DYNAREX TRACHEOSTOMY SPONGE

K983348 · Dynarex Corp. · EFQ · Dec 11, 1998 · SU

Device Facts

• Record ID: K983348
• Device Name: DYNAREX TRACHEOSTOMY SPONGE
• Applicant: Dynarex Corp.
• Product Code: EFQ · SU
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

A Dressing for use around any tracheostomy or IV tube to absorb exudate, protect against chafing and absorb excess fluids.

Device Story

The Dynarex Tracheostomy Sponge is a wound dressing designed for application around tracheostomy or IV tubes. It functions as an absorbent barrier to manage exudate and excess fluids while providing protection against skin chafing. The device is intended for use by healthcare professionals in clinical settings to maintain the site around the tube insertion. It provides a passive physical barrier to support site hygiene and patient comfort.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Absorbent dressing material; non-sterile or sterile (implied by device type); form factor designed for placement around tracheostomy or IV tubes.

Indications for Use

Indicated for use as a dressing around tracheostomy or IV tubes to absorb exudate, protect against chafing, and absorb excess fluids.

Submission Summary (Full Text)

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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