(180 days)
No
The device description and performance studies focus on the physical properties, materials, and mechanical performance of the temporary anchorage screws. There is no mention of software, algorithms, image processing, or any other components that would typically incorporate AI/ML.
Yes.
The device facilitates the orthodontic movement of teeth, which is a therapeutic intervention aimed at correcting dental misalignments.
No
This device is a temporary anchorage screw used in orthodontics to facilitate tooth movement. It is a mechanical device for fixing orthodontic appliances, not one that diagnoses or detects medical conditions.
No
The device description clearly states it is a physical screw made of stainless steel and titanium alloy, intended for surgical implantation. It is a hardware 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 Function: The OBS Anchorage Screw is a physical implant used in vivo (within the body) to provide a fixed point for orthodontic appliances. It is a mechanical device used for structural support and movement of teeth.
- Intended Use: The intended use clearly states it's for providing a fixed anchorage point for orthodontic appliances to facilitate tooth movement. This is a mechanical function, not a diagnostic test on a biological sample.
- Device Description: The description details the materials, sizes, and types of the screw, all of which are consistent with a physical implant, not a diagnostic test kit or instrument.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the OBS Anchorage Screw falls under the category of a medical device, specifically an implantable device used in dentistry, and not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
OAT
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.
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
Where used: Dental practices
Target population: Professional use only - qualified dentists. Strictly reserved to specialized and trained users.
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)
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)
- 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.
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/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.
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 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
2
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 the | ||||||||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | ||||||||
| and review 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: |
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"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)
3
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.
4
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.
5
VI. Table of Safety and Effectiveness Substantial Equivalence Comparison
| Device
Name | OBS Anchorage
Screw | Syntec
orthodontic mini
screws | Syntec Wetali
Orthodontic Mini
Screws | Absoanchor
Microimplant | Leone
orthodontic mini
implant | Length (mm) | 8 / 10 / 12 / 14 | 5-12 | 6-12 | 4 -10 & 12 | 6-12 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Applicant | BOMEI | Syntec Scientific
corporation
(Taiwan) | Syntec Scientific
corporation
(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 |
| Regulation
No. | 872.3640 | 872.3640 | 872.3640 | 872.3640 | 872.3640 | Where used | Dental practices | Dental practices | Dental practices | Dental practices | Dental practices |
| Product
Code | 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 handed
screw
8.OMAS
mushroom | Professional use only - qualified dentists.
Strictly reserved to specialized and trained users. |
| 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) | Stainless Steel
(ISO
5832-1:2007/
ASTM
F138-13) ;
Titanium Alloy
(ISO
5832-3:1996/
ASTM F136-13) | Titanium Alloy
(ISO
5832-3:1996/
ASTM F136-13) | Stainless Steel
(ISO
5832-1:2007/
ASTM F138-13) | | | | | | |
| 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. | The screws are
intended to
provide fixed
anchorage for
attachment of
orthodontic
appliances
intended to
facilitate the
orthodontic
movement of
teeth. They are
used temporarily
and are intended
to be removed
after orthodontic
treatment has
been completed.
The 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. | Provide a fixed
anchorage point
for attachment of
orthodontic
appliances to
facilitate the
orthodontic
movement of
teeth. | Provide a fixed
anchorage for
attachment of
orthodontic
appliances to
facilitate the
orthodontic
movement of the
teeth. It is used
temporarily in
the maxillary and
mandibular bone
and must be
removed after
orthodontic
treatment has
been completed. | | | | | | |
| Supplied
Sterile | Non-Sterile ;
Steam Sterilize
before use | Non-sterile ;
Steam sterilize
before use. | Non-sterile ;
Steam sterilize
before use. | Non-Sterile ;
Steam Sterilize
before use | Non-sterile.
It is
recommended to
sterilize with
steam autoclave
before use. | | | | | | |
| Type | Square collar
Mushroom head:
1.None hole
2.Round hole
3.Slot hole | The screws are
with or without a
0.65mm
diameter hold. | The screws are
with or without a
0.7mm
diameter hold. | 1.Small head
2.No head
3.Long head
4.Circle head
5.Fixation head
6.Bracket head
7. Bracket | 1.High Head
2.Low head | | | | | | |
6
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)
7
- 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.
8
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.