(96 days)
Alpha Bio Orthodontic Fixation Screw System® are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
This submission (K063770) is for a dental device, specifically the Alpha-Bio Tec® Orthodontic Fixation Screw System. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized performance standards and material specifications, rather than clinical performance studies with acceptance criteria, ground truth, or human reader comparisons typically associated with AI/software devices.
Therefore, most of the requested information regarding acceptance criteria, study design elements (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment is not applicable to this type of device submission.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: No specific numerical "acceptance criteria" for clinical performance are stated in this document. Instead, acceptance is based on compliance with recognized standards and demonstration of substantial equivalence to a predicate device. The performance is assessed against these standards and the predicate.
- Reported Device Performance: The document states that "Safety and performance testing" was conducted and that "The Alpha-Bio Tec® System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues." However, the specific results of these performance tests are not detailed in this summary. Instead, compliance with the following standards is asserted:
| Acceptance Criteria (Compliance with Standards/Predicate) | Reported Device Performance (Claimed Compliance) |
|---|---|
| ISO 7405:1997 (Biocompatibility) | Complies |
| F136-02a: 2004 (Titanium Alloy Spec) | Complies |
| ASTM F1350-02 (Stainless Steel Wire Spec) | Complies |
| ISO 13402:1995 (Resistance against autoclaving, corrosion etc.) | Complies |
| UL 544 (1998) (Medical and Dental Equipment) | Complies |
| Substantial Equivalence to Osteomed Orthodontic Screw System L.P. (K031936) | Alpha-Bio Tec® is substantially equivalent in intended use, indications, technological characteristics, performance, and user interface. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This submission does not describe a "test set" in the context of a clinical performance study with patient data. The evaluation relies on laboratory testing against standards and comparison to a predicate device's established safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of "ground truth" is not established for this device, as it's not an AI/diagnostic software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for this device's acceptance is its physical and chemical properties meeting established engineering and biocompatibility standards, and its functional equivalence to a legally marketed predicate device.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable.
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| Alpha-Bio Tec03/06 | RA Department | FDA Traditional 510k | Page 29 of 33 | |
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בס"ד
510(K) SUMMARY
Alpha-Bio Tec® Orthodontic Fixation Screw System
510(k) Number K_________________
MAR 26 2007
| A. Applicant's Name: | Alpha-Bio Tec Ltd |
|---|---|
| 7, Embar st. | |
| Industrial Zone Kiryat Arie | |
| POB 3936 ZIP 49130 | |
| Petach-Tikva, Israel | |
| Tel: +972-3-9291000 / 9390668 | |
| Fax: +972-3-9235055 | |
| e-mail: ophir@alpha-bio.net; Daniela@alpha-bio.net | |
| Web site: www.alpha-bio.net | |
| B. Contact Person: | Daniela Ben Shabat |
| Alpha-Bio Tec Ltd | |
| 7, Embar st. | |
| Industrial Zone Kiryat Arie | |
| POB 3936 ZIP 49130 | |
| Petach-Tikva, Israel | |
| Tel: +972-3-9291000 / 9390668 | |
| Fax: +972-3-9235055 | |
| e-mail: Daniela@alpha-bio.net | |
| Web site: www.alpha-bio.net | |
| C. Date Prepared: | March 2006 |
| D. Trade Name: | Alpha-Bio Tec® |
| E. Classification: | Name: implant, endosseous, root-form |
| Product Code: DZE | |
| Regulation No: 872.3640 | |
| Class: II | |
| Panel: Dental |
F. Predicate Devices: The Alpha Bio Orthodontic Fixation Screw System ® is substantially equivalent to Osteomed Orthodontic Screw System L.P. K031936 in terms of intended use, indications for use, technological characteristics, performance and user interface.
The predicate device is Class II medical devices.
.
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| Alpha-Bio Tec03/06 | RA Department |
|---|---|
| FDA Traditional 510k | Page 30 of 33 |
Alpha Bio
A discussion of substantial equivalence is provided in Section 3 of this submission.
- G. Device Description: Alpha Bio Orthodontic Fixation Screw System® OFS, OFSR consists of titanium alloy Gr-5 mini thread self tapping implants, are available with 1.6 and 2mm diameter and 8, 10, 12 length.
- H. Intended Use / Indication for Use: Alpha Bio Orthodontic Fixation Screw System (OFS, OFSR) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
- I. Performance Standards: No performance standards have been established for such devices under Section 514 of the Federal Food, Drug, and Cosmetic Act.
The device complies with the following recognized standards:
- . ISO 7405:1997, Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental
- . F136-02a: 2004 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (ÜNS R56401).
- . ASTM F1350-02, 2002 Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673).
- ISO 13402:1995, Surgical and dental hand instruments -� - Determination of resistance against autoclaving, corrosion and thermal exposure.
- . UL 544 (1998):, Standard for Medical and Dental Equipment - Ed. 4.0.
- J. Substantial Equivalence: There are no unique applications, indications, materials or specifications presented below. Evidence of equivalence has been demonstrated through:
- · The Alpha-Bio Tec® intended use and indications for use were previously cleared by FDA for the predicate device.
- · The technical characteristics of the Alpha-Bio Tec® are similar to those of the predicate device.
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| Alpha-Bio Tec03/06 | RA Department |
|---|---|
| FDA Traditional 510k | Page 31 of 33 |
- · Safety and performance testing.
Therefore, the Alpha-Bio Tec® System is substantially equivalent to its predicate devices as cited above and raises no new safety and/or effectiveness issues.
:
. . . . . . .
.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alpha-Bio Tec Limited C/O Mr. Daniel J. Manelli Attorney Manelli & Fisher, P.L.L.C. 5335 Wisconsin Avenue, NW Suite 440 Washington, DC 20015
MAR 2 6 2007
Re: K063770
Trade/Device Name: The Alpha Bio Tec® Orthodontic Fixation Screw System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: March 22, 2007 Received: March 23, 2007
Dear Mr. Manelli:
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. Manelli
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 (OS) 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,
Clair Lise, Ph.D.
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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| Alpha-Bio Teq03/06 | RA Department | FDA Traditional 510k | Page 33 of 33 |
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בס"ד
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: The Alpha Bio Tec® Orthodontic Fixation Screw System
Indications for Use:
Indication for use :-
Alpha Bio Orthodontic Fixation Screw System® are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Susan Runge
an agn-Off) Asian of Anesthesiology, General Hospital, in rotion Control, Dental Devices
5 : 0(k) Number: _____________________________________________________________________________________________________________________________________________________________
§ 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.