(35 days)
The Lifecore Stage-1 Angled Abutment is intended to attach to an endosseous implant and provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required.
The Lifecore Stage-1 Angled Abutment System is designed for use with endosseous implants to provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required. The Stage-1 Angled COC Abutment and Screws will facilitate ideal tooth positioning due to lack of available bone, access limitation, or to correct angulation of implant placement. The system consists of 15 and 20 degree angled abutments, angled abutment screw, and angled abutment try-ins. One angled abutment is packaged together with an angled abutment screw to allow the clinician to have the components required for clinical use. The angled abutments and angled abutment screw are manufactured from titanium alloy (Ti 6Al-4V E.L.) which conforms to ASTM Standard Specification F136.
The provided text describes the Lifecore Stage-1 Angled Abutment System, a Class III medical device intended for dental implant support and retention where angle correction is required.
However, the document does not contain specific acceptance criteria, detailed study designs, or performance metrics that would typically be reported for the device's clinical or algorithmic performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of technological characteristics.
Therefore, I cannot fulfill most of your request directly from the provided text. I will, however, extract the information that is present.
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria (e.g., "accuracy > 90%") and their corresponding device performance values are not provided, this table cannot be fully populated. The document only states that the device has "met the design criteria" for various tests.
| Criteria | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Static Loads Performance | (Not specified) | Met the design criteria |
| Fatigue Loads Performance | (Not specified) | Met the design criteria |
| Corrosion Resistance | (Not specified) | Likely to resist corrosion; found to be within acceptable limits |
| Dimensional Specifications | (Routinely inspected) | Routinely performed and found to be within acceptable limits |
| Electrochemical Corrosion (Uncoupled) | (Not specified) | Found to be within acceptable limits |
| Electrochemical Corrosion (Galvanic) | (Not specified) | Found to be within acceptable limits |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document refers to "testing to verify design specifications" but does not detail the sample sizes for these tests (e.g., number of abutments tested for static load) or the provenance of any data beyond indicating it's related to the device's design verification. It appears to refer to in-vitro non-clinical tests rather than human or real-world data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient outcomes to establish ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the non-clinical tests described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document describes non-clinical engineering and material tests, not studies comparing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device (an abutment system), not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been the pre-defined engineering specifications and ASTM standards for static loads, fatigue loads, corrosion resistance, and dimensional accuracy. The device's performance was compared against these established technical benchmarks.
8. Sample Size for the Training Set
Not applicable. As a physical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and regulatory standards, not by iterative training on a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
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Kos 2495 Section 2 - 510(k) Summary and Certification
[As required by 21 CFR 807.92(c)]
1. Submitter's Name / Contact Person
Diane Brinza Regulatory Affairs Supervisor Lifecore Biomedical, Inc. 3515 Lyman Blvd. Chaska, MN 55318 952-368-6394 Ph: Fax: 952-368-4278
2. General Information
| Trade Name | The Lifecore Stage-1 Angled Abutment System consists of the following products:Regular Diameter (RDS) 15° Cement on Crown (COC) Abutment Regular Diameter (RDS) 20° COC Abutment Stage-1 Angled Abutment Screw, .048" Hex, Titanium Accessories: Stage-1 Angled Abutment Try-Ins |
|---|---|
| Common / Usual Name | Angled Abutment System |
| Classification Name | Lifecore Stage-1 Angled Abutment system is a precision attachment system intended for use with a Class III medical device, thereby the Stage-1 Angled Abutment System is considered Class III (per 21 CFR 872.3640). |
| Identification of Equivalent Devices | Pre-Angled Post manufactured by Implant Innovations (3i). ITI Angled Abutment manufactured by Straumann USA. Stage-1 Abutment System manufactured by Lifecore Biomedical, Inc. |
3. Device Description
The Lifecore Stage-1 Angled Abutment System is designed for use with endosseous implants to provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required. The Stage-1 Angled COC Abutment and Screws will facilitate ideal tooth positioning due to lack of available bone, access limitation, or to correct angulation of implant placement.
The system consists of 15 and 20 degree angled abutments, angled abutment screw, and angled abutment try-ins. One angled abutment is packaged together with an angled abutment screw to allow the clinician to have the components required for clinical use. The angled abutments and angled abutment screw are manufactured from titanium alloy (Ti 6Al-4V E.L.) which conforms to ASTM Standard Specification F136.
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4. Intended Use
The Lifecore Stage-1 Angled Abutment is intended to attach to an endosseous implant and provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required.
5. Technological Characteristic Comparisons
The Lifecore Stage-1 Angled Abutment System is substantially equivalent to the Pre-Angled Post manufactured by Implant Innovations (3i), and ITI Angled Abutment manufactured by Straumann USA, and the connection features of the Stage-1 Abutment System, manufactured by Lifecore Biomedical, Inc. Compared to the predicate devices, the Lifecore Stage-1 Angled Abutment System is substantially equivalent in intended use, design, material, and accessories.
6. Summary of Studies / Nonclinical Tests
The Lifecore Stage-1 Angled Abutment System has been subjected to testing to verify design specifications. Test results indicate the Stage-1 Angled Abutment has met the design criteria for static and fatigue loads and is likely to resist corrosion. Dimensional inspections are routinely performed, Electrochemical Corrosion Evaluation of Uncoupled and Coupled Implant and Restorative Alloys has been performed to determine corrosion properties when exposed to artificial saliva and to determine the galvanic corrosion properties of the Precious Alloy/CP titanium and Precious Alloy/Ti-6Al-4V galvanic couples. All have been found to be within acceptable limits.
7. Substantial Equivalence Comparison
The Lifecore Stage-1 Angled Abutment System is substantially equivalent to the following products:
| Implant Innovations (3i)Pre-Angled Posts | Straumann USA ITIAngled Abutments | Lifecore Stage-1Abutments |
|---|---|---|
| Implant Innovations, Inc.4555 Riverside Dr.Palm Beach Gardens, FL33410USA | Straumann USA1601 Trapelo RoadWaltham, MA 02451USA | Lifecore Biomedical, Inc.3515 Lyman Blvd.Chaska, MN 55318USA |
8. Conclusion (statement of equivalence)
The data submitted in this 510(k) is in support of substantial equivalency of Lifecore Stage-1 Angled Abutment System to the following commercially marketed devices:
- Implant Innovations (3i) Pre-Angled Posts .
- Straumann USA ITI Angled Abutments .
- . Lifecore Stage-1 Abutments
These current products as defined by their product literature, demonstrate the basis for the substantial equivalency relative to indications, materials, and design. The intended use of these devices is the same as the Lifecore Stage-1 Angled Abutment System.
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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight inside a circle. The bird is composed of three curved lines that suggest feathers or wings. The circle is not a solid line but appears to be made up of small, broken segments, giving it a rough or textured look. The logo is black and white.
Public Health Service
Rockville MD 20850
SEP 1 7 2003
Ms. Diane Brinza Regulatory Affairs Supervisor Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318-3051
Re: K032495
Trade/Device Name: Lifecore Stage-1 Angled Abutment System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 11, 2003 Received: August 13, 2003
Dear Ms. Brinza:
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. Brinza
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susen Runne
Susan Runner, DDS, MA Interim 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 STATEMENT
510(k) Number (if known):
Page 1 of 1
Device Name: Lifecore Stage-1 Angled Abutment System
Indications for Use:
The Lifecore Stage-1 Angled Abutment is intended to attach to an endosseous implant and provide support and retention for single or multi-unit (splinted) cement retained restorations in the mandible or maxilla where angle correction is required.
K032495 Lee Mulky fan KIR
esthesiology, General Hospital, ontrol. Dental Devices
510(k) Number ..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.