(58 days)
Not Found
Not Found
No
The summary describes a simple sterile dressing and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a dressing intended to absorb fluids and exudate, which is a supportive function and not a direct therapeutic action for a disease or condition.
No
The device is described as a non-woven dressing for absorbing exudate and fluids, which is a therapeutic function, not diagnostic.
No
The device description clearly indicates a physical dressing (non-woven dressing with pre-cut fenestration) used to absorb exudate and fluids, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to absorb exudate and fluids around tracheostomy or IV tubes. This is a physical function performed on the body's surface or around a medical device inserted into the body.
- Device Description: It's described as a "Sterile Drain Sponge," which is a physical dressing.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting substances, or providing diagnostic information. IVDs are used to examine specimens in vitro (outside the body) to provide information about a person's health.
Therefore, this device falls under the category of a medical device used for wound care and fluid management, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.
Product codes
KMF
Device Description
Sterile Drain Sponges, Non-woven dressing with pre-cut fenestration
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a symbol that resembles three stylized human figures or birds in flight, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Mr. John G. Moulden Senior Vice President Dynarex Corporation One International Boulevard Brewster, New York 10509
Re: K991694 Trade Name: Drain Sponge Regulatory Class: Unclassified Product Code: KMF Dated: May 6, 1999 Received: May 18, 1999
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,
Colin M. Wilson, Ph.D., M.P.
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
K991694
Page of
To be assigned 510(K) NUMBER (IF KNOWN) : Sterile Drain Sponges DEVICE NAME :
INDICATIONS FOR USE:
Non-woven dressing with pre-cut fenestration for use around tracheostomy or IV tubes to absorb exudate and absorb fluids.
(SESSED DO NOT WRISE BELCW CHIS LINE-CONTINUE ON ANCIHER PAGE
(SESSION)
Concurrence of cortification of Device svaluation Tober
Prescription Use
(Per 21 CFR 801.109)
ﺗﺮ ﺗ
ેટ્ર
Over-The-Counter-Use (Optional Format 1-2-96)
Division Sign-Off
aral Restorative Devices
Sent 10/15/98
Dwayne