(238 days)
This Mei Ceramic Bracket is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
The proposed device, Mei Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Conducted | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimension Test | Meet dimensions itemized in ISO 27020 | Mei Ceramic Bracket was inspected and met the dimensions itemized in ISO 27020. |
| Bracket Removal Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Shear Bonding Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Torque Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Wire Drag Test | Perform comparably to predicate devices | Testing analysis shows comparable performance to predicate devices. |
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatibility assessment and testing was performed using standard risk assessment techniques and in consideration of FDA and internationally recognized guidance's. This implies it met the standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each non-clinical test (dimension, bracket removal, shear bonding, torque, and wire drag tests). It states "Non-clinical performance data included testing results for dimension, Bracket removal test, Shear bonding test, Torque test, and Wire drag test." and "The testing analysis shows that Mei Ceramic Bracket perform comparably to the predicate devices."
The data provenance is from Orthosun Co., Ltd., located in Incheon, Republic of Korea. The tests appear to be retrospective as they were conducted on the finished device to demonstrate substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an orthodontic ceramic bracket, and the testing described is non-clinical (mechanical and material property testing). Ground truth in the context of expert consensus or medical diagnosis is not relevant for these types of tests. The "ground truth" would be the established international standards (like ISO 27020 or ISO 10993-1) and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review processes for diagnostic accuracy, which is not relevant here. The evaluation of non-clinical tests would usually involve direct measurement against a standard or comparison to a predicate, not expert adjudication in the traditional sense.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data both with and without AI assistance. This document describes a physical medical device (orthodontic bracket) and its non-clinical performance testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone (algorithm only) performance study was not done. This concept is applicable to AI/ML software as a medical device (SaMD). The Mei Ceramic Bracket is a physical medical device, and the described tests are non-clinical, evaluating its physical properties and mechanical performance.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests includes:
- Established International Standards: Specifically, ISO 27020 for dimensional specifications and ISO 10993-1 for biocompatibility.
- Performance of the Predicate Device: The document states that the testing analysis shows the Mei Ceramic Bracket performs "comparably to the predicate devices" for bracket removal, shear bonding, torque, and wire drag tests.
8. Sample Size for the Training Set
Not applicable. The Mei Ceramic Bracket is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 4, 2019
Orthosun Co., Ltd. % Peter Chung Representative Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K190608
Trade/Device Name: Mei Ceramic Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NJM Dated: August 5, 2019 Received: August 13, 2019
Dear Peter Chung:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Orthodontic Ceramic Bracket
Indications for Use (Describe)
This Mei Ceramic Bracket is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
| Type of Use (Select one or both, as applicable) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Image /page/3/Picture/1 description: The image contains a logo for Orthosun.Co., Ltd. The logo consists of a blue abstract shape on the left, followed by the company name "Orthosun.Co., Ltd." in black text. Below the company name is the website address "www.orthosun.co.kr", also in black text. The logo appears to be for a company in the medical or healthcare industry.
510(k) Summary [as required by 807.92(c)]
l. SUBMITTER
- a) Company: Orthosun Co., Ltd.
- b) Address: 2F, 112, Pyeongni-gil, Gyeyang-gu, Incheon, 21008, Republic of Korea
- Tel. : 82-32-545-2825 C)
- d) Fax : 82-32-554-2879
- e) President of Company: Mr. Woo-sik Kim
- f) Contact Person : Mr. Peter Chung, US designated agent
- Contact Person Telephone: 412-687-3976 g)
- Contact Person Address: 300, Atwood Street, Pittsburgh, PA, 15213, USA h)
- i) Submission Date: February 18, 2019
II. DEVICE
- a) Trade Name : Mei Ceramic Bracket b) Common Name : Orthodontic Ceramic Bracket c) Classification Name : bracket, ceramic, orthodontic d) Product Code : NJM Regulation Number : 872.5470 e) 4) Class of device : Class II Panel : Dental g)
III. PREDICATE DEVICE
- a) Primary Predicate Device: K073045, Sapphire Ceramic Bracket / Ortho Technology Inc.
IV. DEVICE DESCRIPTION
The proposed device, Mei Ceramic Bracket, consists of ceramic orthodontic brackets which are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontics wire, to alter the tooth position. The ceramic bracket is produced using Al203, translucent polycrystalline aluminum oxide (99.99%). The brackets are bonded to the teeth with commercially available materials and linked together by "arch wire" that applies steady, gentle pressure to produce desired tooth movement.
V. INDICATIONS FOR USE
This Mei Ceramic Bracket is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
VI. SUBSTANIAL EQUIVALNECE COMPARISON
The Mei Ceramic Bracket is similar designs and dimensions, and has the same material, intended use, and technological characteristics as the identified primary predicate device (K073045). When compared with predicate device, no new questions of substantial equivalence have been
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Image /page/4/Picture/1 description: The image contains the logo for Orthosun.Co., Ltd. The logo consists of a blue abstract shape on the left, followed by the company name in black text. Below the company name is the website address, www.orthosun.co.kr, also in black text.
raised for the Mei Ceramic Bracket.
| SUBJECT Device | Primary PREDICATE DeviceK073045 | |
|---|---|---|
| Manufacturer | Orthosun Co., Ltd. | Ortho Technology Inc. |
| Common Name | Orthodontic Ceramic Bracket | Orthodontic Ceramic Bracket |
| Trade Name | Mei Ceramic Bracket | Sapphire Ceramic Bracket |
| Indications for Use/ IntendedUse | Mei Ceramic Bracket isindicated for the orthodonticmovement of teeth. It is usedtemporarily and is removedafter orthodontic treatment hasbeen completed. The devicesare intended to be single useonly. | This device is indicated for theorthodontic movement ofteeth. It is used temporarily andis removed after orthodontictreatment has been completed.The devices are intended to besingle use only. |
| Clarity | Translucent | Translucent |
| Bracket Design | MBT, ROTH designs withouthook | MBT, ROTH designs with andwithout hook |
| Torque | -21° to 17° | -22° to +17° |
| Angulation | Up to +9° | Up to +11° |
| Available Slot Size | .018″, .022″ | .018″, .022″ |
| Material | Alumina (Al2O3) | Alumina (Al2O3) |
| Colour | White, same as tooth color | White, same as tooth color |
| Indication System | Colored-dot | Colored-dot |
| Biocompatibility | Biocompatible according to ISO10993-1 | Biocompatible according to ISO10993-1 |
| Single Use | yes | yes |
| Non-Sterile Packaging | yes | yes |
VII. NON-CLINICAL TEST DATA
Non-clinical performance data included testing results for dimension, Bracket removal test, Shear bonding test, Torque test, and Wire drag test. The testing analysis shows that Mei Ceramic Bracket perform comparably to the predicate devices.
Biocompatibility assessment and testing was performed using standard risk assessment techniques and in consideration of FDA and internationally recognized guidance's.
Mei Ceramic Bracket was inspected and met the dimensions itemized in ISO 27020, Dentistry -Brackets and tubes for use in orthodontics.
VIII. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification concludes that the Mei Ceramic Bracket is safe and effective and substantially equivalent to the predicate device as described herein.
§ 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.