(140 days)
Not Found
Not Found
No
The device description and intended use clearly describe a sterile surgical drape, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is a back table cover used to provide a sterile surface and protect against contamination during surgical procedures, not to treat a disease, injury, or medical condition.
No
Explanation: The device, a sterile back table cover/surgical drape, is intended to provide a sterile surface and protection against contamination during surgical procedures. Its function is not to diagnose any medical condition.
No
The device described is a physical medical device (back table covers/surgical drape) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a sterile surface for a surgical operating room back table and protect against contamination during surgical procedures. This is a function related to surgical drapes and maintaining a sterile field, not diagnostic testing.
- Device Description: The device is described as a back table cover used as a surgical drape. It is sterilized and used in the operating room. This aligns with surgical supplies, not diagnostic devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the DeRoyal Back Table Covers, as described, fall under the category of surgical drapes or sterile barriers, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
DeRoyal Back Table Covers are intended to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field. DeRoyal's Back Table Covers will provide protection against contamination during surgical procedures.
DeRoyal will receive the nonsterile back table covers from a converter made to DeRoyal's specifications. DeRoyal will use them to wrap convenience kits that will be sterilized in a header pouch. When the convenience kit is removed out of the header pouch it will be used as a surgical drape for the surgical operating room back table.
DeRoyal will market nonsterile sterilization wrap to other OEM customers.
Product codes
KKX
Device Description
DeRoyal Back Table Covers are intended to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field. DeRoyal's Back Table Covers will provide protection against contamination during surgical procedures.
DeRoyal will receive the nonsterile back table covers from a converter made to DeRoyal's specifications. DeRoyal will use them to wrap convenience kits that will be sterilized in a header pouch. When the convenience kit is removed out of the header pouch it will be used as a surgical drape for the surgical operating room back table.
DeRoyal will market nonsterile sterilization wrap to other OEM customers.
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
surgical operating room
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 & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a stylized eagle with three lines representing its wings and head.
Public Health Service
AUG 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Audrey Daniels Regulatory Affairs Specialist DeRoyal Industries, Incorporated 200 Debusk Lane, Powell, Tennessee 37849
Re: K030908
Trade/Device Name: DeRoyal Surgical Drapes BackTable Cover Regulation Number: 878.4370 Regulation Name: Surgical Drapes Regulatory Class: II Product Code: KKX Dated: June 24, 2003 Received: June 25, 2003
Dear Ms. Daniels:
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.
1
Page 2 - Ms. Daniels
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 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 yours,
Susan Runse
Susan Runner, DDS, MD Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
K680908 ર I (Kk): Device Name: DeRoyal Back Table Cover (surgical drape)
Intended Use: DeRoyal Back Table Covers are intended to provide a sterile surface for a surgical operating room back table that becomes part of the sterile field. DeRoyal's Back Table Covers will provide protection against contamination during surgical procedures.
DeRoyal will receive the nonsterile back table covers from a converter made to DeRoyal's specifications. DeRoyal will use them to wrap convenience kits that will be sterilized in a header pouch. When the convenience kit is removed out of the header pouch it will be used as a surgical drape for the surgical operating room back table.
DeRoyal will market nonsterile sterilization wrap to other OEM customers.
Olin S. Lim
Division Sian ision of Anesthesiology, General Hosp tion Control, Dental Devices
510(k) Number: K030908
(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
(Optional Format 1-2-96)