(21 days)
The Straumann© PrefGel™ is indicated for topical application onto exposed root surfaces during periodontal surgery in order to selectively remove the smear-layer PrefGel has been shown to mod remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.
PrefGel is an EDTA gel used for topical application prior to periodontal surgery to remove the smear-layer.
The provided text is a 510(k) summary for the Straumann® PrefGel, a root surface conditioning gel. This FDA submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (PrefGel, K940737), rather than proving performance against specific acceptance criteria through a comprehensive clinical study.
Therefore, the information typically requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies (MRMC, standalone AI performance) is largely not applicable or not explicitly detailed in this type of submission.
Here's an breakdown based on the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in terms of quantitative metrics or a priori thresholds. The core "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device. | Demonstrated substantial equivalence to the currently marketed PrefGel (K940737) in terms of: - Same intended use - Same design characteristics - Same method of application - Similar performance characteristics - Biocompatibility |
Explanation: In a 510(k) for a device like PrefGel, the "performance data" section primarily aims to show that the new device functions in a comparable manner to the predicate. It's not about achieving specific numerical targets (e.g., 90% sensitivity or specificity) in a clinical trial. The performance is indirectly "proven" by its similarity to an already approved device.
Study Details
Given the nature of a 510(k) for a device like this, which relies on substantial equivalence to an existing product, a traditional, large-scale clinical study with the elements you requested is not described.
1. Sample sizes used for the test set and the data provenance:
- Not explicitly stated for a dedicated "test set" in the context of a diagnostic or AI device. The submission indicates "performance characteristics tested and biocompatibility," implying some form of testing was done to confirm the product's properties, but no details on sample size, data provenance, or study design are provided for these tests.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Establishing ground truth with experts is typically for diagnostic devices where human interpretation is the benchmark. This submission is for a topical dental gel.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This is relevant for studies involving human readers and interpretation, which is not the focus here.
4. 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 dental gel, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental gel, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "performance characteristics" and "biocompatibility" mentioned, the ground truth would likely involve established laboratory tests and standards (e.g., chemical analysis, in vitro cell studies, animal models for biocompatibility). Specific details are not provided.
7. The sample size for the training set:
- Not applicable. This device is a dental gel, not an AI device that requires a "training set."
8. How the ground truth for the training set was established:
- Not applicable. See point 7.
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Section 9 510(K) SUMMARY
jan 1 2 2007
| SPONSOR: | Straumann60 Minuteman RoadAndover, MA 01810 |
|---|---|
| CONTACT/SUBMITTER: | Lisa M. QuagliaRegulatory Affairs and Clinical Research DirectorTel: (978) 747-2575 |
| DATE OF SUBMISSION: | December 21, 2006 |
| DEVICE: | Straumann® PrefGel |
| Trade Name: | PrefGel™ |
| Common Name: | Root Surface Conditioning Gel |
| Classification: | DentalClassified Under 21 CFR Part 872.3690.Classified as a Class II Device. |
| PREDICATE DEVICE: | PrefGel (K940737) |
| DEVICE DESCRIPTION: | PrefGel is an EDTA gel used for topical applicationprior to periodontal surgery to remove the smear-layer. |
| INTENDED USE: | PrefGel is intended for topical application onto exposedroot surfaces during periodontal surgery in order toremove the smear-layer. PrefGel has been shown toeffectively remove the smear-layer. PrefGel has alsobeen shown to produce a fibrilliar collagenousmeshwork on the exposed and conditioned surface byselective removal of mineral. In addition, PrefGel doesnot induce any detectable necrosis in the surroundingperiodontal tissues. |
| COMPARISON OFCHARACTERISTICS: | The proposed device is substantially equivalent tocurrently marketed device. They share the sameintended use, same design characteristics, and the samemethod of application. |
| PERFORMANCE DATA: | The proposed device is substantially equivalent to thecurrently marketed PrefGel in terms of performancecharacteristics tested and biocompatibility. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.
JAN 1 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa M. Quaglia Regulatory Affairs and Clinical Research Director Straumann USA 60 Minuteman Road Andover, Massachusetts 01810
Re: K063812
Trade/Device Name: PrefGel™ Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 21, 2006 Received: December 22, 2006
Dear Ms. Quaglia:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Lisa M. Quaglia
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Sincerely yours,
Susan Puon
Chiu S. Lin, PhD 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 Statement
510(k) Number (if known) K063812
Page 1 of 1
Device Name Straumann PrefGel™™
Indications for Use The Straumann© PrefGel™ is indicated for topical application onto
exposed root surfaces during periodontal surgery in order to selectively
remove the smear-layer PrefGel has been shown to mod
remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.
Prescription Use X (Per 21 CFR 801.109)
ーーーーー
OR
Over the Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Ruan
General Hos
vices
K063812
Special 510(k) Premarket Notification for Straumann® PrefGel Proprietary and Confidential Information of Straumann®
N/A