(123 days)
The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.
The provided text describes a 510(k) submission for the "FIXTURE ORIGINAL" endosseous implant. However, it does not include detailed acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the way typically expected for performance-based medical device submissions.
Instead, this submission primarily relies on substantial equivalence to a predicate device (Nobel Biocare AB standard fixture RP with a diameter of 3.75 mm). The core argument is that because the FIXTURE ORIGINAL is similar in material, dimensions, and intended use to the predicate device, further testing "will not raise new issues of safety and efficacy."
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly defined with specific metrics) | The submission argues that due to substantial equivalence in material, dimensions, and intended use to the predicate device, the FIXTURE ORIGINAL performs similarly. The predicate device (Nobel Biocare Standard Fixture) is indicated "To be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patients chewing function." The FIXTURE ORIGINAL has an identical intended use statement. |
- Explanation: The document does not define specific performance acceptance criteria (e.g., minimum tensile strength, fatigue life, osseointegration rates, etc.) for the FIXTURE ORIGINAL itself, nor does it present specific performance data against such criteria. The entire premise of the submission is that the device's characteristics are so similar to a legally marketed predicate that specific new performance testing is deemed unnecessary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. The submission relies on substantial equivalence and does not describe a new performance test set for the FIXTURE ORIGINAL.
- Data Provenance: Not applicable / Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No new test set or ground truth determination described for the FIXTURE ORIGINAL.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No new test set or ground truth determination described.
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
- MRMC Study: No. This is a submission for an endosseous implant, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable for the FIXTURE ORIGINAL itself in this submission. The "ground truth" for the submission's argument is the established safety and effectiveness of the predicate device based on its existing regulatory clearance.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of the Submission's Approach:
The K021355 submission for the Brånemark Integration AB FIXTURE ORIGINAL relies entirely on demonstrating substantial equivalence to a previously cleared predicate device (Nobel Biocare Standard Fixture, K925765). The argument is built on the following points:
- Identical Intended Use: Both devices share the same intended use for permanent anchorage of prosthetic devices and restoring chewing function.
- Similar Dimensions: The FIXTURE ORIGINAL's dimensions (diameter 3.75mm, length 8.5-15mm) fall within the range of the predicate device (diameter 3.75mm, length 7-20mm).
- Similar Material: Although not explicitly stated as "identical material" in the provided text, the phrase "substantially equivalent to Nobel Biocare Standard Fixture in material, dimensions, and intended use" strongly implies material similarity.
- Previous Testing of Predicate: The submission refers to existing "mechanical testing requested for Screw-type Endosseous Implants as described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996," completed for the predicate device.
The conclusion drawn by Brånemark Integration AB is that "further testing will not raise new issues of safety and efficacy" because of this substantial equivalence. The FDA concurred with this assessment, granting 510(k) clearance based on this argument, not on new performance data for the FIXTURE ORIGINAL.
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SECTION 2. SUMMARY AND CERTIFICATION
A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the Brånemark Integration AB summary for the FIXTURE ORIGINAL.
| SUBMITTER'S NAME: | Brånemark Integration AB |
|---|---|
| ADDRESS: | Lilla Bommen 1, SE-411 04 Göteborg, Sweden |
| CONTACT PERSON: | Rickard Brånemark |
| TELEPHONE NUMBER: | +46 (0)31 7601060 |
| FAX NUMBER: | +46 (0)31 155260 |
| DATE OF SUBMISSION: | April 22, 2002 |
1. Identification of device
Proprietary Name: Endosseous Implant Common Name: FIXTURE ORIGINAL Classification Status: Class III per regulations 872.3640 Product Codes: DZE
2. Equivalent devices
Brånemark Integration AB believes the FIXTURE ORIGINAL is substantially equivalent to Nobel Biocare AB standard fixture RP with a diameter of 3,75 mm.
3. Description of the Device
The FIXTURE ORIGINAL consists of 4 implants, diameter 3,75 mm, and length from 8,5 to 15 mm.
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Intended use 4.
The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
Technological characteristics, comparison to predicate device. 5.
Like the predicate devices, the FIXTURE ORIGINAL is intended to restore masticator function.
| Characteristic | Nobel Biocare Standard Fixture | Brånemarsk Integration AB FIXTURE ORIGINAL |
|---|---|---|
| Indication for use | To be placed in the upper or lowerjaw to support prosthetic devices,such as artificial teeth, and to restorea patients chewing function. | The Brånemark Integration AB FixtureOriginal is intended for surgical placementinto the bone of upper /lower jaw arches as apermanent anchorage for prosthetic devicesand to restore chewing function. |
| Dimensions | Diameter 3,75 mm,Length 7-20 mm | Diameter 3,75 mmLength 8,5-15 mm |
| 510(k) | K925765 | No number yet |
Comparison table
Discussion of performance testing. 6.
Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline "Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants", dated December 9, 1996.
Brånemark Integration AB, FIXTURE ORIGINAL is substantially equivalent to Nobel Biocare Standard Fixture in material, dimensions, and intended use why we have come to the conclusion that further testing will not raise new issues of safety and efficacy.
Please see section 5, Part B Performance Testing.
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Conclusion 7.
Based on comparison to the predicate device, the Brånemark Integration AB, FIXTURE ORIGINAL, is substantially equivalent to previously cleared Nobel Biocare AB and presents no new concerns about safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2002
Dr. Richard Branemark President Branemark Integration AB Lilla Bommen 1, 11 tr SE-411 04 Goteborg, SWEDEN
Re: K021355
Trade/Device Name: Fixture Original Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 5, 2002 Received: August 7, 2002
Dear Mr. Branemark:
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.
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.
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Page 2 - Dr. Branemark
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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《021355
Page 1 of 1
B. INDICATIONS FOR USE
510(k) Number
Device Name: Brånemark Integration AB, FIXTURE ORIGINAL.
Indications for Use:
The Brånemark Integration AB, FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| ------------------ | --- |
OR
Over the Counter Use
(Per 21 CFR 801.109)
Suna Runa
esthesiology, General Hospital. Infection Control. De
510(k) Number: K051235
§ 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.