(64 days)
The Variable Parallel Pin is intended to provide a visual reference for evaluating parallelism, prosthetic fit and implant spacing between implants and natural teeth during implant placement surgery.
The Variable Parallel Pin is indicated for use in evaluating parallelism and fit of the many implant maning and fit of prosthetics with up to 25 degrees and to gadge implaire opensy lants and adjacent natural teeth.
The Variable Parallel Pin consists of two pivoting pegs that lock in orientations from straight (0) to 25°. The Variable Parallel Pin has cuff width geometry's that match the flare diameters of prosthetic abutments.
This 510(k) submission (K973521) for the "Variable Parallel Pin" does not contain the detailed information required to describe acceptance criteria and a study proving device performance in the manner requested.
The document is a 510(k) summary and the FDA's clearance letter. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria.
Here's what can be inferred from the provided text, and what information is missing:
Information that CANNOT be Extracted from the Provided Text:
- A table of acceptance criteria and the reported device performance: This document does not present any specific acceptance criteria (e.g., accuracy percentages, precision metrics) or the results of a performance study against such criteria.
- Sample size used for the test set and the data provenance: No information on a test set, its size, or origin is provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: No ground truth establishment is described for a test set.
- Adjudication method for the test set: Not applicable as no test set is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance: This device is a mechanical surgical tool, not an AI or imaging device. Therefore, an MRMC study is not relevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described for a performance study.
- The sample size for the training set: Not applicable as this is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
What the Document DOES State (and why it doesn't fit the requested format directly):
The submission demonstrates substantial equivalence by comparing the "Variable Parallel Pin" to predicate devices (Sulzer Calcitek's Parallel Pins and Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit).
Key Statements Regarding Performance/Equivalence (though not formal "acceptance criteria"):
- Intended Use: "The Variable Parallel Pin is intended to provide a visual reference for evaluating parallelism, prosthetic fit and implant spacing between implants and natural teeth during implant placement surgery." (This describes the purpose but not quantifiable performance metrics.)
- Technological Characteristics: "The technological characteristics between the Variable Parallel Pin and the predicate devices are identical. The addition of a hinging mechanism combines the function of fixed angle pins into a single pin." (This implies that its function is equivalent to the combined function of existing devices.)
- Comparison Analysis: "The overall design of the Variable Parallel Pin is similar or identical to the predicate devices. The Variable Parallel Pin is substantially equivalent to the predicate devices in design, manufacturing, materials and intended use."
Conclusion:
This 510(k) summary does not contain the type of detailed performance study data, acceptance criteria, and ground truth establishment methodology typically found for devices like AI algorithms or diagnostic tools. Its clearance is based on demonstrating substantial equivalence in design, materials, and intended use to existing predicate devices, rather than meeting specific quantifiable performance metrics through a dedicated clinical or technical performance study. The FDA's letter explicitly states, "We have determined the device is substantially equivalent...".
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NOV 20 1997
510(K) SUMMARY RELEASABLE THROUGH FREEDOM OF INFORMATION
Pursuant to 513(i) of the Federal Food, Drug, and Cosmetic Act, as Amended.
| Company Name: | Sulzer Calcitek, Inc. |
|---|---|
| Address: | 2320 Faraday Avenue, Carlsbad, CA 92008 |
| Telephone Number: | (760) 431-9515 |
| Registration Number: | 2023141 |
| Contact Person: | Foster Boop |
| Date Summary Prepared: September 10, 1997 |
| Classification Name: | Implant, Endosseous (76DZE) |
|---|---|
| Common/Usual Name: | Dental Implant System |
| Device Trade Name: | Variable Parallel Pin |
1. Predicate Devices:
Sulzer Calcitek's Parallel Pins. Nobelpharma BRANEMARK SYSTEM® Abutment Selection Kit
Intended Use: 2.
The Variable Parallel Pin is intended to provide a visual reference for evaluating parallelism, prosthetic fit and implant spacing between implants and natural teeth during implant placement surgery.
3. Description:
The Variable Parallel Pin consists of two pivoting pegs that lock in orientations from straight (0) to 25°. The Variable Parallel Pin has cuff width geometry's that match the flare diameters of prosthetic abutments.
Technological Characteristics: 4.
The technological characteristics between the Variable Parallel Pin and the predicate devices are identical. The addition of a hinging mechanism combines the function of fixed angle pins into a single pin.
રું. Comparison Analysis:
The overall design of the Variable Parallel Pin is similar or identical to the predicate devices. The Variable Parallel Pin is substantially equivalent to the predicate devices in design, manufacturing, materials and intended use.
SUMMARY INFORMATION - RELEASABLE THROUGH FOI
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 20 1997
Mr. Foster Boop Regulatory Affairs Associate Sulzer Calcitek Incorporated 2320 Faraday Avenue 92008 Carlsbad, California
K973521 Re : Variable Parallel Pin Trade Name: Requlatory Class: III DZE Product Code: September 15, 1997 Dated: September 17, 1997 Received:
Dear Mr. Boop:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Boop
through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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Page 1 of 1
510(k) Number (if known):___K973521
Device Name: Variable Parallel Pin
Indications For Use:
The Variable Parallel Pin is indicated for use in évaluating parallelism
and fit of the many implant maning and fit of prosthetics with The Variable Paraller Pun is Intricated for and fit of prosthetics with up to 25 degrees and to gadge implaire opensy lants and adjacent natural teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Gerald Shippers |
|---|---|
| --------------------- | ----------------- |
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K973521 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.