(90 days)
The NT/IT System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The NT/IT System is for one and two stage surgical procedures. It is not for immediate load.
The NT/T System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
The NT/IT System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The NT/IT System is substantially equivalent in design, function and intended use to the SS System(K062051), GS System(K063861) and US/SS/GS System(K073247) of Osstem Implant Co., Ltd., NobelEsthetics (K072570) of NobelBiocare USA LLC and SynOcta Prosthetic System(K073628) and Solid Abutment Prosthetic System(K080286) of STRAUMANN USA LLC
The provided text describes an FDA 510(k) premarket notification for a dental implant system called the "NT/IT System." This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully extracted from the provided text. The document's purpose is to demonstrate that the new device is "substantially equivalent" to existing, legally marketed devices, implying that its safety and effectiveness are understood to be similar based on its shared characteristics with those predicates.
Here's an analysis of what can be gleaned, and where the information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "review" section mentions safety tests including biocompatibility to ensure compliance with "applicable International and US regulations," but no specific numerical criteria are given.
- Reported Device Performance: Not provided numerically. The document states, "The NT/IT System has been subjected to safety, performance, and product validations prior to release." However, the results of these validations are not detailed. Instead, the conclusion is: "Osstem concludes that the NT/IT System is safe and effective and substantially equivalent to the predicate device as described herein."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Ground Truth Experts: Not applicable/not mentioned. This type of detailed study is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. This document pertains to a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable/not mentioned. Again, this is for a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The document implies that the "ground truth" for the device's safety and effectiveness is established by its similarity to predicate devices that have already demonstrated safety and effectiveness through their regulatory history and clinical use. There is no mention of a specific ground truth dataset like pathology or outcomes data for this specific premarket notification.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not mentioned. This document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable/not mentioned.
Summary of what the document does provide regarding the device's validation:
- Device Name: NT/IT System
- Intended Use: For use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cemented, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. For one and two-stage surgical procedures (not for immediate load).
- Safety & Performance Statement: "The NT/IT System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." (However, no specific data or acceptance criteria for these validations are provided in the summary.)
- Conclusion: The device is "safe and effective and substantially equivalent to the predicate device."
- Predicate Devices:
In essence, this 510(k) summary asserts equivalence to established devices based on material, indication for use, design, and technological characteristics, rather than presenting a detailed study with explicit acceptance criteria and performance data for the NT/IT System itself.
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Image /page/0/Picture/0 description: The image shows the logo for Osstem. The logo includes a circular graphic to the left of the text "OSSTEM". Below the graphic is the text "osstem". Below the text "OSSTEM" is the address "#507-8 Geoje3-Dong" and the phone number "Tel: +82 51 850-2500".
OSSTEM Implant Co., Ltc #507-8 Geoie3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
JUL 1 5 2008
510(k) Summary
KO81078
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date : April 10, 2008
- Company and Correspondent making the submission:
| - Submitter's Name : | OSSTEM Implant Co., Ltd. |
|---|---|
| - Address : | #507-8 Geoje3-Dong Yeonje-GuBusan, 611-804, Republic of Korea |
| - Contact : | Mr. JongHyuk Seo |
| Device : |
Trade or (Proprietary) Name : Common or usual name :
Classification Name :
NT/IT System Dental Implant Endosseous Dental Implant 21 CFR872.3640 Class II DZE
3. Predicate Device :
The NobelEsthetics, NobelBiocare USA LLC, K072570 The SynOcta Prosthetic System, STRAUMANN USA LLC, K073628 The Solid Abutment Prosthetic System, STRAUMANN USA LLC, K080286 The SS System, Osstem Implant Co., Ltd, K062051 The GS System, Osstem Implant Co., Ltd, K063861 The US/SS/GS System, Osstem Implant Co., Ltd, K073247
-
- Description :
The NT/T System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
- Description :
The NT/IT System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The NT/IT System is substantially equivalent in design, function and intended use to the
QS-QI-505-3(Rev.0)
Letter(8.5 X 1 l in)
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Image /page/1/Picture/0 description: The image shows a logo. The logo is a circular shape with a gap in the upper right quadrant. Below the logo, there is some text, but it is too blurry to read. The logo is black and white.
OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
SS System(K062051), GS System(K063861) and US/SS/GS System(K073247) of Osstem Implant Co., Ltd., NobelEsthetics (K072570) of NobelBiocare USA LLC and SynOcta Prosthetic System(K073628) and Solid Abutment Prosthetic System(K080286) of STRAUMANN USA LLC
-
- Indication for use :
The NT/IT System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The NT/T System is for one and two stage surgical procedures. It is not for immediate load.
- Indication for use :
-
- Review :
The NT/IT System has similar material, indication for use, design and technological characteristics as the predicate device.
- Review :
The NT/IT System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations.
-
- Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the NT/IT System is safe and effective and substantially equivalent to the predicate device as described herein.
- Conclusion :
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2008
OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Osstem, Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K081078
Trade/Device Name: NT/IT System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 10, 2008 Received: April 16, 2008
Dear Mr. Kim:
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 vour 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 – Mr. Kim
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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Antony D. Arata Jr.
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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Image /page/4/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo features a stylized circular design with the company name "osstem" written below it. The contact information includes the address "#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea", telephone number "+82 51 850-2500", fax number "+82 51 850-4341", and website "www.osstem.com".
510(k) Number K Q&1078
Device Name: NT/IT System
Indication for use : The NT/IT System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The NT/IT System is for single and two stage surgical procedures. It is not for immediate load.
Prescription Use_ X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert B.L.DMS for Dr. Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KO81078 510(k) Number:
QS-QI-505-2(Rev.0)
Letter(8.5 X 11in)
§ 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.