(85 days)
The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.
The QuickBridge provisional components consist of a non-hexed titanium alloy cylinder and a PEEK Cap. The titanium cylinder threads onto Biomet 3i Conical Abutments that have a 4.8 mm margin diameter. The QuickBridge Cap is made of PEEK and snaps over the QuickBridge Cylinder to allow it to be picked up in a provisional bridge for an immediate load restoration.
This document is a 510(k) premarket notification for a medical device called "QuickBridge Cylinder and Cap" by Biomet 3i, Inc. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for the QuickBridge Cylinder and Cap. Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to a predicate device.
The reported "device performance" is not presented in quantitative metrics but rather by the successful completion of verification and validation activities under quality system design controls, leading to the conclusion of substantial equivalence.
| Item | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Design Control & Equivalence | Device design modifications completed under Quality System Design Controls (21 CFR 820.30). Appropriate verification and validation activities performed to ensure QuickBridge Cylinder and Cap remain substantially equivalent to the predicate (Certain Provide Temporary Cylinder, K061177). Modifications have not changed the intended use, altered fundamental scientific technology, or safety/effectiveness. | "The design modifications for the proposed QuickBridge Cylinder and Cap were completed under Quality System Design Controls in accordance with 21 CFR 820.30. Appropriate verification and validation activities were performed to provide assurance that QuickBridge Cylinder and Cap remain substantially equivalent to the predicate Provide Temporary Cylinder with the Provide Abutment, and the modifications have not changed the intended use, altered the fundamental scientific technology or the safety and effectiveness of the device." |
| Intended Use | The device is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in partially or fully edentulous patients, specifically for multiple unit prostheses for up to 180 days. | The stated Indications for Use in the submission and confirmed by the FDA: "The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical study or a test set in the conventional sense (e.g., a set of patient data or images). The evaluation relies on a comparison to a predicate device and engineering verification/validation activities. Therefore, there is no specific sample size mentioned for a test set, nor is there any information on data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission for certain types of dental accessories where functional equivalence and material specifications are the primary focus, rather than diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As there is no clinical or diagnostic "test set" and ground truth establishment in the context of diagnostic performance, this information is not provided. The "ground truth" for this device would relate to its engineering specifications, material properties, and functional performance, which are evaluated by Biomet 3i's internal quality system personnel.
4. Adjudication method for the test set
Not applicable. There is no clinical or diagnostic "test set" requiring adjudication by multiple experts.
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 dental implant accessory, not an AI-powered diagnostic tool, and therefore, an MRMC study is outside the scope of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical component, not an algorithm.
7. The type of ground truth used
For this type of device, the "ground truth" is established through:
- Engineering Specifications and Design Requirements: The device must meet predefined specifications for dimensions, material properties, mechanical integrity, and compatibility with other dental components.
- Performance Standards: Compliance with relevant industry standards for dental implants and accessories.
- Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device, as confirmed through verification and validation activities.
8. The sample size for the training set
Not applicable. This document describes a mechanical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this document.
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K07155
BOYET 31
AUG 3 0 2007
Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Biomet 3i, Inc.4555 RiversidePalm Beach Gardens, FL 33410 |
|---|---|
| Contact | Diana TaylorManager, Regulatory AffairsBiomet 3i, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6857Fax. 561-776-6852 |
| Date Prepared | June 5, 2007 |
| Device Name | QuickBridge™ Cylinder and Cap |
| Classification Name | Endosseous dental implant abutment |
| Device Classification | Class IIDental Devices Panel21 CFR § 872.3630 |
| Legally Marketed Predicate Devices | Certain Provide Temporary Cylinder, K061177, 5/16/06 |
| Device Description | The QuickBridge provisional components consist of a non-hexed titanium alloy cylinder and a PEEK Cap. Thetitanium cylinder threads onto Biomet 3i ConicalAbutments that have a 4.8 mm margin diameter. TheQuickBridge Cap is made of PEEK and snaps over theQuickBridge Cylinder to allow it to be picked up in aprovisional bridge for an immediate load restoration. |
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| Indications for Use | The QuickBridge System is intended to be mated withBIOMET 3i conical abutments for use as an accessory toendosseous dental implants to support a prosthetic device ina partially or fully edentulous patient. The QuickBridgeSystem is intended for use to support multiple unitprostheses in the mandible or maxilla for up to 180 daysduring endosseous and gingival healing. |
|---|---|
| Conclusion | The design modifications for the proposed QuickBridgeCylinder and Cap were completed under Quality SystemDesign Controls in accordance with 21 CFR 820.30.Appropriate verification and validation activities wereperformed to provide assurance that QuickBridge Cylinderand Cap remain substantially equivalent to the predicateProvide Temporary Cylinder with the Provide Abutment,and the modifications have not changed the intended use,altered the fundamental scientific technology or the safetyand effectiveness of the device. |
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diana Taylor Manager, Regulatory Affairs Biomet 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
AUG 3 0 2007
Re: K071551
Trade/Device Name: QuickBridge Cylinder and Cap Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 5, 2007 Received: June 6, 2007
Dear Ms. Taylor:
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 - Ms. Taylor
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Supa y. Michie Omd
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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Biomet 3i, Inc. Special 510(k) Premarket Notification - QuickBridge™
Indications for Use
510(k) Number (if known): K071551
Device Name: QuickBridge Cylinder and Cap
Indications for Use:
The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K071531 |
|---|---|
| ---------------- | --------- |
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)