(144 days)
The HS II Short Fixture 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 HS II Short Fixture System is for single and two stage surgical procedures. It is not for immediate load.
The HS II Short Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.
This report describes a 510(k) premarket notification for the "HS II Short Fixture System," a dental implant device. The provided text mainly focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study specifically designed to assess its performance against predefined acceptance criteria for a new AI/medical device.
Therefore, the requested information regarding acceptance criteria and performance against those criteria, especially in the context of an AI device, cannot be extracted from this document. The document confirms the device's material, indications for use, and technological characteristics are similar to the predicate devices, leading to a conclusion of substantial equivalence.
However, based on the provided text, here's a breakdown of what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in this context. The document is a 510(k) summary for a legacy medical device (dental implant). It does not present acceptance criteria or reported performance metrics in the way an AI/software device would, such as sensitivity, specificity, accuracy, or AUC. The "performance" assessment here is focused on demonstrating that the new device is "substantially equivalent" to existing, legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This document describes a dental implant, not an AI or software device that would typically use test sets of data for performance evaluation. Product testing for a device like this would involve mechanical, biological, and material properties testing, not data-driven performance assessments against a ground truth dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. As above, there is no "test set" in the context of AI or diagnostic imaging for this device. The regulatory submission relies on comparison to predicate devices and established standards for dental implants.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication is discussed in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This document pertains to a physical dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to readers improving with AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable. No "ground truth" (in the sense of a definitive diagnosis or outcome for data evaluation) is discussed here. The "truth" for this device's approval lies in its material composition, design, and functional equivalence to legally marketed predicates.
8. The Sample Size for the Training Set:
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set, there is no ground truth establishment for it.
In summary, the provided 510(k) summary for the "HS II Short Fixture System" is exclusively focused on demonstrating substantial equivalence to predicate dental implants through a comparison of their materials, design, indications for use, and technological characteristics. It is not a study about an AI/software device and therefore does not contain information about acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, or human-AI interaction studies typically associated with such devices.
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Image /page/0/Picture/1 description: The image shows the logo for Osstem. The logo consists of a stylized circular design above the word "osstem" in lowercase letters. A line is drawn underneath the word "osstem".
SSTEM 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
510(k) Summary
MAY - 1 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: November 20, 2008
- Company and Correspondent making the submission:
- Submitter's Name :
- Address :
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
- Contact :
Mr. JongHyuk Seo
- Device :
Trade or (Proprietary) Name : Common or usual name :
Classification Name :
HS II Short Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
-
- Description :
The HS II Short Fixture 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 HS I Short Fixture 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 HS II Short Fixture System is substantially equivalent in design, function and intended use to the HS II Fixture System (K080387) of HIOSSEN Inc. and Straumann Standard Implant (K033922) of Institut Straumann Ag.
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Image /page/1/Picture/1 description: The image shows the logo for Osstem. The logo consists of a circular design with two crescent shapes facing each other within the circle. Below the logo, the word "osstem" is written in lowercase letters.
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
5. Indication for use :
The HS I Short Fixture 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 HS II Short Fixture System is for one and two stage surgical procedures. It is not for immediate load.
6. Review :
The HS II Short Fixture System has similar material, indication for use, design and technological characteristics as the predicate device.
7. Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the HS II Short Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Public Health Service
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Hiossen Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K083633
Trade/Device Name: HS II Short Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 1, 2009 Received: May 1, 2009
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 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Susan Runner, D.D.S., MA
Acting 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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OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korca Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Number K 083433
osstem
Device Name : HS I Short Fixture System
Indication for use : The HS II Short Fixture 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 HS II Short Fixture 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)
Kein Mibley for MSR
(Division Sign-Off)
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Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083633
QS-QI-505-2(Rev.0)
Letter(8.5 X 1 in)
§ 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.