(891 days)
This device 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, and to restore the patient's chewing function.
The Quantum Versatility Implants are screw-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Quantum Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112.
This document describes a 510(k) submission for the Quantum Versatility Implant System, a dental implant device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through novel studies. Therefore, many of the requested sections (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted directly from this type of regulatory submission.
The core of this submission is a claim of equivalence to existing devices that have already been proven safe and effective.
Here's an analysis based on the provided text, addressing the points where information is available or noting where it's not applicable:
Analysis of Acceptance Criteria and Study for Quantum Versatility Implant System
This 510(k) submission for the Quantum Versatility Implant System relies on demonstrating substantial equivalence to predicate devices rather than conducting a new efficacy study against specific, novel acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the device is functionally and materially similar to legally marketed devices. The "study that proves the device meets the acceptance criteria" in this context is the literature review and comparison to established predicate devices and their historical performance.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission for substantial equivalence, formal, quantitative acceptance criteria and device performance metrics (e.g., sensitivity, specificity, accuracy for an AI device) as typically understood are not explicitly stated or measured for the Quantum Versatility Implant System itself in this document. Instead, the acceptance criteria are implicitly derived from the established performance and safety of the predicate devices.
| Acceptance Criterion (Implicitly based on Predicate Devices) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Material Composition: Use of high-purity titanium or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). | Quantum Versatility Implant System: Manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Coated forms (hydroxyapatite or titanium plasma spray) also available, equivalent to other market devices. |
| Design and Manufacturing Concepts: Screw-type endosseous dental implants, similar to preamendment and equivalent devices. | Quantum Versatility Implant System: Screw-type endosseous dental implants with design and manufacturing concepts quite similar to the preamendment device and to others rated substantially equivalent. |
| Intended Use: Surgically placed in jaw bone to support prosthetic devices and restore chewing function. | Quantum Versatility Implant System: Intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function. (Matches predicate devices and preamendment devices). |
| Safety and Effectiveness: Proven safety and effectiveness through years of use of similar devices. | Quantum Versatility Implant System: Safety and effectiveness are inferred by substantial equivalence to well-established devices (e.g., Branemark implant technique, DB Precision, Sabertech, etc.) which have been "proved safe and effective through the years." |
| Biocompatibility: Materials meet ASTM voluntary standards. | Quantum Versatility Implant System: Materials meet ASTM voluntary standards. (Specific ASTM standards are not detailed but the claim is made). |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" or a new study of the Quantum Versatility Implant System with a specific sample size. The substantial equivalence argument relies on a comprehensive literature review and comparison to predicate devices, which collectively represent decades of clinical experience.
- Data Provenance: The "data" provenance is primarily from published scientific literature (Medline search, Consensus Development Conference on Dental Implants, 10-year study by Zarb on Branemark implants), regulatory records of predicate devices cleared by the FDA, and market history of preamendment devices. This data would generally be considered retrospective in the context of this submission, as it looks back at prior studies and existing devices. The country of origin of the data is primarily international and US-based for the literature, given the context of dental implant research and regulatory approvals.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as there was no new "test set" and a corresponding "ground truth" established specifically for the Quantum Versatility Implant System's performance within this submission. The "ground truth" for the safety and effectiveness of dental implants in general implicitly comes from the vast body of scientific literature and consensus among the dental and medical community over many years. The 1988 Consensus Development Conference on Dental Implants (NIH) cited in the document would involve multiple experts, though their specific qualifications beyond being part of such a conference are not detailed here.
4. Adjudication Method for the Test Set
This is not applicable as there was no new "test set" requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a physical dental implant, not an AI or imaging diagnostic device where MRMC studies would typically be performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical dental implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the safety and effectiveness of endosseous implants, on which the substantial equivalence argument rests, is based on:
- Expert Consensus: Highlighted by the "Consensus Development Conference on Dental Implants" (NIH, 1988), which summarized available scientific data.
- Outcomes Data: Referenced through the "detailed Toronto 10-year study by Zarb" concluding predictability and reliability of the Branemark implant technique, which serves as a benchmark for the field.
- Literature Review: A comprehensive Medline search (653 entries + 111 new review articles) providing a summary of scientific data on dental implants.
- Historical Clinical Experience: The document frequently refers to implants being "proved safe and effective through the years" and "wide-spread usage."
8. Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. The "training" for the substantial equivalence claim comes from the collective body of scientific literature and clinical experience with dental implants over decades.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated above. The "ground truth" for the broader field of dental implantology, as derived from the literature review, was established through traditional clinical research, long-term follow-up studies, and expert consensus.
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XIV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)
A. Submitter: Raul R. Mena, Quantum BioEngineering, Ltd., 201 N. University Dr., Plantation, Florida, 33324
I. Classification Name and Number: Endosseous Implant (76DZE),
II. Common/Usual Name: Dental Implant, Endosseous, Post- or Screw-type, titanium or titanium alloy.
III. Proprietary Name: Quantum Versatility Implant System
IV. Classification: This device is being finally classified by the Dental Devices Panel (Title 21 CFR 872.3640.
V. Performance standards: None applicable. Materials meet ASTM voluntary standards
VI. Description: The Quantum Versatility Implants are screw-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Quantum Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112.
VII. Labels and Instructions for Use are provided, as are labels for competitive products.
VIII. Intended Use: These devices are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
IX. Substantial Equivalence: This device is equivalent to devices manufactured and sold before 1976,having a U. S. classification number of 76 DZE, and those described under 21 CFR 872.3640. It is also equivalent to several devices currently on the market that have been determined by the FDA to be substantially equivalent to the above preamendment devices. Some examples of other equivalent products are:
Bofors Nobelpharma, Goteborg, Sweden: Titanium Implant Device, K-820013; Boehringer/Miter Corp. of Warsaw, IN: Titanoloy P.S.I.; Driskell Bioengineering, Inc.,
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Westerville, OH: DB Precision Implants, K853788; Core-Vent Corp., Encino, CA: Screw-Vent Endosseous Implants, K-861426, A, B; Impla-med, Inc., Sunrise, FL: P.M.T. Surgical Implant Components, K-892124A: Steri-Oss (Subs. Denar, Anaheim, CA.). Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845. Artech, Inc., Chantilly, VA: Artech Submerged Screw Implant, K-891346, K-895267; Genentech, Seattle WA: Sabertech, K-924112; Astra Tech Inc., Astra Tech Implants, K-931767; and Vancouver Implant Resources, Inc., Simpler One Threaded Implant, K-974401.
VIII. Clinical Discussion and Brief Literature Review. Endosseous implants, and especially those of titanium or titanium alloy, in the "post" or "screw" configuration, have been proved safe and effective through the years. The possible adverse effects summarized in this 510(k) cover those listed by the United States classification panel [Federal Register, vol. 45, No. 251, pp 86025-6, Dec. 30, 1980], as well as to those revealed in a recent literature search. Matukas, "Medical Risks Associated with Dental Implants," states, "Little or no hard data could be found on the medical risks associated with [dental] implants." Because of the wide-spread usage of dental implants, Smith and Zarb made a careful review of the literature and proposed criteria for implant success.
A thorough computerized Medline literature search produced 653 entries. An update of this search produced 111 new review articles. The Journal of Dental Education published a special issue "Proceedings of the Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988], Vol. 52, No. 12, pp. 677-831, Dec. 1988. This added to the literature search above, with some especially pertinent reprints from the scientific literature, provide a comprehensive summary of available scientific data.
Zarb completed his report of the detailed Toronto 10-year study by concluding that "the tried and tested Branemark implant technique has revolutionized the treatment options open to the prosthodontist. For the edentulous patient...the prospect for a lifetime of restored oral comfort, function, and appearance have now become predictable and reliable." These results are ample evidence of the safety and effectiveness of these endosseous implants.
END OF 510(k) SUMMARY
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
SEP 2 0 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Raul R. Mena, D.M.D. President Quantum BioEngineering, Ltd. 201 University Drive Suite 101 Plantation, Florida 34134
Re : K991250 Quantum™ Versatility Implant System Trade Name: Requlatory Class: III Product Code: DZE Dated: April 7, 1999 April 13,1999 Received:
Dear Raul R. Mena, D.M.D.:
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, Druq, 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, 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Raul R. Mena, D.M.D.
this response to your premarket notification Please note: Please note: "Chis response co your action you might have under submission does not afreed any can for devices under the Sections 331 chrough 342 on one on one of other Federal laws or regulations.
This letter will allow you to begin marketing your device as This lecter will arrow you co respect notification. - The FDA described in your 510 kr prumence of your device to a legally finding of substancial equivalence of yolassification for your marketed predicate device robated in to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 crk Farss), please contact the Office of Vitto diagnostic devices), prouble one of accessor of the contact Compliance at (301) 354 1032 of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation encrease, Mibranding of 97). Other general premation on your responsibilities under the Act may be information on your responsible and Manufacturers Assistance obtained from the Division of 6:00 or (301) 443-6597 or at at its coll-free number (000)- oo =aa.gov/cdrh/dsmamain.html".
its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Pattacia Cusente for
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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IX. Indications for Use: [Separate Page]
K991250 510(k) Number: 仙谷
Device Name: Quantum Versatility™ Implant System
This device 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, and to restore the patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use __
(Optional Format 1-2-96)
8
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
***imber -
§ 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.