(279 days)
No
The description focuses on the mechanical properties and materials of a physical orthodontic anchor plate, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as an "anchor in orthodontic procedures" and is intended to provide "intraoral absolute anchorage for the intrusion or molars," which are therapeutic actions to correct dental alignment.
No
The device is described as an "anchor in orthodontic procedures" used for skeletal anchorage, designed to provide "intraoral absolute anchorage for the intrusion or molars." Its function is mechanical support for tooth movement, not the diagnosis of a medical condition.
No
The device description explicitly states the device is made of pure titanium alloy and describes physical components (head, arm, body, plates). The performance studies focus on mechanical properties and biocompatibility, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be place in the mouth for use as an anchor in orthodontic procedures." This describes a device used in vivo (within the body) for a structural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical implant made of titanium alloy for providing anchorage. This aligns with a medical device used for treatment or support, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Performance Studies: The performance studies focus on mechanical properties (bending strength, tensile force, pullout force) and biocompatibility, which are relevant to the physical function and safety of an implantable device, not the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
Product codes
OAT
Device Description
The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion.
Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
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)
The test such as appearance, dimension and bending strength is to verify the performance of the device as it designed. Bending strength was performed according to ISO 9585. All of test results obtained from these tests indicated that Anchor Plate is substantially equivalent to the predicate device in terms of mechanical properties and performance.
The biocompatibility evaluation for the Anchor Plate was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:
- . Genotoxicity, ISO 10993-3(2014)
- Cytotoxicity, ISO 10993-5(2009)
- Implantation, ISO 10993-6(2007)
- Sensitization(GPMT), ISO 10993-10(2010)
- Oral mucous irritation / Intracutaneous reactivity, ISO 10993-10(2010)
- . Systemic toxicity(Acute), ISO 10993-11(2006)
Anchor Plate and the primary predicate device were tested for the non-clinical performance including Pullout force with 3-point bending test according to JS T 0312:2008, Testing methods for bending properties of metallic osteosynthesis devices and tensile force test. For tensile force test, there is no international standard or required guidance, therefore it is performed according to own test method. The results showed that the subject and predicate devices are fundamency. Based on the comparative data, subject devices are essentially the same as currently marketed devices for the same indication, with similar physical properties or design, which supports our claim for substantial equivalence. Anchor plate shows no differences in technological characteristics compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bending strength (Avg., N·mm): 102.428
Tensile force (Avg., N): 301.814
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The seal features an abstract design, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
BioMaterials Korea, Inc Jiyea Kim Staff #413, #329, #331 150, Jojeong-daero, Hanam-si Gyeonggi-do, KR 12930
Re: K173623
Trade/Device Name: Anchor plate Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: November 9, 2017 Received: November 24, 2017
Dear Jiyea Kim:
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.
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
August 30, 2018
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173623
Device Name Anchor plate
Indications for Use (Describe)
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
| 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
Date: August 30, 2018
1. Submitter:
| Manufacturer Name: | BioMaterials Korea, Inc
#413, #329, #331 150, Jojeong-daero, Hanam-si,
Gyeonggi-do, Rep of Korea
Phone: +82-31-790-4511
Fax: +82-31-790-4519
Contact name: Jiyea Kim
Email: jiyea210@biomk.com
Web page: www.BioMK.com |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent Name: | Regulatory Insight, Inc
33 Golden Eagle Lane, Littleton, CO, 80127
Phone: 720-9625412
Fax: 720-9625413
Contact name: Kevin Walls
Email: Kevin@Reginsight.com |
2. Device Name and Classification
| Trade/Proprietary Name: | Anchor Plate |
|---|---|
| Common Name: | Endosseous Dental Implant |
| Regulatory Class: | Class II, 872.3640 |
| Product Code: | OAT |
3. Predicated Device
- . Primary Predicate Device BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM, TITA-LINK, K091051
- . Reference Predicate Devices KLS MARTIN ORTHO ANCHORAGE SYSTEM, KLS-MARTIN L.P., K040891 SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM, SYNTHES(USA), K063473
4. Device Description
The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion.
Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.
4
| Anchor plate | Screw | |||
|---|---|---|---|---|
| Design | Type | Design | Trade names | Model name |
| Image: T-Type Anchor Plate | T-Type | Image: Bone Screw | Bone Screw | OSS-T2004S |
| OSS-T2005S | ||||
| OSS-T2006S | ||||
| Image: I-Type Anchor Plate | I-Type | Image: Bone Screw | Bone Screw | OSS-T2004S |
| OSS-T2005S | ||||
| OSS-T2006S | ||||
| Image: I-Type Anchor Plate | ||||
| Image: Y-Type Anchor Plate | Y-Type | Image: Bone Screw | Bone Screw | OSS-T2004S |
| OSS-T2005S | ||||
| OSS-T2006S | ||||
| Image: W-Type Anchor Plate | W-Type | Image: CT Type Screw | CT Type | OAS-T1506T |
| Image: C-Type Screw | C-Type | OAS-T1507 |
Compatibility information is summarized in the table below.
5
| Image: W-Type | CT Type | OAS-T1506T |
|---|---|---|
| C-Type | OAS-T1507 |
5. Intended Use
The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
6
| - | Proposed Device | Primary Predicate Device
(K091051) | Reference
Device I
(K040891) | Predicate
Reference
Device II
(K063473) | Predicate Discuss/Justify
differences |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade name | Anchor Plate | BOLLARD MINIPLATE
SKELETAL
ANCHORAGE SYSTEM | KLS MARTIN ORTHO
ANCHORAGE SYSTEM | SYNTHES
ORTHODONTIC BONE
ANCHOR SYSTEM | |
| Common name | Endosseous dental
implant | Endosseous dental
implant | Bone plate | Endosseous dental
implant | Same |
| Classification name | Endosseous implant | Endosseous implant | Endosseous implant | Endosseous implant | Same |
| Class | II | II | III | II | Same |
| Product Code | OAT | DZE | DZE | OAT | There are different product
codes, DZE and OAT
between proposed device
and predicate devices.
However, all devices consist
of orthodontic anchorage
system under same intended
use.
For product code as DZE,
Bollard Miniplate Skeletal
Anchorage System
(K091051) and Ortho
Anchorage System
(K040891) are used as an
anchor for orthodontic
procedures by providing
skeletal fixation which are
same with T-Type, I-Type
and Y-Type of proposed
device.
For product code as OAT, |
| | | | | | The
Orthodontic
Bone
Anchor System (K063473)
are used as an anchor for
orthodontic procedure by
providing bone fixation
which is same with W-Type
of proposed device. |
| Device description | The anchor plates for the
attachment to the
orthodontic device offer
four types (T-Type, I-
Type, Y-Type and W-
Type). This plate has three
portions; head, arm and
body, and there are two
types of head portion.
Anchor plate is developed
to provide intraoral
absolute anchorage for the
intrusion or distalization
of molars. Anchor Plate
does not disturb any kind
of tooth movement
because they are placed
outside the dentition. The
anchor plate consists of
pure titanium and titanium
alloy, which is suitable for
osseointegration and also
tissue integration. | The Bollard Miniplate
Skeletal Anchorage
System was invented by
Dr. Hugo DeClerck.
The Bollard Miniplate
Skeletal Anchorage
System provides a fixed
anchorage point for the
attachment of orthodontic
appliances to facilitate
orthodontic movement of
teeth. Small stationary
points connected to bone
inside the Mouth allow
connection of wire,
elastic, or other hardware.
The Bollard Miniplate
Skeletal Anchorage
System includes
Commercially Pure
Titanium miniplates fixed
by miniscrews to the
cortical bone. After
insertion by the surgeon
the miniplates are
completely covered by
soft tissue. The miniplates
and miniscrews are sold
sterile and are sterilized
using Gamma Radiation
per ISO 111137-1. | The KLS-Martin Ortho
Anchorage System
includes several different
designs of titanium plates. | The Synthes (USA) Same
Orthodontic Bone Anchor
System is a plate and
screw system designed to
be implanted intraorally
and used as an anchor for
orthodontic procedures.
The plate anchor portion
of the system consists of
T-shaped plate anchors
which are attached to the
bone via 1.55 mm cortex
screws and 1.85 mm
emergency screws. The
plate anchors are offered
in various designs for
attachment to the
orthodontic device. The
screw anchor portion of
the system consists of
1.55 mm self-drilling and
self-tapping screw
anchors which incorporate
a non-threaded gingival
collar beneath the screw
head which protects the
soft tissue. | |
| | | | | | |
| | | The bone anchor consists
of a miniplate (M) with 2
or 3 holes, a round
connecting bar (C), and a
fixation unit (F) with a
blocking screw (5). The
miniplate is fixed to the
bone by self-tapping or
selfdrilling screws. The
fixation unit contains 2
slots with a diameter of
0.045" (1.1mm). A
square connecting wire
with a maximum size of
0.032x0.032" can be
inserted and tightly fixed
by the blocking
screw.
The Bollard miniplates
are also offered with a
hook. The Bollard with
hook is smaller than the
original model and
contains a tube with
section 0.020"x0.020".
The hook can affix
directly to elastics or coil
springs
The subject devices are
used with standard
instrumentation for
orthodontic surgery
including pliers,
punches, screwdrivers,
burrs, and grasping or
holding instruments. | | | |
| | | | | | |
| Indications for use | The subject devices are
intended to be place in the | The subject devices are
intended to be placed in | Orthodontic tooth-
moving procedures where | The Orthodontic Bone
Anchor (OBA) System is | Same |
| | mouth for use as an
anchor in orthodontic
procedures. | the mouth for use as an
anchor in orthodontic
procedures. | maximum stability is
required
• Patients in their
permanent dentition
• Patients where dental
fixation is not possible
(tooth or alveolar loss,
trauma) | indicated for intrusion and
extrusion of teeth, distal
and mesial movement of
teeth, treatment of
anterior cross bite and
open bite, space closure,
3-D control of teeth. | |
| Raw material | ASTM F67
ASTM F136-02a | Pure titanium | F67 grade 2 titanium | ASTM-F67 grade 4
ASTM-R136-02a | Same |
| Design | T-Type
Image: T-Type | The Bollard
Image: The Bollard | C-tube plates
Image: C-tube plates | Mesh plate anchor
Image: Mesh plate anchor | Different.
In clinical application
literature, different shapes
of the plates are described in
the literature as following; |
| | Image: I-Type | The Bollard with hook
Image: The Bollard with hook | Image: Hook plates | Image: Mesh plate anchor | L-shaped, T-shaped, Y-
shaped, I-shaped rectangular
or triangular comprising 2,
or 5 holes for screw
fixation.(Reference 1-5)
Also, some articles studied
the influence of the shape of
the bone plate, but it didn't
seem to be a significant
factor for
success.(Reference 1) |
| | Image: I-Type | | | | Finally, the variations in
shape mean that the surgeon
can select the most
appropriate anchor plate
according to the bone
contour of the implantation
site. Therefore, its minor |
6. Comparison of technological characteristics with the predicate device
7
8
9
10
Image /page/10/Picture/0 description: This image shows different types of surgical plates. The plates are labeled as Y-Type, W-Type, BH-UR-19 Y, C-palatal Plate, Bondable surface plates, Bracket Plate anchor, and Domed plate anchor. The bracket plate anchor has 4-hole and 5-hole variations.
11
| Intended Use | The subject devices are
intended to be place in the
mouth for use as an
anchor in orthodontic
procedures. | | In cases of dental
regulations a C-tube
(Chung's
microplate with tube) can
be fixed in the lateral part
of the maxilla or
mandible. The eyelet will
remain
in the buccal sulcus and
serves to hold the dental
arch wire.
The KLS-Martin Ortho
Anchorage System is
intended to be surgically
placed in the mouth for
use as an anchor for
orthodontic procedures. | The Orthodontic Bone
Anchor(OBA) System is
intended to be implanted
intraorally and used as an
anchor for orthodontic
procedures. | Similar |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions(unit:mm) | Thickness : 0.8/ 1
Length : 13.35 - 40.35 | Not Listed | Thickness : 0.6/1.0/1.5 | Not Listed | Similar.
As literature (Reference 6)
C-tube plate, 0.66 of
dimension and 14.0 of
length, were used. and
Synthes OBA domed design |
| | | | | | 4 holes, 0.76 of thickness
and 13.5 of length, were
used. |
| | | | | | Generally, Anchor plate was
selected according to the
distance between the
implantation site and the
dentition by professional. |
| Surface Treatment | Machined | Machined | Machined | Not Listed | Same |
| Sterilization | Provided as non-sterile,
needs autoclave prior to
use.
· Temperature : 121 °C
· Exposure time : 30 min
· Dry time : 15 min | Gamma Radiation
ISO 11137-1 | Not Listed | Provided as non-sterile,
needs autoclave prior to
use.
Thermal disinfect at 93°C
for minimum of 2 minutes
and 30 seconds. | Same |
| Usage | Single use Only | Single use Only | Not Listed | Single use Only | Same |
| Biocompatibility | Device is biocompatible
when used as directed by
dental professionals per
ISO 10993-1. | Device is biocompatible
when used as directed by
dental professionals per
ISO 10993-1. | Device is biocompatible
when used as directed by
dental professionals per
ISO 10993-1. | Device is biocompatible
when used as directed by
dental professionals per
ISO 10993-1. | Same |
| mechanical properties | Bending strength (Avg.,
N·mm): 102.428
Tensile force (Avg., N):
301.814 | Bending strength (Avg.,
N·mm): 97.125
Tensile force (Avg., N):
176.782 | Not Listed | Not Listed | Different.
Mechanical and physical
properties of subject device
are compared with primary
predicate device where
details method, apparatus
and results can be found in |
12
13
| | the test report (Bench test
report (subject device VS |
|--|----------------------------------------------------------|
| | predicate device). Since |
| | there is no unknown |
| | standard for performance, |
| | the results showed that the |
| | properties considered were |
| | similar when used for |
| | intended use. |
The subject device is similar to predicate device in terms of indication for use, design, raw material etc.
The subject device consists of orthodontic anchorage system, as is the mechanical properties and performance of subject device are not significantly from the predicate device, as indicated by non-clinical performance testing.
The shape, dimension and mechanical properties are different between the primary predicate device. But the variations in shape or dimension mean that the surgeon can select the most according to the bone contour or distance of the implantation site by professional. Also, in terms of mechanical properties, these differences are not significantly difference on its intended use or performance. Therefore, its minor deviation is acceptable for clinical application.
14
7. Performance Data(Non-Clinical)
The test such as appearance, dimension and bending strength is to verify the performance of the device as it designed. Bending strength was performed according to ISO 9585. All of test results obtained from these tests indicated that Anchor Plate is substantially equivalent to the predicate device in terms of mechanical properties and performance.
The biocompatibility evaluation for the Anchor Plate was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1:Evaluation and Testing" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The device of testing included the following tests:
- . Genotoxicity, ISO 10993-3(2014)
- Cytotoxicity, ISO 10993-5(2009)
- Implantation, ISO 10993-6(2007)
- Sensitization(GPMT), ISO 10993-10(2010)
- Oral mucous irritation / Intracutaneous reactivity, ISO 10993-10(2010)
- . Systemic toxicity(Acute), ISO 10993-11(2006)
Anchor Plate and the primary predicate device were tested for the non-clinical performance including Pullout force with 3-point bending test according to JS T 0312:2008, Testing methods for bending properties of metallic osteosynthesis devices and tensile force test. For tensile force test, there is no international standard or required guidance, therefore it is performed according to own test method. The results showed that the subject and predicate devices are fundamency. Based on the comparative data, subject devices are essentially the same as currently marketed devices for the same indication, with similar physical properties or design, which supports our claim for substantial equivalence. Anchor plate shows no differences in technological characteristics compared to the predicate devices.
8. Substantial Equivalence Discussion
The subject device is similar to predicate device in terms of indication for use, design, raw material etc.
The subject device consists of orthodontic anchorage system, as is the predicate device. The mechanical properties and performance of subject device are not significantly different from the predicate device, as indicated by non-clinical performance testing.
The length and thickness are different between subject device and predicate device.
9. Conclusions
The indications and technological characteristics of anchor plate are very similar to predicate device. Therefore, anchor plate is substantially equivalent to the identified predicate device.