(341 days)
The ETII Bio-SA 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 ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intend for delayed loading.
The ETII Bio-SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface treatment is Bio-SA. ETII Bio-SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has Bio-SA surface treatment. ETIII Bio-SA Fixture is coated with nano thickness calcium phosphate on the SA surface of Al2O3 blasting & acid etching.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ETIII Bio-SA Fixture System:
Based on the provided 510(k) summary (K112532), this document does not describe a study that uses acceptance criteria related to typical performance metrics like sensitivity, specificity, accuracy, or other statistical measures often associated with medical device performance studies (e.g., for diagnostic algorithms or imaging devices).
Instead, this 510(k) submission focuses on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" here are defined by the regulatory requirements for showing that the new device is as safe and effective as existing legally marketed devices, primarily through comparison of design, materials, intended use, and non-clinical testing.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission as they are for a different kind of device performance evaluation.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence to Predicate Devices) | Reported Device Performance / Characteristics (New Device: ETIII Bio-SA Fixture System) |
|---|---|
| Intended Use: Comparable to predicate devices. | "The ETII Bio-SA 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 ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intend for delayed loading." (Matches predicates closely). |
| Technological Characteristics: Similar design, materials, and function to predicate devices. | Material: Pure Titanium Grade 4 (ASTMF67-06) - Same as predicates. |
| Structure: Single Thread, Taper body Type, Self tapping, Submerged fixture - Similar to ETIII SA (K101096). | |
| Connection: Internal hex connection - Same as ETIII SA (K101096). | |
| Diameter (D): 3.5~5.0mm - Similar to most predicates. | |
| Length (mm): 7.0~15.0mm - Similar to most predicates. | |
| Safety and Effectiveness: Demonstrated through biocompatibility and mechanical testing, comparable to predicate performance. | Surface: Bio-SA (Al2O3 blasting & acid etching with nano thickness calcium phosphate) - Different from ETIII SA (RBM) but similar to NanoTite (NanoTite) and manufacturing process similar to Dio Biotite-H (HA). "The ETIII Bio-SA Fixture System has similar the surface treatment as the NanoTite PREVAIL Implant and the manufacturing process as the Dio Biotite-H Implant System." |
| Sterilization: Radiation Sterile - Same as predicates. | |
| Fatigue Testing: Performed according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" using the worst-case scenario of a similar device (GSIII Fixture and angled abutment). Conclusion: The fatigue test result of GSIII Fixture System can be used as a proof of ETIII Bio-SA Fixture given similar material and design. | |
| Biocompatibility Testing: Conducted according to ISO 10993-5, ISO 10993-6, ISO 10993-10, and ISO 10993-11. Results were in compliance. | |
| No New Questions of Safety or Effectiveness: The differences between the new device and the predicate devices do not raise new questions of safety or effectiveness. | The submission concludes: "Based on the information provided in this premarket notification HiOSSEN concludes that the ETIII Bio-SA Fixture System is substantially equivalent to the predicate device as described herein." |
Regarding the device and studies for typical AI/algorithm performance (which are not in this document):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes non-clinical laboratory testing of a physical implant, not an AI/algorithm-driven device evaluated with patient data.
- 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. Ground truth for this device involves material properties, mechanical strength, and biocompatibility, not expert interpretation of data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests mentioned:
- Fatigue Testing: Ground truth is established by engineering standards and specifications, i.e., whether the implant can withstand specified forces for a certain number of cycles without failure.
- Biocompatibility Testing: Ground truth is established by the pass/fail criteria defined in the ISO 10993 series of standards for assessing biological effects (e.g., cytotoxicity, irritation, sensitization).
- The sample size for the training set: Not applicable. This isn't an AI/machine learning device. The "training" for a physical device like this involves designing and manufacturing processes to meet specifications.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study Information Provided in the 510(k):
The device (ETIII Bio-SA Fixture System) demonstrated "acceptance" by establishing substantial equivalence to three predicate devices (ETII SA Fixture System K101096, NanoTite PREVAIL Implant K072363, and Dio Biotite-H Implant System K073070) through:
- Comparison of Intended Use: Shown to be identical.
- Comparison of Design and Materials: Material (Pure Titanium Grade 4), diameter, length, structure (single thread, taper body type, self-tapping, submerged), and connection (internal hex) were shown to be the same or similar to the predicates.
- Surface Treatment: While different from one predicate (ETIII SA Fixture, which was RBM), the Bio-SA surface treatment was deemed similar to another predicate (NanoTite PREVAIL Implant) which used NanoTite, and the manufacturing process was similar to the Dio Biotite-H Implant System. The key here is that the new surface did not raise new questions of safety or effectiveness.
- Non-Clinical Testing:
- Fatigue Testing: Performed with a representative worst-case scenario using a "GSIII Fixture and an angled abutment" (a system with similar material and design to the ETIII Bio-SA Fixture). The results from this predicate/similar device were used as proof for the new device.
- Biocompatibility Testing: Performed according to ISO 10993 standards (ISO 10993-5, -6, -10, -11) and demonstrated compliance.
- No Clinical Testing: The submission explicitly states "No clinical studies are submitted," indicating that the regulatory pathway required only non-clinical data for substantial equivalence.
This is a common approach for demonstrating the safety and effectiveness of new medical devices that are similar to existing ones, particularly Class II devices like dental implants.
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112532
AUG
6 2012
Image /page/0/Picture/1 description: The image shows the word "Hiossen" in a bold, sans-serif font. The "O" in "Hiossen" is stylized with a curved line extending from the top of the "O" and arching over the "H". The text is black against a white background.
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.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.
HiOSSEN Inc.
888 678 0001
Mr. Patrick Lim
85 Ben Fairless Dr. Fairless Hills PA 19030
Date : Aug 31th, 2011
- Company and Correspondent making the submission:
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Submitter's Name :
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Address :
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- Telephone No.
- Contact :
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- Device :
Trade or (Proprietary) Name : Common or usual name : Classification Name :
- Device :
ETII Bio-SA Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE
4. Description :
I) The ETII Bio-SA Fixture System is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface treatment is Bio-SA.
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- ETII Bio-SA Fixture is composed of single threads with internal hex connection taper body of bone level for two stage surgery. It has Bio-SA surface treatment.
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- ETIII Bio-SA Fixture is coated with nano thickness calcium phosphate on the SA surface of Al2O3 blasting & acid etching
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Image /page/1/Picture/0 description: The image shows the word "HIOSSEN" in a bold, sans-serif font. The letters are all capitalized and black. The top of the "T" in the word has a curved extension over the "O".
Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
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- The ETIII Bio-SA 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.
| ETIII Bio-SA Fixture | Predicate devices | |||
|---|---|---|---|---|
| ETIII SA Fixture(K101096) | NanoTite PREVAILImplant (K072363) | Dio Biotite-HImplant System(K073070) | ||
| Manufacturer | HIOSSEN Inc. | HIOSSEN Inc. | Biomet 3I Inc. | DIO Department, DSI,Inc. |
| IntendedUse | The ETIII Bio-SAFixture System isindicated for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including ;cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. The ETIIIBio-SA Fixture System isfor single and two stagesurgical procedures. It isintendedfordelayedloading. | The ETIII SA FixtureSystem is indicated foruse in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including :cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. The ETIIISA Fixture System is forsingle and two stagesurgical procedures. It isnot for immediate load. | BIOMET 3i dentalimplants are intended forsurgical placement in theupper or lower jaw toprovide a means forprosthetic attachment insingle tooth restorationsand in partially or fullyedentulous spans withmultiple single teethutilizing delayed orimmediate loading, or asa terminal orintermediary abutmentfor fixed or removablebridgework, and to retainoverdentures. BIOMET3i NanoTite dentalimplants are intendedfor immediate functionon single tooth and/ormultiple toothapplications when goodprimary stability isachieved, withappropriate occlusalloading, in order torestore chewing function. | The DIO Biotite-HImplant System is anendosseous dentalimplant that is indicatedto use for surgicalplacement in the upperand lower jaw arches, toprovide a root formmeans for single ormultiple units' prostheticappliance attachment torestore a patient'schewing function. Also,angled abutments onsmall diameter implants(3.8mm) of the DIOBiotite-H Implant Systemare intended for theanterior region of themouth and not intendedfor the posterior region ofthe mouth due to possiblefailure of the implant. |
| Structure | -Single Thread-Taper body Type-Self tapping-Submerged fixture | -Single Thread-Taper body Type-Self tapping-Submerged fixture | -Single Thread-Straight body Type-submerged fixture | Morse taper with thread |
| Connection | Internal hex connection | Internal hex connection | Internal connection | Internal connection |
- Substantial Equivalence Matrix
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Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004
| Type | ||||
|---|---|---|---|---|
| Diameter (D) | 3.5~5.0 | 3.5~5.0 | 3.25~5.0 | 3.8~5.3 |
| Length (mm) | 7.0~15.0 | 7.0~15.0 | 8.5-15.0 | 8.0~14.0 |
| Material ofFixture | Pure Titanium Grade 4(ASTMF67-06) | Pure Titanium Grade 4(ASTMF67-06) | Pure Titanium Grade 4(ASTMF67-06) | Pure Titanium Grade 4(ASTMF67-06) |
| Surface | Bio-SA | RBM | NanoTite | HA |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| S & E | The ETIII Bio-SA Fixture System has same material, indication for use and design as the ETIII SA FixtureSystem. But they have different surface treatment. The ETIII Bio-SA Fixture System has similar the surfacetreatment as the NanoTite PREVAIL Implant and the manufacturing process as the Dio Biotite-H ImplantSystem |
5. Indication for use :
The ETII Bio-SA 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 ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intend for delayed loading.
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- Review :
The ETIII Bio-SA Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device.
- Review :
The ETIII Bio-SA 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.
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- Summary of nonclinical testing
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- Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GSIII Fixture and an angled abutment in support of the ETII Bio-SA Fixture. The ETIII Bio-SA Fixture System has same material and similar design as the GSIII Fixture System.
Therefore, the fatigue test result of GSIII Fixture System can be used as a proof of ETШ Bio-SA Fixture.
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- The biocompatibility test was conducted according to ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11. The results are in compliance with it.
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- Summary of clinical testing No clinical studies are submitted
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Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
- Conclusion :
Based on the information provided in this premarket notification HiOSSEN concludes that the ETIII Bio-SA Fixture System is substantially equivalent to the predicate device as described herein.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Patrick Lim Manager of Quality Assurance & Regulatory Affairs Hiossen Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
AUG 6 2012
Re: K112532
Trade/Device Name: ET III Bio-SA Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 17, 2012 Received: August 1, 2012
Dear Mr. Lim:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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- Mr. Lim
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hu for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Tel : 1-888-678-0001 / Fax : 1-267-759-7004 www.hiossen.com
510(k) Number K
Device Name : ETIII Bio-SA Fixture System
Indication for use : ETIII Bio-SA 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. ETⅢ Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.
X Prescription Use (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)
Sheena Green for Dr. Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
6112532 510(k) Number: -
§ 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.