(184 days)
C-LineTM orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position
C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.
Here's an analysis of the provided text regarding the acceptance criteria and study details for the C-Line Orthodontic Ceramic Bracket, structured to answer your specific questions.
Important Note: The provided document is a 510(k) summary for a medical device (orthodontic ceramic bracket). It establishes substantial equivalence by comparing the new device to a predicate device, rather than proving a specific clinical performance. Therefore, sections related to AI performance, human reader improvement, and distinct ground truth for training/test sets are not applicable as this is not an AI/ML medical device.
Acceptance Criteria and Study Overview
The C-Line Orthodontic Ceramic Bracket K163467 sought to demonstrate substantial equivalence to a predicate device (Clarity Advanced Ceramic Bracket, K102803) by showing similar performance in non-clinical (bench) tests and comparable design characteristics and intended use. The "acceptance criteria" here are implied by the comparison to the predicate device, meaning the new device should perform similarly or better than the predicate in engineering tests without raising new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence determination based on non-clinical testing against a predicate, "acceptance criteria" are not explicitly defined as numerical thresholds. Instead, the performance of the applicant device (C-Line) is compared directly to the predicate device (Clarity Advanced) to demonstrate similarity.
| Performance Characteristic | Acceptance Criterion (Implied - Similar to Predicate) | Reported Device Performance (C-Line) |
|---|---|---|
| Mechanical Properties | "similar to the predicate device" | |
| Wire Slot Drag Test | Similar to predicate | Result of test data was similar for both brackets. |
| Wire Slot Torque Test | Similar to predicate | C-Line brackets had higher torque strength than Clarity Advanced brackets due to the higher in/out thickness of C-Line. (This difference was not flagged as raising new safety/effectiveness concerns). |
| Shear Test | Similar to predicate | Two brackets had a very similar shear strength. No fracture occurred during debonding. |
| Bracket Removal Test | Similar performance to predicate | C-Line brackets had a tendency to remain adhesive lower than Clarity Advanced because of the undercut pattern base, implying an acceptable debonding outcome. Most adhesive remained on enamel. |
| Biocompatibility | Compliance with ISO 10993 standards | All user directly contacting materials are compliance with ISO10993 requirements (Cytotoxicity, Sensitization, Oral Mucosal Irritation, Systemic Toxicity, Degradation Products from Ceramics). |
| Design Characteristics | Conforming to ISO 27020:2010 | Conforms to ISO 27020:2010. Slight differences in bracket in-out and torque angles were noted but deemed not to raise new safety/effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample sizes for the "test set" for each individual bench test. It mentions "bench testing" was conducted on the C-Line device and the predicate device. The provenance is not specified, but the manufacturing company is based in the Republic of Korea, suggesting the testing was likely performed there or by a contract lab. The tests are "non-clinical," so "retrospective or prospective" data provenance is not applicable in the human data sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical, bench testing study, not a study involving human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is a non-clinical, bench testing study.
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 not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be the established scientific and engineering principles and the performance of the legally marketed predicate device. For example:
- For mechanical properties (shear strength, torque strength), the "ground truth" is measured physical values and established material science expectations.
- For biocompatibility, the "ground truth" is established by adherence to recognized international standards (ISO 10993 series).
- For design characteristics, the "ground truth" is conforming to the referenced international standard (ISO 27020:2010).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set in the context of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
Biocetec Co., Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K163467
Trade/Device Name: C-Line Orthodontic Ceramic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: May 17, 2017 Received: May 22, 2017
Dear Dave Kim:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mary S. Runner -A
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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)
Device Name
C-LineTM Orthodontic Ceramic Bracket
Indications for Use (Describe)
C-LineTM orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: May 17, 2017
I. SUBMITTER
| Submitter's Name | BIOCETEC CO., LTD. |
|---|---|
| Submitter's Address | RM 3-952AB, H1-dong, KIST, 5, Hwarang-ro 14-gil(Hawolgok-dong 39-1), Seongbuk-gu, SeoulREPUBLIC OF KOREA |
| Submitter's Telephone | +82 2-704-2876 |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | +713-467-2607 |
| Fax: | +713-583-8988 |
II. DEVICE
C-Line™ Orthodontic Ceramic Bracket Trade/proprietary Name Common or Usual Name Orthodontic Ceramic Bracket Regulation Name Bracket, Ceramic, Orthodontic Regulation Number 21 CFR 872.5470 Product Code NJM Regulatory Class Class II
III. PREDICATE DEVICE
| Primary Manufacturer | 3M UNITEK Corporation |
|---|---|
| Device Name | Clarity Advanced Ceramic Bracket |
| 510(k) Number | K102803 |
| Regulation Name | Orthodontic Plastic Bracket |
| Regulation Number | 21 CFR 872.5470 (Product Code: NJM) |
| Regulatory Class | Class II |
| Over the Counter Use |
IV. REFERENCE DEVICE
| Trade/proprietary Name | Transbond™ XT |
|---|---|
| ------------------------ | --------------- |
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| 510(k) Number | K073697 |
|---|---|
| Regulation Name | Adhesive, bracket and tooth conditioner, resin |
| Regulation Number | 21 CFR 872.3750 |
| Product Code | DYH |
| Regulatory Class | Class II |
DEVICE DESCRIPTION V.
C-Line ™ orthodontic ceramic brackets are intended to be bonded to a tooth to apply pressure to a tooth to alter its position. C-Line ™ orthodontic ceramic brackets consist of a translucent alumina body and a bonding base. The bracket's color marking and cords indicates the bracket positioning and facilitate bracket identification.
INDICATIONS FOR USE: VI.
C-Line™ orthodontic ceramic bracket is intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.
PREDICATE COMPARISON VII.
| Candidate Device | Predicate 1 | SubstantialEquivalenceAnalysis | |
|---|---|---|---|
| 510(k) Number | Pending | K102803 | - |
| Device Name | C-Line™ | Clarity™ Advanced CeramicBrackets | - |
| Common Name | Orthodontic Ceramic bracket | Orthodontic Ceramic bracket | - |
| Manufacturer | BIO CETEC CORPORATION | 3M Unitek Corp. | - |
| Indication for Use | C-Line™ orthodontic ceramicbracket is intended to bebonded to a tooth to applypressure to a tooth from aflexible orthodontic wire toalter its position. | Clarity™ Advanced CeramicBrackets are intended for usein orthodontic treatment. Thebrackets are affixed to teethso that pressure can beexerted on the teeth. | SubstantialEquivalence |
| Material compositionof Bracket | PolycrystallineAlumina(100%) | PolycrystallineAlumina(100%) | SubstantialEquivalence |
| Material compositionof colorants for | Polyvinylpyrrolidone(25wt%)Sweet whey powder(25wt%) | Different | |
| bracket placementorientation | TiO2(25wt%)Food dye(25wt%) | ||
| Transparency | Half-transparency | Half-transparency | SubstantialEquivalence |
| Bracket design | MBT, ROTH designs with andwithout hook, conforming toISO 27020:2010 Dentistry –Brackets and tube for Use inOrthodontics | MBT, ROTH, High Torquedesigns with and withouthook, conforming to ISO27020:2010 Dentistry –Brackets and tube for Use inOrthodontics | SubstantialEquivalence |
| Design parts | Hook, Slot, Round home, baseand marking | Hook, Slot, Round home,base and marking | SubstantialEquivalence |
| Bracket In-out(mm) | 0.56 to 1.45 | 0.51 to 1.14 | Different |
| Bracket Torque(°) | -22 to +17 | -17 to +17 | Different |
| BracketAngulation(°) | 0 to 11 | 0 to 11 | SubstantialEquivalence |
| Available slot sizes | 0.018 / 0.022 inch | 0.018 / 0.022 inch | SubstantialEquivalence |
| Orientation marking | Yes | Yes | SubstantialEquivalence |
| Sing use | Yes | Yes | SubstantialEquivalence |
| Non-SterilePackaging | Yes | Yes | SubstantialEquivalence |
| Target Population | Patients in need of teethalignment correction | Patients in need of teethalignment correction | SubstantialEquivalence |
| Anatomical Site | Teeth | Teeth | SubstantialEquivalence |
| Location of Use | Use only by professionalorthodontists | Use only by professionalorthodontists | SubstantialEquivalence |
| Bio-compatibility | All user directly contactingmaterials are compliance withISO10993 requirements. | All user directly contactingmaterials are compliance withISO10993 requirements. | SubstantialEquivalence |
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C-Line™ and the predicate device have identical indication for use statements and the same intended use.
The 510k(k) also includes data from bench testing to evaluate the performance of C-Line™ to the predicate device. The properties evaluated include wire slot drag test, wire slot torque test, shear test, and bracket removal test.
There are differences in the device design characteristics. The subject device's bracket in-out is 0.56 to 1.45 mm whereas the predicate device's range is between 0.51 to 1.14 mm. The bracket torque for the subject device is -22 to +17° wider than the predicate device's-17 to +17°. Also, the predicate device and subject device have a different color coding system to indicate the bracket positioning and identification.
These differences do not raise different questions of safety or effectiveness.
SUMMARY OF NON-CLINICAL TESTS VIII.
Non-clinical performance testing was conducted as follows: design characteristics based on and in accordance with ISO 27020:2010 Dentistry - Brackets and tubes for use in Orthodontics; adhesive strength and analysis of detached teeth surface were conducted in accordance with ISO 11405:2015. Dentistry -Testing of adhesion to tooth structure; in-house comparative performance testing was conducted for the submission device and the predicate device, including wire slot drag test, wire slot torque test, shear test, and bracket removal test. A risk analysis was conducted based on ISO 14971:2012 Medical Devices Application of risk management to medical devices:
According to the bench test result of the two ceramic brackets, their performances in the technical property seemed similar to one another. In the Wire Slot Torque test, C-Line brackets had higher torque strength than Clarity Advanced brackets due to the higher in/out thickness of C-Line.
In the Shear Bonding test, two brackets had a very similar shear strength. When two ceramic brackets were debonded, there were no fracture occurred.
The removal test with plier showed that the most of adhesive remained on the enamel despite of base patterns. C-Line brackets had a tendency to remain adhesive lower than Clarity Advanced because of undercut pattern base.
In the Wire Drag Test, the result of test data was similar for both brackets. Because two brackets were made of same raw materials(Alumina) and the structure of both product is poly-crystal alumina. Also, the width of the slot is approximatively the same as each other.
IX. BIOCOMPATIBILTY TESTING
Biocompatibility testing including cytotoxicity, sensitization, oral mucosal irritation was completed according to the following standards:
ISO 10993-1 (2010) Biological Evaluation of Medical Devices -Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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ISO 10993-5 (2009) Biological Evaluation of Medical Devices - Part 5 Cytotoxicity ISO 10993-10 (2010) Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11 (2006) Biological Evaluation of Medical Devices Part 11: Tests for systemic toxicity test
ISO 10993-14 (2001) Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
X. SUMMARY OF CLINICAL TESTS
Clinical testing was not required to demonstrate the substantial equivalence of the C-Line™ orthodontic ceramic bracket to its predicate device.
XI. CONCLUSIONS
Based on the information above, C-Line™ orthodontic ceramic bracket have similar indications for use and intended use. Both have shown similar performance results in these bench tests In conclusion, C-Line™ orthodontic ceramic bracket is substantially equivalent to the predicate device and would be comparable with Clarity Advanced ceramic bracket in functional performance during the course of orthodontic treatment.
§ 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.