(79 days)
Not Found
Not Found
No
The summary describes a simple dressing/sponge and contains no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
This device is described as a "dressing" and a "sponge" to absorb exudate, protect against chafing, and absorb excess fluids around tracheostomy or IV tubes. Its function is protective and absorptive, not to treat a disease or condition.
No
This device, a tracheostomy sponge, is described as absorbing exudate and fluids and protecting against chafing. Its function is to manage an existing condition or wound, not to identify or diagnose a medical condition.
No
The device description clearly indicates a physical product ("Tracheostomy Sponge") used as a dressing, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a dressing for absorbing exudate and protecting against chafing around tracheostomy or IV tubes. This is a physical function performed on the body surface or around an external device, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "Tracheostomy Sponge," which aligns with a physical dressing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or analytical methods
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / 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 fluids.
Product codes
EFO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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