K Number

Validate with FDA (Live)

Device Name

GIRAFFE2

Manufacturer

KERR CORPORATION

Date Cleared

2010-10-07

(70 days)

Product Code

MVL

Regulation Number

N/A

Type

Traditional

Panel

Dental

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

Device Description

Giraffe2 is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. Girgffe2 is a tissue management solution that allows clinicians to quickly and easily obtain sulcular expansion in clinical situations prior to an impression. Additionally, Giroffe2 will help stop bleeding and prevent the flow of crevicular fluid upon removal, further assuring accurate and complete impressions.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular criteria in the format requested. The document is a 510(k) summary for a medical device (Giraffe2), focusing on its substantial equivalence to a predicate device (Expa-syl).

Here's an analysis based on the information provided, highlighting what is present and what is missing:

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

Missing. The document states that "Biocompatibility studies have been completed on Giraffe2, which demonstrate that the material is safe for its intended use" and "This 510(k) submission also includes data from bench testing used to evaluate the physical properties of Giraffe2 compared to the predicate device, Expa-syl." However, it does not provide specific acceptance criteria (e.g., "retraction depth must be X mm") or quantitative performance data. It broadly concludes that "Based upon the biocompatibility and bench testing, the clinical performance of Giraffe2 is deemed to be substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document mentions "biocompatibility studies" and "bench testing" but does not provide details on sample sizes, study designs (prospective/retrospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This type of information is typically relevant for studies involving expert interpretation or consensus (e.g., imaging studies, diagnostic devices). For a gingival retraction paste, the evaluation would likely involve objective measurements or clinical observations rather than expert "ground truth" establishment in this sense. No such expert involvement is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As with point 3, this is for studies involving expert interpretation. No adjudication method is mentioned or implied.

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. The device is a gingival retraction/hemostatic paste, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant to its evaluation.

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

Not applicable. As above, this is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Implicitly objective/benchmarking. While not explicitly stated as "ground truth," the evaluation of Giraffe2 relies on biocompatibility studies and "bench testing" of "physical properties" compared to a predicate device. This suggests that the "ground truth" or reference points are likely established through standardized biological tests (for biocompatibility) and objective physical measurements (for bench testing) against a known device.

8. The sample size for the training set

Not applicable / Missing. There's no indication of a "training set" as this is not a machine learning or AI device. If "training set" refers to samples used for product development prior to formal testing, that information is not provided.

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

Not applicable. As above, no training set for an AI/ML model is involved.

Summary of available information regarding compliance/testing:

Acceptance Criteria/Performance: The device is "substantially equivalent" to Expa-syl based on biocompatibility and bench testing. The key difference highlighted is the removal method (light-cured vs. rinsed). No specific quantitative criteria or performance metrics are provided.
Study Type: Biocompatibility studies and bench testing were performed.
Comparison: The device's performance was compared to a predicate device, Expa-syl.
Conclusion: The studies demonstrated the material is safe for its intended use and that the clinical performance of Giraffe2 is substantially equivalent to the predicate device.

Summary

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<102133

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font with a curved line above them. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font.

Section III - 510(k) Summary of Safety and Effectiveness

OCT - 7 2010

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: July 2010

Device Name:

· Trade Name Giraffe2
· Common Name Gingival Retraction/Hemostatic Paste
Classification Name Unclassified

Device for Which Substantial Equivalence is Claimed:

· Expa-syl, Produits Dentaires Pierre Rolland

Device Description:

Intended Use of the Device:

{1}------------------------------------------------

Substantial Equivalence:

Giraffe2 is substantially equivalent to another legally marketed device in the United States. Giroffe2 functions in a manner similar to and is intended for the same use as Expa-syl, which is currently marketed by Kerr Corporation.

Giraffe2 contains the same hemostatic agent contained in Expa-syl. The difference between the Giraffe2 and Expa-syl is the method of removal: Giraffe2 is light cured allowing for easier removal, whereas Expa-syl needs to be rinsed thoroughly with water in order to be removed from the tooth.

Biocompatibility studies have been completed on Giraffe2, which demonstrate that the material is safe for its intended use. This 510(k) submission also includes data from bench testing used to evaluate the physical properties of Girgffe2 compared to the predicate device, Expa-syl.

Based upon the biocompatibility and bench testing, the clinical performance of Girgffe2 is deemed to be substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion on the left. A dotted line separates the text from the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K102133

Trade/Device Name: Giraffe2 Regulation Number: None Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Codes: MVL Dated: July 26, 2010 Received: July 29, 2010

QCT - 7 2010

Dear Ms. Garman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Garman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

OCT - 7 2010

121021 33

510(k) Number (if known):

Device Name: Giraffe2

Indications For Use:

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruaser

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102133 Page 1 of 1

Regulation Number and Section

N/A