(122 days)
The HG II 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 HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.
The HG II 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.
The provided document describes a 510(k) premarket notification for the "HG II Fixture System," a dental implant device, and focuses on demonstrating its substantial equivalence to existing predicate devices.
This type of submission does not involve clinical studies with acceptance criteria, human readers, or ground truth establishment in the way requested for software algorithms or diagnostic devices. Instead, substantial equivalence is established by comparing the new device's material, design, function, intended use, and performance characteristics to legally marketed predicate devices.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not applicable to this 510(k) submission.
Here's an explanation based on the document:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) or quantitative performance metrics from a study that would typically be presented in such a table. The evaluation is based on demonstrating similarity to predicate devices rather than meeting a pre-defined performance threshold against a "ground truth."
- The document states: "The HG II Fixture 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, the specific results or acceptance criteria for these internal validations are not detailed in this 510(k) summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No "test set" in the context of an algorithm or diagnostic study is mentioned. This filing is about a medical device (dental implant).
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):
- Not Applicable. No ground truth establishment by experts for a test set is part of this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is relevant to this submission.
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:
- Not Applicable. This is a hardware medical device (dental implant), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. No "ground truth" as typically defined for diagnostic or AI devices is used in this 510(k) submission. The evaluation relies on demonstrating equivalence to predicate devices through comparisons of material properties, design, intended use, and safety testing (biocompatibility).
8. The sample size for the training set:
- Not Applicable. No training set, as typically understood for machine learning or AI models, is used for this device.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or associated ground truth establishment is relevant to this 510(k) submission.
In summary, this 510(k) document demonstrates substantial equivalence by:
- Comparing the device's material, indication for use, design, and technological characteristics to predicate devices.
- Stating that safety tests, including biocompatibility, were performed. (The specific results of these tests are not provided in this public summary, but would have been part of the full 510(k) submission.)
- Concluding that based on this information, the device is safe, effective, and substantially equivalent.
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JUL 1 7 2008
Image /page/0/Picture/1 description: The image shows a logo with the word "osstem" in lowercase letters below a circular graphic. The graphic is composed of two curved lines that form an incomplete circle, with the top curve being thicker than the bottom curve. The logo is in 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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: March 10, 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 :
HG II Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
3. Predicate Device :
The GS System, Osstem Implant Co., Ltd, K063861 The OsseoSpeed™, Astra tech Inc, K053384
4. Description :
The HG II 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.
The HG II 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 HG II Fixture System is substantially equivalent in design, function and intended use to the GS System(K063861) of Osstem Implant Co., Ltd and OsseoSpeed™ (K053384) of Astra tech Inc.
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Image /page/1/Picture/0 description: The image shows a logo with a circular design at the top and the word "osstem" in lowercase letters below it. The circular design consists of two curved shapes that resemble crescent moons facing each other, creating a sense of enclosure. The word "osstem" is written in a simple, sans-serif font, and the overall design is clean and modern.
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 HG I 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 HG II Fixture System is for single and two stage surgical procedures. It is not for . immediate load.
6. Review :
The HG II Fixture System has similar material, indication for use, design and technological characteristics as the predicate device.
The HG II Fixture 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.
7. Conclusion :
Based on the information provided in this premarket notification Osstem concludes that the HG II Fixture System is safe and effective and substantially equivalent to the predicate device as described herein.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OSSTEM Implant Company, Limited C/O Mr. MinJoo Kim Manager Osstem, Incorporated One Ben Fairless Drive Fairless Hills, Pennsylvania 19030
JUL 1 7 200
Re: K080744
Trade/Device Name: HG H Fixture System Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 11, 2008 Received: July 14, 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 prematket 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 - 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 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 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 vour 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
Chiu Lin, Ph.D.
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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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
510(k) Number K O80744
Device Name: HG II Fixture System
Indication for use : The HG II 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 HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load.
Prescription Use 文 (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)
Susar Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K080744
QS-QI-505-2(Rev.0)
§ 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.