(79 days)
A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.
Tracheostomy Sponge
The provided document is a 510(k) clearance letter from the FDA for a device called "Dynarex Tracheostomy Sponge." This type of document does not typically contain the detailed information necessary to answer your questions about acceptance criteria and a study proving a device meets those criteria.
510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on new clinical performance data in the way a PMA (Premarket Approval) would require.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the tracheostomy sponge, nor does it provide a table of reported performance. Its purpose is to state that the device is substantially equivalent to existing ones.
- Sample size used for the test set and the data provenance: Not applicable, as a clinical study with a test set is not described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical dressing, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document only states the device's Indications for Use: "A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids." The FDA's determination is based on the device being "substantially equivalent" to predicate devices already on the market, implying that it performs similarly for these stated indications.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling a person embracing another, with flowing lines suggesting movement or support. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 1998
Mr. John G. Moulden Senior Vice President Dynarex Corporation One International Boulevard Brewster, New York 10509
Re: K983348
Trade Name: Dynarex Tracheostomy Sponge Regulatory Class: Unclassified Product Code: EFO Dated: October 15, 1998 Received: October 20, 1998
Dear Mr. Moulden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{1}------------------------------------------------
Page 2 - Mr. John G. Moulden
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510 (k) NUMBER (IF KNOWN) : K983348
DEVICE NAME : Tracheostomy Sponge
INDICATIONS FOR USE:
A Dressing for use around any tracheostomy or IV tube
to absorb exudate, protect against ghafirm and and cound for use around any tracheostomy or IV tube
to absorb exudate, protect against chafing and absorb excess f
fluids.
(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)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K983348
N/A