(98 days)
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is intended for use in patients where orthodontic treatment has been completed. Screws are intended for single use only.
The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
This document is a 510(k) premarket notification for the "O.A.S.I. System" (Mini Screws) by Lancer Orthodontics. It seeks to establish substantial equivalence to a predicate device, the "Dual Top Anchor Systems Screws" by Jeil Medical Corporation (K033767).
Based on the provided text, a formal study demonstrating the device meets specific acceptance criteria is not included. The document's purpose is to show substantial equivalence to an existing legally marketed device, not to present a new clinical or performance study with defined acceptance criteria.
Therefore, many of the requested items cannot be extracted directly from this document because they pertain to a type of study that was not performed or detailed here. This submission relies on a comparison of technological characteristics to a predicate device rather than presenting novel performance testing data against specific acceptance criteria.
However, I can extract information related to the comparison of technological characteristics used to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
As no specific performance study with acceptance criteria is detailed in this 510(k) submission, a table of acceptance criteria and reported device performance cannot be generated. The submission's "performance" is based on its similarity to the predicate device in the following areas:
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (vs. Predicate) |
|---|---|
| Indications For Use | Similar / Equivalent |
| Target Population | Similar / Equivalent |
| Design | Similar / Equivalent |
| Materials (specifically Titanium Grade 5 (Ti6A14V)) | Similar / Equivalent (Predicate device's material not specified here, but similarity is claimed) |
| Sterility | Similar / Equivalent |
| Biocompatibility | Similar / Equivalent |
| Anatomical Sites Where Used | Similar / Equivalent |
| Standards Met | Similar / Equivalent |
Note: The "reported device performance" in this context refers to the technological characteristics being "similar and therefore equivalent" to the predicate device, which is the basis for 510(k) clearance.
The remaining requested items (2-9) are typically associated with a performance study designed to demonstrate a device meets specific clinical or analytical endpoints. Since this document is a 510(k) submission focused on substantial equivalence through comparison of technological characteristics, most of these details are not present.
Summary of what is not present in the provided document:
- 2. Sample size used for the test set and data provenance: No test set is described.
- 3. Number of experts used to establish the ground truth for the test set and qualifications: No test set or ground truth establishment is described.
- 4. Adjudication method for the test set: No test set or adjudication process is described.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- 7. The type of ground truth used: No specific ground truth is referenced for performance testing, as the equivalence is based on technological characteristics.
- 8. The sample size for the training set: Not applicable; there is no "training set" for this type of device submission.
- 9. How the ground truth for the training set was established: Not applicable.
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SEP 1 9 2005
Image /page/0/Picture/3 description: The image shows the logo for Lancer Orthodontics. The word "LANCER" is in large, bold, sans-serif font. Below it, in a smaller font, is the word "ORTHODONTICS". Above the word "LANCER" is a curved line that resembles a comet tail.
SUMMARY
Submitter's name: Address:
Phone: Fax number: Name of contact person: Lancer Orthodontics 253 Pawnee Street San Marcos, CA 92078 760-744-5585 760-744-5842 Grace Holland Requlatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
| Date the summary was prepared: | June 7, 2005 |
|---|---|
| Name of the device: | O.A.S.I. System |
| Trade or proprietary name: | O.A.S.I. System |
| Common or usual name: | Mini Screws |
| Classification name: | Endosseous dental implant |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Dual Top Anchor Systems Screws by Jeil Medical Corporation, Reference number K033767.
Description of the device:
The O.A.S.I. System consists of self tapering titanium grade 5 (Ti6A14V) screws,
Indications:
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
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Summary of the technological characteristics of our device compared to the predicate device:
The predicate Dual Top Anchor Systems Screws by Jeil Medical Corporation, K033767 and O.A.S.I. System microscrews were compared in the following areas and found to have similar technological characteristics and therefore to be equivalent.
Indications For Use Target Population Design Materials Sterility Biocompatibility Anatomical Sites Where Used Standards Met
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract symbol, possibly representing a human figure or a flame. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2005
Lancer Orthodontics, Inc. C/O Ms. Grace Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, California 92606
Re: K051552
Trade/Device Name: O.A.S.I. System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: August 24, 2005 Received: August 26, 2005
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to actives that the Act (Act) that do not require approval of a premarket the rederal I vou, Drug, and Ocennens , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condois provisions of the From Fion , 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 If your device is classified (boo as additional controls. Existing major regulations affecting (FMA), it may oc subject to Sach adam 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 - Ms. Holland
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualler of a substantial vith other requirements
mean that FDA has made a determination that your device complies with of connects mean that FDA has made a deceminations administered by other Federal agencies. of the Act of ally receital statutes and regaraters, including, but not limited to: registration You must comply with an the Act 8 requires (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 607), labeling (21 cms (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 12, of requirements as set form in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailing of substantial equivalence of your device to a premarket nothfication. The PDF maing or 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), If you desire specific advice for your de at (240) 276-0115. Also, please note the regulation please contact inc Other or Ochiphian promarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on consumer Assistance at its toll-free DIVIsion of Small Partier (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clive
St. Ives, 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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Indications for Use
510(k) Number (if known): 《OS 1552
Device Name: O.A.S.I. System
Indications For Use:
This device is intended to provide a fixed anchorage point for attachment of This device is intended to provide a mod antic movement of teeth. It is
orthodontic appliances to facilitate the orthodontic movement has heen orthodonlic appliances to faolikato the orthodontic treatment has been completed. Screws are intended for single us only.
AND/OR Over-The-Counter Use Prescription Use __ > (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
(Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Division Control, Dental Devi
510(k) Number:
Page 1 of 1
REGULATORY SPECIALISTS, INC.
§ 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.