(795 days)
No
The 510(k) summary describes a purely mechanical device (orthodontic screw) and makes no mention of AI or ML technology in its description, intended use, or performance studies.
No
Explanation: The device is indicated for use as a fixed anchorage point to facilitate the orthodontic movement of teeth, which is a structural or mechanical function, not a therapeutic one (i.e. treating a disease or disorder).
No
The device, an Orthodontic Screw, is used as a fixed anchorage point for orthodontic appliances to facilitate tooth movement. Its function is mechanical and structural support, not to detect, monitor, or diagnose a medical condition.
No
The device description explicitly states the screws are manufactured from physical materials (stainless steel and titanium alloy) and describes their physical dimensions and design features. The performance studies also focus on mechanical and biocompatibility testing of the physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is an "Orthodontic Screw" used as a "fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth." This is a physical device implanted into the bone to aid in tooth movement.
- No Mention of Biological Samples or Testing: The text does not mention any interaction with biological samples for diagnostic purposes. The performance studies focus on mechanical properties, biocompatibility, and sterilization, which are typical for implantable medical devices, not IVDs.
Therefore, this device falls under the category of a medical device, specifically an implantable device used in orthodontics, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Mico One Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
OAT
Device Description
The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are 1.5mm and 2.0 mm, and total thread lengths is 7.0mm. The minor technological modification for Mico One Orthodontic Screw is designed for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm/0.8mm diameter hole can supply different orthodontic methods for orthodontists.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device.
- ASTM F543-Standard Specification and Test Methods for Metallic Medical Bone Screws
Mico One Orthodontic Screw's mechanical function including Shear Bond Strength, Torque Strength test and structure integrity were tested and demonstrated that the design specification from design input are fulfilled. Mechanical performance tests were also conducted to demonstrate the reliability of the device for the intended function during use.
Biocompatibility testing
The biocompatibility evaluation and testing of the Mico One Orthodontic Screw was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", 2020.
- ISO 10993-3,Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-6, Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation.
- ISO 10993-10, Biological evaluation of medical device-Part 10: Tests for . irritation and skin sensitization.
- ISO 10993-11, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
- ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.
Sterilization Validation
Device is provided in non-Sterile but user will sterilized before use. Moist Heat sterilization validation was conducted in accordance with ISO 17665-1.
No animal studies or clinical testing have been required for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ze Fang Technology Co., Ltd. % Anita Chen Advisor ZhengCheng Consulting Limited Company No.19, 335 Lane, Fu-Xi Road, Shulin District New Taipei City, 238 TAIWAN
Re: K202163
Trade/Device Name: Mico One Orthodontic Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: September 2, 2022 Received: Septemeber 14, 2022
Dear Anita Chen:
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.
1
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) 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.
Andrew I. Steen 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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Mico One Orthodontic Screw
Indications for Use (Describe)
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Type of Use (select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to re instructions, search existing data sources, gather and maintain the data needed and complete and re the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." PSC Publishing Services (301) 443-6740 FORM FDA 3881 (6/20) EF
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510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
| 1. | Submitter | |
|---|---|---|
| Manufacturer | Ze Fang Technology Co., Ltd. | |
| Mailing Address | 1F, No. 17, Alley 81, Lane 2, Zhongxing Rd., | |
| Sec. 1, Dali Dist., Taichung City, Taiwan (R.O.C.) | ||
| Establishment Registration No.:3013689189 | ||
| Contact Person | Mrs. Anita Chen/ Regulatory Adviser of Ze Fang | |
| Technology Co., Ltd. | ||
| Phone: | +886(0) 939-855-759 | |
| E-mail: | m9104303@gmail.com | |
| Date Prepared | October 7, 2022 | |
| 2 | Device Name | |
| Proprietary Name: | Mico One Orthodontic Screw | |
| Common or usual name | Orthodontic screw | |
| Product Code | OAT | |
| Device | Orthodontic screw | |
| CFR Classification | CFR Part 872.3640 | |
| Device Class | II | |
| Classification Panel | Dental | |
| 3 | Primary Predicate | K142001 |
| Trade or proprietary or | ||
| model name: | Syntec Wetali Orthodontic Mini Screws | |
| Manufacturer: | Syntec Scientific Corporation | |
| No.2, Kung San Road | ||
| Chuan Shing Industrial Zone, | ||
| Shen Kang, Chang Hua Hsien, Taiwan R.O.C | ||
| Reference Device: | K042345 | |
| Trade or proprietary or | LIN/LIOU ORTHODONTIC MINI ANCHOR | |
| model name: | SYSTEM | |
| (LOMAS) | ||
| Manufacturer: | Mondeal Medical Systems GmbH | |
| Amstel 320-1 1017AP Amsterdam The | ||
| Netherlands | ||
| 4 | Device Description: | The screws are manufactured from commercially |
| SUS316L (stainless steel) and Ti6AL-4V | ||
| (Titanium alloy). The screws are available with | ||
| thread diameter are 1.5mm and 2.0 mm, and total | ||
| thread lengths is 7.0mm. The minor technological | ||
| modification for | ||
| Mico One Orthodontic Screw is designed for | ||
| easy insertion and removal. The design of smooth | ||
| curve surface of screw head is comfortable to | ||
| patient and the screws with or without a | ||
| 0.7mm/0.8mm diameter hole can supply different | ||
| orthodontic methods for orthodontists. | ||
| 5. | Intended Use: | Mico One Orthodontic Screw is indicated for use as a |
| fixed anchorage point for attachment of orthodontic | ||
| appliances to facilitate the orthodontic movement of | ||
| teeth. It is used temporarily and is removed after | ||
| orthodontic treatment has been completed. Screws | ||
| are intended for single use only. | ||
| Special Conditions for | ||
| Use Statement(s): | For orthodontic patient only | |
| 6. | Technological | |
| Characteristics and | ||
| Substantial Equivalence | ||
| Comparison with | ||
| Predicate: | A comparison of the device features, intended | |
| use, and other | ||
| information demonstrates that the Mico One | ||
| Orthodontic Screw is substantially equivalent to | ||
| the predicate device as summarized in Table 1. | ||
| The differences raise no new question of safety | ||
| and effectiveness. |
The assigned 510(k) Number: K202163
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Table 1
5
| 510(K)
| Number | K202163 | K142001 | K042345 |
|---|---|---|---|
| Device | |||
| Name | Mico One Orthodontic | ||
| Screw | Syntec Wetali | ||
| Orthodontic Mini | |||
| Screws | Lin/Liou Orthodontic | ||
| Mini Anchor System | |||
| (Lomas) | |||
| Manufactu | |||
| rer | Ze Fang Technology | ||
| Co., Ltd. | Syntec Scientific | ||
| Corporation | Mondeal Medical | ||
| Systems GmbH | |||
| Head | |||
| structure | Hexagon mushroom | ||
| head, | |||
| Four-corner mushroom | |||
| head, Tetragonal | |||
| mushroom head, Four- | |||
| corner mushroom head | |||
| half thread type, | |||
| Four-corner headless, | |||
| Hexagonal wing head, | |||
| Hexagon HOOK head | |||
| type, Round cross- | |||
| shaped groove, | |||
| Hexagonal hole type | |||
| above the round head, | |||
| Small hexagon | |||
| mushroom head | Four-corner | ||
| mushroom head, | |||
| Tetragonal | |||
| mushroom head, | |||
| Four corner | |||
| HOOK head type, | |||
| Hexagon | |||
| mushroom head, | |||
| Small hexagonal | |||
| mushroom head, | |||
| Short four- | |||
| cornered | |||
| mushroom head | Four-corner cross- | ||
| section, Four corner | |||
| HOOK head type, | |||
| Four-corner wing | |||
| head | |||
| Body | |||
| Diameter | |||
| (D) | Ø 1.5mm, Ø 2.0mm | From 1.4mm to | |
| 2.0mm | From 1.5mm to | ||
| 2.0mm | |||
| Length | |||
| (mm) | 7mm | From 5.0mm to | |
| 17.0mm | From7mm to 11mm | ||
| Material of | |||
| Fixture | SUS316L (stainless | ||
| steel) ASTM-F138, | |||
| Ti6Al-4V ASTM-F136 | SUS316L | ||
| (stainless steel), | |||
| Ti6Al-4V | Ti6AL-4V |
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| Shelf life | 2 years | 15 years | NA |
|---|---|---|---|
| Indication for use | Mico One Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only | The screws are indicated for use as a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are used temporarily and are removed after orthodontic treatment has been completed. They are intended for single use only. | The Lin/Liou Orthodontic Mini Anchor System (LOMAS) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only |
A minor technological difference between the predicate device and subject device is one piece assembled with main device and 3 components of Mico One Orthodontic Screw. But both of us used the same technological design for ligating. Bench testing
7
demonstrates that Mico One Orthodontic Screw can successfully remove the tooth to maintain the position. And the diameter and length are included in the range of the predicate device. Although there is a slightly different technological design, as compared to the predicate, the performance data demonstrates the proposed device performs in a similar manner as the predicate device. Therefore, we believe Orthodontic screw is "Substantially Equivalent" to the predicate devices.
7. Performance Testing
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intend use. The following tests were performed on the device.
- . ASTM F543-Standard Specification and Test Methods for Metallic Medical Bone Screws
Mico One Orthodontic Screw's mechanical function including Shear Bond Strength, Torque Strength test and structure integrity were tested and demonstrated that the design specification from design input are fulfilled. Mechanical performance tests were also conducted to demonstrate the reliability of the device for the intended function during use.
Biocompatibility testing
The biocompatibility evaluation and testing of the Mico One Orthodontic Screw was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- . FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", 2020.
- . ISO 10993-3,Biological evaluation of medical device-Part 3: Test for genotoxicity, carcinogenicity and reproductive toxicity.
- . ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-6, Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation.
- ISO 10993-10, Biological evaluation of medical device-Part 10: Tests for . irritation and skin sensitization.
8
- . ISO 10993-11, Biological evaluation of medical device-Part 11: Tests for systemic toxicity.
- . ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials.
Sterilization Validation
Device is provided in non-Sterile but user will sterilized before use. Moist Heat sterilization validation was conducted in accordance with ISO 17665-1.
No animal studies or clinical testing have been required for these devices.
-
- Conclusion
Based on the intended use and/or indications for use, technological characteristics, performance testing and comparison to the predicate device, the Mico One Orthodontic Screw is substantially equivalent.
- Conclusion