(552 days)
The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.
The Custom-made Invisible Aligners System is a series of dental aligners that are fabricated of clear, thin thermoformed Polyethylene terephthalate (PETG) plastic to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.
The provided text describes a 510(k) premarket notification for a medical device, the "Custom-made Invisible Aligners." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. For this submission, the manufacturer primarily relies on non-clinical performance testing and biocompatibility testing, rather than clinical studies or AI algorithm performance studies. Therefore, many of the requested items related to AI and human reader studies are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
1. Table of acceptance criteria and the reported device performance:
| Test Item | Test Standard/Method | Acceptance Criteria | Result |
|---|---|---|---|
| Thickness | Internal standard | ≤1.2mm | Pass |
| Appearance | "ZMT-FD-SS-052" | No crack or bubbling; No defects | Pass |
| Odor | Internal standard | Odorless | Pass |
| Density | ASTM D792-2013 | ≤2.6g/cm³ | Pass |
| Water absorption | ISO20795.1-2013 | ≤32 μg/mm³ | Pass |
| Dissolution | ISO20795.1-2013 | ≤1.6 μg/mm³ | Pass |
| Color stability | ISO20795.1-2013 | No change | Pass |
| Tear resistance | ISO6383.1-2015 | >200N/cm | Pass |
| Wear resistance | ISO9352-2012 | <0.25g/1000r | Pass |
| Flexural modulus of elasticity | ISO20795.1-2013 | ≥600Mpa | Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993 | Non-cytotoxic | Pass |
| Biocompatibility (Irritation) | ISO 10993 | Not an intracutaneous irritant | Pass |
| Biocompatibility (Sensitization) | ISO 10993 | Non-sensitizing | Pass |
| Manufacturing Accuracy | Pre-established specifications | 3D molding and aligner molding meet specs; suitability, function, form comply with specs | Pass |
| Shelf Life | Real-time aging testing | Performance maintained after 30 months | Pass |
The tests demonstrate that the subject device (Custom-made Invisible Aligners) meets the pre-established quality, safety, and performance criteria, aligning with or improving upon the predicate device.
Study Details:
2. Sample size used for the test set and the data provenance:
- Performance Testing (Physical/Mechanical properties): The document does not specify the exact sample size for each performance test (e.g., thickness, density, etc.). It states that "A comparison testing was performed in combination with the subject and predicate device." This suggests multiple samples were tested for each characteristic but does not provide a number.
- Manufacturing Accuracy Validation: 12 different patient cases were evaluated at the beginning, middle, and end of the treatment sequence.
- Shelf Life Testing: Performance testing was conducted after 30 months of real-time aging under commercial storage conditions.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the manufacturer's location (Zhejiang, China), the testing was likely conducted in China. The non-clinical nature of these tests means "retrospective" or "prospective" as typically applied to patient data is less relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The ground truth for the non-clinical performance and biocompatibility tests is based on established international standards (e.g., ASTM, ISO) and internal specifications, rather than expert human interpretation or diagnosis. For manufacturing accuracy, it's evaluated against pre-established specifications and the treatment design in software.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. As the tests are non-clinical and compliance-based, there is no human adjudication process involved in establishing "ground truth" errors. The results are objective measurements against defined criteria.
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. No MRMC study was conducted. This submission does not involve an AI algorithm intended for human interpretation or diagnostic assistance. The device is a physical medical device (aligners).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is not an AI algorithm. While there is software involved in ordering and processing, its verification and validation are described as supporting the device's safety and effectiveness, not as an AI-driven diagnostic or treatment planning tool being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Test Standards and Specifications: The ground truth for the non-clinical tests (material properties, biocompatibility, manufacturing accuracy, shelf-life) is based on:
- Established international standards (e.g., ASTM, ISO).
- Internal specifications and methods.
- Pre-established specifications and the treatment design in the software for manufacturing accuracy.
8. The sample size for the training set:
- Not Applicable. This submission does not involve a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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June 16, 2022
Zhejiang Yinchili Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA
Re: K203624
Trade/Device Name: Custom-made Invisible Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 7, 2022 Received: May 12, 2022
Dear Ivy Wang:
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 mediation-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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203624
Device Name Custom-made Invisible Aligner
Indications for Use (Describe)
The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligners positions teeth by way of continuous gentle force.
Type of Use (Select one or both, as applicable)
| Permitted Use (Part 21 CFR 601 Subpart E) |
|---|
| Secondary Use (21 CFR 601 Subpart E) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
A. Applicant:
Zhejiang Yinchili Medical Technology Co., Ltd. Address: North 4F, Building 1, No.239 Yatai Road, Daqiao Town, Nanhu District, Jiaxing, Zhejiang Province, China Contact Person: Ms. Hangli Chen Tel: +86-15024335314 Email: chenhangli@smartee.cn Date of summary prepared: 2022-05-24
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Custom-made Invisible Aligners Common Name: Sequential Aligners Regulatory Information Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental
C. Primary Predicate device:
K180346 Byte Aligner System Straight Smile, LLC
D. Indications for use of the device:
The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth
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by way of continuous gentle force.
E. Device Description:
The Custom-made Invisible Aligners System is a series of dental aligners that are fabricated of clear, thin thermoformed Polyethylene terephthalate (PETG) plastic to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.
F. Comparison to predicate device
The Custom-made Invisible Aligners is substantially equivalent in intended use, indications for use, mode of action, mode of use, design, and materials to the predicate Straight Smile Byte Aligner System (K180346). Only minor differences exist between the subject product and the predicate, which do not affect the safety or effectiveness of the subject device.
| Table 1: Comparison to Predicate Device | |||
|---|---|---|---|
| Device | Subject Device | Primary Predicate Device | Result |
| Manufacturer | Zhejiang Yinchili MedicalTechnology Co., Ltd. | Straight Smile, LLC | - |
| 510K number | K203624 | K180346 | - |
| Model Name | Custom-made InvisibleAligners | Byte Aligner System | - |
| Classification | Class II Device, NXC (21 CFR 872.5470) | Class II Device, NXC (21 CFR 872.5470) | Same |
| Classification Name | Aligner, Sequential | Aligner, Sequential | Same |
| Indications for use | The Custom-made InvisibleAligners is indicated for thetreatment of toothmalocclusion in patients withpermanent dentition (i.e., allsecond molars). TheCustom-made InvisibleAligner positions teeth byway of continuous gentleforce. | The Byte Aligner System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e., all secondmolars). The Byte AlignerSystem positions teeth byway of continuous gentleforce. | Same |
| Mode of Action | Orthodontic tooth movementoccurs through forces appliedby the device to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription. | Orthodontic toothmovement occurs throughforces applied by the deviceto the dentition as eachtooth follows theprogrammed displacementbased on a doctor'sprescription | Same |
| Anatomical Site of Use | Oral cavity | Oral cavity | Same |
| Mode of Use | Each aligner is worn by the patient as determined by the treating dental practitioner, generally for 22 hrs/day (or full time except for eating and hygiene) for 2 weeks prior to being replaced by the next aligner in sequence. This is repeated for a duration as prescribed by a Dental Professional. | Each aligner is worn by the patient as determined by the treating dental practitioner, generally for 2 weeks prior to being replaced by the next aligner in sequence. This is repeated for a duration as prescribed by a Dental Professional. | Same |
| Application | Removable | Removable | Same |
| Raw Material Used | Thermoplastic copolyester (polyethylene terephthalate-ethylene glycol copolyester) | Thermoplastic polymers (polyethylene terephthalate glycol or PETG) | Similar. Both are thermoplastic forming materials that do not raise any additional questions of safety or efficacy. |
| Method of Manufacturing | Thermoforming | Thermoforming | Same |
| OTC or Rx | Rx | Rx | Same |
| Sterile | No | No | Same |
| Biocompatibility | In compliance with ISO 10993, tests including Cytotoxicity Oral Mucosa Irritation Sensitization | In compliance with ISO 10993, tests including Cytotoxicity Sensitization | Similar. Both are in compliance with ISO 10993 |
| Design | Image: Clear aligner | Image: Clear aligner | Similar. Both are transparent plastic films. |
Table 1 provides a comparison of the subject and predicate device.
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G. Non-clinical Test
1) Performance Testing
Bench testing has demonstrated that the device is in compliance with pertinent standards and
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specifications, the expectations of the dental community and the product labeling. A comparison testing was performed in combination with the subject and predicate device including thickness, appearance, odor, density, water absorption, dissolution, color stability, tear resistance, wear resistance, flexural modulus of elasticity. Please see below table 2.
| Test item | Test standard/method | Acceptance criteria | Result |
|---|---|---|---|
| Thickness | Internal standard | ≤1.2mm | Pass |
| Appearance | "ZMT-FD-SS-052" | No crack or bubbling; No defects | Pass |
| Odor | Odorless | Pass | |
| Density | ASTM D792-2013 | ≤2.6g/cm3 | Pass |
| Water absorption | ISO20795.1-2013 | ≤32 μg/mm3 | Pass |
| Dissolution | ISO20795.1-2013 | ≤1.6 μg/mm3 | Pass |
| Color stability | ISO20795.1-2013 | No change | Pass |
| Tear resistance | ISO6383.1-2015 | >200N/cm | Pass |
| Wear resistance | ISO9352-2012 | <0.25g/1000r | Pass |
| Flexural modulus of elasticity | ISO20795.1-2013 | ≥600Mpa | Pass |
The results showed that the subject device is as effective as the predicate device.
Manufacturing validation accuracy testing
Manufacturing accuracy validation were conducted to the Custom-made Invisible Aligners from 12 different patient case were evaluated at the beginning, middle and end throughout the sequence. The accuracy of 3D molding and aligner molding are checked and meet the pre-established specification. The suitability, function and form of the aligner were checked and comparing it to the treatment design in the software, and the results were comply with the pre-established specifications and acceptance criteria.
Shelf life – 2 years
A 2-year shelf life was determined by real-time aging testing. Performance testing were conducted after 30 months real-time aging under commercial storage condition. The test results showed conformity with the pre-established specifications and acceptance criteria.
2) Biocompatibility Testing
The biocompatibility evaluation for the device was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process –Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The testing included the following tests:
- Cytotoxicity
- Irritation
- Sensitization
The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.
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3) Software Verification and Validation Testing
Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Custom-made Invisible Aligner to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
H. Clinical Test Conclusion
No clinical study is included in this submission.
l. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K180346.
§ 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.