(155 days)
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
The Straumann® CARES Screw-Retained Bridges and Bars ("SRBB") are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms (Figure 1). The purpose of this premarket notification is to expand the currently cleared abutment-to-implant interfaces to include the BLX implant system of the Straumann Dental Implant System (SDIS). The materials available include coron and titanium.
SRBB devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e., they are designed by a dental professional (clinician or dental technician) and fabricated by Straumann specifically for an individual patient.
SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Straumann® CARES® Visual software includes the ability to generate digital restoration models incorporating the subject devices as well as the predicate devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)techniques.
The provided document is a 510(k) Premarket Notification for the Straumann® CARES® Screw-Retained Bridges and Bars. The purpose of the submission is to expand the cleared abutment-to-implant interfaces to include the BLX implant system. This document does not describe an AI/ML-enabled device or a study involving human readers or expert consensus for ground truth. Instead, it describes a dental device and its performance is evaluated through bench studies, software validation, sterilization validation, and biocompatibility testing.
Therefore, many of the specific details requested in your prompt (e.g., acceptance criteria for AI performance, sample size for test set with data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable to this document as it pertains to a physical dental device, not an AI/ML system.
However, I can extract information related to the performance data and the conclusion about substantial equivalence.
Here's what can be extracted and inferred based on the document:
1. Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria in a table format for this specific 510(k) submission's tests. Instead, it states that the device's substantial equivalence is addressed via bench studies that conform to FDA guidance and ISO standards. The "performance" is implicitly deemed acceptable if it meets these standards and supports the claim of substantial equivalence to the predicate device.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Implicitly Met) |
|---|---|
| Conformance to FDA Guidance: Root-form Endosseous Dental Implants and Endosseous Dental Abutments (May 12, 2004) for dynamic fatigue testing | Device passed dynamic fatigue testing |
| Conformance to ISO 14801 (Dynamic fatigue testing) | Device passed dynamic fatigue testing |
| Conformance to IEC 62304 (Software validation) | Software validated successfully |
| Conformance to ISO 17665-1 and ISO/TS 17665-2 (Sterilization validation) | Sterilization validated successfully |
| Conformance to ISO 10993-1 (Biocompatibility testing) | Biocompatibility testing passed |
| Substantial Equivalence to predicate device (K132844) with expanded interface supporting BLX implant system | Determined to be substantially equivalent based on assessment of design and performance data. |
Study that Proves the Device Meets the Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria consists of a series of bench studies and validations.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes used for each of the bench tests (e.g., how many devices were dynamically fatigued).
- Data Provenance: Not explicitly stated, given it's a physical device and bench testing. It's implied that the testing was conducted by or on behalf of the manufacturer, Straumann USA, LLC (on behalf of Institut Straumann AG), a global company based in Switzerland with operations in the US. The tests are "bench studies," meaning they are laboratory-based, not clinical data from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is a physical dental device. "Ground truth" in the context of AI/ML models (e.g., annotated images by experts) is not relevant here. The "truth" is established by adherence to engineering standards and material science principles, as verified through bench testing.
4. Adjudication Method for the Test Set:
- Not Applicable. As no expert review or human interpretation of data (in the AI/ML sense) is mentioned, no adjudication method would be used. The testing is based on objective measurements and conformance to standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not an AI/ML-enabled device or an diagnostic imaging device where human readers would interpret results. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (dental implants/bridges), not a software algorithm or AI. While the design uses CAD/CAM software, the "performance" evaluated is that of the manufactured physical product, not the design software itself as a standalone diagnostic tool. The software validation mentioned (IEC 62304) ensures the design software functions correctly, but this is distinct from evaluating an AI algorithm's standalone diagnostic performance.
7. The Type of Ground Truth Used:
- Engineering Standards and Objective Measurements: The "ground truth" for evaluating this device's performance is based on established engineering standards (ISO 14801), regulatory guidance (FDA guidance on dental implants), and scientific principles for material performance. Tests performed include dynamic fatigue, software validation, sterilization validation, and biocompatibility testing. The outcome is whether the device meets the specified performance requirements under these conditions, not a "diagnosis" or "classification" like in an AI context.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical device, not an AI/ML model. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
June 26, 2019
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K190097
Trade/Device Name: Straumann® CARES® Screw-Retained Bridges and Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 10, 2019 Received: April 11, 2019
Dear Jennifer Jackson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190097
Device Name
Straumann® CARES® Screw-Retained Bridges and Bars
Indications for Use (Describe)
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screwretained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
5 510(k) Summary
Submitter 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
| 60 Minuteman Road | |
|---|---|
| Andover, MA 01810 | |
|---|---|
| Phone Number: | +1 978 747 5209 |
| Fax Number: | +1 978 747 0023 |
| Contact Person: | Jennifer M. Jackson, MS |
| Director, Regulatory Affairs | |
| Prepared By: | Dr. Gordon Dodds |
| Manager Design Control QM, etkon GmbH |
Date of Submission: June 14, 2019
5.2 Device
| Trade Name: | Straumann® CARES® Screw-Retained Bridges and Bars |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Classification Panel: | Dental Devices |
Predicate Device 5.3
| Primary Predicate: | K132844 - Straumann CARES Bone Level Screw-Retained Bars,Straumann CARES Bone Level Screw-Retained Bridges |
|---|---|
| Reference Devices: | K173961 – Straumann BLX Implant SystemK150203 – Medentika CAD/CAM Abutments |
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Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
Device Description 5.4
The Straumann® CARES Screw-Retained Bridges and Bars ("SRBB") are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms (Figure 1). The purpose of this premarket notification is to expand the currently cleared abutment-to-implant interfaces to include the BLX implant system of the Straumann Dental Implant System (SDIS). The materials available include coron and titanium.
SRBB devices facilitate customization to meet the functional and esthetic requirements of the individual patient. They are patient-specific medical devices, i.e., they are designed by a dental professional (clinician or dental technician) and fabricated by Straumann specifically for an individual patient.
SRBB devices are designed via Computer Aided Design (CAD). After importing a scan of the patient model, Straumann® CARES® Visual software includes the ability to generate digital restoration models incorporating the subject devices as well as the predicate devices. The digital restoration model is transferred to the milling center where the restoration is produced using Computer Aided Manufacturing (CAM)techniques.
Image /page/4/Picture/7 description: The image shows examples of dental bars and bridges. The top row shows three different types of dental bridges. The bottom row shows different types of dental bars and bridges, including basic fixed bar, advanced fixed bar, bridge, dolder bar u-shape/dolder bar egg shape, ackerman bar, MP clip, round bar, and milled bar.
Figure 1 - Straumann® CARES® Screw-Retained Bridges and Bars
5.5 Indications for Use
Straumann® CARES® Screw-retained Bridges and Bars are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such
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Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann® CARES® Screw-retained Bridges and Bars are indicated for screw-retained restorations. Straumann® CARES® Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), and BLX implants of the Straumann Dental Implant System (SDIS).
Technological Characteristics 5.6
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1. The change to the previously cleared primary predicate SRBBs is to add the BLX implant-to-abutment interface. No other technological changes (e.g., design parameters, process, materials, etc.) have been made as compared to the primary predicate other than the additional implant-toabutment connection interface (BLX). The indications for use statement for the subject devices has been modified from the primary predicate to clarify the implant-to-abutment interfaces included. The reference devices (K173961) are included for comparison of the BLX interface. The reference devices (K150203) are included for comparison of the dynamic fatique performance.
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Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICES | |
|---|---|---|---|---|
| Straumann CARES ® Screw-Retained Bridges and Bars | K132844Straumann® CARES® BoneLevel Screw-RetainedBars/Bridges | K173961Straumann BLX ImplantSystem | K150203Medentika CAD/CAM Abutments | |
| Indications forUse | Straumann® CARES® Screw-retained Bridges and Bars areindicated for use as bars andbridges that attach to implants toprovide support for prostheticreconstructions such as bridgesand overdentures. The finalprocessed products have thepurpose of restoring chewingfunction.Straumann® CARES® Screw-retained Bridges and Bars areindicated for screw-retainedrestorations.Straumann® CARES® Screw-retained Bridges and Bars aredesigned to interface with the BoneLevel (BL), Tissue Level (TL), andBLX implants of the StraumannDental Implant System (SDIS). | Straumann CARES Screw-Retained Bridges and Bars areindicated for use as bars andbridges that attach to implants ofthe Straumann Dental ImplantSystem (SDIS) to provide supportfor prosthetic reconstructions suchas bridges and over-dentures. Thefinal processed products have thepurpose of restoring chewingfunction.Straumann CARES Screw-Retained Bridges and Bars areindicated for screw-retainedrestorations. | Straumann® Variobase® prostheticcomponents directly or indirectlyconnected to the endosseousdental implant are intended for useas an aid in prostheticrehabilitations. The prostheticrestoration (crowns) can becemented onto the Straumann®Variobase® prosthetic components.A temporary restoration can beused prior to the insertion of thefinal components to maintain,stabilize and shape the soft tissueduring the healing phase; they mustbe placed out of occlusion. Finalabutments and restorations may beplaced into occlusion when theimplant is fully osseointegrated. Alldigitally designed copings and/orcrowns for use with the Straumann®Variobase® Abutment system areintended to be sent to Straumannfor manufacture at a validatedmilling center. | Medentika TiBase CAD/CAM Abutments are intended foruse with dental implants as a support for single or multipletooth prostheses in the maxilla or mandible of a partially orfully edentulous patient.Implant System Compatibility Series Implant Diameter(mm) Platform Diameter (mm)Nobel Biocare Replace™ Select E 3.5, 4.3, 5.0, 6.0 3.5,4.3, 5.0, 6.0Nobel Biocare NobelActive™ F 3.5, 4.3, 5.0 3.5, 3.9 (4.3),3.9 (5.0)Biomet 3i Osseotite® Certain® H 3.25, 4.0, 5.0 3.4, 4.1, 5.0Biomet 3i Osseotite® I 3.25, 3.75, 4.0, 5.0 3.4, 4.1, 5.0Nobel Biocare Brånemark K 3.3, 3.75, 4.0, 5.0 3.5, 4.1,4.1, 5.1Straumann Bone Level L 3.3, 4.1, 4.8 3.3, 4.1, 4.8Straumann Standard N 3.3, 4.1, 4.8 3.5(NNC), 4.8, 6.5Zimmer Tapered Screw-vent® R 3.3, 3.7, 4.1, 4.7, 6.0 3.5,4.5, 5.7Astra Tech OsseoSpeed™ S 3.5, 4.0, 4.5, 5.0 3.5, 4.0,4.5, 5.0Dentsply Friadent® Frialit/XiVE® T 3.4, 3.8, 4.5, 5.5 3.4,3.8, 4.5, 5.5Dentsply Friadent® Ankylos® Y 3.5, 4.5, 5.5, 7.0 3.5, 4.5,5.5, 7.0Medentika TiBase is intended for use with the Straumann®CARES® System. All digitally designed abutments for usewith Medentika CAD/CAM Abutments are intended to bemanufactured at a Straumann® CARES® validated millingcenter. |
| Material | Restorations:Cobalt Chrome AlloyTitanium Grade 4 | Restorations:Cobalt Chrome AlloyTitanium Grade 4 | Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb) | Titanium-Aluminum-Vanadium alloy (Ti-6Al-4V) |
| Screws:Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb) | Screws:Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb) | |||
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICES | |
| Straumann CARES® Screw-Retained Bridges and Bars | K132844Straumann® CARES® Bone Level Screw-Retained Bars/Bridges | K173961Straumann BLX Implant System | K150203Medentika CAD/CAM Abutments | |
| SupportedStraumannInterfaces | Bone Level - RC,NCTissue Level – RN, WNBLX - RB, WB | Bone Level - RC,NCTissue Level – RN, WN | BLX - RB, WB | Bone Level - RC,NCTissue Level – RN, WN |
| SRBBAbutmentImplant/ApicalDesign | BL external coneTL internal coneBLX internal cone | BL external coneTL internal cone | Not applicable | Not applicable |
| RestorationTypesSupported | Bridges and Bars from 2 units tofull-arch | Bridges and Bars from 2 units tofull-arch | Not applicable | Not applicable |
| DesignWorkflow | CAD | CAD | CAD | CAD |
| ManufacturingWorkflow | Straumann Milling Center | Straumann Milling Center | Straumann Milling Center | Straumann Milling Center |
| DesignSoftware | Straumann CARES Visual | Straumann CARES Visual | Straumann CARES Visual | Straumann CARES Visual |
| Design Limitsfor Bridges | Critical geometry parameters areenforced by CARES Visual limits | Critical geometry parameters areenforced by CARES Visual limits | Not applicable | Not applicable |
| Design Limitsfor Bars | Critical geometry parameters areenforced by CARES Visual limits | Critical geometry parameters areenforced by CARES Visual limits | Not applicable | Not applicable |
| Sterilization | Steam autoclave | Steam autoclave | Steam autoclave | Steam autoclave |
| Mode ofAction | Screw-retained | Screw-retained | Cement-retainedScrew-retained | Cement-retainedScrew-retained |
| Reusable | No | No | No | No |
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Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
Table 1 – Comparison of technological features
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Straumann® CARES® Screw-Retained Bridges and Bars
510(k) Summary
5.7 Performance Data
Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies.
The following testing has been conducted:
- Dynamic fatigue testing conforming to FDA guidance (referenced above) and ISO 14801
- o The test environment was 0.9% NaCl at 37°
- Software validation conforming to the requirements of IEC 62304 .
- . Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2
- . Biocompatibility testing according to ISO10993-1
Conclusion 5.8
.
Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.
§ 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.)