(180 days)
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.
OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) 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 preprosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length.
- Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) .
- Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) .
There are three types of OBS Anchorage Screw.
- . Square collar mushroom head none hole
- . Square collar mushroom head round hole
- Square collar mushroom head slot hole .
OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use.
The sterilization recommendations documented in the instructions for use (IFU) are according to "AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities" have been validated.
Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes.
The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.
The provided text describes a 510(k) premarket notification for the "OBS Anchorage Screw," a temporary orthodontic anchorage device. The submission focuses on demonstrating substantial equivalence to predicate devices through performance data, not on the performance of a standalone AI-powered device or comparative effectiveness with human readers.
Therefore, many of the requested elements, such as those related to AI performance, sample sizes for test sets in the context of AI, ground truth establishment for AI, expert involvement for AI adjudication, and MRMC studies, are not applicable to this document. The document describes a medical device, not an AI device.
However, I can extract information related to the acceptance criteria and supporting studies for the physical medical device itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Area | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10, ISO 10993-11 standards. | Testing performed in accordance with ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization and Irritation), and ISO 10993-11 (Systemic Toxicity). Results indicate compliance (implied by conclusion of substantial equivalence). |
| Sterilization Validation | Compliance with ISO 11737-1, ISO 11737-2, ISO 17665-1, ISO 17665-2, and AAMI/ANSI ST79 for steam sterilization. | Testing performed in accordance with these standards for sterility validation and steam sterilization. |
| Mechanical Performance | Performance comparable to predicate devices Syntec Orthodontic Mini Screws and Absoanchor Microimplant, as per ASTM F543. | Mechanical Performance Testing performed with predicate devices in accordance with ASTM F543. Results indicate that OBS Anchorage Screw met acceptance criteria and is substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of data for an AI algorithm. The performance data refers to physical testing of the device for biocompatibility, sterilization, and mechanical properties. The sample sizes for these tests are not explicitly stated in the provided text.
Data provenance: N/A, as this refers to physical device testing, not data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI device where experts would establish ground truth for a test set.
4. Adjudication method for the test set
Not applicable.
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. This is not an AI device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
For the physical device:
- Biocompatibility: In vitro and in vivo biological responses to the device material, evaluated against established ISO standards.
- Sterilization Validation: Microbiological testing and adherence to established sterilization efficacy standards (ISO and AAMI/ANSI).
- Mechanical Performance: Physical and mechanical properties of the screw (e.g., strength, torque) compared against the performance of legally marketed predicate devices and ASTM F543 standards.
8. The sample size for the training set
Not applicable. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Bomei Co., Ltd % Shaoyin Peng Official Correspondent 258 N Bay Dr. Bullard. Texas 75757
Re: K152297
Trade/Device Name: Obs Anchorage Screw Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: December 29, 2015 Received: January 7, 2016
Dear Shaoyin Peng:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, 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 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152297
Device Name
OBS 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) | ||||||||
|---|---|---|---|---|---|---|---|---|
| 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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: |
Department of Health and Human Services Food and Druq 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."
Type of Use (Select one or both, as applicable)
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510(k) summary complying with 21 CFR 807.92.
- Submitter 1.
BOMEI CO., LTD.
Tel: +886-3-355-4989
Fax:+886-3-346-0897
Address: 4F, No 1492-2, Chunrih Rd., Taoyuan City, Taoyuan County, 33051 ,
Taiwan.
Contact Person: Linney Chiang
E-mail: linney.chiang@biomech.com.tw
Date prepared: December 29 , 2015
- II. Device
Name of the device: OBS Anchorage Screw
Common or Usual Name: OBS Anchorage Screw
Product Type: OBS(BD)
Classification Name: Endosseous dental implant (21 CFR 872.3640)
Regulatory Class: II
Product Code: OAT
Predicate Device =
K090476(Primary Predicate), Syntec Orthodontic Mini Screws ,
Syntec Scientific Corporation
K142001(Reference Predicate), Syntec Scientific Corporation ,
Syntec Wetali Orthodontic Mini Screws
K060126(Reference Predicate), Absoanchor Microimplant , Dentos Inc K071490(Reference Predicate), Leone SpA , Leone orthodontic mini implant
- IV. 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.
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Device Description >
OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) 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 preprosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length.
- Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) .
- Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) .
There are three types of OBS Anchorage Screw.
- . Square collar mushroom head none hole
- . Square collar mushroom head round hole
- Square collar mushroom head slot hole .
OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use.
The sterilization recommendations documented in the instructions for use (IFU) are according to "AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities" have been validated.
Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes.
The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.
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VI. Table of Safety and Effectiveness Substantial Equivalence Comparison
| DeviceName | OBS AnchorageScrew | Syntecorthodontic miniscrews | Syntec WetaliOrthodontic MiniScrews | AbsoanchorMicroimplant | Leoneorthodontic miniimplant | Length (mm) | 8 / 10 / 12 / 14 | 5-12 | 6-12 | 4 -10 & 12 | 6-12 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Applicant | BOMEI | Syntec Scientificcorporation(Taiwan) | Syntec Scientificcorporation(Taiwan) | Dentos Inc(South Korea) | Leone SpA(Italy) | Diameter (mm) | 1.5 / 2 | 1.3-2 | 1.4-2 | 1.2-1.8 | 1.5-2 |
| 510(K)Number | K152297 | K090476 | K142001 | K060126 | K071490 | Energy Sources | Non-active implantable devices | Non-active implantable devices | Non-active implantable devices | Non-active implantable devices | Non-active implantable devices |
| RegulationNo. | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | Where used | Dental practices | Dental practices | Dental practices | Dental practices | Dental practices |
| ProductCode | OAT | OAT | OAT | DZE | OAT | 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. | Professional use only - qualified dentists.Strictly reserved to specialized and trained users. | Professional use only - qualified dentists.Strictly reserved to specialized and trained users.head-left handedscrew8.OMASmushroom | Professional use only - qualified dentists.Strictly reserved to specialized and trained users. |
| Material | Stainless Steel(ISO5832-1:2007/ASTMF138-13) ;Titanium Alloy(ISO5832-3:1996/ASTM F136-13) | Stainless Steel(ISO5832-1:2007/ASTMF138-13) ;Titanium Alloy(ISO5832-3:1996/ASTM F136-13) | Stainless Steel(ISO5832-1:2007/ASTMF138-13) ;Titanium Alloy(ISO5832-3:1996/ASTM F136-13) | Titanium Alloy(ISO5832-3:1996/ASTM F136-13) | Stainless Steel(ISO5832-1:2007/ASTM F138-13) | ||||||
| IntendedUse | Temporaryanchoragescrews areintended toprovide a fixedanchorage pointfor attachment oforthodonticappliances tofacilitate theorthodonticmovement of theteeth.It is usedtemporarily andis removed afterorthodontictreatment hasbeen completed. | The screws areintended toprovide fixedanchorage forattachment oforthodonticappliancesintended tofacilitate theorthodonticmovement ofteeth. They areused temporarilyand are intendedto be removedafter orthodontictreatment hasbeen completed.The screws areintended forsingle use only. | The screws areindicated for useas a fixedanchorage forattachment oforthodonticappliances tofacilitate theorthodonticmovement ofteeth. They areused temporarilyand areremoved afterorthodontictreatment hasbeen completed.They areintended forsingle use only. | Provide a fixedanchorage pointfor attachment oforthodonticappliances tofacilitate theorthodonticmovement ofteeth. | Provide a fixedanchorage forattachment oforthodonticappliances tofacilitate theorthodonticmovement of theteeth. It is usedtemporarily inthe maxillary andmandibular boneand must beremoved afterorthodontictreatment hasbeen completed. | ||||||
| SuppliedSterile | Non-Sterile ;Steam Sterilizebefore use | Non-sterile ;Steam sterilizebefore use. | Non-sterile ;Steam sterilizebefore use. | Non-Sterile ;Steam Sterilizebefore use | Non-sterile.It isrecommended tosterilize withsteam autoclavebefore use. | ||||||
| Type | Square collarMushroom head:1.None hole2.Round hole3.Slot hole | The screws arewith or without a0.65mmdiameter hold. | The screws arewith or without a0.7mmdiameter hold. | 1.Small head2.No head3.Long head4.Circle head5.Fixation head6.Bracket head7. Bracket | 1.High Head2.Low head |
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VII. Comparison Of Technological Characteristics With The Predicate Devices
OBS anchorage screws and predicate devices Syntec Orthodontic Mini Screws , Syntec Wetali Orthodontic Mini Screws , Absoanchor Microimplant , and Leone orthodontic mini implant are based on the following same technological elements.
- . Intended use
- . Material
- . The sterilization method
- Potential adverse effects .
The following technological differences exist between the subject and predicate devices.
- . The type
- The dimensions (the diameter and the length) .
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing has been performed in accordance with ISO 10993-5 , ISO 10993-10 , ISO 10993-11.
- Cytotoxicity: ISO 10993-5 Biological evaluation of medical devices -- Part . 5: Tests for In Vitro cytotoxicity (Biocompatibility)
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- Sensitization and Irritation: ISO 10993-10 Biological evaluation of . medical devices - Part 10: Tests for irritation and skin sensitization (Biocompatibility)
- Systemic toxicity: ISO 10993-11 Biological evaluation of medical devices • Part 11: Tests for systemic toxicity. (Biocompatibility)
Sterilization validating testing has been performed in accordance with ISO 11737-1 , ISO 11737-2 and ISO 17665-1 , ISO 17665-2 , AAMI / ANSI ST79 for steam sterilization.
- ISO 11737-1 Sterilization Of Medical Devices Microbiological Methods . Part 1: Determination Of The Population Of Microorganisms On Product, 2ed. (Sterility)
- . 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. (Sterility)
- . 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. (Sterility)
- . ISO 17665-2 Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On The Application Of ISO 17665-1. (Sterility)
- . 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 Syntec Orthodontic Mini Screws and Absoanchor Microimplant in accordance with ASTM F543 that used in comparative performance testing were performed to demonstrate substantial equivalence.
- . ASTM F543 Standard Specification And Test Methods For Metallic Medical Bone Screws.
The results of this testing indicate that OBS Anchorage Screw met acceptance criteria and is substantially equivalent to predicate devices.
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IX. Conclusion
In comparison to the legally marketed devices, OBS anchorage screw has the same device characteristics as the predicates devices , intended use, material and the sterilization method.
The differences between the subject device and the predicate devices are the type, the dimensions (the diameter and the length).
However, testing data such as biocompatibility and mechanical performance testing provided in the submission prove that these differences would not raise issues in performance.
Based on the information provided in this premarket notification BOMEI concludes that OBS anchorage screw is substantially equivalent to the predicate device as described herein.
Therefore no clinical testing was conducted.
§ 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.