(93 days)
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
SULCUSBLUE is a paste containing aluminium chloride which is used, in association with compression caps (SULCUSCAP), for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
The paste is applied directly into the sulcus thanks to the a cannula. It is left in place between 1 and 2 minutes depending upon the tonicity of the marginal and removed by an air and water spray with simultaneous aspiration. A dry retracted sulcus is obtained.
This document describes the 510(k) premarket notification for SULCUSBLUE, a gingival retraction/hemostatic paste. The information provided heavily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria in the typical sense of a medical device performance validation for AI/algorithm-based devices.
Therefore, many of the requested fields regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device cannot be directly populated from the provided text. The document is for a physical medical device (gingival paste), and its "performance" is demonstrated through its composition and comparison to predicate devices, and a tolerance study.
I will populate the table and answer the questions based on the information provided, reinterpreting "acceptance criteria" and "device performance" in the context of a 510(k) for a physical product, primarily focusing on safety and equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Reinterpreted for Physical Device) | Reported Device Performance |
|---|---|
| Safety: Device does not induce significant irritation or systemic toxicity. | Tolerance Study on Hamsters (HEMOSTASYL): - Immediately stopped bleeding on scarified oral mucosa. - Did not induce systemic toxicity signs. - Locally, a benign irritation reaction after 5 days, totally reversible within 14 days. |
| Hemostasis: Device effectively stops bleeding. | Tolerance Study: Stopped bleeding immediately. |
| Gingival Retraction: Device achieves temporary gingival retraction. | Claimed Intended Use & Substantial Equivalence: Implied through equivalence to predicate devices (HEMOSTASYL, EXPASYL, TRAXODENT) that also perform gingival retraction. The study specifically notes immediate bleeding cessation. |
| Substantially Equivalent Composition: Device composition is comparable to legally marketed predicate devices. | Composition Comparison: SULCUSBLUE has an identical composition (Kaolin, 15% Aluminium chloride hexahydrate, Purified water, Dye, Anhydrous colloidal silica, Propylene glycol, Strawberry Aroma) to HEMOSTASYL. |
| Substantially Equivalent Intended Use: Device intended use matches legally marketed predicate devices. | Intended Use: "temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions" - stated to be similar to HEMOSTASYL, TRAXODENT, and EXPASYL. |
Note: The term "acceptance criteria" is typical for performance studies of AI/algorithm-based devices, specifying metrics like sensitivity, specificity, or AUC thresholds. For this physical device, "acceptance criteria" are inferred from the safety and equivalence arguments made for 510(k) clearance.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- The "test set" in the provided document refers to the subjects in the "Tolerance study of a dental paste on the injured oral mucosa in the Hamster."
- Group 1 (control): Number of hamsters not specified, but this group received 0.9% NaCl solution.
- Group 2 (treated): Number of hamsters not specified, but this group received 0.5ml of HEMOSTASYL (same composition as SULCUSBLUE).
- The exact number of hamsters in each group is not provided in the summary.
- Data Provenance: Retrospective for SULCUSBLUE, as it reuses data from a previous study conducted on HEMOSTASYL (dated January 13, 2006). The original study on HEMOSTASYL was prospective. Country of origin not explicitly stated, but the submitter is from France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this physical device's performance study (tolerance/hemostasis) was established by direct observation and measurement in the hamster study, not by expert interpretation of images or clinical data.
4. Adjudication method for the test set
Not applicable. This was a direct observation study on animal subjects, not a study requiring adjudication of expert interpretations.
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 is a physical dental paste, not an AI/algorithm-based device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental paste, not an AI/algorithm.
7. The type of ground truth used
The ground truth for the safety and performance claims was established through:
- Direct observation: Bleeding cessation, local irritation reaction in the hamster study.
- Compositional analysis: Comparison of ingredients between SULCUSBLUE and predicate devices.
8. The sample size for the training set
Not applicable. This is a physical dental paste, not an AI/algorithm trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. This is a physical dental paste, not an AI/algorithm.
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1. Submitter Information:
Produits Dentaires Pierre Rolland ZI du Phare, 17 avenue Gustave Eiffel Mérignac 33700 France Telephone: 011 33 556 34 0607 Fax: 011 33 556 34 9292
Contact person: RICK ROSATI 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: 856 222-9988 Fax: 856 222-4726
Date summary prepared: June 30th, 2011
2. Device name
SULCUSBLUE Trade Name: Common/Usual Name: Gingival retraction/Hemostatic paste Unclassified Classification Name: MVL Product code:
-
- Devices for which Substantial Equivalence is claimed:
4. Device description
SULCUSBLUE is a paste containing aluminium chloride which is used, in association with compression caps (SULCUSCAP), for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
The paste is applied directly into the sulcus thanks to the a cannula. It is left in place between 1 and 2 minutes depending upon the tonicity of the marginal and removed by an air and water spray with simultaneous aspiration. A dry retracted sulcus is obtained.
Image /page/0/Picture/16 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text is "K111978", with the "K" being a capital letter and the rest being numerical digits. The text is slightly tilted, giving it a dynamic appearance. The handwriting style is simple and clear, making the text easily readable.
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Intended use of the Device 5.
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
6. Substantial Equivalence:
SULCUSBLUE is substantially equivalent to other legally marketed devices in the United States: HEMOSTASYL, TRAXODENT and EXPASYL are intended for a similar use (gingival retraction and hemostasis during dental procedures).
7 Safety of the Device
Hereafter a comparative table regarding the composition of SULCUSBLUE with the other products: EXPASYL and HEMOSTASYL:
| SULCUSBLUE | EXPASYL | HEMOSTASYL | |
|---|---|---|---|
| Kaolin | X | X | X |
| Aluminium chloridehexahydrate | 15% | 15 % | 15% |
| Purified water | X | X | X |
| Dye | X | X | X |
| Anhydrous colloidalsilica | X | - | X |
| Propylene glycol | X | - | X |
| Strawberry Aroma | X | - | X |
Because SULCUSBLUE and HEMOSTASYL have exactly the same composition, we can use for SULCUSBLUE the results of the test performed on HEMOSTASYL:
· Tolerance study of a dental paste on the injured oral mucosa in the Hamster
- (study TL 537 /05-2908 dated January 13th, 2006)
- Method: according to NF EN ISO 10 993-10 standard February 2003.
Group 1 (control): 0.9% NaCl solution
Group 2 (treated): 0.5ml of HEMSOTASYL (same composition than SULCUSBLUE)-Contact time : 3 minutes* then rinsed with
0.9% NaCl solution
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Results and conclusion: Under the experimental conditions adopted, HEMOSTASYL applied on the scarified mucous membrane of the cheek pouch of the Hamster stopped immediately the bleeding ; it did not induce any systemic toxicity signs. Locally, after 5 days an irritation reaction considered as begnin was noted on the lesion treated with HEMOSTASYL ; it was totally reversible within14 days.
The complete report is presented in Appendix G.
- Under normal conditions of use the contact time of HEMOSTASYL is 2 minutes. The contact time has voluntarily been increased in this test in order to be in the "worse case".
CONCLUSION :
Regarding the different results obtained, it appears that SULCUSBLUE stops the bleeding and has a good local and systemic tolerance
According to the results obtained, SULCUSBLUE is substantially equivalent to predicate devices as well as the legally marketed retraction and hemostatic paste.
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Image /page/3/Picture/1 description: The image shows the seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design that resembles an abstract eagle or bird-like figure, composed of three curved lines that converge at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 3 2011
Produits Dentaires Pierre Rolland C/O Mr. Rick Rosati Quality Manager ACTEON. Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054
Re: K111978
Trade/Device Name: SULCUSBLUE Regulation Number: None Regulation Name: Unclassified Regulatory Class: None Product Code: MVL Dated: September 7, 2011 Received: September 8, 2011
Dear Mr. Rosati:
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, I DA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Rosati
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 l'ederal 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 (OS) 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 CDRF/'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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh 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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Indication for Use
<111.978
510(k) Number (if known):
SULCUSBLUE
Indications For Use:
Device Name:
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
Please refer to the attached file for a complete description.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
C. Ree
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K111978
510(k) Pre-market notification for SUL、 NCE راب
N/A