Frank Enterprise Co., Ltd. |
|----|-------------------|--------------------------------------------------------------|
| | Address: | 15F-1, No. 57, Sec. 2, Tun Hwa S. Rd. Taipei, Taiwan, R.O.C. |
| | Phone: | 886-2-2325-5066 |
| | Fax: | 886-2-2702-6577 |
| | Contact: | Mr. Frank Wu (General Manager) |
| | 2. Device Name | |
| | Trade Name: | Master & Frank Surgical Drapes (Sterile) i |

| Trade Name: | Master & Frank Surgical Drapes (Sterile |
|----------------------|-----------------------------------------|
| Common Name: | Sterile Surgical Drapes |
| Classification name: | Drape , SURGICAL |

- 3. Classification: Class II
- Medline Disposable Surgical Drapes & Gowns ( K964142 ) 4. Predicate Device:
- 5. Device Description: Master & Frank Surgical Drapes (Sterile), is manufactured from nonwoven fabric , PE & Reinforce layer. The Surgical Drapes includes (3) basic configurations of SPLIT DRAPE , THYROID SHEET and PEDIATRIC LAPAROTOMY DRAPE. The Surgical Drapes is supplied sterile and for single use only.
- 6. Intended Use: Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..
- 7. Performance Summary: In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards --- etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards ..

## 8. Conclusions:

The Master & Frank Surgical Drapes (Sterile) have the same intended use and similar 'echnological characteristics as the Medline Disposable Surgical Drapes & Gowns ( K964142 ). 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 Master & Frank Surgical Drapes (Sterile) is substantially equivalent to the predicate devices.

FDA 510(K) SUMMARY Page Revision (A1)

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K 020393 510 (k) NUMBER (IF KNOWN):

Master & Frank Surgical Drapes (Sterile) DEVICE NAME:

INDICATIONS FOR USE:

Master & Frank Surgical Drapes (Sterile) is a single use article intended to be used as a protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination..

Qhu S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 020393 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation

| Prescription Use | |
|----------------------|---|
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter | X |