Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

The PrimaConnex Internal Connection Implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction into the extraction socket.

The PrimaConnex Internal Connection Implant is intended for immediate provisionalization with non-occlusal load. Immediate Provisionalization is described by the International Congress of Oral Implantologists (ICOI) as a clinical protocol or the placement of an interim prosthesis with or without occlusal contact with the opposing dentition at the same critical visit of implant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

Device Description

The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form tapered and straight-walled threaded dental implants and associated abutment systems, which provide the clinician with screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.

AI/ML Overview

This 510(k) premarket notification for the Lifecore PrimaConnex™ Internal Connection Implant System does not include a study with acceptance criteria and device performance results as typically requested for AI/ML device submissions. Instead, it demonstrates substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested sections (e.g., acceptance criteria, test set sample size, ground truth details, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text. The document focuses on comparing the new device's design, materials, intended use, and general characteristics to existing FDA-cleared dental implants to show that no new questions of safety or effectiveness are raised.

Here's an attempt to address the prompts based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a device showing substantial equivalence, specific "acceptance criteria" and direct "device performance" in the context of a new study are typically not presented in this format. The acceptance is based on demonstrating similarity to predicates.

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

This information is not applicable/not provided. There is no "test set" in the context of a new performance study described. The 510(k) relies on comparison to predicate devices, not on new clinical performance data with a specific test cohort.

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

This information is not applicable/not provided. Since no new clinical study with a "test set" is described, there's no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or adjudication process described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or described in this 510(k) submission. The submission is based on demonstrating substantial equivalence to predicate devices, not on a new comparative effectiveness study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

This information is not applicable/not provided. The device is an endosseous dental implant system, which is a physical medical device, not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

This information is not applicable/not provided. As no new performance study is described, there is no "ground truth" established for the device's performance in the context of this 510(k) summary. The "truth" for substantial equivalence is based on established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical dental implant, not an AI/ML system. Therefore, there is no "training set."

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

This information is not applicable/not provided. As explained above, there is no "training set" for this device.

Summary of the 510(k) Submission:

The provided document is an Abbreviated 510(k) Premarket Notification for the PrimaConnex™ Internal Connection Implant System. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing extensive new clinical study data with detailed performance metrics and acceptance criteria.

Key points from the document indicating an equivalence approach:

Section 5. Substantial Equivalence Comparison: This section explicitly states the purpose is to compare the new device to identified predicates.
The document highlights similarities in:
- Intended Use: "The PrimaConnex Internal Connection Implant System has a substantially equivalent intended use as the identified predicates."
- Fundamental Scientific Technology: All are "threaded, root form implants constructed of titanium."
- Size and Materials: "similar in size and materials."
- Sterilization: "sterilized via gamma irradiation and intended for single use only."
- Instrumentation: "include instruments to assist with the implant procedure."
Conclusion: "When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex Internal Connection Implant System."

The FDA's response (SEP - 9 2005 letter) confirms this: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

Therefore, the "study" proving the device meets "acceptance criteria" here is the comparison to established predicate devices, and the "acceptance criteria" is essentially demonstrating that the new device is as safe and effective as the predicates, raising no new safety or effectiveness concerns. No specific quantitative performance metrics beyond this comparison are presented in the provided text.

Summary

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Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System

K05/614

SEP - 9 2005

510(K) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]

1. Submitter's Name and Contact Person

Lifecore Biomedical, Inc.	Rachel Kennedy
3515 Lyman Blvd	Regulatory Affairs Manager
Chaska, MN 55318	Ph: 952-368-6294; Fax: 952-368-4278

2. General Information

Trade Name	Lifecore PrimaConnex™ InternalConnection Implant System
Common Name	Endosseous dental implant system
Classification Name	Endosseous implant
Identification of Predicate Devices	Restore® Self-Tapping DentalImplant System, RD (LifecoreBiomedical, Inc.) (K924589) Restore® Self-Tapping DentalImplant System, WD (LifecoreBiomedical, Inc.) (K944068) Restore® Self-Tapping DentalImplant System, SD (LifecoreBiomedical, Inc.) (K951111) Renova™ Internal Hex ImplantSystem (Lifecore Biomedical, Inc.)(K032774) PrimaSolo™ One-Piece ImplantSystem (Lifecore Biomedical, Inc.)(K050506)

3. Device Description

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K05/6/4

Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System

screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.

4. Intended Use

Lifecore Biomedical Dental Implants are intended for use intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

5. Substantial Equivalence Comparison

The PrimaConnex Internal Connection Implant System has a substantially equivalent intended use as the identified predicates. All implants are intended for replacing missing teeth and supporting single or multiple-unit restorations in the mandible or maxilla. The Lifecore PrimaConnex Internal Connection Implants are similar in fundamental scientific technology to the predicate devices in that they are all threaded, root form implants constructed of titanium. The subject and predicate devices are similar in size and materials, are sterilized via gamma irradiation and intended for single use only. The PrimaConnex Internal Connection Implant System and the predicates include instruments to assist with the implant procedure. When compared with the predicate devices, no new

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K051614

Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System

questions of safety or effectiveness have been raised for the PrimaConnex Internal Connection Implant System.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized abstract symbol resembling a bird or human figure with three curved lines, enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.

SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Rachel Kennedy Regulatory Affairs Manager Lifecore Biomedical, Incorporated 3515 Lyman Blvd. Chaska, Minnesota 55318-3015

Re: K051614

KUJ1014
Trade/Device Name: PrimaConnex™ Internal Connection Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: June 16, 2005 Received: June 17, 2005

Dear Ms. Kennedy:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becamer of the device is substantially equivalent (for the relerenced above and have determined te to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Alliendlinens, of to dovrees that in tic Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocements , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (see above) into sontrols. Existing major regulations affecting g (PMA), it may of subject to back additions, 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. Kennedy

Please be advised that FDA's issuance of a substantial equivalence determination does not r least be advisod that I Dr. o to mination that your device complies with other requirements Incall that I DTT mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal but is requirements, including, but not limited to: registration T ou inust comply with as 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), caselling systems (QS) regulation (21 CFR Part 820); and if requirements us set form in are quadiation 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) This teller will anow you to began finding of substantial equivalence of your device to a premarket notification. - The Fire 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), if you desire specific and 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 may overn banel 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,

Clu

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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Indications for Use

510(k) Number (if known): K051614

PrimaConnex™ Internal Connection Implant System Device Name:

Indications for Use:

Indications for Use:
Lifecore Biomedical Dental Implants are intended for use in partially or fully Lifecore Biomedical Dental Implant System informations on the prouting including,
edentulous mandibles and maxillae, in support of single or intermediate edentulous mandibles and maxiliae, in support of singlo of millions of intermediate abutment support for fixed bridgework.

The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The The PrimaConnex Internal Connection Implant is intended for immediate placement, where PrimaConnex Internal Connection in the local relines of Oral Implantologists
immediate implant placement is defined by the lother into the extraction socket immediate implant placement is delined by the memational only outs of the extraction socket.
(ICOI) as the placement of an implant at the time of tooth extraction socket.

The PrimaConnex Internal Connection Implant is intended for immediation,
Andress of Connection Production in discripcd by the International Congress of The PrimaConnex internal Connection in international on the International Congress of
non-occlusal load. Immediate Provisionalization is discreational of an interim prosthes non-occlusal load. Immediate Provisionalization for the placement of an interim prosthesis with
Oral Implantologists (ICOI) as a clinical protocol for the same clinical visi Oral Implantologists (ICO) as a Cinical proceed for the same clinical visit of implant
or without occlusal contact with the opt of the same clinical visit a tempor or without occlusal contact will the opposing the on be restored with a temporary
placement. The PrimaConnex Internal Connection with and erestored with a temporary placement. The PrimaConnex internal Gonnection maps
prosthesis in single tooth and multiple tooth applications with good quality bone.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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

Susan Ruanor

Division of Anesthesiology, General Hose Infection Control, Dental D

510(k) Number: K051614

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.