(150 days)
No
The 510(k) summary describes a physical medical device (temporary anchorage screws) and its specifications. There is no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on biocompatibility, sterilization, and mechanical properties.
Yes
The device is intended to facilitate the orthodontic movement of teeth, which is a therapeutic purpose.
No
Explanation: The device, OBS/Biokey Anchorage Screw, is described as providing a fixed anchorage point for orthodontic appliances to facilitate tooth movement. Its function is to assist in treatment, not to diagnose a condition.
No
The device description explicitly states it is a physical screw made of stainless steel and titanium alloy, intended for temporary implantation. It also mentions associated accessories and sterilization, all indicative of a hardware device.
No, 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, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that the OBS/Biokey Anchorage Screw is a physical screw made of stainless steel and titanium alloy. It is implanted into the body (specifically, the jawbone) to provide an anchorage point for orthodontic appliances.
- Intended Use: The intended use is to facilitate the mechanical movement of teeth by providing a fixed point for orthodontic forces. This is a physical intervention, not a diagnostic test performed on a specimen.
The device is a medical device used for treatment, not a diagnostic device used for testing specimens.
N/A
Intended Use / Indications for Use
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Product codes
OAT
Device Description
The OBS/Biokey Anchorage Screw, consisting of stainless steel (SUS-316LVM) and titanium alloy (Ti-6Al-4V ELI), is a self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and pre-prosthetic appliances, in order to facilitate the orthodontic movement of teeth. The OBS/Biokey Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The devices are used temporarily with the intention to be removed after orthodontic treatment. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single-use only.
The purpose of this submission is to implement six additional specification models: BM, AT, AY, CH, FH, and HH. The BD model was previously cleared under K152297.
The intended use, materials, manufacturing process, and sterilization method of the OBS/Biokey Anchorage Screw for BD, BM, AT, AY,CH, FH, and HH are the same. The differences are the type and dimensions (diameter and length). Different kinds of OBS/Biokey Anchorage Screw are manufactured to meet market needs. The BD model is available in diameters of 1.5. 2mm and lengths of 6. 8. 10. 12. 14mm. The BM and AT models are available in diameters of 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm. The AY model is available in diameter of 1.4mm and lengths of 6, 8, 10mm. The CH, FH, and HH models are available in diameters of 1.4, 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm.
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
Professional use only - qualified dentists
Strictly reserved to specialized and trained users.
Dental practices
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
- Non-clinical performance testing
The following performance data were provided in support of the substantial equivalence determination. - Biocompatibility testing in accordance to ISO 10993-5, ISO 10993-10, and ISO 10993-11 and referenced from K152297:
- Cytotoxicity: ISO 10993-5 Biological evaluation of medical . devices - Part 5: Tests for In Vitro cytotoxicity
- Sensitization and Irritation: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . Systemic toxicity: ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- Sterilization validating testing in accordance to ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization and referenced from K152297:
- · ISO 11737-1 Sterilization of medical devices Microbiological Methods Part 1: Determination of the population of microorganisms on product, 2ed
- ISO 11737-2 Sterilization of medical devices Microbiological Methods Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
- ISO 17665-1 Sterilization of health care products -- Moist Heat --Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ISO 17665-2 Sterilization Of Health Care Products Moist Heat -Part 2: Guidance On The Application Of ISO 17665-1
- AAMI/ANSI ST79 Comprehensive Guide to Steam Sterilization . and Sterility Assurance in Health Care Facilities
- Mechanical Performance Testing has been performed with the predicate devices in accordance to ASTM F543 used comparatively to demonstrate substantial equivalence.
- · ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
- Animal Studies: None
- Clinical Studies: None
Key Results: The results of this testing indicate that the OBS/Biokey Anchorage Screw met acceptance criteria and is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Bomei Co., Ltd. % Chih-Hao Kao General Manager Voler Biotech Consulting Co., Ltd. No. 3-1, Ln. 58, Hejiang St., Zhongshan Dist., Taipei City 10480 TAIWAN
Re: K202278
Trade/Device Name: OBS Anchorage Screw, Biokey Anchorage Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: December 2, 2020 Received: December 11, 2020
Dear Chih-Hao Kao:
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 (OS) 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 Steen Assistant 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) K202278
Device Name
OBS Anchorage Screw, Biokey Anchorage Screw
Indications for Use (Describe)
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
OBS Anchorage Screw/Biokey Anchorage Screw
1. Submitter
(a) Contact person
Name: Howard Kao Title: General Manager E-mail: leon.howard01@gmail.com Office address: 4F, No. 1492-2, Chunrih Rd., Taoyuan Dist., Taoyuan City, 33051, TAIWAN Tel: (O) +886-933-872-972 Date prepared: January 6, 2021
Manufacturer information (b)
| Submitter name: | BOMEI CO., LTD. |
|---|---|
| Submitter address: | 4F, No. 1492-2, Chunrih Rd., Taoyuan Dist., |
| Taoyuan City, 33051, TAIWAN | |
| Submitter phone number: | +886-3-355-4989 |
| Submitter fax number: | +886-3-346-0897 |
2. Device Name and Classification
| Product Name: | OBS Anchorage Screw, Biokey Anchorage Screw |
|---|---|
| Classification Name: | Implant, Endosseous, Orthodontic |
| Common or Usual Name: | Endosseous dental implant |
| Classification Panel: | Dental |
| Regulation Number: | 21 CFR 872.3640 |
| Device Class: | Class 2 |
| Product Code: | OAT |
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3. Predicate Device(s)
K152297 OBS Anchorage Screw
4. Device Description
The OBS/Biokey Anchorage Screw, consisting of stainless steel (SUS-316LVM) and titanium alloy (Ti-6Al-4V ELI), is a self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and pre-prosthetic appliances, in order to facilitate the orthodontic movement of teeth. The OBS/Biokey Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The devices are used temporarily with the intention to be removed after orthodontic treatment. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single-use only.
The purpose of this submission is to implement six additional specification models: BM, AT, AY, CH, FH, and HH. The BD model was previously cleared under K152297.
The intended use, materials, manufacturing process, and sterilization method of the OBS/Biokey Anchorage Screw for BD, BM, AT, AY,CH, FH, and HH are the same. The differences are the type and dimensions (diameter and length). Different kinds of OBS/Biokey Anchorage Screw are manufactured to meet market needs. The BD model is available in diameters of 1.5. 2mm and lengths of 6. 8. 10. 12. 14mm. The BM and AT models are available in diameters of 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm. The AY model is available in diameter of 1.4mm and lengths of 6, 8, 10mm. The CH, FH, and HH models are available in diameters of 1.4, 1.6, 2mm and lengths of 6, 8, 10, 12, 14mm.
5. Indications for Use
Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
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6. Comparison of technological characteristics with the predicate device
We compared the modified device with the existing device (K152297) in the Comparison Table below.
| Device
Name | OBS Anchorage Screw
(Existing) | OBS Anchorage Screw/Biokey Anchorage
Screw
(Modified) | Comparison |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Applicant | BOMEI | BOMEI | Identical |
| 510(k) Number | K152297 | K202278 | - |
| Regulation No. | 21 CFR 872.3640 | 21 CFR 872.3640 | Identical |
| Product Code | OAT | OAT | Identical |
| Trade Name | OBS Anchorage Screw | OBS Anchorage Screw
Biokey Anchorage Screw | Different
Add new trade name |
| Material | Stainless Steel (ISO 5832-1:2007 /
ASTM F138-13)
Titanium Alloy (ISO 5832-3:1996 / ASTM
F136-13) | Stainless Steel (ISO 5832-1:2007 /
ASTM F138-13)
Titanium Alloy (ISO 5832-3:1996 / ASTM
F136-13) | Identical |
| Device
Name | OBS Anchorage Screw
(Existing) | OBS Anchorage Screw/Biokey Anchorage
Screw
(Modified) | Comparison |
| Intended
Use | Temporary anchorage screws are intended to
provide a fixed anchorage point for
attachment of orthodontic appliances to
facilitate the orthodontic movement of the
teeth.
It is used temporarily and is removed after
orthodontic treatment has been completed. | Temporary anchorage screws are intended to
provide a fixed anchorage point for
attachment of orthodontic appliances to
facilitate the orthodontic movement of the
teeth.
It is used temporarily and is removed after
orthodontic treatment has been completed. | Identical |
| Model | BD | BD, BM, AT, AY, CH, FH, HH | Different
Add new six specifications |
| Sterility | Supplied non-sterile; steam sterilize before
use | Supplied non-sterile; steam sterilize before
use | Identical |
| Type | Square collar, Mushroom
head, None/Round/Slot hole
(BD) | Square collar, Mushroom
head, None/Round/Slot hole
(BD)
Hexagonal collar, Mushroom
head, None/Round/Slot hole
(BM)
Hexagonal collar, Oval head,
None/Round/Slot hole (AT)
Hexagonal collar, Slight head,
None/Round hole (AY) | Different |
| | | Cap head, None/Round/Slot
hole (CH)
Flat head, None/Round/Slot
hole (FH)
Hook head, None/Round/Slot
hole (HH) | |
| Length (mm) | 8, 10, 12, 14 | 6, 8, 10, 12, 14 | Different
Add length of 6mm |
| Diameter (mm) | 1.5, 2 | 1.4, 1.5, 1.6, 2 | Different
Add diameters of 1.4mm,
1.6mm |
6
7
8
| Device
Name | OBS Anchorage Screw
(Existing) | OBS Anchorage Screw/Biokey Anchorage
Screw
(Modified) | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Non-thread
region
(mm) | 0mm | 0, 2, 4mm | Different
Add non-thread region
lengths of 2mm, 4mm
(except AY)
In the non-thread region,
there is no pitch on the
screw. |
| Energy sources | Non-active implantable devices | Non-active implantable devices | Identical |
| Where used | Dental practices | Dental practices | Identical |
| Target
population | Professional use only - qualified dentists
Strictly reserved to specialized and trained
users. | Professional use only - qualified dentists
Strictly reserved to specialized and trained
users. | Identical |
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| Device
Name | OBS Anchorage Screw
(Existing) | OBS Anchorage Screw/Biokey Anchorage
Screw
(Modified) | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------|
| Biocomp.
Testing | ISO 10993-5
ISO 10993-10
ISO 10993-11 | ISO 10993-5
ISO 10993-10
ISO 10993-11 | Identical |
| Sterilization
Validation
Testing | ISO 11737-1, ISO 11737-2, ISO 17665-
1, ISO 17665-2, AAMI/ANSI ST79
for steam sterilization | ISO 11737-1, ISO 11737-2, ISO 17665-
1, ISO 17665-2, AAMI/ANSI ST79
for steam sterilization | Identical |
| Mechanical
Performance
Testing | ASTM F543 | ASTM F543 | Identical |
10
| Device
Name | OBS Anchorage Screw
(Existing) | OBS Anchorage Screw/Biokey Anchorage
Screw
(Modified) | Comparison |
| ---------------- | ----------------------------------- | ------------------------------------------------------------- | ------------ |
|---|
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7. Performance data
-
Non-clinical performance testing
The following performance data were provided in support of the substantial equivalence determination. -
Biocompatibility testing in accordance to ISO 10993-5, ISO 10993-10, and ISO 10993-11 and referenced from K152297:
- Cytotoxicity: ISO 10993-5 Biological evaluation of medical . devices - Part 5: Tests for In Vitro cytotoxicity
- Sensitization and Irritation: ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . Systemic toxicity: ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
Sterilization validating testing in accordance to ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization and referenced from K152297:
- · ISO 11737-1 Sterilization of medical devices Microbiological Methods Part 1: Determination of the population of microorganisms on product, 2ed
- ISO 11737-2 Sterilization of medical devices Microbiological Methods Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
- ISO 17665-1 Sterilization of health care products -- Moist Heat --Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ISO 17665-2 Sterilization Of Health Care Products Moist Heat -Part 2: Guidance On The Application Of ISO 17665-1
- AAMI/ANSI ST79 Comprehensive Guide to Steam Sterilization . and Sterility Assurance in Health Care Facilities
-
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12
substantial equivalence.
- · ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws
- Animal Studies .
- ・ None
- Clinical Studies .
- None .
The results of this testing indicate that the OBS/Biokey Anchorage Screw met acceptance criteria and is substantially equivalent to the predicate device.
8. Conclusions
In comparison to the legally marketed device, the OBS/Biokey Anchorage Screw has the same intended use, materials, manufacturing process, and sterilization method. The differences between the subject device and the predicate device are the type and dimensions (diameter and length).
However, testing data such as mechanical performance testing provided in the submission show that these differences do not raise issues in performance. Based on the information provided in this premarket notification, BOMEI concludes that the OBS/Biokey Anchorage Screw is substantially equivalent to the predicate device.