(162 days)
No
The summary describes a physical dental implant system and its components, focusing on materials, surface treatment, and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes
The device is designed to restore a patient's chewing function by providing prosthetic attachment, which addresses a physiological dysfunction (loss of teeth and chewing ability).
No
The device is a dental implant system designed to restore chewing function and provide support for prosthetic devices, not to diagnose a medical condition.
No
The device description clearly states it is a "substructure of a dental implant system made of CP Ti Grade 4" and lists physical components like "Comfort Cap". The performance studies also focus on physical properties and testing of the implant itself (sterilization, shelf life, surface treatment, fatigue testing). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a dental implant system designed for surgical placement in the jaw to support prosthetic devices and restore chewing function. This is a surgical and prosthetic device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a dental implant fixture made of CP Ti Grade 4. This is a physical implant intended for surgical insertion.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is a medical device, specifically a dental implant system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The Advanced Intermezzo Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. The system offers the following components. - Comfort Cap
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw, mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Sterilization validating testing has been performed in accordance with ISO 11137 -1.2.3
- The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 year shelf life.
- The following tests were done to evaluate the fixtures that have SLA treatment: Surface Morphology by energy dispersive spectrometer (EDS), Surface Roughness Analysis, GC(Gas Chromatography)/LC (Liquid chromatography) Analysis, and IC Analysis.
- The fixture has the same material as the predicate device (K051018), the cap to protect abutment parts has the same material as the predicate device (K051018). The biocompatibility of the predicate final products was evaluated under the previous 510K submission.
- The endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL which was referenced from the USP 39 .
- Comparative fatigue testing per ISO 14801 was conducted on the subject device and primary predicate. The test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
October 8, 2019
MegaGen Implant Co., Ltd. JiYoung Son Assistant Reserch Engineer 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun Daegu REPUBLIC OF KOREA
Re: K191127
Trade/Device Name: Advanced Intermezzo Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 20, 2019 Received: July 10, 2019
Dear JiYoung Son:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Srinivas Nandkumar for Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191127
Device Name
Advanced Intermezzo Implant St stem
Indications for Use (Describe)
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodonic one-stage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants.
The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition. Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C )
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3
V. 510(k) SUMMARY (K191127)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: October 08, 2019
Applicant / Submitter 1.
MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2828
2. Submission Correspondent
JiYoung Son MegaGen Implant Co., Ltd. 45, Secheon-ro, 7-gil, Dasa-eup, Dalesong-gun, Daegu, Republic of Korea Tel: + 82-53-222-2988 Fax: + 82-53-289-3420 Email: rnd_ra5@imegagen.com
3. Device
- Trade Name: Advanced Intermezzo Implant System "
- . Common Name: Endosseous Dental Implant
- Classification Name: Endosseous Dental Implant י
- " Product Code: DZE, NHA
- Classification regulation: Class II, 21 CFR 872.3640 .
4. Predicate Device:
- . Primary Predicate: K051018 Intermezzo Implant System
- . Reference Devices: K112540 S-MiNi Implant K123870 XPEED AnyRidge Internal Implant System
4
| Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | |
|---|---|---|---|---|
| 510(k) | ||||
| Number | K191127 | K051018 | K112540 | K123870 |
| Device | ||||
| Name | Advanced Intermezzo | |||
| Fixture | IntermezzoTM Implant | |||
| Fixture | S-MiNi Implant | XPEED AnyRidge Internal | ||
| Implant System | ||||
| Manufacturer | MegaGen Implant Co., | |||
| Ltd. | MegaGen Implant Co., | |||
| Ltd. | Neobiotech Co., Ltd. | MegaGen Implant Co., Ltd. | ||
| Indications | ||||
| for Use | ||||
| Statement | Advanced Intermezzo | |||
| Implant Systems is | ||||
| threaded one-piece | ||||
| implants designed for | ||||
| orthodontic one-stage | ||||
| surgical procedures in | ||||
| upper and lower jaw to | ||||
| provide a means of | ||||
| prosthetic attachment to | ||||
| restore a patient's chewing | ||||
| function. | ||||
| Advanced Intermezzo | ||||
| Implant System consists of | ||||
| single-stage, root-form | ||||
| dental implants. | ||||
| The system is designed to | ||||
| provide immediate | ||||
| provisional implant to | ||||
| provide temporary support | ||||
| for prosthetic devices | ||||
| during the healing phase of | ||||
| permanent root form | ||||
| implants. Depends on a | ||||
| patient's quality of bone | ||||
| condition, Advanced | ||||
| Intermezzo Fixtures are to | ||||
| be removed within six to | ||||
| ten weeks after the surgery. | ||||
| The system is intended for | ||||
| immediate placement in | ||||
| partially or fully | ||||
| edentulous mandibles and | ||||
| maxillae, in support of | ||||
| single or multiple-unit | ||||
| restorations including; | ||||
| cement retained, screw | ||||
| retained, or overdenture | ||||
| restorations. | IntermezzoTM Implant | |||
| Systems is threaded one- | ||||
| piece implants designed for | ||||
| orthodontic one-stage | ||||
| surgical procedures in | ||||
| upper and lower jaw to | ||||
| provide a means of | ||||
| prosthetic attachment to | ||||
| restore a patient's chewing | ||||
| function. | ||||
| IntermezzoTM Implant | ||||
| System consists of single- | ||||
| stage, root-form dental | ||||
| implants. | ||||
| The system is designed to | ||||
| provide immediate | ||||
| provisional implant to | ||||
| provide temporary support | ||||
| for prosthetic devices | ||||
| during the healing phase of | ||||
| permanent root form | ||||
| implants. Depends on a | ||||
| patient's quality of bone | ||||
| condition, IntermezzoTM | ||||
| Fixtures are to be removed | ||||
| within six to ten weeks | ||||
| after the surgery. The | ||||
| system is | ||||
| intended for immediate | ||||
| placement in partially or | ||||
| fully edentulous mandibles | ||||
| and maxillae, in support of | ||||
| single or multiple-unit | ||||
| restorations including; | ||||
| cement retained, screw | ||||
| retained, or overdenture | ||||
| restorations. | The S-MiNi Implant is | |||
| indicated for use in the | ||||
| treatment of missing | ||||
| maxillary lateral incisors or | ||||
| the mandibular central and | ||||
| lateral incisors to serve as | ||||
| temporary support | ||||
| prosthetic devices during | ||||
| the healing phase of | ||||
| permanent endosseous | ||||
| dental implant, such as | ||||
| artificial teeth, in order to | ||||
| restore chewing function in | ||||
| partially edentulous | ||||
| patients. | The Xpeed AnyRidge | |||
| Internal Implant System is | ||||
| intended to be surgically | ||||
| placed in the maxillary or | ||||
| mandibular molar areas for | ||||
| the purpose providing | ||||
| prosthetic support for | ||||
| dental restorations (Crown, | ||||
| bridges, and overdentures) | ||||
| in partially or fully | ||||
| edentulous individuals. It is | ||||
| used to restore a patient's | ||||
| chewing function. Smaller | ||||
| implants (less than Ø 6.0 | ||||
| mm) are dedicated for | ||||
| immediate loading when | ||||
| good primary stability is | ||||
| achieved and with | ||||
| appropriate occlusal | ||||
| loading. Larger implants | ||||
| are dedicated for the molar | ||||
| region and are indicated for | ||||
| delayed loading. | ||||
| Appearance | Image: silver colored implant | Image: gold colored implant | Image: silver colored implant | Image: dark blue colored implant |
| Material | CP Ti Grade 4 | CP Ti Grade 3 | CP Ti Grade 4 | CP Ti Grade 4 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Diameter(Ø) | 2.2/ 2.6/ 3.0 mm | 1.8/ 2.2/ 2.5/ 3.1 mm | 2.0 / 2.5/ 3.0/ 3.5 mm | Internal type |
| 4.0, 4.4, 4.9, 5.4, 5.9mm | ||||
| (For normal ridge) | ||||
| Length (mm) | 7.0/ 8.5/ 10.0/ 11.5/ 13.0 mm | 10.0/ 11.5/ 13.0/ 15.0 mm | 7.0/8.5/10.0/11.5/13.0/15.0 mm | 6.4, 6.9, 7.4, 7.9, 8.4mm |
| (For low ridge) | ||||
| Internal type | ||||
| 7.7, 9.2, 10.7, 12.2, | ||||
| 14.20, 17.2mm | ||||
| (For normal ridge) | ||||
| 7.9, 9.4, 10.9, 12.4, | ||||
| 14.4mm | ||||
| (For low ridge) | ||||
| Surface | ||||
| treatment | Sand-blasted, Large grit, | |||
| Acid-etched (S.L.A) | RBM | RBM | Sand-blasted, Large grit, | |
| Acid-etched (S.L.A) | ||||
| Implant-to- | ||||
| abutment | ||||
| connection | One-Piece Implant | One-Piece Implant | One-Piece Implant | Hex |
| Feature | Root-Form, Threaded | Root-Form, Threaded | Root-Form, Threaded | Tapered Form, Threaded |
| Sterilization | Sterile | Sterile | Sterile | Sterile |
| Principle of | ||||
| operation | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. | This product is a root-type | |||
| fixture which is inserted in | ||||
| the alveolar bone. | This product is a tapered | |||
| body fixture which is | ||||
| inserted in the alveolar | ||||
| bone. It replaces the | ||||
| functions of the missing | ||||
| teeth as a dental implant | ||||
| fixture. | ||||
| Shelf Life | 5 Years | 5 Years | - | 5 Years |
| Substantial Equivalence Discussion | ||||
| The subject device has the same material, indication for use, and principle of operation as the predicate device. | ||||
| The difference between the subject device has the same material, indication for use, and principle of operation as the predicate device. |
5
The unfect between the subject device and the difference in diameter and length is covered by reference 1 In comparison with fixture design, the test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.
6
| Comfort Cap | ||
|---|---|---|
| Subject Device | Predicate Device | |
| 510(k) Number | K191127 | K051018 |
| Device Name | Comfort Cap | |
| for Advanced Intermezzo System | Intermezzo Protective Cap | |
| for Intermezzo System | ||
| Manufacturer | MegaGen Implant Co., Ltd. | MegaGen Implant Co., Ltd. |
| Indications for | ||
| Use Statement | Advanced Intermezzo Implant Systems is threaded | |
| one-piece implants designed for orthodontic one-stage | ||
| surgical procedures in upper and lower jaw to provide a | ||
| means of prosthetic attachment to restore a patient's | ||
| chewing function. | ||
| Advanced Intermezzo Implant System consists of | ||
| single-stage, root-form dental implants. | ||
| The system is designed to provide immediate | ||
| provisional implant to provide temporary support for | ||
| prosthetic devices during the healing phase of | ||
| permanent root form implants. Depends on a patient's | ||
| quality of bone condition, Advanced Intermezzo | ||
| Fixtures are to be removed within six to ten weeks after | ||
| the surgery. The system is intended for immediate | ||
| placement in partially or fully edentulous mandibles | ||
| and maxillae, in support of single or multiple-unit | ||
| restorations including; cement retained, screw retained, | ||
| or overdenture restorations. | IntermezzoTM Implant Systems is threaded one-piece | |
| implants designed for orthodontic one-stage surgical | ||
| procedures in upper and lower jaw to provide a means | ||
| of prosthetic attachment to restore a patient's chewing | ||
| function. | ||
| IntermezzoTM Implant System consists of single-stage, | ||
| root-form dental implants. | ||
| The system is designed to provide immediate | ||
| provisional implant to provide temporary support for | ||
| prosthetic devices during the healing phase of | ||
| permanent root form implants. Depends on a patient's | ||
| quality of bone condition, IntermezzoTM Fixtures are to | ||
| be removed within six to ten weeks after the surgery. | ||
| The system is intended for immediate placement in | ||
| partially or fully edentulous mandibles and maxillae, in | ||
| support of single or multiple-unit restorations | ||
| including; cement retained, screw retained, or | ||
| overdenture restorations. | ||
| Appearance | Image: [Appearance of subject device] | Image: [Appearance of predicate device] |
| Diameter | 3.6 mm | 3.2 mm |
| Length | 9.0 mm | 9.2 mm |
| Surface treatment | Injection molding | Injection molding |
| Sterility | Non-sterile; intended for terminal sterilization via | |
| moist heat(autoclave) | Non-sterile; intended for terminal sterilization via | |
| moist heat(autoclave) | ||
| Angulation | Straight | Straight |
| Material | POM | POM |
| Principle of | ||
| operation | This product is a cap to prevent damage of tongue by | |
| the post area of fixture in oral cavity. | This product is a cap to prevent damage of tongue by | |
| the post area of fixture in oral cavity. | ||
| Substantial Equivalence Discussion | ||
| device. | The subject device has the same intended use, material, surface treatment, design, and principle of operation as the predicate | |
| The size range of the subject device is slightly different from the predicate devices. |
5. Description:
The Advanced Intermezzo Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method.
The system offers the following components. - Comfort Cap
7
Indication for use: 6.
Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic onestage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function.
Advanced Intermezzo Implant System consists of single-stage, root-form dental implants.
The system is designed to provide immediate provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
7. Basis for Substantial Equivalence
Advanced Intermezzo Implant System is substantially equivalent to the predicate devices in terms of intended use and technical characteristics. They are material and have similar design. There are slight differences in design, however, it is very minor not affecting substantial equivalence. We have performed the fatigue test, and the test result of fatigue test supported that the subject device is substantially equivalent to the predicate device.
Based on the information and test results provided in submission, we conclude that the subject device is substantially equivalent to the predicate devices.
8. Non-Clinical Testing
- · Sterilization validating testing has been performed in accordance with ISO 11137 -1.2.3
- · The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980 and the test results validated 5 year shelf life.
- The following tests were done to evaluate the fixtures that have SLA treatment: Surface Morphology by energy dispersive spectrometer (EDS), Surface Roughness Analysis, GC(Gas Chromatography)/LC (Liquid chromatography) Analysis, and IC Analysis.
- The fixture has the same material as the predicate device (K051018), the cap to protect abutment parts has the same material as the predicate device (K051018). The biocompatibility of the predicate final products was evaluated under the previous 510K submission.
- · The endotoxin testing will be conducted on every batch for the subject device with the testing limit of below 0.5 EU/mL which was referenced from the USP 39 .
- · Comparative fatigue testing per ISO 14801 was conducted on the subject device and primary predicate
9. Conclusion
Based on the similarities, we conclude that the Advanced Intermezzo Implant System is substantially equivalent to the predicate devices.