(380 days)
The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.
The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes.
The provided document describes the BIO-RAY A-1 Anchor Screw System, an orthodontic mini-screw, and its substantial equivalence to predicate devices. The document explicitly states that clinical studies were determined to be not required to support substantial equivalence. Therefore, the information regarding acceptance criteria and study design elements related to clinical performance (such as sample size for test set, data provenance, expert ground truth, adjudication methods, MRMC studies, effect size, and standalone algorithm performance) is not available or applicable in this context.
The acceptance criteria and the study that proves the device meets them are based on non-clinical performance (bench testing, biocompatibility, and sterilization validation).
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance and Acceptance |
|---|---|---|
| Bench Performance | Self-tapping per ASTM F543 | Met (Substantially equivalent to predicate) |
| Torsional per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Axial pullout per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Driving torque per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Shear loading per ASTM F543 | Met (Substantially equivalent to predicate) | |
| Biocompatibility | Cytotoxicity per ISO 10933-5 | Met (Mitigated risks) |
| Sensitization per ISO 10933-10 | Met (Mitigated risks) | |
| Intracutaneous Reactivity per ISO 10933-10 | Met (Mitigated risks) | |
| Acute Systemic Toxicity per ISO 10933-11 | Met (Mitigated risks) | |
| Material-Mediated Pyrogenicity per USP39/NF34(151) | Met (Mitigated risks) | |
| Implantation per ISO 10993-6 | Met (Mitigated risks) | |
| Sterilization Validation | Sterilization validation per ISO 17665-1 | Met |
2. Sample size used for the test set and the data provenance:
Not applicable as no clinical test set was used. The non-clinical tests were conducted on device samples. The provenance of these samples is the manufacturer, Microware Precision Co., Ltd. in Taiwan. The tests are prospective in nature, as they are conducted for regulatory clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical test set requiring expert ground truth was used. Ground truth for non-clinical tests is established by adhering to the standards (e.g., ASTM, ISO, USP) and the results obtained from standardized testing methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was used.
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 device is a medical implant, not an AI-assisted diagnostic or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a medical implant, not an AI algorithm.
7. The type of ground truth used:
For non-clinical performance, the "ground truth" is defined by the established industry standards (e.g., ASTM F543 for mechanical properties, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization) and the expected performance thresholds specified within those standards or internal specifications derived from predicate device performance.
8. The sample size for the training set:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable as this is a physical device, not an AI algorithm that requires a training set.
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November 6, 2019
Microware Precision Co., Ltd. Harrison Du General Manager No. 12, Keyuan 2nd Rd., Situn District Taichung, 40763 TAIWAN
Re: K182929
Trade/Device Name: BIO-RAY A-1 Anchor Screw System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: October 7, 2019 Received: October 8, 2019
Dear Harrison Du:
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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182929
Device Name
BIO-RAY A-1 Anchor Screw System
Indications for Use (Describe)
The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended after orthodontic treatment has been completed. The screw is intended for single use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Submitter's Name: Microware Precision Co., Ltd. Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Tel: +886-4-24636275 # 100 Fax: +886-4-24636276
Contact Name: Harrison Du
Preparation date: Nov 06, 2019
Registration Number: 3007738812
Device Name: BIO-RAY A-1 Anchor Screw System
Common Name: Orthodontic Screws
Classification Name: Class II, Sec. 872.3640 Endosseous dental implant
Product Code: OAT
Predicate Device Information:
| Primary device: | Syntec Orthodontic Mini Screws (K090476) |
|---|---|
| Reference device: | Storm Mini Screw (K122069) |
| Absoanchor Microimplant (K060126) | |
| Lin/Liou Orthodontic Mini Anchor System (Lomas) (K050257) | |
| Tandry Locking Plate System (K171904) |
Device Description:
The BIO-RAY A-1 Anchor Screw System is made of stainless steel 316L (ASTM F138) and titanium alloy Ti-6Al-4V (ASTM F136). Electrolytic polishing is for surface treatment of stainless steel screws and anodizing is for surface treatment of Ti-6Al-4V screws. There is a self-drilling and self-tapping feature in the screw tip for insertion and removal . The screw head designs include a mushroom, hook, or none head feature for attachment to orthodontic appliances. The screws are available in various configurations, shapes and sizes as follows;
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| Model | A-1C | A-1P | A-1PL | A-1C IZC | |||
|---|---|---|---|---|---|---|---|
| Material | Stainless steelTi-6Al-4V | Stainless steelTi-6Al-4V | Stainless steelTi-6Al-4V | Stainless steelTi-6Al-4V | |||
| Head type | Small Mushroom | StandardMushroom | StandardMushroom | Small Mushroom | |||
| OrthodonticAppliance | Coil Spring | Elastic Chain orRubber Band | Elastic Chain orRubber Band | Elastic Chain orRubber Band | |||
| Diameter(mm) | 1.5 | 2.0 | 1.5 | 2.0 | 1.5 | 2.0 | 2.0 |
| Length(mm) | 8-12 | 8-17 | 8-12 | 8-17 | 8-12 | 8-17 | 14, 17 |
| Model | A-1P IZC | A-1H | A-1DH | A-1N |
|---|---|---|---|---|
| Material | Stainless steelTi-6Al-4V | Stainless steelTi-6Al-4V | Stainless steelTi-6Al-4V | Stainless steelTi-6Al-4V |
| Head type | StandardMushroom | Hook | Double Hook | None Head |
| OrthodonticAppliance | Elastic Chain orRubber Band | Coil Spring, ElasticChain or RubberBand | Coil Spring, ElasticChain or RubberBand | None |
| Diameter(mm) | 1.52.0 | 1.52.0 | 1.52.0 | 1.52.0 |
| Length(mm) | 1414, 17 | 8-128-17 | 8-128-17 | 8-128-17 |
Indication for use:
The BIO-RAY A-1 Anchor Screw System is intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It's used temporarily and intended to be removed after orthodontic treatment has been completed. The screw is intended for single use only.
Technological Characteristics:
The BIO-RAY A-1 Anchor Screw System is similar to the predicate devices in features including indication for use, materials, dimensions, surface treatment, and sterilization as shown in Table 1 below.
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Summary of Performance Data (Nonclinical and/or Clinical)
Clinical Performance
Clinical studies were determined to be not required to support substantial equivalence.
Non-Clinical Performance
-
Bench Performance Tests
The bench performance tests per ASTM F543 were conducted to determine substantial equivalence for the BIO-RAY A-1 Anchor Screw System. These tests included self-tapping, torsional, axial pullout, driving torque, and shear loading. Results indicate that the mechanical properties and performance of the proposed device are substantially equivalent to the predicate device. -
Biocompatibility
The proposed device is manufactured from stainless steel (ASTM F138) and titanium alloy ASTM F136). Cytotoxicity per ISO 10933-5, Sensitization and Intracutaneous Reactivity per ISO 10933-10, Acute Systemic Toxicity per ISO 10933-11, Material-Mediated Pyrogenicity per USP39/NF34(151), and Implantation per ISO 10993-6 were performed to mitigate the risks associated with materials used during manufacturing. -
Sterilization Validation
The sterilization validation was performed in according with the ISO 17665-1. The test results show that the acceptance criteria are met. -
The BIO-RAY A-1 Anchor Screw System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of the BIO-RAY A-1 Anchor Screw System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
Summary of Substantial Equivalence:
The BIO-RAY A-1 Anchor Screw System is substantially equivalent to the predicated devices. Results of non-clinical tests show substantial equivalence to the legally marketed predicate device, and indicate that the device will perform adequately for its intended use.
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| Table 1 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Proposed device | Primary predicatedevice | Reference predicatedevice | Reference predicatedevice | Reference predicatedevice | SE? | |||
| Device Name | Microware BIO-RAY A-1Anchor Screw System | Syntec OrthodonticMini Screws | ABSOANCHORMICROIMPLANT | STORM MINI SCREW | Lin/Liou OrthodonticMini Anchor System(Lomas) | NA | ||
| 510K Number | K182929 | K090476 | K060126 | K122069 | K050257 | NA | ||
| Trade Name | BIO-RAY A-1 | Syntec | DENTOS INC. | LANCERORTHODONTICS, INC. | MONDEAL MEDICALSYSTEMS GMBH | NA | ||
| Indication for Use | The BIO-RAY A-1 AnchorScrew System isintended to providefixed anchorage forattachment oforthodontic appliancesintended to facilitatethe orthodonticmovement of teeth. It'sused temporarily andintended to be removedafter orthodontictreatment has beencompleted. The screw isintended for single useonly. | The screws are intendedto provide fixedanchorage forattachment oforthodontic appliancesintended to facilitatethe orthodonticmovement of teeth.They are usedtemporarily and areintended to be removedafter orthodontictreatment has beencompleted. The screwsare intended for singleuse only. | The intended purpose ofthe AbsoAnchorMicroimplant is toprovide a fixedanchorage point forattachment oforthodontic appliancesto facilitate theorthodontic movementof teeth. | The Storm Mini Screw isa threaded titaniumdental implant screwintended to provide afixed anchorage pointfor the attachment oforthodontic appliancesand facilitate theorthodontic movementof teeth. It is usedtemporarily and must beremoved afterorthodontic treatmenthas been completed.The Storm Mini Screw isprovided sterile and isintended for single useonly. | The Lin/LiouOrthodontic MiniAnchor System (LOMAS)(Sterile) is intended toprovide a fixedanchorage point forattachment oforthodontic appliancesto facilitate theorthodontic movementof teeth. The device isused temporarily and isremoved afterorthodontic treatmenthas been completed.Screws are intended forsingle use only. | Yes |
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| Materials | SUS 316L: ASTM F138(Refer to Appendix I-Cert No:1210052459000020 01) | SUS 316L: ASTM F138 | Titanium Alloy: ASTMF136 | Titanium Alloy: ASTMF136 | Titanium Alloy: ASTMF136 | Yes |
|---|---|---|---|---|---|---|
| Titanium Alloy: ASTMF136 | Titanium Alloy: ASTMF136 | |||||
| Screw thread diameter:1.5 and 2.0mm | Screw thread diameter:1.3, 1.4, 1.5 and 2.0mm | Screw thread diameter:1.2-1.8mm | Screw thread diameter:1.5 and 2.0mm | Screw thread diameter:1.5, 2.0, and 2.3mm | ||
| Dimensions | Screw length:8, 9, 10, 11, 12, 13, 14,15, 16 and 17mm | Screw length:5, 6, 7, 8, 9, 10, 11, 12,13, 14, 15, 16 and17mm | Screw length:4-10mm & 12mm | Screw length:8.0 and 10.0mm | Screw length:7, 9, 11mm | Yes |
| Screw HeadDesign | 1. Hook Type (A-1H)2. Double Hook Type (A-1DH)3. None Head Type (A-1N)4. Standard MushroomType (A-1P)5. Small Mushroom Type(A-1C) | 1. --2. --3. --4. Type I, II5. Type I, II | 1. Hook Head Type (HH)2. Bracket Head Type(BH)3. No Head Type (NH)4. Fixation Head Type(FH)5. Small Head Type (SH) | 1. --2. Storm Mini-Screw3. --4. --5.-- | 1. Hook Screw2. QUATTRO Screw3. —4. Standard Screw5. — | |
| Surface | 1.Stainlesssteel screws:Electrolyticpolishing2.Titanium alloyscrews:Anodizing | 1. Stainless steelscrews:Electrolyticpolishing2. Titanium alloyscrews:Anodizing | Titanium alloy screws:Anodizing | Titanium alloy screws:Anodizing | Titanium alloy screws:Anodizing | Yes |
| Sterilization | Non-sterilize. Steamsterilization before use | Non-sterilize. Steamsterilization before use | Non-sterilize. Steamsterilization before use | Sterile via betairradiation | Sterile | Yes |
5-6
§ 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.