(136 days)
The Straumann® screw-retained abutments are indicated to be placed implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® screw-retained abutments are indicated for screw-retained restorations.
The subject device is a modification of the NC Straight Ø4.6 mm GH 1.0 mm Screw Retained Abutment originally cleared to market per K133421. Dimensional changes have resulted in improved dynamic fatigue performance such that this device can now be used in the pre-molar region of the mouth in addition to the incisors.
The provided text is a 510(k) summary for a medical device (Straumann Screw-Retained Abutment) and outlines its equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation. The "Performance Testing" section describes bench testing for fatigue load limits, which is a mechanical engineering test, not a clinical or AI performance study.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation.
However, I can provide the information that is available about the "Performance Testing" from the document:
1. A table of acceptance criteria and the reported device performance
The document states that "Dynamic fatigue tests were conducted in accordance with the FDA guidance document dated May 12, 2004: 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments' and ISO 14801."
While specific acceptance criteria values (e.g., minimum load cycles or maximum load) and reported performance values are not explicitly provided in this summary, the standard ISO 14801 and the FDA guidance document would define these. The general performance claim is "improved dynamic fatigue performance" and "greater wall thickness in the flexure zone of the abutment."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was bench testing, not a clinical study with patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This was bench testing, not an expert-driven ground truth establishment.
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
No, an MRMC study was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing is typically the physical measurement of material properties and performance under stress, as defined by engineering standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015
Straumann USA, LLC Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810
Re: K150814
Trade/Device Name: Straumann Screw-Retained Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 6, 2015 Received: July 8, 2015
Dear Mr. Klaczyk:
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. 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.
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
{1}------------------------------------------------
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 (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K150814
Device Name Straumann Screw Retained Abutments
Indications for Use (Describe)
The Straumann® screw-retained abutments are indicated to be placed implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® screw-retained abutments are indicated for screw-retained restorations.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
K150814
| Submitter: | Straumann USA, LLC(on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810 |
|---|---|
| Contact Person: | Christopher KlaczykDirector of Regulatory and Clinical Affairschristopher.klaczyk@straumann.com978.747.2575 |
| Preparation Date: | August 5, 2015 |
| Product Code: | NHA (21 CFR §872.3630) |
| Device Class: | II (21 CFR §872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR §872.3630) |
| Proprietary Name: | Straumann® Screw-Retained Abutment |
| Primary Predicate: | (K133421) Straumann® Magellan™ Screw Retained Abutment System |
| Reference Devices: | None |
| Device Description: | The subject device is a modification of the NC Straight Ø4.6 mm GH1.0 mm Screw Retained Abutment originally cleared to market perK133421. Dimensional changes have resulted in improved dynamicfatigue performance such that this device can now be used in the pre-molar region of the mouth in addition to the incisors. |
{4}------------------------------------------------
| Indications For Use: | The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars.The final processed devices have the purpose of restoring chewing function.Straumann® Screw-Retained Abutments are indicated for screw-retained restorations. |
|---|---|
| Intended Use: | Straumann® Screw-Retained Abutments are intended to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns and bridges. |
| Technological Characteristics: | See table below. |
{5}------------------------------------------------
| Feature | Subject Device Straumann®Screw-Retained Abutment | Primary Predicate DeviceStraumann® Magellan™ Screw-Retained Abutments(K133421) | Equivalence Discussion |
|---|---|---|---|
| Indications For Use | Straumann® Screw-RetainedAbutments are indicated to beplaced into dental implants toprovide support for prostheticreconstructions such as crown,bridges and bars. The finalprocessed devices have thepurpose of restoring chewingfunction. Straumann® screw-retained abutments areindicated for screw-retainedrestorations. | Straumann® Magellan™ Screw-Retained Abutments are indicatedto be placed into dental implants toprovide support for prostheticreconstructions such as crown,bridges and bars. The finalprocessed devices have thepurpose of restoring chewingfunction. Magellan™abutments are indicated forscrew-retained restorations. | EquivalentMagellan project name is notbeing used as a trade name. |
| Abutment Material | Titanium Alloy (Ti-6Al-7Nb) | Titanium Alloy (Ti-6Al-7Nb) | Identical |
| Abutment PlatformDiameter | Ø 4.6 mm | Ø 4.6 mm | Identical |
| Abutment PlatformThickness | 0.55 mm | 0.20 mm | EquivalentThe platform thickness does notaffect the implant or the prostheticinterfaces of the abutment;affecting only the emergenceprofile between the implant andthe abutment platform. |
| Gingival Height | 1 mm | 1 mm | Identical |
| Abutment ApicalGeometry | Engaging Bone Level NC | Engaging Bone Level NC | Identical |
| Feature | Subject Device Straumann®Screw-Retained Abutment | Primary Predicate DeviceStraumann® Magellan™ Screw-Retained Abutments(K133421) | Equivalence Discussion |
| Abutment CoronalGeometry | Straight, 22° Conic taper, 1.9 mmtall, with milled flats; supportsengaging and non-engagingprostheses | Straight, 22° Conic taper, 1.9 mmtall, with milled flats; supportsengaging and non-engagingprostheses | Identical |
| Packaging | PETG thermoformed tray withTyvek 1073B lid | PETG thermoformed tray withTyvek 1073B lid | Identical |
| Sterilization | Device provided non-sterile.Instructions provided for terminalsterilization by the clinician viasteam at 134℃ for 5 minutes. | Device provided non-sterile.Instructions provided for terminalsterilization by the clinician viasteam at 134℃ for 5 minutes. | Identical |
{6}------------------------------------------------
{7}------------------------------------------------
| SubstantialEquivalenceDiscussion: | The Indications For Use of the subject and predicate devices are thesame. The overall abutment material, height, diameter, implant-to-abutment interface, coronal geometry, packaging and sterilizationmethod are unchanged.The only difference between the subject Straumann® NC Straight Ø4.6mm GH 1.0 mm Screw-Retained Abutment and the predicateStraumann® NC Straight Ø4.6 mm GH 1.0 mm Screw-RetainedAbutment cleared to market per K133421 is the angle of the transitionbetween the apical implant-to-abutment interface and the coronalrestoration platform resulting from a change in the thickness of therestoration platform. This change in the external geometry has resultedin greater wall thickness in the flexure zone of the abutment which hasresulted in improved dynamic fatigue performance. |
|---|---|
| PerformanceTesting: | Bench testing was performed to evaluate the fatigue load limits of theproposed Straumann® Screw-Retained Abutment. Dynamic fatiguetests were conducted in accordance with the FDA guidance documentdated May 12, 2004: “Guidance for Industry and FDA Staff – Class IISpecial Controls Guidance Document: Root-form Endosseious DentalImplants and Endosseous Dental Abutments“ and ISO 14801. |
| Conclusion: | Based upon our assessment of the design and applicable performancedata, the subject devices have been determined to be substantiallyequivalent 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.)