(269 days)
Not Found
No
The 510(k) summary describes a simple surgical drape, a physical barrier, with no mention of any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as a protective covering for use in surgical settings, not for treating any medical condition.
No
The text describes surgical drapes and utility covers, which are protective coverings used during surgical procedures. Their purpose is to isolate a surgical site from contamination and cover accessories, not to diagnose medical conditions or provide information for diagnosis.
No
The device description explicitly states it is made from "natural and synthetic materials," indicating it is a physical product, 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 "protective coverings" used to isolate a surgical site and cover accessories in the operating room. This is a physical barrier function, not a diagnostic one.
- Device Description: The description reinforces that they are "protective coverings."
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are specifically designed for this purpose.
The function of surgical drapes is to maintain a sterile field during surgery, which is a crucial part of patient care but is not a diagnostic activity.
N/A
Intended Use / Indications for Use
Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.
These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.
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
medical professionals
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB - 3 2005
Summary of Safety and Effectiveness
Submitted by:
Jov Shuford Foothills Industries 172 Lukfin Street Marion, NC 28752
Date Summary Prepared: December 6, 2004
Proposed Devices: Surgical drapes and utility drapes
Classification Name: Surgical Drape and Drape Accessories
Comparison Devices:
Foothills Industries surgical drapes and utility drapes are substantially equivalent to surgical drapes and utility drapes currently marketed by 3M Steri Drape (K031287) and Alcon (K830822).
Description of Device:
Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings.
Intended Use:
Foothills Industries disposable surgical drapes and utility covers are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.
These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
Technological Characteristics:
Foothills Industries surgical and utility drapes are made from the same materials and designs as other currently marketed surgical drapes. They provide the same absorbency, packaging, and other performance characteristics and are similarly labeled as disposable and non-sterile.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health, with a double helix representing DNA.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 3 2005
Ms. Joy Shuford Chief Executive Foothills Industries, Incorporated 172 Lukin Street Marion, North Carolina 28752
Re: K041224
Trade/Device Name: Foothills Surgical Drapes Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX Dated: January 19, 2005 Received: January 21, 2005
Dear Ms. Shuford:
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.
2
Page 2 - Ms. Shuford
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 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.
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
3
Indications for Use
510(k) Number (if known): K041224
Device Name: Foothills Surgical Drapes
Indications For Use:
Foothills Surgical Drapes are devices made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination and to cover accessories in the operating room.
These disposable single-use drapes are designed to be repackaged and sterilized before use by the user using a 100% EtO cycle that has been validated to achieve a SAL of 10-6 in accordance with ANSI/AAMI/ISO 11135:1994. Sterilization residual limits should meet the requirements of the ANSI/AAMI/ISO 10993-9:1995.
Cichosio D.P. for Loretta Michael 2/1/05, Acting Branch Chief
on Figh-6 Ston of Anesthesiology, General Hospital, Interior Control, Dental Devices
Number: K041224
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)