(88 days)
The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System Ø3,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar. The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments. Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.
The provided text describes a 510(k) premarket notification for a dental implant system (Neoss Implant System Ø3,25). This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study proving a device meets specific performance acceptance criteria through clinical trials or detailed non-clinical performance benchmarks. Therefore, most of the requested information regarding acceptance criteria, specific study details, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable or not available in the provided document.
However, I can extract information related to the device's technological characteristics and the general approach to demonstrating safety and effectiveness based on the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, "compliance to device specifications and recognized standards" and "all functions were verified to operate as designed" are mentioned in the context of performance and fatigue testing. The performance is then discussed in terms of "substantial equivalence" to predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance to device specifications | Confirmed through performance testing |
| Compliance to recognized standards | Confirmed through performance testing |
| All functions operate as designed | Verified through performance testing |
| Safety and effectiveness comparable to predicate devices | Demonstrated through "Substantial Equivalence Discussion" based on dimensional changes not affecting safety/performance. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes a 510(k) submission for a modified dental implant, which primarily relies on demonstrating substantial equivalence to existing predicate devices through engineering analysis and limited non-clinical testing rather than new clinical trials with patient test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The substantial equivalence argument does not involve establishing ground truth from expert consensus on a test set in the way a diagnostic AI device would.
4. Adjudication Method 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
Not applicable. This is a medical device (dental implant), not an AI diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for the device's performance is implicitly defined by its ability to function safely and effectively as a dental implant, comparable to its predicate devices, based on engineering tests and intended use.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
{0}------------------------------------------------
Section 6: 510(k) Summary
Applicant:
יר
Neoss Ltd Windsor House Cornwall Road Harrogate, HG1 2PW, UK Johanne Hamill Phone: +44 (0) 1423 817733 , +44 (0) 7766913429 Fax: +44(0) 1423 817744 E-mail: Johanne.hamill@neoss.com Registration Number: 3005846524
US Contact:
Cherita James M Squared Associates, Inc. 901 King Street, Suite 200 Alexandria, Virginia 22314 Phone: 703-562-9800 Ext. 257 Facsimile: 703-562-9797
Manufacturing:
Implants, abutments and abutment screws
Elos AB Bäckedalsvägen 6 SE-540 16Timmersdala, Sweden. Registration Number: 3003847101
Pinol AS Engsvei 33 DK-3330 Gorlose, Denmark. Registration Number: Not yet available
Samaplast AG Neugruetstr 3 St Margrethen SG CH 9430 Registration Number : Not yet available
Packaging Facility
Wesley Coe Ltd Gas Lane Ely, Cambridgeshire CB7 4GH, UK Registration Number: 8044131
Sterilization Facility
Swann-Morton Ltd
CONFIDENTIAL
MAY 22 2009
1 -
{1}------------------------------------------------
Owlerton Green Hillsborough, Sheffield, S6 2BJ, UK Registration Number: 9611194
| Date submitted: | 19 February 2009 |
|---|---|
| Proprietary Name: | Neoss Implant System Ø3,25 |
| Common Name: | Dental implant |
| Classification Status: | Class II |
| Product Codes: | DZE, NHA |
| Regulation: | 872.3640 Implant, Endosseous, Root Form; 872.3630 Abutment, implant , dental, endosseous |
| Predicate Device: | Neoss Bimodal Implant K043195, Neoss ProActive Implant K083561 and Neoss Abutment System K071838. |
Device Description:
The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments.
Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.
Indication for Use: The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System Ø3,25 is intended for immediate loading on single tooth and for multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and
CONFIDENTIAL
{2}------------------------------------------------
intended for use as an aid in prosthetic rehabilitation.
Summary of Technological Characteristics:
.
The modification to the Neoss Bimodal Implant, since its previous clearance in K043195 and Neoss ProActive Implant , previously cleared under K083561 and Neoss Abutment cleared under K071838 are as follows:
- a) Diameter of Implant Thread 03.5 to 03.25
- b) Diameter of Abutment connection Ø4,0 to Ø3,5
- c) Outer Diameter of Abutment screw M2 to M1,6
- d) Smaller Countersink and Screw Tap instruments for compatibility with modified implant dimensions
These dimensional changes do not affect the safety nor performance of the device or instruments and do not change the intended use of the Neoss Implant System Ø3.25 when compared to Neoss Bimodal Implant, Neoss ProActive Implant and Neoss Abutments when used as intended. They allow the clinician a range of options comparable to other currently marketed devices in relation to narrow bone ridges & narrower mesio distal spaces.
Summary of Nonclinical Testing:
Based on the Risk Analysis, performance testing and fatigue testing was conducted to confirm compliance to device specifications and recognized standards; all functions were verified to operate as designed.
Substantial Equivalence Discussion:
The introduction of the Neoss Implant System Ø3,25 does not change the intended use nor does it affect the safety and effectiveness as compared to the Neoss Bimodal Implant previously cleared in K043195 and Neoss ProActive Implant, previously cleared in K083561 and Neoss Abutments , previously cleared in K071838. Performance of the modified device is as safe and effective as other currently marketed devices of comparable dimension.
Conclusion:
The introduction of Neoss Implant System Ø3,25 has the following similarities to the Neoss Bimodal Implant previously cleared in K043195 and Neoss ProActive Implant previously cleared in K083561 and Neoss Abutments , previously cleared in K 071838:
CONFIDENTIAL
{3}------------------------------------------------
-
has the same indicated use, .
ﺎﻧﺘ -
uses the same operating principle, .
-
. incorporates the same basic device design and physical properties,
-
incorporates the same materials. .
Therefore, the Neoss Implant System Ø3,25 is substantially equivalent to the predicate devices.
CONFIDENTIAL
{4}------------------------------------------------
Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wing strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2009
Neoss Limited C/o Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, Virginia 22314
Re: K090452
Trade/Device Name: Neoss Implant System Ø3,25 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 19, 2009 Received: May 20, 2009
Dear Ms. James:
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 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 with all the Act's requirements, including, but not limited to: registration
{5}------------------------------------------------
Page 2- Ms. James
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Susan Rare
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Section 5: Indications for Use Statement
510(k) Number (if known): K090452
Device Name: Neoss Implant System Ø3,25 Indications For Use:
The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations.
The Neoss Implant System Ø3,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar. The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __ 1_
Rai Muelly for MSA
on Sian-Off) (Divi Division of Anesthesiology, General Hospital Infection Control, Dental Devices
090452 510(k) Number:
CONFIDENTIAL
Page 1 of 5
§ 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.