(132 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, image processing, AI/ML mentions, or performance studies, which are typical indicators of AI/ML technology in medical devices.
No
The device is compared to legally marketed predicate devices marketed prior to May 28, 1976, which is typically done for devices that are not therapeutic but rather diagnostic or assistive. The "Intended Use" also refers to "indications for use stated in the enclosure", which does not explicitly indicate a therapeutic purpose.
No
The provided text does not contain enough information to determine if the device is diagnostic. The "Intended Use / Indications for Use" section refers to an "enclosure" which is not provided, and the remaining sections are marked "Not Found" or refer to predicate devices without specifying their diagnostic nature.
Unknown
The provided 510(k) summary is extremely sparse and lacks a device description. Without a description of the device's components and how it functions, it is impossible to determine if it is software-only or includes hardware.
Based on the provided information, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section is incomplete. It only states "for the indications for use stated in the enclosure," but the enclosure itself is not provided. The intended use is the primary factor in determining if a device is an IVD. IVDs are specifically intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- The "Device Description" is "Not Found." Without a description of what the device is and how it functions, it's impossible to assess if its mechanism of action aligns with typical IVD activities.
- Other key sections that might provide clues are also "Not Found" or irrelevant to the IVD determination. Sections like image processing, AI/ML, imaging modality, anatomical site, patient age, and user/setting are not directly indicative of whether a device is an IVD. Performance studies and key metrics would be relevant to the performance of an IVD, but not necessarily its classification as one.
The only potentially relevant information is the mention of predicate devices marketed before May 28, 1976, or reclassified devices that don't require PMA. This suggests the device might be a Class I or Class II device, but this doesn't automatically mean it's an IVD. There are many non-IVD devices in these classifications.
To determine if this device is an IVD, you would need to see the full "Intended Use / Indications for Use" as stated in the enclosure. If the intended use involves the examination of human specimens (blood, urine, tissue, etc.) to provide diagnostic or related information, then it is likely an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
KKX, FYA
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
JUL 2 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lara N. Simmons Corporate Director, QA/RA Medline Industries, Incorporated One Medline Place Mundelein, Illinois 60060-4486
Re: K964142
Trade Name: Medline Disposable Surgical Drapes and Gowns Regulation Number: 21 CFR 878.4370 and 878.4040 Regulation Name: Surgical Drapes and Accessories and Surgical Gowns Regulatory Class: II Product Code: KKX, FYA Dated: February 4, 1997 Received: February 10, 1997
Dear Ms. Simmons:
This letter corrects our substantially equivalent letter of February 25, 1997.
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 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 (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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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