(183 days)
This device 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, Alpha Pure, 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Alpha Pure" device:
The provided document is a 510(k) summary for an orthodontic bracket, Alpha Pure. The entire document focuses on demonstrating substantial equivalence to a predicate device (Sapphire Ceramic Bracket, K073045), rather than establishing new performance acceptance criteria through clinical or comprehensive standalone studies.
Therefore, many of the requested sections (2-9, related to a standalone study or clinical trial) are not applicable or cannot be extracted directly from this type of regulatory submission. The "acceptance criteria" here are effectively the demonstration of comparable characteristics to a legally marketed device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for "Alpha Pure" are implicitly defined by its ability to demonstrate substantial equivalence to the predicate device, "Sapphire Ceramic Bracket (K073045)", across various technological characteristics and indications for use. The reported "performance" for Alpha Pure reflects these characteristics.
| Acceptance Criteria (Demonstrates Equivalence to Predicate) | Reported Device Performance (Alpha Pure) | Predicate Device Performance (Sapphire Ceramic Bracket) |
|---|---|---|
| Indications for Use | "This device is indicated 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." | "This device is indicated 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." |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement of ISO 10993 | Meets the applicable requirement of ISO 10993 |
| Maxillary Torque (mm) | -21 to +17 | -22 to +17 |
| Maxillary Angulation | 0 – 9 | 0 – 11 |
| Slot | 0.018", 0.022" | 0.018", 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Color | White, same as tooth color | White, same as tooth color |
| Indication system | Colored-dot | Colored-dot |
| Design | Tie wings for ligature, Hook, Archwire Slot, Round home, base and identification marks for placement. Hooks for ligation, for additional tooth movement, Molded ceramic body with rounded corners and edges, Slot to hold orthodontic wires. | Tie wings for ligature, Hook, Archwire Slot, Round home, base and identification marks for placement. Hooks for ligation, for additional tooth movement, Molded ceramic body with rounded corners and edges, Slot to hold orthodontic wires. |
| Single Use | Yes | Yes |
| Non-Sterile Packaging | Yes | Yes |
Note on Differences: The document explicitly mentions slight differences in the range of Maxillary Torque and Maxillary Angulation. However, it concludes that "these differences are not expected to affect the overall performance of the device since they are still within the range of what is typically observed for orthodontic brackets."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission focuses on demonstrating substantial equivalence based on material properties, design, and intended use, rather than a clinical performance study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth establishment by experts for a test set is not part of this type of 510(k) submission for an orthodontic bracket based on substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are relevant for studies involving subjective interpretation of data, which is not the primary focus of this submission.
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
This information is not applicable. MRMC studies are used for evaluating diagnostic image interpretation systems, typically AI-assisted tools. The Alpha Pure is an orthodontic bracket, a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is an orthodontic bracket, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility study, the ground truth was based on the applicable requirements of ISO 10993 standards. These standards provide benchmarks and methods for evaluating biological responses to medical devices. No other "ground truth" (like pathology or outcomes data) in a clinical sense is mentioned for the device's functional performance, as substantial equivalence relies on comparison to an existing device.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of this 510(k) submission for a physical orthodontic bracket.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth established for it.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 9, 2017
Koroad America % Joyce Bang President Provision Consulting Group Inc. 3248 Willow Hollow Rd Chino Hills, California 91709
Re: K163117
Trade/Device Name: Alpha Pure Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: March 15, 2017 Received: April 6, 2017
Dear Joyce Bang:
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. Isting 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.
Michael J. Ryan -S
for 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) K163117
Device Name Alpha Pure
Indications for Use (Describe)
This device 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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K163117
510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter:
Yeon Jae Lee, President Koroad America, Inc. 895 Dove Street, Suite 300 Newport Beach, CA 92660 Phone: 714-213-6910
Official Correspondent:
Joyce Bang, President Provision Consulting Group, Inc. 3248 Willow Hollow Rd. Chino Hills, CA 91709 Phone: 909-680-8562 Fax: 909-942-2571
Submission Date: 5/04/2017
Submission Type: Traditional 510(k) Trade/Proprietary Name: Alpha Pure Device Common Name: Bracket, Ceramic, Orthodontic Regulation Class: II Product Code: NJM Regulation Number: 21 CFR 872.5470 Predicate Device: Sapphire Ceramic Bracket (K073045)
Device Description:
The proposed device, Alpha Pure, 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.
Indications for Use:
This device is indicated 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.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- Indications for use
-
- Technological characteristics
-
- Performance properties
Summary of the technological characteristics compared to the predicate device
The subject device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table provided below.
| Subject device | Predicate | |
|---|---|---|
| Device Name | Alpha Pure | Sapphire Ceramic Bracket |
| Manufacturer | Luce castle Co., Ltd. | Ortho Technology Inc. |
| 510(k) number | N/A | K073045 |
| Indications for Use | This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after | This device is indicated for the orthodontic movement of teeth. It is used temporarily and is removed after |
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| orthodontic treatment has been | orthodontic treatment has been | |
|---|---|---|
| completed. The devices are intended to | completed. The devices are intended to | |
| be single use only. | be single use only. | |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement ofISO 10993 | Meets the applicable requirement of ISO10993 |
| Maxillary Torque (mm) | -21 to +17 | -22 to +17 |
| Maxillary Angulation | 0 – 9 | 0 – 11 |
| Slot | 0.018", 0.022" | 0.018", 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Color | White, same as tooth color | White, same as tooth color |
| Indication system | Colored-dot | Colored-dot |
| Design | Tie wings for ligature, Hook, ArchwireSlot, Round home, base andidentification marks for placement | Tie wings for ligature, Hook, ArchwireSlot, Round home, base andidentification marks for placement |
| Hooks for ligation, for additional toothmovement, Molded ceramic body withrounded corners and edges, Slot tohold orthodontic wires | Hooks for ligation, for additional toothmovement, Molded ceramic body withrounded corners and edges, Slot to holdorthodontic wires | |
| Single Use | Yes | |
| Non-Sterile Packaging | Yes | Yes |
Non-Clinical Study performance
The subject device was found to be in compliance with biocompatibility. The standards which have been applied to the biocompatibility study were ISO 10993 Biological evaluation of medical devices Part 1 – Evaluation and testing in the risk management process, Part 4 - Selection of tests of interactions with blood, Part 5 – Tests for in vitro cytotoxicity and Part 10 – Tests for irritation and delayed-type hypersensitivity.
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Substantial Equivalence Discussion
The subject device is substantially equivalent to the predicate device in it's a variety of characteristics stated in the comparison table provided below.
| Subject device | Predicate | |
|---|---|---|
| Device Name | Alpha Pure | Sapphire Ceramic Bracket |
| Manufacturer | Luce castle Co., Ltd. | Ortho Technology Inc. |
| 510(k) number | N/A | K073045 |
| Indications for Use | This device is indicated for theorthodontic movement of teeth. It isused temporarily and is removed afterorthodontic treatment has beencompleted. The devices are intended tobe single use only. | This device is indicated for theorthodontic movement of teeth. It isused temporarily and is removed afterorthodontic treatment has beencompleted. The devices are intended tobe single use only. |
| Material | Aluminum Oxide | Aluminum Oxide |
| Biocompatibility | Meets the applicable requirement ofISO 10993 | Meets the applicable requirement of ISO10993 |
| Maxillary Torque (mm) | -21 to +17 | -22 to +17 |
| Maxillary Angulation | 0 – 9 | 0 - 11 |
| Slot | 0.018", 0.022" | 0.018", 0.022" |
| Transparency | Half-transparency | Half-transparency |
| Color | White, same as tooth color | White, same as tooth color |
| Indication system | Colored-dot | Colored-dot |
| Design | Tie wings for ligature, Hook, ArchwireSlot, Round home, base andidentification marks for placementHooks for ligation, for additional toothmovement, Molded ceramic body withrounded corners and edges, Slot tohold orthodontic wires | Tie wings for ligature, Hook, ArchwireSlot, Round home, base andidentification marks for placementHooks for ligation, for additional toothmovement, Molded ceramic body withrounded corners and edges, Slot tohold orthodontic wires |
| Single Use | Yes | Yes |
| Non-Sterile Packaging | Yes | Yes |
Substantial Equivalence Comparison Chart and Discussion
Design Comparison:
The subject device and its predicate device both incorporate specific torques, angulations, and distal offset dimensions, along with archwire slots that are designed to accommodate the correct size archwire (typically .018″ or .022″ thick). They both feature tie wing undercut spaces for orthodontic ligatures, have a molded ceramic bracket bodies with rounded corners and edges for patient comfort, and rounded hooks on the tie wings to accommodate ligation during orthodontic treatment. They both have bases that are designed to provide maximum adhesion to the tooth while still allowing for easy and complete removal when necessary. However, there are slight differences on the range of Maxillary Torque and Maxillary Angulation between the subject and the predicate. While the ranges are not identical, these differences are not expected to affect the overall performance of the device since they are still within the range of what is typically observed for orthodontic brackets.
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Material Comparison:
Like its predicate, the subject devices are manufactured from polycrystalline alumina (ceramic) material, which has a well-documented history of biocompatibility within the oral environment. Like its predicate, the subject devices do not incorporate medicinal substances, tissues, or blood products. They are delivered non- sterile to the end user and are intended to be used once by a single patient.
Indications For Use Comparison:
The subject and predicate device have indications for use. They both are indicated 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.
Conclusion:
The subject device is designed, manufactured and engineered to be substantially equivalent to the predicate with respect to its equivalent indications for use, technological characteristics, device design, materials, performance and biocompatibility. Although there are slight differences in the range of Maxillary Angulation between the subject and predicate devices, they both are within the range of what is typically observed for orthodontic brackets.
Thus, the subject device Alpha Pure is demonstrated to be substantially equivalent to the predicate device.
§ 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.