MASTER & FRANK SURGICAL DRAPES (STERILE) by MASTER & FRANK ENTERPRSES CO.LTD.

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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Master & Frank Surgical Drapes (Sterile). It describes the device, its intended use, and a performance summary. However, it does not contain a detailed study with acceptance criteria, reported device performance, sample sizes, ground truth establishment, or specific types of studies (MRMC or standalone) as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Medline Disposable Surgical Drapes & Gowns K964142) by stating that the device meets applicable standards.

Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit via Standards Met): The document states: "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 .."
- This implies that the acceptance criteria are adherence to these specific standards for physical properties, biological safety, and sterilization.
Reported Device Performance: The document only generically states that the device is "designed to meet applicable standards." It does not provide specific numerical or qualitative results for each standard (e.g., actual tensile strength measurements, specific flammability ratings, or detailed biocompatibility test reports).

Acceptance Criteria (Implied by Standards)	Reported Device Performance (as stated)
ASTM D1424 (Physical specification)	Designed to meet applicable standards
ASTM D5034 (Physical specification)	Designed to meet applicable standards
NFPA Flammability standards	Designed to meet applicable standards
ISO 10993 series (Biological specification)	Designed to meet applicable standards
ISO 11137 (Sterilization Specification)	Designed to meet applicable standards
ISO 11607-1 (Sterilization Specification)	Designed to meet applicable standards

The following information is NOT available in the provided text:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document mentions "bench testing contained in this submission" but provides no details on sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This type of information is not relevant or included for a physical device like a surgical drape. Ground truth is established by adherence to documented standards and test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as no human adjudication is described for the physical and biological testing of a surgical drape.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device (surgical drape), not an AI/software product requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For this device, the "ground truth" would be established by the specifications defined in the referenced ASTM, NFPA, and ISO standards, and the results of laboratory tests performed according to those standards. The document only confirms the device "is designed to meet applicable standards."

8. The sample size for the training set:

Not applicable as this is not a machine learning/AI model that requires a training set. The "design" for a physical device is not "trained" in this context.

9. How the ground truth for the training set was established:

Not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.

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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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

1. Classification: Class II
Medline Disposable Surgical Drapes & Gowns ( K964142 ) 4. Predicate Device:
1. 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.
1. 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..
1. 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:

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

Regulation Number and Section

§ 878.4370 Surgical drape and drape accessories.

(a)
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.(b)
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.