(85 days)
The Medline Reusable Surgical Gown is intended to be used by operating room personnel du surgical procedures to help protect both the patient and the health care worker from transfer mirco-organisms, body fluids, and particulate material.
Medline Reusable Surgical Gowns (100X)
This document is a 510(k) premarket notification letter for a medical device, specifically Medline Reusable Surgical Gowns. It is not a study report or a technical document detailing the performance of an AI/ML powered device.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies or standalone performance cannot be extracted from the provided text.
The document confirms that the FDA has determined the Medline Reusable Surgical Gowns are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed. This determination is based on the device meeting the existing regulatory framework for surgical apparel (Regulation Number: 878.4040, Product Code: FYA).
The letter does include an "Indications for Use" statement, which typically describes what the device is intended for, but does not provide performance metrics or acceptance criteria in the manner requested for an AI/ML study.
In summary, none of the requested information regarding acceptance criteria and a study to prove device performance (especially in the context of AI/ML) is present in the provided FDA 510(k) letter.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2003
Ms. Stacy Bolden-Wolverton Director of Textile Quality Medline Industries, Incorporated One Medline PL. Mundelein, Illinois 60060-4486
Re: K031933
Trade/Device Name: Medline Reusable Surgical Gowns (100X) Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 14, 2003 Received: August 5; 2003
Dear Ms. Bolden:
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. Bolden
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 (OS) 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 (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 vours.
Suoom Runner
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 word "MEDLINE" in a stylized font. The word is positioned above a compass-like symbol. The compass symbol has four points, with the top point extending above the word "MEDLINE" and the bottom point extending below the word.
One Medling Place Mundelein, Illinois 600ca 1486
1-817-94 WATS: 1-800-050 Fax: 1-847-949
Stacey L. Bolen - Web erton Regulatory Specialist Director of Textile Quality Section 2.0 Intended Use
1031433 510(k) Number (if known): Device Name: Medline Reusable Surgical Gowns
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Indications for Use:
The Medline Reusable Surgical Gown is intended to be used by operating room personnel du surgical procedures to help protect both the patient and the health care worker from transfer mirco-organisms, body fluids, and particulate material.
Susan Ruma
nesthesiology. General Hospital. 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usc _____________________________________________________________________________________________________________________________________________________________ or Over-the-Counter___________________________________________________________________________________________________________________________________________________________
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.