(86 days)
Not Found
No
The 510(k) summary describes a standard surgical drape and does not mention any AI or ML components or functionalities.
No.
The device is a surgical drape intended to protect a surgical site from contamination, not to treat a disease or condition.
No
Explanation: The device is described as a surgical drape intended to be a protective patient covering and to isolate a surgical site, which is a therapeutic or protective function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly states it is manufactured from nonwoven fabric, PE, and a reinforce layer, indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "protective patient covering, such as to isolate a site of surgical incision for microbial and other contamination." This describes a physical barrier used during surgery.
- Device Description: The description details the materials (nonwoven fabric, PE, Reinforce layer) and configurations (SPLIT DRAPE, THYROID SHEET, PEDIATRIC LAPAROTOMY DRAPE) of a surgical drape.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests. It is a physical barrier.
The information provided consistently describes a surgical drape, which is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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..
Product codes
KKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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 |
-
- Classification: Class II
- Medline Disposable Surgical Drapes & Gowns ( K964142 ) 4. Predicate Device:
-
- 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.
-
- 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..
-
- 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)
3
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 |