(43 days)
Not Found
None
No
The device description and intended use clearly describe a simple gauze sponge, and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is a gauze sponge, intended for wound care (controlling bleeding, absorbing fluid, and protecting wounds), which functions as a wound dressing rather than providing a therapeutic effect like healing or treatment of disease.
No
Explanation: The device, STARRYSHINE Gauze Sponges, is described as being used to control bleeding, absorb body fluid, and protect wounds. These are therapeutic and protective functions, not diagnostic ones. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description clearly states it is a physical gauze sponge made of cotton, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding, absorb body fluid, and protect wounds from contamination. These are all actions performed on the body or on a wound, not on a sample taken from the body for diagnostic purposes.
- Device Description: The device is a gauze sponge made of cotton. This is a physical barrier and absorbent material, not a reagent, instrument, or system used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVDs are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely physical and protective.
N/A
Intended Use / Indications for Use
STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination
Product codes
EFQ
Device Description
STARRYSHINE GAUZE SPONGE Are composed of USP type VII gauze, available in the thickness of 8 ply (2" x 2") 4 ply (2" x 2"), it's non-sterile and made with 100% cotton.use in control bleeding, absorb body fluids and protect wounds from contamination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental office or hospital setting
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
Not Found
Predicate Device(s)
Surgicade TM Non-Sterile Gauze Sponges
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K9 93450
NOV 1 2 1998
510(K) SUMMARY
I. ADMINISTRATIVE
Submitter: TC DENTAL PRODUCTS INC.
20957 Currier road (E ) Walnut, CA 91789 Tel:909-839-0868 Fax:909-839-0766
Contact Person: Jen Wang, Vice Presdent
Date of Summary : September 21 1998
II. Device Name
Proprietary Name : STARRYSHINE Gauze Sponges
Classification Name: Gauze Sponges
III. Predicate Device
Surgicade TM Non-Sterile Gauze Sponges
IV. Device Description:
STARRYSHINE GAUZE SPONGE Are composed of USP type VII gauze, available in the thickness of 8 ply (2" x 2") 4 ply (2" x 2"), it's non-sterile and made with 100% cotton.use in control bleeding, absorb body fluids and protect wounds from contamination.
V. Intended Use
STARRYSHINE Gauze Sponges are used in a dental office or hospital setting where Gauze is required,the instructions for use by physicaians using gauze sponges are exactly the same as the instructions for use found on present labeling for similar products currently on the market.It is use to control bleeding absorb body fluid, and protect wounds from contamination
VI. Comparison to predicate device
STARRYSHINE GAUZE SPONGES are similar or identical in composition function and intended use to legally marketed gauze sponges, such as Surgicade Non-sterile gauze sponges,all such device are composed of absorbent gauze in various thickness and size, and had the same intended use.
TC DENTAL PRODUCTS INC. has concluded that the STARRYSHINE Gauze sponges are effective and safe for their intended use and perform as well as legally marketed predicate device,Such as Surgicade Non-sterile gauze sponges.
1
Image /page/1/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 eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1998
Mr. Jen Wang Vice President TC Dental Products, Inc. 20957 Currier Road (E) Walnut, California 91789
Re: K983450 Trade Name: STARRYSHINE™ GAUZE SPONGES Regulatory Class: Unclassified Product Code: EFQ Dated: September 21, 1998 Received: September 30, 1998
Dear Mr. Wang:
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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against
2
Page 2 - Mr. Jen Wang
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 (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP 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.
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
3
STATEMENT OF INDICATIONS FOR USE
510(K) Number: K983450 Device Name: STARRYSHINE Thi GAUZE SPONGES
Indications for use:
ations for use.
STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination
Concurrence of CDRH, Office of the Device Evaluation (ODE)
Prescription Use X OR Over the counter Use __
Fion Sign-Off)
of General Restorative Devices
K Number K983450
Page 6