(81 days)
Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact.
Not Found
The provided text does not contain information about acceptance criteria or a study proving device performance for "Medline Band Bags and Equipment Covers." The document is a 510(k) clearance letter from the FDA, indicating that the device is substantially equivalent to a legally marketed predicate device.
Specifically, the letter from the FDA (Pages 0-1) and the "Indications for Use" section (Page 2) discuss the following:
- Device Name: Medline Band Bags and Equipment Covers
- Regulation Number: 878.4370
- Regulation Name: Surgical Drape and Drape Accessories
- Regulatory Class: II
- Product Code: MMP
- Indications for Use: "Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact."
The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert qualifications is not available in the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized, curved shapes that resemble a bird in flight or a caduceus without the staff.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 22 2003
Ms. Lara N. Simmons Director, Quality Assurance Medline Industries, Incorporated 1170 S. Northpoint Boulevard Waukegan, Illinois 60085
Re: K032065
Trade/Device Name: Medline Band Bags and Equipment Covers Regulation Number: 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: MMP Dated: August 18, 2003 Received: August 25, 2003
Dear Ms. Simmons:
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 - Ms. Simmons
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 vour 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runnes
Susan Runner, DDS, MA Interim 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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Medline Industries, Inc.
Image /page/2/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font, with a symbol above and below the text. The symbol resembles a compass rose or a stylized star, with a point facing upwards and a point facing downwards. The logo is in black and white.
One Medline Place Mundelein. Illinois 60060.4486
Para N. Sanyal.
Director.
Intended Use Section 4.0
Page
K032065 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Medline Band Bags and Equipment Covers
Indications for Use:
Medline Band Bags and Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and have no patient contact.
Susan Russo
Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control. Denta 510(k) Number:
(PLEASE DO NOT WRITE BLOEW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use
(Optional Format 12-4
§ 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.