(58 days)
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire ligation
This FDA 510(k) submission for the "CDB Flip-Slide-Clip Bracket" is a premarket notification for a Class II medical device. As such, it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, the information you're requesting regarding detailed acceptance criteria, study designs, sample sizes, expert involvement, and comparative effectiveness studies is not typically present in this type of submission.
Here's an assessment based on the provided document:
Analysis of Acceptance Criteria and Device Performance Study
The provided document describes a 510(k) submission for an orthodontic bracket. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance metric acceptance criteria through new clinical efficacy studies. Therefore, the submission relies on the established safety and effectiveness of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
No explicit quantitative acceptance criteria or detailed performance metrics are provided in this 510(k) submission. The core "acceptance criteria" here is the FDA's determination of substantial equivalence to legally marketed predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Framework) | Reported Device Performance (Summary from Submission) |
|---|---|
| Intended Use: Device is indicated for orthodontic movement of natural teeth. | The device is indicated for orthodontic movement of natural teeth, identical to the predicate device. |
| Technological Characteristics: Similar materials and functional principles. | "The function and performance of the CDB Flip-Slide-Clip Bracket is similar to the predicate." "Minor design changes and incorporation of self-ligation are the only modifications..." "All of the materials used in the device have been used in legally marketed CDB Corporation's devices." |
| Safety and Effectiveness: Does not raise new questions regarding safety and effectiveness. | "There are no major differences... therefore the CDB Flip-Slide-Clip Bracket does not raise any questions regarding the safety and effectiveness." "The CDB Flip-Slide-Clip Bracket... is as safe and effective as the predicate device(s)." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical "test set" for performance evaluation in the way you might expect for a diagnostic or AI device. The comparison is primarily based on design specifications, material equivalency, and functional principles relative to the predicate devices.
- Data Provenance: Not applicable. No new clinical performance data from a test set is presented. The "data" provenance would relate to the established safety and effectiveness of the cited predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No ground truth was established by experts for a novel test set performance evaluation. The "ground truth" here is effectively historical: the predicate devices have established their safety and effectiveness through their regulatory history and market use.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No performance adjudication of a new test set was conducted for this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. Such studies are typically reserved for devices where the performance difference between a new device (especially AI-assisted) and standard practice is being quantified, which is beyond the scope of a substantial equivalence claim for a mechanical bracket.
- Effect Size of Human Readers Improvement with AI vs. Without AI: Not applicable, as this is not an AI-based device and no such study was conducted.
6. If a Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: Not applicable. This device is a mechanical orthodontic bracket, not an algorithm. Therefore, no standalone algorithmic performance study was conducted or is relevant.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices currently on the market. This is based on their historical regulatory clearances, clinical use, and performance data accrued over time, rather than a prospectively established gold standard for a new device's performance.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm.
In summary: This 510(k) submission is for a modified mechanical device. Its acceptance hinges on demonstrating that it is as safe and effective as existing devices (predicates) through a comparison of intended use, technological characteristics, and materials. It does not involve new clinical performance studies with specific acceptance criteria, test sets, or expert ground truthing as would be associated with the evaluation of a new diagnostic or AI-driven medical device.
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510(k) Summary
Submitter:
AUG 0 7 2009 CDB Corporation 9201 Industrial Blvd. Leland, NC 28451 USA Phone: 910-383-6464 Fax: 910-383-6465 Contact: Charles Vernon Title: Quality/Regulatory Affairs Manager Email: cvernon@cdbcorp.net
Date Prepared:
May 20, 2009
Regulatory class II Product code: NJM
CDB Flip-Slide-Clip Bracket
Classification Panel: Dental Regulation Number: 872.5470
Bracket, Ceramic, Orthodontic
Name of Device:
Classification Name:
Device Classification:
Predicate Devices(s):
CDB Corporation Dentsply Int.
CDB Corporation
Company
Product CDB Clip Reflection Ceramic Dental Bracket In-Ovation C
Device Description:
Indications:
CDB Flip-Slide-Clip Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The modified orthodontic ceramic bracket has both aesthetic and self-ligating qualities. The modifications were aimed at facilitating easier orthodontic wire ligation
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
Technical Characteristics:
The function and performance of the CDB Flip-Slide-Clip Bracket is similar to the predicate. Minor design changes and incorporation of self-ligation are the only modifications made to the Orthodontic Ceramic Brackets (Reflection®) (K922499).
CDB Corporation 510(k) Submission
Page 12 of 30
510(k)
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There are no changes in the intended use and fundamental scientific technology. All of the materials used in the device have been used in legally marketed CDB Corporation's devices. We believe that the modified device is substantially equivalent to the predicate Orthodontic Ceramic Brackets (In-Ovation C®) (K060837).
Conclusion:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device.
There are no major differences between the CDB Flip-Slide-Clip Bracket and the predicate device(s) cited, therefore the CDB Flip-Slide-Clip Bracket does not raise any questions regarding the safety and effectiveness.
The CDB Flip-Slide-Clip Bracket, as designed, is as safe and effective as the predicate device(s) and the device is determined to be substantially equivalent to the referenced predicate device(s) currently on the market.
CDB Corporation 510(k) Submission
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
AUG 0 7 2009
Mr. Charles Vernon Quality/Regulatory Affairs Manager CDB Corporation 9201 Industrial Boulevard Leland, North Carolina 28451
Re: K091702
Trade/Device Name: CDB Flip-Slide-Clip Self Ligating Bracket Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: May 28, 2009 Received: June 10, 2009
Dear Mr. Vernon:
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 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- Mr. Vernon
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting 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
510(k) Number (if known): KD91702
Device Name: CDB Flip-Slide-Clip Self Ligating Bracket
Indications for Use:
The CDB Flip-Slide-Clip Bracket is indicated for orthodontic movement of natural teeth.
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use ਡ (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ve. Wiley for KSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number
.
Page 11 of 30
CDB Corporation 510(k) Submission
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.