Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical properties and materials of a physical screw system, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No.
The device facilitates orthodontic movement of teeth by providing fixed anchorage for orthodontic appliances, which is a structural or mechanical support function rather than a direct therapeutic one. It does not treat a disease or condition itself.

Diagnostic

No

The device is an anchor screw system designed to provide fixed anchorage for orthodontic appliances, facilitating tooth movement. It is a therapeutic device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states the device is made of stainless steel and titanium alloy, and describes physical features like self-drilling/tapping tips and various head designs. This indicates a physical hardware device, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the BIO-RAY A-1 Anchor Screw System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is to provide fixed anchorage for orthodontic appliances to facilitate tooth movement. This is a mechanical function performed directly on the patient's body.
Device Description: The device is a physical screw made of metal alloys, designed for insertion into bone.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The BIO-RAY A-1 Anchor Screw System does not interact with or analyze such specimens.

The device is a medical device used for a therapeutic purpose (orthodontic treatment), not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 after orthodontic treatment has been completed. The screw is intended for single use only.

Product codes

OAT

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.

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

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)

Clinical studies were determined to be not required to support substantial equivalence.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K090476

Reference Device(s)

K122069, K060126, K050257

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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.

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 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

2

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)

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:

Department of Health and Human Services Food and Drug 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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

3

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;

4

Model	A-1C	A-1P	A-1PL	A-1C IZC
Material	Stainless steel
Ti-6Al-4V	Stainless steel
Ti-6Al-4V	Stainless steel
Ti-6Al-4V	Stainless steel
Ti-6Al-4V
Head type	Small Mushroom	Standard
Mushroom	Standard
Mushroom	Small Mushroom
Orthodontic
Appliance	Coil Spring	Elastic Chain or
Rubber Band	Elastic Chain or
Rubber Band	Elastic Chain or
Rubber 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
Material	Stainless steel
Ti-6Al-4V	Stainless steel
Ti-6Al-4V	Stainless steel
Ti-6Al-4V	Stainless steel
Ti-6Al-4V
Head type	Standard
Mushroom	Hook	Double Hook	None Head
Orthodontic
Appliance	Elastic Chain or
Rubber Band	Coil Spring, Elastic
Chain or Rubber
Band	Coil Spring, Elastic
Chain or Rubber
Band	None
Diameter
(mm)	1.5
2.0	1.5
2.0	1.5
2.0	1.5
2.0
Length
(mm)	14
14, 17	8-12
8-17	8-12
8-17	8-12
8-17

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.

5

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.

6

Table 1
	Proposed device	Primary predicate
device	Reference predicate
device	Reference predicate
device	Reference predicate
device	SE
?
Device Name	Microware BIO-RAY A-1
Anchor Screw System	Syntec Orthodontic
Mini Screws	ABSOANCHOR
MICROIMPLANT	STORM MINI SCREW	Lin/Liou Orthodontic
Mini Anchor System
(Lomas)	NA
510K Number	K182929	K090476	K060126	K122069	K050257	NA
Trade Name	BIO-RAY A-1	Syntec	DENTOS INC.	LANCER
ORTHODONTICS, INC.	MONDEAL MEDICAL
SYSTEMS GMBH	NA
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.	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 intended purpose of
the AbsoAnchor
Microimplant is to
provide a fixed
anchorage point for
attachment of
orthodontic appliances
to facilitate the
orthodontic movement
of teeth.	The Storm Mini Screw is
a threaded titanium
dental implant screw
intended to provide a
fixed anchorage point
for the attachment of
orthodontic appliances
and facilitate the
orthodontic movement
of teeth. It is used
temporarily and must be
removed after
orthodontic treatment
has been completed.
The Storm Mini Screw is
provided sterile and is
intended for single use
only.	The Lin/Liou
Orthodontic Mini
Anchor System (LOMAS)
(Sterile) is intended to
provide a fixed
anchorage point for
attachment of
orthodontic appliances
to facilitate the
orthodontic movement
of teeth. The device is
used temporarily and is
removed after
orthodontic treatment
has been completed.
Screws are intended for
single use only.	Yes

7

| Materials | SUS 316L: ASTM F138
(Refer to Appendix I-
Cert No:
1210052459000020 01) | SUS 316L: ASTM F138 | Titanium Alloy: ASTM
F136 | Titanium Alloy: ASTM
F136 | Titanium Alloy: ASTM
F136 | Yes |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------------------|-----|
| | Titanium Alloy: ASTM
F136 | Titanium Alloy: ASTM
F136 | | | | |
| | 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 and
17mm | Screw length:
4-10mm & 12mm | Screw length:
8.0 and 10.0mm | Screw length:
7, 9, 11mm | Yes |
| Screw Head
Design | 1. Hook Type (A-1H)
2. Double Hook Type (A-
1DH)
3. None Head Type (A-
1N)
4. Standard Mushroom
Type (A-1P)
5. Small Mushroom Type
(A-1C) | 1. --
2. --
3. --
4. Type I, II
5. 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-Screw
3. --
4. --
5.-- | 1. Hook Screw
2. QUATTRO Screw
3. —
4. Standard Screw
5. — | |
| Surface | 1.
Stainless
steel screws:
Electrolytic
polishing
2.
Titanium alloy
screws:
Anodizing | 1. Stainless steel
screws:
Electrolytic
polishing
2. Titanium alloy
screws:
Anodizing | Titanium alloy screws:
Anodizing | Titanium alloy screws:
Anodizing | Titanium alloy screws:
Anodizing | Yes |
| Sterilization | Non-sterilize. Steam
sterilization before use | Non-sterilize. Steam
sterilization before use | Non-sterilize. Steam
sterilization before use | Sterile via beta
irradiation | Sterile | Yes |

5-6