(566 days)
Not Found
Not Found
No
The 510(k) summary describes a disposable surgical drape, a physical barrier device, and contains no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device, Medline Disposable Surgical Drapes, is intended to protect patients and personnel from contamination during surgical procedures, not to treat a disease or condition.
No
Explanation: The device, Medline Disposable Surgical Drapes, is described as surgical apparel intended to protect the patient and operating room personnel from contamination, and to isolate a surgical incision site. Its function is protective and barrier-related, not diagnostic.
No
The 510(k) summary describes disposable surgical drapes, which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical drapes are for protecting patients and personnel during surgical procedures by preventing the transfer of fluids, microorganisms, and particulate material. This is a physical barrier function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to obtain information about a patient's health, which is the core definition of an IVD.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No Mention of Diagnostic Processes: There is no mention of image processing, AI/ML, input imaging modality, or any other technology typically associated with diagnostic devices.
Therefore, the Medline Disposable Surgical Drapes are classified as a medical device, specifically surgical apparel and patient covering, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Medline Disposable Surgical Gowns are surgical apparel 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 body fluids, micro-organisms, and particulate material.
Medline Disposable Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Product codes
FYA, KKX
Device Description
Not Found
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
Operating room personnel / surgical procedures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three parallel lines forming the snake and staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Ms. Lara N. Simmons Corporate Director, Quality Assurance/Regulatory Affairs Medline Industries, Incorporated 1170 NorthPoint Boulevard Waukegan, Illinois 60085
Re: K032666
Trade/Device Name: Medline Surgical Gowns and Surgical Drapes, Medline Surgical Drapes, Medline Surgical Gowns Regulation Number: 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA, KKX Dated: March 3, 2005 Received: March 4, 2005
Dear Ms. Simmons:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave 10 rowed your and have determined the device is substantially equivalent (for the referenced above and have a to 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 approvisions of the Act. The general controls provisions of the Act include controls 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 (1 writ), it may of our of our of Federal Regulations, Title 21, Parts 800 to 898. In your device tax may publish further announcements concerning your device in the Eederal Register.
1
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 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 vou 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,
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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510(k) Number (if known): __K032666
Device Name: Medline Surgical Gowns and Surgical Drapes
Indications for Use:
Medline Disposable Surgical Drapes are surgical apparel that are intended to be worn by Meditie Disposative Burgical procedures to protect both the surgical patient and the operating room personnel from transfer of body fluids, micro-organisms, and particulate material.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use xx (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BLOEW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
Page 1 of 2
n Bion-Gio രേന of AnasMestology, General Hospital : Scrion Control, Dental Devices
Number: K432666
3
510(k) Number (if known):__K032666
Device Name: Medline Surgical Drapes
Indications for Use:
Medline Disposable Surgical Drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
and the same of the same of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the sta
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use xx (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BLOEW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2