(179 days)
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No
The summary describes surgical drapes, which are physical barriers, and there is no mention of AI, ML, image processing, or any computational analysis of data.
No
Surgical drapes are protective coverings used during medical procedures and do not provide any therapeutic effect to the patient.
No
Surgical drapes are used for protective covering during medical procedures, not for diagnosing conditions.
No
The device description clearly indicates the device is a physical product (surgical drapes) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patient protective covering" during surgical procedures. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The descriptions of the various drapes (Surgical Drapes, MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET AND POLY-U-DRAPE) all point to physical coverings used during surgery.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. Surgical drapes do not fit this description.
N/A
Intended Use / Indications for Use
Surgical Drapes are single use and shall be used by medical professionals in an operating room or healthcare setting for patient protective covering.
Product codes
KKX
Device Description
Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET AND POLY-U-DRAPE
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals in an operating room or healthcare setting
Description of the training set, sample size, data source, and annotation protocol
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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.)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings and a stylized tail.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 2000
Custom Medical Products, Incorporated C/O Mr. Steve Woody Quality Assurance Coordinator Integrated Quality Systems 1 Holiday Inn Drive, Building E Asheville, North Carolina 28806
K994199 Re :
Various Sterile and Non-Sterile Surgical Trade Name: Drapes, (i.e., Disposables Minor Procedure Drapes, Large Aperture Drapes, Absorbent Angiography Sheet, Cesarean Birth Sheet and Poly-u-Drape) Requlatory Class: II Product Code: KKX March 21, 2000 Dated: Received: March 23, 2000
Dear Mr. Woody:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Woody
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Custom Medical Products, Inc.
Appendix B
Indication for Use Statement
| 510(k) Number (if known): | K994199 |
|---|---|
| --------------------------- | --------- |
Device Name: Various Sterile and Non-Sterile Surgical Drapes, DISPOSABLES
MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPE, ABSORBANT ANG'IO GRAPHY SHEET, CEGEAREAN BIRTH SHEET
AND POLY-U-DRAPE
Indications for Use:
Surgical Drapes are single use and shall be used by medical professionals in an operating
room or healthcare setting for patient protective covering.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K994199 |
|---|---|
| --------------- | --------- |
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The Counter Use
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