(10 days)
An orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.
The BioMers Translucent Orthodontic Wire is a translucent arch wire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases theabrasion resistance properties of the wire.
The provided text describes a 510(k) submission for the BioMers Translucent Orthodontic Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance criteria for safety and effectiveness through extensive human studies. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test/training sets, expert ground truth establishment, and adjudication methods is not typically part of a 510(k) summary for this type of device.
The submission relies on bench testing against established industry standards to demonstrate that the new device has comparable technical characteristics to the predicate device and does not raise new questions of safety or effectiveness.
Here's an attempt to answer the questions based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with numerical targets and direct reported device performance against those targets. Instead, it indicates that the device was "designed and tested using the following standards" to assess its technical characteristics. The acceptance criteria are implicitly met if the device's performance, when tested according to these standards, is comparable to or deemed safe and effective given the predicate devices.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Implied by Substantial Equivalence Claim) |
|---|---|
| Flexural Properties: Compliance with ASTM D 790-03 (Standard test methods for flexural properties of unreinforced and reinforced plastics and electrical insulating materials) | The BioMers Translucent Orthodontic Wire was designed and tested using ASTM D 790-03, implying its flexural properties are acceptable and comparable to predicate devices. The document states "no known substantial differences... and any differences in technological characteristics do not raise issues of safety and effectiveness." |
| Tensile Properties: Compliance with ASTM D 3916-02 (Standard test method for tensile properties of pultruded glass fiber reinforced plastic rods) | The BioMers Translucent Orthodontic Wire was designed and tested using ASTM D 3916-02, implying its tensile properties are acceptable and comparable to predicate devices. |
| Water Absorption: Compliance with ASTM D 570-98 (Reapproved 2005) (Standard test method for water absorption of plastics) | The BioMers Translucent Orthodontic Wire was designed and tested using ASTM D 570-98, implying its water absorption characteristics are acceptable and comparable to predicate devices within the oral environment. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the "test set" in terms of clinical or human data. The testing mentioned refers to bench testing against engineering standards. Therefore, concepts like country of origin for clinical data or retrospective/prospective study design are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the submission relies on bench testing against engineering standards rather than expert-derived ground truth from clinical or image-based data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the submission relies on bench testing against engineering standards, not an adjudicated test set.
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
There is no mention of an MRMC comparative effectiveness study, nor is "AI" or "human readers" relevant to this device's submission. This is a physical orthodontic wire, not a diagnostic or AI-driven tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical orthodontic wire and does not involve an "algorithm" or standalone software performance in the way described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by its compliance with the technical specifications and performance characteristics outlined in the referenced ASTM standards. This is a materials science/engineering-based ground truth, not a clinical or expert-consensus ground truth. The primary ground for acceptance is substantial equivalence to legally marketed predicate devices, supported by bench test data.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is not an AI/ML algorithm requiring a training set.
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K08//43
SioMers
We Make You Smile
MAY - 2 2008
510(k) Summary (per 21 CFR 807.92)
- I. Applicant BioMers Products, LLC. 2316 Pine Ridge Road, Suite 459 Naples, FL, 34109
Contact Person: George Aliphtiras, Vice President of Operations Tel: (239) 776-6344 Fax: (239) 213-0062 Email: george(a)biomersbraces.com
Date Prepared: December 19, 2007
II. Device Name
| Proprietary Name: | BioMers Translucent Orthodontic Wire |
|---|---|
| Common/ Usual Name: | Orthodontic wire |
| Classification Name: | Orthodontic appliance and accessories |
| Regulation Number: | 872.5410 |
| Product Codes: | DZC |
| Classification: | I |
| Classification Panel: | Dental |
III. Predicate Device
The BioMers Translucent Orthodontic Wire is substantially equivalent to the Optiflex from Ormco Corp. and the Super Elastic Nickel Titanium Arch Wire from Acme Monaco Corp. The Optiflex was cleared by the FDA on September 15, 1989 under 510(k) K894781. The Super Elastic Nickel Titanium Arch Wire is exempt from 510(k) filings.
IV. Intended Use of the Device
The BioMers Translucent Orthodontic Wire is indicated for use as an orthodontic arch wire to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment.
V. Description of the Device
The BioMers Translucent Orthodontic Wire is a translucent arch wire comprised of glass fibers, a polymer composite resin, and a polymer coating. The embedded glass fibers function as the reinforcement, providing the necessary force to straighten teeth. The translucent polymer composite resin serves as the matrix, binding together the individual glass fibers. The outer coating, made of a USP Class VI polycrystalline and amorphous linear polymer, increases theabrasion resistance properties of the wire.
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SioMers
Me Make You Smile
VI. Summary of the Technical Characteristics
The BioMers Translucent Orthodontic Wire is an orthodontic arch wire used to provide force to the teeth to effect movement in the early (leveling and aligning) stage of orthodontic treatment. The BioMers Translucent Orthodontic Wire was designed and tested using the following standards:
- ASTM D 790 03 Standard test methods for flexural properties of . unreinforced and reinforced plastics and electrical insulating materials
- . ASTM D 3916 - 02 Standard test method for tensile properties of pultruded glass fiber reinforced plastic rods
- . ASTM D 570 - 98 (Reapproved 2005) Standard test method for water absorption of plastics
VII. Safety & Effectiveness
There are no known substantial differences between the BioMers Translucent Orthodontic Wire defined in this 510(k) submission and the predicate devices. They have the same intended use and any differences in technological characteristics do not raise issues of safety and effectiveness.
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Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
BioMers Products, LLC C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K081143
Trade/Device Name: BioMers Translucent Orthodontic Wire Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, DZC Dated: April 21, 2008 Received: April 22, 2008
Dear Mr. Lehtonen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Lehtonen
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Quitte Y. Michau Ous
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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BioMers
Be Malz Von Smile
4. Indication for Use Statement
510(k) Number (if known):
Device Name:
BioMers Translucent Orthodontic Wire
Indications for Use:
- An orthodontic arch wire used to provide force to the teeth to effect movement in . the early (leveling and aligning) stage of orthodontic treatment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Ruppe | |
|---|---|
| -- | ------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K081143 |
|---|---|
| ---------------- | --------- |
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§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.