(286 days)
3L. Surgical Drapes described in this submission are intended to be used to provide an isolating barrier during surgical procedures. The drapes cover the patient and are made of plastic with a protective film that stops fluid strike-through.
The drapes submitted provide an isolator as a vertical barrier to keep the C-arm from the surgical field during hip/femur fracture or trauma procedures, or create a isolating barrier during orthopedic procedures, or provide secure adhesion on drapes for general use, or meet surgical minor procedural needs, or give a sterile surface all of the way to the wound.
3L® Surgical Drapes are made from PE or PU sheets with adhesive strips, sterilized or nonsterilized. They provide an isolating barrier during surgical procedures to cover the patients and stops fluid strike-through.
The provided text describes a 510(k) premarket notification for a medical device, specifically 3L® Surgical Drapes. It does not contain information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, or ground truth establishment for a diagnostic or AI-driven device.
The document states that the 3L® Surgical Drapes are "generally identical to 3M™ Surgical Drape in design, material, specifications and intended use" and that "Physical and biological tests were performed in accordance with industry recognized test methods." However, the details of these tests, including specific acceptance criteria and the results, are not present in the provided excerpts.
This submission is for a Class II medical device (Surgical Drape), and the FDA's decision is based on substantial equivalence to a predicate device (3M™ Surgical Drape, K031287), not on a study demonstrating clinical performance against predefined acceptance criteria in the manner one would see for a diagnostic or AI product.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, ground truth, or an MRMC study for an AI device based on the given text. The information required for those points is not contained within this 510(k) summary.
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AUG 15 2005
510(k) Summary of safety and effectiveness
| 1. General information | |
|---|---|
| Establishment: | 3L Medical Products Group Co., Ltd. |
| Registration number: | 3004133236 |
| Contact Person: | George SuCrosslinks International1800 Century Park East, Suite 600Los Angeles, CA 90067USA |
| Common Name: | Surgical drape |
| Classification Name: | Surgical drape and drape accessories |
| Predicate Device: | 3M™ Surgical Drape |
| Product Code: | KKX |
| 510(K) Number: | K031287 |
2. Device Description
3L® Surgical Drapes are made from PE or PU sheets with adhesive strips, sterilized or nonsterilized. They provide an isolating barrier during surgical procedures to cover the patients and stops fluid strike-through.
3. Substantial Equivalence
3L® Surgical Drapes are generally identical to 3M™ Surgical Drapes in design, material, specifications and intended use
4. Description of Testing
Physical and biological tests were performed in accordance with industry recognized test methods,
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "U.S. Department of Health and Human Services, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3L Medical Products Company, Limited C/O Mr. George Su Crosslinks International Incorporated 1800 Century Park East, Suite 600 Los Angeles, California 90067
Re: K043015
Trade/Device Name: 3L® Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape Regulatory Class: II Product Code: KKX Dated: July 28, 2005 Received: July 28, 2005
Dear Mr. Su:
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 - Mr. Su
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Ques
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): K043015
Device Name: 3 3L® Surgical Drape
Indications For Use:
3L. Surgical Drapes described in this submission are intended to be used to provide an isolating barrier during surgical procedures. The drapes cover the patient and are made of plastic with a protective film that stops fluid strike-through.
The drapes submitted provide an isolator as a vertical barrier to keep the C-arm from the surgical field during hip/femur fracture or trauma procedures, or create a isolating barrier during orthopedic procedures, or provide secure adhesion on drapes for general use, or meet surgical minor procedural needs, or give a sterile surface all of the way to the wound.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Anesthesiology, General Hoss Infection Control, Dental Devic
510(k) Number:
§ 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.