(109 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to a predicate device, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The device is described as an anchorage point for orthodontic appliances, which facilitates movement of teeth, but it does not directly treat or cure a disease or condition.
No
Explanation: The device is described as an orthodontic anchorage point to facilitate tooth movement, not to diagnose a condition.
No
The device description clearly states it is a physical screw made of titanium alloy with varying dimensions, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The ORTHO MI SYSTEM is a physical implant used as an anchorage point within the body to facilitate orthodontic tooth movement. It does not analyze any biological samples.
- Intended Use: The intended use clearly states its purpose is for mechanical anchorage in orthodontic treatment, not for diagnostic testing.
Therefore, the ORTHO MI SYSTEM falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ORTHO MI SYSTEM 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. It is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
OAT
Device Description
The ORTHO MI SYSTEM 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. It is intended for single use only.
The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaw and palatal
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)
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
- Mechanical performance
- Sterilization, shelf-life and packaging for sterile product
- Sterilization for non-sterile product
- Biological safety assessment
No clinical data were necessary for the demonstration of substantial equivalence.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 15, 2021
Osteonic Co., Ltd. Lee Jisun Manager 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho 1202Ho, 1206Ho, 38 Digital-ro 29-gil Guro-gu, Seoul 08381 REPUBLIC OF KOREA
Re: K211992
Trade/Device Name: Ortho MI System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: July 14, 2021 Received: July 19, 2021
Dear Lee Jisun:
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 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 Andrew 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
2
Indications for Use
510(k) Number (if known) K211992
Device Name ORTHO MI SYSTEM
Indications for Use (Describe)
The ORTHO MI SYSTEM 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. It is intended for 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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3
Image /page/3/Picture/0 description: The image contains the logo for Osteonic, a medical company. The logo features a blue geometric shape resembling a stylized diamond or cube, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, sans-serif font, with the tagline "The Medical Explorer" appearing in a smaller font size beneath it.
510(k) Summary
The assigned 510(k) Number: K211992
01. Date of Submission: 2021.10.15
02. Applicant
LEE JISUN OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8411 FAX: +82-2-6902-8401 Email: jisun@osteonic.com
03. Submission Correspondent
LEE JISUN OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8411 FAX: +82-2-6902-8401 Email: jisun(@osteonic.com
04. Subject Device Identification
Trade Name: ORTHO MI SYSTEM Common Name: Non sterile, sterile orthodontic anchor screw Classification Name: Implant, Endosseous, Orthodontic Product Code: OAT Panel: Dental Regulation Number: 21 CFR 872.3640 Device Class: II
05. Indication for use
The ORTHO MI SYSTEM 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. It is intended for single use only.
06. Predicate devices
Predicate device 510(k) Number: K103105 Device Name: Orthodontic screw Manufacturer: OSSTEM Implant Co., Ltd.
Reference device 510(k) Number: K161335 Device Name: Dual Top Screw System Manufacturer: Jeil Medical Corporation
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Image /page/4/Picture/0 description: The image contains a logo for a company called OSTEONIC. The logo consists of a blue geometric shape on the left and the company name "OSTEONIC" in bold, dark font on the right. Below the company name is the tagline "The Medical Explorer" in a smaller, lighter font.
07. Device Description
The ORTHO MI SYSTEM 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. It is intended for single use only.
The screw diameters and lengths vary as shown below. It is made of a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13).
| Structure (head type) | Thread diameter and Length | Remark |
|---|---|---|
| Double head | - Ø1.4mm, 6.0/8.0mm | Exceptionally S5T (Double head) and S5R (Slot) |
| Button head | - Ø1.6mm, 6.0/8.0/10.0mm | are Ø1.8mm, 10.0 to 16.0mm per 1.0mm. |
| Wing | - Ø1.8mm, 6.0/8.0/10.0mm | |
| Slot | - Ø2.0mm, 6.0/8.0/10.0/12.0mm |
These size combinations are the same across all model types (Double Head, Wing, Slot) with exception case.
08. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
▪ Mechanical performance
- ISO 19023: 2018 Dentistry Orthodontic anchor screws
- ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
▪ Sterilization, shelf-life and packaging for sterile product
-
ISO11137-1:2006/Amd.2:2018 Sterilization of health care products - Radiation - Part 1: Requirement, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2018)]
-
ISO11137-2:2013Sterilization of health care products -Requirements for validation and routine control - Radiation -Part 2: Establishing the sterilization dose
-
ISO11137-3:2017Sterilization of health care products -Requirements for validation and routine control - Radiation -Part 3: Guidance on dosimetric aspects
-
ISO11737-1:2018 Sterilization of medical devices - Microbiological methods- Part 1: Estimation of microorganisms on products
-
ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods- Part 2. Tests of sterility performed in the validation of a sterilization process
-
ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices - part 1: requirements for materials, sterile barrier systems and packaging system
-
ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
-
ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
-
ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
-
ASTM F1140/F1140M:2013 Standard test methods for internal pressurization failure resistance of unrestrained packages for medical applications
-
ASTM F2096:2011 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
-
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration - ASTM D882:2012 Standard test method for tensile properties of thin plastic sheeting.
-
ASTM F1886F1886M:2016 Standard Test Method for Determining Integrity of Seals for flexible packaging by visual inspection
· Sterilization for non-sterile product
- ANSI/AAMI ST79:2017 Comprehensive guide to steam sterility assurance in health care facilities - ISO 17665-1:2006 Sterilization of health care products -- moist heat -- part 1: requirement, validation, and routine control of a sterilization process for medical devices.
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Image /page/5/Picture/0 description: The image shows the logo for Osteonic, a medical company. The logo features a stylized blue geometric shape resembling a stylized letter "O" or a series of interconnected rectangles. To the right of the geometric shape is the company name "OSTEONIC" in bold, dark gray letters. Below the company name is the tagline "The Medical Explorer" in a smaller, lighter font.
-
ISO TS 17665-2:2009 Sterilization of health care products - moist heat - part 2: guidance on the application of iso 17665-1.
-
ISO 11138-1:2017 Sterilization of health care products - biological indicators - part 1: general requirements
▪ Biological safety assessment
Biological assessment has been performed according to ISO 10993-1:2018, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process," and to the FDA Guidance document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff", for the subject devices.
09. Clinical Test Summary
No clinical data were necessary for the demonstration of substantial equivalence.
10. Substantially Equivalent Conclusion
| Table 1: Substantial Equivalence Comparison | ||
|---|---|---|
| Product Name | SUBJECT Device
ORTHO MI SYTEM
(K211992) | PREDICATE Device
Orthodontic screw (K103105) | REFERENCE Device
Dual Top Screw System
(K161335) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OSTEONIC Co., Ltd. | OSSTEM Implant Co., Ltd. | Jeil Medical Corporation |
| Product code | OAT | OAT | OAT |
| Regulatory
class | Class II | Class II | Class II |
| Regulation
Number | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 |
| Indication for
use | The ORTHO MI SYSTEM 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. It is intended
for single use only. | 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. | The Dual Top Screw System is
intended for use as a temporary
anchor for orthodontic
treatment for use in patients
aged 12 and older. |
| Operating
Principles | Orthodontic anchorage screw is
inserted into jaw and palatal to
help the orthodontist move the
correct teeth and stop the
wrong teeth from moving in the
wrong direction. | Orthodontic anchorage screw is
inserted into jaw and palatal to
help the orthodontist move the
correct teeth and stop the wrong
teeth from moving in the wrong
direction. | Orthodontic anchorage screw is
inserted into jaw and palatal to
help the orthodontist move the
correct teeth and stop the wrong
teeth from moving in the wrong
direction. |
| Material | Titanium alloy (Ti6Al4V)-
ASTM F136 | Titanium alloy (Ti6Al4V)-
ASTM F136 | Titanium alloy (Ti6Al4V)-
ASTM F136 |
| Form | Orthodontic Anchorage Screw | Orthodontic Anchorage Screw | Orthodontic Anchorage Screw |
| Structure | Double head
Button head
Wing
Slot | Through hole: wire hole
Simple head: no hole
Tapered body | Double head
Button head
Wing
Slot |
| Color | Silver | Silver | Silver |
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Image /page/6/Picture/0 description: The image shows the logo for Osteonic, a medical company. The logo features a blue diamond shape with a stylized "O" inside, next to the company name in bold, dark gray letters. Below the name is the tagline "The Medical Explorer" in a smaller, lighter font.
| Product Size | Diameter: Ø1.4 to 2.0
Thread Length: 6.0mm to
16.0mm (included an
unthreaded length under head)
Diameter by thread length
Ø1.4mm- 6.0mm to 8.0mm
Ø1.6mm and Ø1.8mm- 6.0mm
to 10.0mm
Ø2.0mm- 6.0mm to 12.0mm
Exception -S5T and S5R-:
Ø1.8mm- 10.0mm to 16.0mm) | Diameter: Ø1.4 to 1.8
Thread Length: 6mm to 10mm | Diameter: Ø1.3 to 2.5
Thread Length: 5mm to 16mm
(included an unthreaded length
under head) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Sterilization | Non sterile (user sterilization)
or
Sterile (Radiation) | Sterile (Radiation) | Non sterile (user sterilization)
or
Sterile (Radiation) |
| Single Use/
Reuse | Single use | Single use | Single use |
| Packaging | 1 or 10ea / Pack | 1ea / Pack | - |
| Shelf-life | Non sterile product- N/A,
Sterile product-3 Years | 5 Years | Non sterile product- N/A,
Sterile product-5 Years |
There are slightly different diameters and thread length between the subject and predicate device was added to support the difference diameters and lengths of the size of the subject device is included in the range of the predicate and reference device. The result of the comparative bench testing in line with ISO 19023 demonstrate that all screws are similar performance with predicate and/or reference device.
The technological characteristics of subject device is same materials and has similar dimension as the predicate and/or reference device.
The Indication for use of subject device is same as the predicate device.
Based on above, the subject device, ORTHO MI SYSTEM, is determined to be Substantially Equivalent (SE) to the predicate devices and reference device, Orthodontic screw (K103105) and Dual Top Screw System (K161335).