(64 days)
Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Honorst Implant System are devices made of titanium 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, and to restore the patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.
This is a 510(k) premarket notification for a medical device called "Honorst Implant System," a dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about the performance criteria of a device or a study proving that it meets them in the way described in your request.
The document is a submission to the FDA for market clearance, arguing that the new device is as safe and effective as devices already on the market. It describes the Honorst Implant System's features and compares them to predicate devices, particularly the "CHAORUM Implant System (K160536)" by the same manufacturer.
Here's why the requested information cannot be extracted from this document:
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Acceptance Criteria and Reported Device Performance: This document does not list explicit performance acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, specificity, etc.) for the Honorst Implant System. Instead, it argues that the device is "substantially equivalent" to existing devices based on similar design, materials, and intended use. The "Performance Data" section (page 6) states that "The verification/validation testing activities were conducted on the subject device for the modifications made" and that a "worst-case analysis demonstrated that the primary predicate remains the worst-case scenario with respect to fatigue testing." It also explicitly states that "Sterilization, shelf life, endotoxin, and biocompatibility testing were not conducted since the materials, surface treatments, packaging, and sterilization have not changed from the primary predicate device (K160536) and the device modifications do not raise a concern for the worst case for these tests." This means the performance data is primarily focused on mechanical aspects and demonstrating that changes did not negatively impact the existing safety/effectiveness profile, rather than establishing new performance metrics.
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Sample Size for Test Set and Data Provenance: Not applicable. There is no clinical trial or performance study detailed with a "test set" in the context of AI/diagnostic device performance. The testing mentioned is engineering/materials-based.
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Number of Experts and Qualifications: Not applicable. There are no experts establishing ground truth in the context of diagnostic performance for this type of device submission.
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Adjudication Method: Not applicable.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a physical dental implant system, not an AI-assisted diagnostic tool.
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Standalone Performance (Algorithm only): Not applicable. This is a physical device.
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Type of Ground Truth Used: Not applicable in the context of AI/diagnostic performance. The "ground truth" here is implied by the established safety and effectiveness of the existing predicate devices through their long-standing use and prior FDA clearances. The applicant validates the new device's engineering and material properties against industry standards and comparisons to these predicate devices.
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Sample Size for Training Set: Not applicable. There is no AI component or training set in this submission.
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How Ground Truth for Training Set Was Established: Not applicable.
In summary, this document is a regulatory submission for market clearance based on substantial equivalence, not a performance study that measures and reports against acceptance criteria for a diagnostic/AI device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 25, 2020
Medimecca Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K202039
Trade/Device Name: Honorst Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 22, 2020 Received: August 27, 2020
Dear Priscilla Chung:
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.
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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 (OS) 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.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Honorst Implant System
Indications for Use (Describe)
Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (K202039)
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 09/25/2020
1. Submitter/Applicant
Medimecca Co., Ltd. Daeryung Techno Town 3-Cha 104, 105, 109, 110 Gasan-Dong, 115, Gasan Digital 2-Ro, Geumcheon-Gu Seoul, Republic of Korea, 08505
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
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- Device
- . Trade Name: Honorst Implant System
- Common Name: Dental Implant System ●
- Classification: Class II
- Classification regulation: 21 CFR 872.3640 ●
- Product Code: DZE, NHA ●
Predicate Devices: 4.
Primary Predicate Device: CHAORUM Implant System (K160536) by MEDIMECCA Co., Ltd.
Reference Devices:
- 31 OSSEOTITE CERTAIN DENTAL IMPLANTS (K063341) by IMPLANT -INNOVATIONS, INC.
- TS Fixture System (K121995) by OSSTEM Implant Co., Ltd. ।
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న్. Description:
Honorst Implant System are devices made of titanium 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, and to restore the patients chewing function. Honorst Implant System consists of fixtures, abutments, and screws. Its material, structure and intended use are substantial equivalent to the predicate devices in the market. Honorst Implant System offers two different implants in SLA treatment and also offers two different onebody implants in SLA treatment. The Milling Abutment is only to be hand milled and not undergo CAD/CAM fabrication.
5.1. Fixtures - SLA (Titanium Gr4, ASTM F67)
5.2. Abutments
· NP (Narrow Platform) Connection Type Abutments
| Abutments | Material | Dia. (mm) | Gingival Height |
|---|---|---|---|
| Dual Abutment | Titanium Gr4,ASTM F67 | 4.0 / 4.6 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Combi Abutment | 4.0 / 4.6 / 4.8 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 | |
| Milling Abutment | Titanium Gr4,ASTM F67 | 4.0 | 1.5 / 3.0 |
| Temporary Abutment | Titanium Gr4,ASTM F67 | 4.0 | 1.0 / 3.0 |
| Angled Abutment(17°) | 4.0 / 4.5 | 2.0 / 4.0 | |
| Ball Abutment | 3.5 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 | |
| Abutments | Material | Dia. (mm) | Height |
| Healing Abutment | Ti 6Al4V ELI,ASTM F136 | 4.3 / 4.8 | 3.0 / 4.0 / 5.0 / 7.0 / 9.0 |
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| Abutments | Material | Dia. (mm) | Gingival Height |
|---|---|---|---|
| Dual Abutment | Titanium Gr4,ASTM F67 | 4.6 / 5.0 / 6.0 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
| Combi Abutment | 4.0 / 4.6 / 4.8 / 5.0 / 6.0 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 | |
| Milling Abutment | 4.0 / 5.0 / 6.0 | 1.5 / 3.0 | |
| Temporary Abutment | 4.5 | 1.0 / 3.0 | |
| Angled Abutment(17°) | 4.5 / 5.0 / 6.0 | 2.0 / 4.0 | |
| Ball Abutment | 3.5 | 1.0 / 2.0 / 3.0 / 4.0 / 5.0 |
· RP (Regular Platform) Connection Type Abutments
| Abutments | Material | Dia. (mm) | Height |
|---|---|---|---|
| Healing Abutment | Ti 6Al4V ELI,ASTM F136 | 4.3 / 4.8 / 5.3 / 6.3 / 7.3 / 8.3 | 3.0 / 4.0 / 5.0 / 7.0 / 9.0 |
5.3. Cover Screw (Ti 6A14V ELI, ASTM F136)
3.05mm Dia. x 5.25mm (L) 3.60mm Dia. x 5.88mm (L)
Indication for use: 6.
Honorst Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Honorst Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.
7. Performance Data
The verification/validation testing activities were conducted on the subject device for the modifications made. The activities include identifying reference devices for external fixture design changes and a worst-case analysis of the subject device and primary predicate for fixture size and angled abutment modifications. The worstcase analysis demonstrated that the primary predicate remains the worst-case scenario with respect to fatigue testing. Sterilization, shelf life, endotoxin, and biocompatibility testing were not conducted since the materials, surface treatments, packaging, and sterilization have not changed from the primary predicate device (K160536) and the device modifications do not raise a concern for the worst case for these tests.
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8. Substantial Equivalence
The Honors Implant System has the same intentified predicate devices. They are similar in findamental soientific technology in that they are all threaded, root form implans constructed of transmiss. The subject and predicate fixtures are both bone-level implants that share similar body shape design such as straight walled neck and tapen . The modifications were made after the 510k clearance including fixture exterior design and size, but we found reference devices which encompasses the size range of the subject device with similar design.
The subject abutments are very similar to the medications are very minor which does not result in an issue to question substantial equivalence.
| Item | Subject Device | Primary Predicate Device | Reference Predicate Devices |
|---|---|---|---|
| 510(K)Number | K202039 | K160536 | K063341K121995 |
| Device Name | Honorst Implant System | CHAORUM Implant System | 3I OSSEOTITE CERTAINDENTAL IMPLANTSTS Fixture System |
| Manu-facturer | MEDIMECCA Co., Ltd. | MEDIMECCA Co., Ltd. | IMPLANT INNOVATIONS, INC.OSSTEM Implant Co., Ltd. |
| Indicationsfor Use | Honorst Implant System isintended for use in partiallyor fully edentulous mandiblesand maxilla, insupport of single of multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutmentsupport for fixed bridgework.Honorst Implant Systemis for single stage and twostage surgical procedures.This system is intended fordelayed loading. | CHAORUM Implant System isintended for use in partially or fullyedentulous mandibles and maxilla, insupport of single of multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework.CHAORUM Implant Systemis for single stage and two stagesurgical procedures. This system isintended for delayed loading. | 3i dental implants are intended forsurgical placement in the upper orlower jaw toprovide a means for prostheticattachment in single toothrestorations and in partially orfully edentulous spans with multiplesingle teeth, or as a terminal orintermediaryabutment for fixed or removablebridgework, and to retainoverdentures.In addition, when a minimum of 4implants, >IOmni in length, areplaced in themandible and splinted in the anteriorregion, immediate loading isindicated.The TS Fixture System is designedfor dental implant surgery, it isplaced on the maxillary ormandibular alveolar bone through asurgical procedure, and afterosseointegration with the alveolarbone, it can replace a lost tooth byconnecting the abutment post. TheTS Fixture System is indicated foruse in partially of fully edentulousmandibles and maxillae, in supportof single or multiple-unit restorationsincluding; cemented retained, screwretained, or overdenture restorations,and final or temporary abutmentsupport for fixed bridgework. It isintended for delayed loading. |
- Fixture
510(k) Submission.
510(k) summary , 4 / 9 page
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| Design/ TechnologicalCharacteristics | - Internal Hexagonconnection- Self-tapping cutting edgethreads | - Internal Hexagon connection- Self-tapping cutting edge threads | - Internal Hexagon connection- Self-tapping cutting edge threads | - Internal Hexagon connection- Submerged Fixture- Tapered body shape and straightbody shape- 4 sided cutting edge with self-tapping |
|---|---|---|---|---|
| EndosseousImplantMaterial | Titanium(ASTM F67) | Titanium(ASTM F136, ASTM F67) | Titanium(ASTM F136, ASTM F67) | Titanium(ASTM F67) |
| SurfaceTreatment | SLA | RBM,SLA | SLA | SLA |
| ImplantSterilizationMethod | Radiation Sterile | Radiation Sterile | - | Radiation Sterile |
| ImplantDiameters | 3.75-6.0mm | 3.25-6.0mm | 3.25-6.0mm | 3.5~6.8mm |
| ImplantLengths | 7.0-13.0mm | 7.3-15.0mm | 7.0-20.0mm | 7.0~15.0mm |
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2. Abutments
| Subject Device | Predicate Device | ||
|---|---|---|---|
| 510(K) Number | K202039 | K160536 | |
| Device Name | Honorst Implant System | Chaorum Dental Implant System | |
| Manufacturer | Medimecca Co., Ltd. | Medimecca Co., Ltd. | |
| Indications for Use | Honorst Implant System is intendedfor use in partially or fully edentulousmandibles and maxilla, in support ofsingle of multiple-unit restorationsincluding; cemented retained, screwretained, or overdenture restorations,and terminal or intermediateabutment support for fixedbridgework. Honorst Implant Systemis for single stage and two stagesurgical procedures. This system isintended for delayed loading. | CHAORUM Implant System isintended for use in partially or fullyedentulous mandibles and maxilla, insupport of single of multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, and terminaor intermediate abutment support forfixed bridgework. CHAORUMImplant System is for single stageand two stage surgical procedures.This system is intended for delayedloading. | |
| Principle ofOperation | - Internal Hexagon connection | - Internal Hexagon connection | |
| Dual Abutment | |||
| Design & Size Range | Hex/Non-HexDiameter: 4.0 | Hex/Non-HexDiameter: 3.5 | |
| TechnologicalCharacteristics | Screw retained restoration | Screw retained restoration | |
| MaterialComposition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| The subject Dual Abutment is substantially equivalent to the predicate devicesin terms of intended use and technical characteristics. They are made of theSubstantialEquivalencesame material. There is a size option change, but the predicate deviceDiscussionencompasses the size range of the subject device. | |||
| Combi Abutment | |||
| Design & Size Range | Diameter: 4.0 | Diameter: 3.5 | |
| TechnologicalCharacteristics | Abutment and screw in one-piecestructure. | Abutment and screw in one-piecestructure. | |
| MaterialComposition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| SubstantialEquivalenceDiscussion | The subject Combi Abutment is substantially equivalent to the predicatedevices in terms of intended use and technical characteristics. They are madeof the same material. There is a size option change, but the predicate deviceencompasses the size range of the subject device. | ||
| Milling Abutment | |||
| Design & Size Range | Hex/Non-HexDiameter: 4.0 | Hex/Non-HexDiameter: 3.5 | |
| TechnologicalCharacteristics | Screw retained restoration | Screw retained restoration | |
| MaterialComposition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| SubstantialEquivalenceDiscussion | The subject Milling Abutment is substantially equivalent to the predicatedevices in terms of intended use and technical characteristics. They are madeof the same material. There is a size option change, but the predicate deviceencompasses the size range of the subject device. | ||
| Temporary Abutment | |||
| Design & Size Range | Hex/Non-HexDiameter: 4.0 | Hex/Non-HexDiameter: 3.5 | |
| Angle: 0° | Angle: 0° | ||
| TechnologicalCharacteristics | Screw retained restoration | Screw retained restoration | |
| MaterialComposition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | No | No | |
| Sterile | No | No | |
| SubstantialEquivalenceDiscussion | The subject Temporary Abutment is substantially equivalent to the predicatedevices in terms of intended use and technical characteristics. They are madeof the same material. There is a size option change, but the predicate deviceencompasses the size range of the subject device. | ||
| Angled Abutment | |||
| Design & Size Range | Hex/Non-HexDiameter: 4.0~6.0mmGingival Height: 2.0, 4.0mmAngle : 17° | Hex/Non-HexDiameter: 3.5 | |
| TechnologicalCharacteristics | Screw retained restoration | Screw retained restoration | |
| MaterialComposition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| SubstantialEquivalenceDiscussion | The subject Angled Abutment is substantially equivalent to the predicatedevices in terms of intended use and technical characteristics. They are madeof the same material. The angle has changed to 17° but it is within the range ofthe unmodified device. Also the location of TiN coating has changed but thedifference is very minor not affecting substantial equivalence. | ||
| Ball Abutment | |||
| Design & Size Range | Diameter: 3.5mmGingival Height: 1.0~5.0mmAngle: 0° | Diameter: 3.5 | |
| TechnologicalCharacteristics | Abutment and screw in one-piecestructure. | Abutment and screw in one-piecestructure. | |
| MaterialComposition | Ti Grade 4 (ASTM F67) | Ti Grade 4 (ASTM F67) | |
| Surface Treatment | TiN Coating | TiN Coating | |
| Sterile | No | No | |
| SubstantialEquivalenceDiscussion | The subject Ball Abutment is substantially equivalent to the predicate devicesin terms of intended use and technical characteristics. They are made of thesame material. The size and the design are also the same. | ||
| Healing Abutment | |||
| Design & Size Range | Diameter: 4.3 | Diameter: 3.5 | |
| TechnologicalCharacteristics | Abutment and screw in one-piecestructure. | Abutment and screw in one-piecestructure. | |
| MaterialComposition | Ti 6Al 4V ELI (ASTM F136) | Ti 6Al 4V ELI (ASTM F136) | |
| Surface Treatment | Anodizing | No | |
| Sterile | No | No | |
| SubstantialEquivalenceDiscussion | The subject Healing Abutment is substantially equivalent to the predicatedevices in terms of intended use and technical characteristics. They are madeof the same material. There is a size option change, but the predicate deviceencompasses the size range of the subject device. |
510(k) Submission.
510(k) summary , 6 / 9 page
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510(k) Submission.
510(k) summary , 7 / 9 page
{10}------------------------------------------------
510(k) Submission.
510(k) summary , 8 / 9 page
{11}------------------------------------------------
9. Conclusion
The new device and the predicate device are substantially equivalent in the areas of technical characteristics, raw material, and design. The new device does not introduce a fundamentally new scientific technology, and the validation activities demonstrate that the subject device is substantially equivalent to the predicate device.
§ 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.