STARRYSHINE GAUZE SPONGE

• K Number: K983450
• Device Name: STARRYSHINE GAUZE SPONGE
• Manufacturer: T.C. DENTAL PRODUCTS, INC.
• Date Cleared: 1998-11-12 ( 43 days)
• Product Code: EFQ
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination

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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (STARRYSHINE Gauze Sponges). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about a study proving the device meets specific acceptance criteria using performance data.

This type of submission (510(k)) focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with performance metrics. For devices like gauze sponges, substantial equivalence is typically demonstrated by showing similar or identical composition, function, and intended use as an existing device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not available in the provided document.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not available. The document does not specify quantitative acceptance criteria or provide performance data.

2. Sample sized used for the test set and the data provenance

• Not applicable/Not available. No test set or associated data provenance is mentioned as part of a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not available. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

• Not applicable/Not available. No adjudication method is mentioned.

5. 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 gauze sponge, not an AI-powered diagnostic tool, so an MRMC study with AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical product, not an algorithm.

7. The type of ground truth used

• Not applicable/Not available. No ground truth is mentioned. The equivalence is based on the characteristics of the device itself and comparison to a predicate.

8. The sample size for the training set

• Not applicable/Not available. No training set is mentioned.

9. How the ground truth for the training set was established

• Not applicable/Not available. No ground truth for a training set is mentioned.

Summary of what the document implies about "meeting acceptance criteria":

The "acceptance criteria" here are implicitly centered around demonstrating substantial equivalence to an existing, legally marketed predicate device. The study that "proves" the device meets these criteria is the submission of information detailing the device's characteristics and directly comparing them to the predicate.

• Acceptance Criteria (Implicit for Substantial Equivalence):

  • Similar or identical composition (USP type VII gauze, 100% cotton).
  • Similar or identical function (control bleeding, absorb body fluids, protect wounds from contamination).
  • Similar or identical intended use (dental office or hospital setting).
  • Similar or identical physical characteristics (e.g., thickness: 8 ply, 4 ply; size: 2" x 2").
  • Safety and effectiveness comparable to the predicate device.

• Reported Device Performance (as presented for substantial equivalence):

  • The device is composed of USP type VII gauze, 100% cotton.
  • Available in 8 ply (2" x 2") and 4 ply (2" x 2").
  • Intended for use in controlling bleeding, absorbing body fluids, and protecting wounds from contamination.
  • The manufacturer states: "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."

In essence, the "study" described is the comparison to the predicate device, Surgicade TM Non-Sterile Gauze Sponges, which serves as the benchmark for establishing safety and effectiveness. No specific quantitative performance data of STARRYSHINE Gauze Sponges itself is provided beyond its descriptive attributes and intended use.

Summary

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K9 93450

NOV 1 2 1998

510(K) SUMMARY

I. ADMINISTRATIVE

Submitter: TC DENTAL PRODUCTS INC.

20957 Currier road (E ) Walnut, CA 91789 Tel:[phone] Fax:[phone]

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.

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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:

• 1. This device may not be labeled for use on third degree burns.
• 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
• 3. 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

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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 [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 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

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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

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Regulation Number and Section

N/A