(133 days)
Medline Medcrest Surgical Gowns are surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Medline Surgical Gowns, non sterile, reusable
I apologize, but the provided text from the FDA 510(k) letter for "Medline Medcrest Surgical Gowns and Surgical Drapes" does not contain information regarding acceptance criteria or a study to prove device performance in the context of an AI/ML powered medical device.
The document is a standard 510(k) clearance letter confirming substantial equivalence to a predicate device for traditional medical devices (surgical gowns and drapes). It mentions general controls, manufacturing practices, labeling, and responsibilities under the Act. It also includes the intended use for the surgical gowns.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) as it is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
SEP 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lara Simmons Corporate Regulatory Affairs Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060
Re: K982694
Trade/Device Name: Medline Medcrest Surgical Gowns and Surgical Drapes, Non-Sterile Reusable Regulatory Class: II Product Code: FYA and KKX Dated: November 12, 1998 Received: November 24, 1998
Dear Ms. Simmons:
This letter corrects our substantially equivalent letter of December 14, 1998, regarding the 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. 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 (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 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), 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/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Chiu Lin, 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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Page 1 of any 1
INTENDED USE
510(k) Number (if known): (N/A) 长982694
Medline Surgical Gowns, non stercle, remably Device Name:
Indications for Use:
Medline Medcrest Surgical Gowns are surgical apparel that is intended to be worn by operating room mosone would be reargical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional Format 1-2-96)
Clim S. Lin
(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device 510(k) Number
§ 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.