The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the KOG1169 Endosseous Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on establishing performance criteria through clinical studies.

Therefore, many of the requested details about acceptance criteria, specific device performance, clinical study design, and ground truth establishment are not applicable or available in this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A): This submission is for an Endosseous Dental Implant System, and the document explicitly states, "FDA has not established a performance standard applicable to endosseous implants and their accessories." The submission relies on demonstrating substantial equivalence to predicate devices and meeting applicable voluntary standards for materials (ASTM F67-95 Grade III or Grade IV Titanium), sterilization, and packaging. The document does not provide specific quantitative performance metrics beyond these material and process standards.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable (N/A): No test set, in the context of an AI/algorithm performance study, was used or described. The submission is for a physical medical device (dental implant).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable (N/A): As no test set for an AI/algorithm was used, no ground truth experts were involved in this context.

4. Adjudication Method for the Test Set

Not Applicable (N/A): No adjudication method was involved as this is not an AI/algorithm performance study.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not Applicable (N/A): No MRMC study was conducted. The device is a physical dental implant, not an AI-assisted diagnostic tool. The document explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

6. Standalone (Algorithm Only) Performance Study

Not Applicable (N/A): No standalone algorithm performance study was done as the device is a physical dental implant.

7. Type of Ground Truth Used

Not Applicable (N/A): As this is a submission for a physical device, not an AI/algorithm, the concept of "ground truth" in the context of diagnostic accuracy is not directly relevant. The assessment of the device's characteristics relies on compliance with material specifications (ASTM F67-95 Grade III or Grade IV Titanium) and validated sterilization and packaging methods (ISO, ASTM, EN standards).

8. Sample Size for the Training Set

Not Applicable (N/A): No training set was used as this is not an AI/algorithm submission.

9. How the Ground Truth for the Training Set Was Established

Not Applicable (N/A): No training set was used or ground truth established in this context.

Summary of Acceptance Criteria and Study:

Instead of typical AI/algorithm acceptance criteria and studies, this 510(k) submission demonstrates compliance by meeting material, sterilization, and packaging standards and demonstrating substantial equivalence to existing predicate devices.

Acceptance Criteria (based on compliance requirements):

Criterion	Reported Device Performance/Compliance Summary
Material Composition	Meets ASTM F67-95 Grade III or Grade IV Titanium. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.
Sterility Assurance Level (SAL)	Achieves SAL of 10-6. Sterilization using Co60 irradiation with a minimum dose of 25.0 kGy (2.5 m rads) is validated as specified by AAMI and ISO 11137, ISO 11737-2, and ISO 13409.
Packaging Integrity & Performance	Validated to ASTM and EN standards. Packaging is validated following ASTM D 4169-04, ASTM F 88-00, ASTM F 1929-98, EN 552, EN556-1:1997, EN 868-1:1997, EN 868-5:1999, EN 868-9:2000, EN 868-10:2000, and ISO 11607.
Technological Characteristics	Comparable to legally marketed predicate devices. "The physical properties and designs of the additional implants and accessories in the NSI Endosseous Dental Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable."
Safety and Effectiveness (overall)	No new issues of safety or effectiveness raised compared to predicates. "Any differences in the technological characteristics did not raise new issues of safety or effectiveness." The FDA's substantial equivalence determination implies it meets general controls of the Act.

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) involves:

Conformance to Voluntary Standards: Explicitly stating that materials meet ASTM standards and sterilization/packaging processes are validated according to a comprehensive set of ISO, AAMI, ASTM, and EN standards.
Predicate Device Comparison: A direct comparison of the technological characteristics and intended use of the new implants and accessories with a list of previously cleared predicate devices (K003620, K020617, K033171, K052490, K053478 NSI systems, and several Straumann Implant Systems K894595, K955281, K012757, K013798, K990342, K962023). The conclusion drawn is that the new components are substantially equivalent.
Declaration of No Clinical Studies Needed: The submission explicitly states, "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission," indicating that the justification for safety and effectiveness is based on the substantial equivalence argument and adherence to recognized standards, rather than new clinical data.

Summary

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KOG1169

JUN 20 2006

510(K) PREMARKET NOTIFICATION SUMMARY

Name/Address of Submitter: Northern Implants, LLC 10355 B Democracy Lane Fairfax, VA 22030

Establishment Registration Number: 3003845138

Contact Person: Greta M. Hols Phone: (703) 278-3953 Fax: (703) 278-3954

Date Summary Prepared: April 21, 2006

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640 and 21 CFR 872.3630

Device Regulatory Status: Class II Special Controls

Trade Name: Endosseous Dental Implant

Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions for our system.
Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Implant System meet applicable voluntary standards. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.
Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K033171 NSI Hexed and Non-Hexed Implant System K052490 NSI Hexed and Non-Hexed Implant System K053478 NSI Hexed and Non-Hexed Implant System K894595 Straumann Implant System K955281 Straumann Implant System K012757 Straumann Implant System K013798 Straumann Implant System K990342 Straumann Implant System K962023 Straumann Implant System
Device Description and Intended Use: The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

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Sterilization Methods Used: Sterilization of these implants will be achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 10 d. Validation of sterilization will be done as specified by the Association for the Advancement of Medical Instrumentation (AAMI). Standards utilized include:

ISO 11137	Sterilization of Health Care Products – Requirements for validation and routine control –Radiation sterilization
ISO 11737-2	Sterilization of Medical Devices – Microbial Methods – Part 2: Tests of sterilityperformed in the validation of a sterilization process
ISO 13409	Sterilization of Health Care Products – Radiation Sterilization – substantiation of 25kGy asa sterilization dose for small or infrequent production batches.

Packaging Validation:

All Northern Implants are packaging is validated following these standards:

ASTM D 4169-04	Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F 88-00	Standard Test Method for Seal strength of Flexible Barrier Materials
ASTM F 1929-98	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging byDye Penetration
EN 552	Sterilization of medical devise - Validation and routine control of sterilization byirradiation
EN556-1:1997	Sterilization of medical devices - Requirements for medical devices to be labeled"Sterile"
EN 868-1:1997	Packaging materials and systems for medical devices with are to be sterilized:Part 1 General requirements and test methods
EN 868-5:1999	Packaging materials and systems for medical devices which are to be sterilized -Part 5: Heat and self-sealable pouches and reels of paper and plastic filmconstruction - Requirements and test methods
EN 868-9: 2000	Packaging materials and systems for medical devices which are to be sterilized -Part 9: Uncoated non-woven materials of polyolefines suitable for use aspackaging of medical devices which are to be terminally sterilized -Requirements and test methods.
EN 868-10:2000	Packaging materials and systems for medical devices which are to be sterilized -Part 10: Adhesive coated nonwoven material of polyolefines for use in themanufacture of heat sealable pouches, reels and lids - Requirement s and testmethods
ISO 11607	Packaging for terminally sterilized medical devices

Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Endosseous Dental Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.

Brief Discussion of Clinical Studies: Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.

Conclusions Drawn: The NSI Endosseous Dental Implant System has the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird, with three curved lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the bird.

JUN 20 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Greta M. Hols Director of Operations Northern Implants, LLC 10355 B Democracy Lane Fairfax, Virginia 22030

Re: K061169

Trade/Device Name: Endosseous Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: April 21, 2006 Received: April 27, 2006

Dear Ms. Hols:

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.

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Page 2 - Ms. Hols

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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sylie Y. Michael Davis

Chiu Lin, Ph.D. 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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INDICATION FOR USE

510(k) Number: K0b||69

Device Name: Endosseous Dental Implant System

Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

CONCURRENCE OF CDRH OFFICE OF DEVICE EVALUATION

Prescription Use

Over-the-counter Use

(Per 21 CFR801.109)

Susan Puorro

111 Sisti-Oli on of Anesthesiology, General Hospital tion Control. Dental D

Nankar. K06 1lb9

Regulation Number and Section

§ 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.