(296 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only.
The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.
Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.
The provided text is a 510(k) Summary for the S.I.N. Dental Implant System (K170392). It details the device, its intended use, and a comparison to predicate devices, but does not contain any information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies related to device performance.
The document states: "No clinical data were included in this submission."
Therefore, based on the provided text, I cannot complete the requested information. However, I can extract the information provided about performance data (non-clinical) and the device's characteristics.
Here's what I can provide based on the given text:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the traditional sense of performance metrics for a clinical study with a device output. Instead, it describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices.
| Non-Clinical Test Category | Reported Performance (Demonstrated Equivalence) |
|---|---|
| Sterilization Validation | Radiation sterilization validated according to ISO 11137-1 and 11137-2. Steam sterilization according to ISO 17665-1 and ISO 17665-2. Both demonstrating a sterility assurance level (SAL) of 10-6. |
| Endotoxin Testing | Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72. |
| Shelf Life Testing | According to ASTM F1980, ASTM F1929, and ASTM F88/F88M. |
| Biocompatibility Testing | According to ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity), demonstrating acceptable biocompatibility. |
| Surface Area Analysis | Showing substantial equivalence to a predicate device. |
| Performance Testing | For insertion, showing substantial equivalence to the predicate device. |
2. Sample sized used for the test set and the data provenance
Not applicable. No clinical test set. Non-clinical tests were conducted; however, specific sample sizes for these tests are not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process is mentioned.
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
No MRMC study was done. The device is a dental implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical dental implant system, not an algorithm or AI.
7. The type of ground truth used
Not applicable. No clinical ground truth is mentioned.
8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it is mentioned.
Summary of what the document implies about meeting acceptance criteria:
The document demonstrates that the "S.I.N. Dental Implant System" meets the requirements for substantial equivalence to its predicate devices through a series of non-clinical tests. These tests cover aspects like sterilization, shelf-life, biocompatibility, and physical performance (e.g., insertion). The "acceptance criteria" here implicitly refer to the successful completion of these standard tests demonstrating that the device is as safe and effective as the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The absence of clinical data in the submission indicates that the FDA deemed the non-clinical evidence sufficient for a finding of substantial equivalence.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which 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.
December 5, 2017
S.I.N. - Sistema de Implante Nacional S.A. Linda K. Schulz Regulatory Affairs PaxMed International, LLC 12264 El Camino Real. Suite 400 San Diego, California 92130
Re: K170392
Trade/Device Name: S.I.N. Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2017 Received: November 3, 2017
Dear Linda K. Schulz:
This letter corrects our substantially equivalent letter of December 1, 2017.
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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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); 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
S.I.N. Dental Implant System
Indications for Use (Describe)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only.
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) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary S.I.N. - Sistema de Implante Nacional S.A. S.I.N. Dental Implant System K170392 December 1, 2017
ADMINISTRATIVE INFORMATION
| Manufacturer Name | S.I.N. – Sistema de Implante Nacional S.A.Avenida Vereador Abel Ferreira, 1100São Paulo, São Paulo03340-000 BrazilTelephone: +55-11-21693000 ext 3236 | |
|---|---|---|
| Official Contact | Dênis Oliveira | Quality and Regulatory Manager |
| Representative/Consultant | Linda K. Schulz, BSDH, RDHFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +1 (858) 792-1235Fax: +1 (858) 792-1236Email: lschulz@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | S.I.N. Dental Implant System |
|---|---|
| Common Name | Dental implant |
| Dental implant abutment | |
| Classification Name | Implant, endosseous, root form |
| Endosseous dental implant abutment | |
| Classification Regulations | 21 CFR 872.3640, 21 CFR 872.3630, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
| Primary Predicate | ||
|---|---|---|
| K051859 | Sistema de Implante Nacional Dental Implant System | Sistema de Implante Nacional, Ltda. |
| Reference Predicates | ||
| K120414 | OsseoSpeedTM Plus | Astra Tech AB |
| K072570 | NobelActive Multi Unit Abutment | Nobel Biocare AB |
| K081653 | MDI MII 2.9 mm Implants | IMTEC Corporation |
| K101225 | Promimic Dental Implant | Promimic AB |
| K092035 | Bicon Implants with a 2.5mm Internal Connection | Bicon, L.L.C |
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INDICATIONS FOR USE
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only.
DEVICE DESCRIPTION
The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.
Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.
| IMPLANT | BodyDiametermm | PlatformDiametermm | Lengthmm |
|---|---|---|---|
| Unitite Slim | 2.9 | 2.9 | 10, 11.5, 13 |
| Unitite | 3.5 | 3.5 | 8.5, 10, 11.5, 13, 15 |
| 4.3 | 4.3 | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | 5.0 | 8.5, 10, 11.5, 13, 15 | |
| Unitite Compact | 4.0 | 4.0 | 5, 6, 7 |
| 5.0 | 5.0 | 5, 6, 7 | |
| 6.0 | 6.0 | 5, 6, 7 | |
| Strong SW CM | 3.5 | 3.5 | 8.5, 10, 11.5, 13, 15 |
| 3.8 | 3.8 | 8.5, 10, 11.5, 13, 15 | |
| 4.5 | 4.5 | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | 5.0 | 8.5, 10, 11.5, 13, 15 |
PERFORMANCE DATA
Non-clinical testing data submitted or relied upon to demonstrate substantial equivalence included: radiation sterilization validation according to ISO 11137-1 and 11137-2 and steam sterilization according to ISO 17665-1 and ISO 17665-2, demonstrating a sterility assurance level (SAL) of 10 %; Limulus amebocyte lysate (LAL) testing according to AANSI/AAMI ST 72: Shelf life testing according to ASTM F1980. ASTM F1929. and ASTM F88/F88M; biocompatibility testing according to ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity) demonstrating acceptable biocompatibility; surface area analysis showing substantial equivalence to a predicate; and performance testing for insertion to show substantial equivalence to the predicate.
No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the Indications for Use and the technological characteristics of the subject device and the predicate devices.
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Comparison of Indications for Use Statements
| Subject Device | |
|---|---|
| K170392S.I.N. Implant SystemSIN - Sistema de ImplanteNacional S.A. | S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support forsingle-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental ImplantSystem is intended for immediate loading when good primary stability is achieved and with appropriate occlusalloading. Implants with lengths less than 7 mm are intended for delayed loading only. |
| Primary Predicate Device | |
| K051859Sistema de ImplanteNacional Dental ImplantSystemSIN - Sistema de ImplanteNacional, Ltda. | The Sistema de Implante Nacional Dental Implant System is intended to be surgically placed in the bone of themaxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. Implants may be placedimmediately after tooth extraction or following bone healing. Restorations supported by two or more Sistemade Implante Nacional implants may be loaded immediately after implant placement if primary implant stabilityhas been achieved. |
| Reference Predicate Devices | |
| K120414OsseoSpeed™ PlusAstra Tech AB | Implants: The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in thefollowing situations and with the following clinical protocols:• replacing single and multiple missing teeth in the mandible and maxilla,• immediate placement in extraction sites and in situations with a partially or completely healed alveolarridge,• especially indicated for use in soft bone applications where implants with other implant surfacetreatments may be less effective,• immediate loading in all indications, except in single tooth situations on implants shorter than 8 mm, orin soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may notbe appropriate.The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors andmandibular incisors.Abutments: Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra TechImplant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to providesupport for crowns, bridges or overdentures.Atlantis Abutments: The Atlantis™ Abutment is intended for use with an endosseous implant to support aprosthetic device in a partially or completely edentulous; patient. It is intended for use to support single andmultiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or frictionfit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous; implant to function as asubstructure that also serves as the final restoration, in partially or completely edentulous; patients. The prosthesisis screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant. |
| K072570NobelActive Multi UnitAbutmentNobel Biocare AB | NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directlyconnected to the endosseous dental implant and intended for use as an aid in prostheticrehabilitation. |
| K081653MDI MII 2.9 mm ImplantsIMTEC Corporation | The MII Implant is intended to support single or multi-unit restorations in both long-term and temporaryapplications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loadingwhen good primary stability is achieved. Additionally, this device will permit stability and long term fixation ofupper and lower dentures in edentulous cases. |
| K101225Promimic Dental ImplantPromimic AB | The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/lower jawarches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic DentalImplant can be immediately loaded only with good primary stability and appropriate occlusal loading. ThePromimic Dental Implants are only to be used with straight abutments. |
| K092035Bicon Implants with a 2.5mmInternal ConnectionBicon, L.L.C. | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a completedenture prosthesis, a final or intermediate abutment for fixed bridgework or for partial dentures, or as a singletooth replacement. |
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Comparison of Technological Characteristics
| Subject Device | PrimaryPredicate Device | ReferencePredicate Devices | |||||
|---|---|---|---|---|---|---|---|
| K051859 | K120414 | K072570 | K081653 | K101225 | K092035 | ||
| S.I.N. ImplantSystem | Sistema de ImplanteNacionalDental Implant System | OsseoSpeed™ Plus | NobelActive MultiUnit Abutment | MDI MII 2.9 mmImplants | PromimicDental Implant | Bicon Implants witha 2.5mm InternalConnection | |
| S.I.N. – Sistema deImplante NacionalS.A. | S.I.N. – Sistema deImplante Nacional,Ltda. | Astra Tech AB | Nobel Biocare AB | IMTEC Corporation | Promimic AB | Bicon, L.L.C. | |
| DESIGN | |||||||
| Prosthesis Attachment | Screw-retainedCement-retained | Screw-retainedCement-retained | Screw-retainedCement-retained | Screw-retained | Cement-retained | Screw-retainedCement-retained | Screw-retainedCement-retained |
| Restoration | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit | Multi-unit | Single-unitMulti-unit | Single-unitMulti-unit | Single-unitMulti-unit |
| Implant/Abutment Interface | ExternalInternal | ExternalInternal | Internal | Internal | One Piece | External | Internal |
| Implant Diameter, mm | 2.9 - 6.0 | 3.25 - 6.3 | 3.0 - 5.4 | NA | 2.9 | 3.75 | 4.0 - 4.5 |
| Implant Length, mm | 5.0 - 15 | 7.0 - 18 | 6.0 - 17 | NA | 10 - 18 | 8.5 - 15 | 5 - 11 |
| Abutment PlatformDiameter, mm | 3.3 - 4.8(Prosthetic Ø) | 3.4 - 5.5(Prosthetic Ø) | 3.0 - 5.4 | NP, RP | NA | 3.75 | 4.0 - 6.5 |
| Abutment Angle | 0° | 0° - 19° | 0° - 30° | 0° - 30° | 0° | 0° | 0° |
| MATERIAL | |||||||
| Implant | CPTi Gr 4 | CPTi Gr 4 | CPTi Gr 4 | NA | Titanium Alloy | CPTi Gr 4 | Ti6Al4V |
| Surface | Acid-EtchedHA | Acid-Etched | OsseoSpeed™ | NA | Unknown | HA | HA, TPS, Integra Ti,NanoTite™ |
| Abutment | Ti-6Al-4VCoCr | CPTi Gr 2Ti-6Al-4VCoCrGold alloy | Ti-6Al-4VZirconiaGold alloyPEEK | Ti-6Al-4V | NA | Titanium Alloy | Ti-6Al-4V |
| Abutment Screw | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V | NA | Titanium Alloy | Ti-6Al-4V |
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The subject device and predicate devices are substantially equivalent in intended use. Minor differences in language in the Indications for Use Statement between the subject device and the predicate devices do not change the intended use of implant placement and function. All are implant systems placed in the maxilla or mandible for single or multi-unit restorations with possible immediate loading for implants shorter than 7 mm is substantially equivalent to the statement in K120414 limiting immediate loading to implants 8 mm or greater.
Indications for Use Statements of the above predicates, K101225, K120414, and K081653 include an indication for immediate loading. The phrase, "Restorations supported by two or more Sistema de Implante Nacional implants may be loaded immediately after implant placement if primary implant stability has been achieved" in the primary predicate submission, K051859, has been replaced with the phrase, "S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading" as seen for the reference predicate K101225. The phrase, crowns, bridges and overdentures has been replaced with the equivalent statement, "single-unit or multi-unit restorations." Minor changes in language to the Indications for Use Statement do not affect the safety, efficacy or substantial equivalence of the subject device.
Subject device implants are substantially equivalent to K051859 implants in body, connection design, material and acid-etched surface. The subject device implant HA surface is substantially equivalent to the K101225 surface treatment. The short implant is substantially equivalent to K092035 in size, surface area and function. Subject device abutments are substantially equivalent to K051859 and K120414 abutments in material, design and function. Subject device multi-unit abutments are substantially equivalent to K072570 abutments in material, design and function.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter, length and angle of the subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
§ 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.