(303 days)
The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.
This document is a 510(k) premarket notification for a dental abutment system. It does not describe a study involving device performance concerning AI or reader performance. Therefore, I cannot provide the requested information about acceptance criteria for AI performance, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This involves comparing material, angle, geometry, socket heights, surface treatment, sterilization, and accessories between the new device and predicate devices.
- Non-clinical testing: This includes validation of sterilization, packaging validation (aging studies), and surface analysis (cytotoxicity and cleaning validation).
- Engineering studies: Fatigue testing was conducted according to ISO 14801:2003 (E).
Here is a summary of the provided information related to the device and its testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance in the form of a table that would be common for AI/diagnostic devices. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting relevant ISO standards for dental implants.
| Category | Reported Device Performance / Assessment |
|---|---|
| Technological Characteristics Comparison | The technological characteristics (Material, Abutment Angle, Exterior geometry, Socket heights, surface treatment, Sterilization, Accessories, Indications) of the 4plus6Line Abutment System were found to be "comparable" to the predicate devices (Nobelactive Multi Unit Abutment K072570). Key differences noted: - Material: Predicate has Titan Grade 1 for straight abutments vs. New device: All Titanium Grade 5. - Socket heights: Predicate offers more options (1.5, 2.5, 3.5, 4.5 mm) vs. New device (1.5, 3 mm). - Surface treatment: New device has anodization in implant-connecting-area; predicate has pure machined surface. |
| Sterilization Validation | - Microbiological Performance MDS Test 103706-10 (Submitted Oct. 19, 2011) - Dose mapping (Submitted Dec 04, 2012) |
| Packaging Validation | - Ageing Study over 5 years by MDS, Test 094466-10 (Submitted Oct. 19, 2011) - Ageing Study real time aging 5 years by MDS, Test 142775-10 (dye penetration test) (Submitted June 04, 2014) - Ageing Study real time aging 5 years by MDS, Test 151504-10 (microbial properties) (Submitted April 09, 2015) |
| Surface Analysis | - Test Cytotoxicity abutments, MDS report no. 123335-20 (Submitted July 30, 2012) - Report cleaning validation_2013RV02-2010 (Submitted Sept 18, 2013) |
| Engineering Studies (Fatigue) | Conducted as per ISO standard 14801:2003 (E) – (Dentistry – Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI/diagnostic device. For the non-clinical and engineering studies, specific sample sizes are not explicitly stated, but the studies refer to standard tests (e.g., ISO 14801 for fatigue testing, MDS reports for cytotoxicity, sterilization, and packaging). These typically involve a defined number of units to meet statistical significance for the specific test.
- Data Provenance: The document is a submission to the FDA from a German company (OT medical GmbH, Bremen, Germany). The non-clinical and engineering study reports are listed with submission dates, indicating they were conducted retrospectively for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/diagnostic device that requires expert-established ground truth for a test set. The validation relies on laboratory and engineering testing standards.
4. Adjudication method for the test set
Not applicable. This is not an AI/diagnostic device that involves human reader adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This is not an AI/diagnostic device; therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI algorithm.
7. The type of ground truth used
For the engineering studies, the "ground truth" is adherence to the performance requirements outlined in the ISO standard (ISO 14801:2003 (E)) for fatigue testing, aiming to demonstrate a "stable screw joint." For non-clinical tests, the ground truth relates to meeting established criteria for sterilization effectiveness, packaging integrity, cytotoxicity, and cleaning validation as per relevant standards and test methods.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; there is no training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
OT medical GmbH Ms. Martina Behlau Quality Manager/Manager Regulatory Affairs Konsul-Smidt-Straße 8b Bremen 28217 GERMANY
Re: K151608
Trade/Device Name: 4plus6Line Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 15, 2016 Received: March 16, 2016
Dear Ms. Martina Behlau:
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.
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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 (reporting of medical device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151608
Device Name
4plus6Line Abutment System for Endosseous Dental Implant System OT-F2
Indications for Use (Describe)
The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) PREMARKET NOTIFICATION SUMMARY K151608
Name/Address of submitter: OT medical GmbH Konsul-Smidt-Str. 8b D-28217 Bremen/Germany
Establishment Registration Number: 10033109
Contact Person: Martina Behlau Phone ++49-421-557161-15 Fax ++49-421-557161-95
Date Summary Prepared: April 11, 2016
Trade Name: 4plus6Line Abutment System
Common name: Dental Abutment
Device Classification Name: Endosseous dental implant abutment
Device Classification Regulation Number: CFR 872.3630
Classification Product code: NHA
Device Regulatory Status: Class II Special Controls
Purpose: The purpose of this 510(k) is to obtain clearance for sale in the U.S.A. for the 4plus6Line Abutment System as an extension of the dental abutments previously cleared in the OT-F2 Dental Implant System.
Predicate Devices: K072570 Nobelactive Multi Unit Abutment (primary predicate) K113113 OT medical Endosseous Dental Implant System as reference predicate K151432 OT medical NaturalLine Abutment (Endosseous Dental Implant Abutment) as reference predicate for fatigue testing
Device Description: The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.
Indication for Use: The 4plus6 Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
Technological Characteristics: The physical properties and designs of the abutment for the 4plus6Line Abutment System were compared with the legally marketed predicate devices. The technological characteristics were comparable:
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Comparison of Properties and Features of OT medical's 4plus6Line Abutment System to Predicate device
| OT-F2 4plus6Line | Multi Unit Abutment (K072570) | |
|---|---|---|
| Specification of Material | All abutments: Titanium Grade 5acc. to ASTM-F 136 | Angled Abutments: Titanium Grade5 acc. to ASTM-F 136Straight abutments and TemporaryCoping: Titan Grade 1 (pureTitanium) |
| Abutment Angle: | 0° / 17° / 30° | 0° / 17° / 30° |
| Exterior geometry: | Straight abutments non-engaging | Straight abutments non-engaging |
| Angled abutments engaging | Angled abutments engaging | |
| Socket heights | 1,5 / 3mm | 1,5 / 2,5 / 3,5 / 4,5 mm |
| surface treatment | Pure machined surface withanodization in the implant-connecting-area | Pure machined surface |
| Sterilization | 0°, 17° and 30° abutments aresterilized by irradiation | 0°, 17° and 30° abutments aresterilized by irradiation |
| Cylinder Titan is sold unsterile | Temporary Coping is sold unsterile | |
| Accessories for abutments | abutment screw for eachabutment included | abutment screw for each abutmentincluded |
| Cylinder Titan inclusive Prostheticscrew | Temporary Coping Multi-unitAbutment (with Prosthetic screw) | |
| Indications | The 4plus6 Line Abutment is apremanufacturedprostheticcomponent intended for use asan aid in prostheticrehabilitation. | NobelActive Multi Unit Abutment isa pre-manufactured prostheticcomponent directly connected tothe endosseous dental implant andis intended for use as an aid inprosthetic rehabilitation. |
Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Non-Clinical Testing:
| Submitted on | |
|---|---|
| Validation Sterilization | |
| - Microbiological Performance MDS Test 103706-10 | Oct. 19, 2011 |
| - Dose mapping | Dec 04, 2012 |
| Packaging validation | |
| - Ageing Study over 5 years by MDS, Test 094466-10 | Oct. 19, 2011 |
| - Ageing Study real time aging 5 years by MDS, Test 142775-10 (dye penetration test) | June 04, 2014 |
| - Ageing Study real time aging 5 years by MDS, Test 151504-10 (microbial properties) | April 09, 2015 |
| Surface analysis: |
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| - Test Cytotoxicity abutments, MDS report no. 123335-20 | July 30, 2012 |
|---|---|
| - Report cleaning validation_2013RV02-2010 | Sept 18, 2013 |
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Brief Discussion of Engineering Studies: Engineering studies were conducted as per ISO standard 14801:2003 (E) – (Dentistry – Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested.
Conclusions Drawn: The OT-F² 4plus6Line Abutment System and associated components have the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. The information and data provided in the submission demonstrates that the proposed device is substantially equivalent to its declared predicate.
§ 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.)