(125 days)
Not Found
No
The summary describes a simple medical device (surgical drapes) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device, a surgical drape, is described as a protective covering to isolate a surgical site from contamination, not to treat or cure a disease or condition.
No
Explanation: The device, surgical drapes, is used as a protective covering during surgery to isolate a surgical site from contamination. It does not diagnose any condition or disease.
No
The device is described as "Surgical drapes made from natural and synthetic materials," which are physical objects, 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 as a protective covering during surgery to isolate a surgical site from contamination. This is a physical barrier function.
- Device Description: The device is described as surgical drapes made from natural and synthetic materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic or other health-related information. Surgical drapes, while medical devices, do not fit this definition.
N/A
Intended Use / Indications for Use
Non-sterile surgical drapes 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. These are provided non-sterile to kit packers, who then may sterilize the drape as part of a kit.
Product codes (comma separated list FDA assigned to the subject device)
KKK
Device Description
Austin Medical offers a series of non-sterile surgical drapes for various surgical procedure applications, i.e., table covers, OB/GYN, General Surgery, Orthopedic, ENT and ENNT, Drape Sheets, Cystoscopy, Craniotomy, Angiography, Fluid Pouches, Instrument Covers, U Drapes, Minor procedure drapes, and pediatric drapes.
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
Any individual
Intended User / Care Setting
Medical professionals / Physician office, hospital, sub-acute institutions
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.
Webster Enterprises – K864899
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
Premarket Notification 510(k) Section 5 -- 510(k) Summary