(288 days)
Not Found
No
The device description and performance studies section indicate a simple surgical sponge with no mention of AI/ML or image processing.
No
The device is a surgical sponge used to protect neural tissues and absorb fluids during neurosurgical procedures, which is a supportive function rather than directly treating a disease or condition.
No.
The device's intended use is to protect neural tissues from drying, abrasion, or contamination and absorb fluids during neurosurgical procedures, which are operational functions rather than diagnostic ones. It performs mechanical tasks (protection, absorption) and is described as a surgical sponge.
No
The device description clearly states it is a physical surgical sponge, which is a hardware 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 protect neural tissues during neurosurgical procedures, absorb fluids, and prevent drying, abrasion, or contamination. This is a direct surgical intervention and protection of tissue in vivo (within the living body).
- Device Description: The device is a surgical sponge. Surgical sponges are used during procedures on the body, not for testing samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue biopsies, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and protective during surgery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.
Product codes
Not Found
Device Description
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.
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
trained physicians during neurosurgical procedures
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)
Performance evaluations (comparisons with the predicate) were not conducted as there are no significant technological differences between the devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4700 Neurosurgical paddie.
(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).
0
American Surgical Sponges Div. of American Silk Sutures, Inc.
DEVELOPERS OF TAKA'S™, COL-R-SPONGE™, AMERICOT™, RAY-COT™ & UNIQCOT™ SPONGES
MAY - 2 1997
ATTACHMENT #1 510(K) SUMMARY Page 1 of 2
510(k) SUMMARY AMERICAN SURGICAL SPONGE NEUROLOGICAL SPONGE
Submitter Information:
American Surgical Sponges, a Division of American Silk Sutures 82 Sanderson Avenue Lynn. MA 01921
510(k) Summary Prepared By:
Carolann Kotula mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021 Telephone Number: (516) 482-9001
July 12, 1996 Date 510(k) Summary Prepared:
.
Name of the Device:
Trade or Proprietary Name:
Neurological Sponges Neurosurgical paddie or sponge Common Name:
Classification Name:
Cottonoid Paddie (21 CFR 882.4700)
American Surgical Sponges (brand)
Identification of Legally Marketed device to which the Submitter claims equivalence:
This device is substantially equivalent to a Telfa Non-Adherent neurological sponge marketed by American Surgical Sponges, a Division of American Silk Sutures under K904519.
1
ATTACHMENT #1 510(K) SUMMARY Page 2 of 2
Description of the Subject Devices:
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.
Intended Use:
This device is intended to be used by trained physicians during neurosurgical procedures to protect neural tissues from drying, abrasion, or contamination and to absorb fluids.
Technological Characteristics of the Subject Device:
Performance evaluations (comparisons with the predicate) were not conducted as there are no significant technological differences between the devices.