(288 days)
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.
The device is a non-adherent, strung, x-ray detectable surgical sponge that is sterile and disposable.
This document is a 510(k) summary for a neurological surgical sponge, and it explicitly states that "Performance evaluations (comparisons with the predicate) were not conducted as there are no significant technological differences between the devices."
Therefore, a study demonstrating that the device meets specific acceptance criteria, as requested in the prompt, was not performed, nor was it required for this submission. The basis for clearance is substantial equivalence to a legally marketed predicate device (K904519), and since no significant technological differences were identified, performance testing was deemed unnecessary by the manufacturer for this submission.
As a result, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as such information is not present in the provided text.
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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.
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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.
§ 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).