(88 days)
s-Clean SQ-SL Implant System Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
s-Clean SQ-SL Implant System Mini is composed of Fixture and Abutments. s-Clean SQ-SL Implant System Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
The s-Clean SQ-SL Implant System Mini Abutments are composed as below;
s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Mini Fixture Cover Screw
s-Clean SQ-SL Fixture and s-Clean Mini Fixture Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.
s-Clean SO-SL Fixture is enclosed with s-Clean Mini Fixture Cover Screw in a set packing. s-Clean Mini Fixture Cover Screw is also provided separately.
Based on the provided text, the document is a 510(k) Premarket Notification from Dentis Co., Ltd. for their s-Clean SQ-SL Implant System Mini. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
The document discusses the design, materials, and intended use of the dental implant system and compares it to predicate devices. However, the provided text does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or human reader improvement with AI assistance.
The "Non-Clinical Test Data" section lists various tests performed on the predicate devices and leveraged for the subject device to demonstrate substantial equivalence, specifically regarding sterilization, shelf life, biocompatibility, and bacterial endotoxin. These are safety and manufacturing standard compliance tests, not performance studies as typically understood for AI/diagnostic devices.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the manner you've outlined for AI or diagnostic devices, as this information is not present in the provided FDA 510(k) summary. The document focuses on demonstrating substantial equivalence to similar dental implants based on material, design, and manufacturing standards, rather than clinical performance outcomes or AI accuracy.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out next to it.
April 13, 2020
Dentis Co., Ltd. April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620
Re: K200099
Trade/Device Name: s-Clean SQ-SL Implant System Mini Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 10, 2020 Received: January 16, 2020
Dear April Lee:
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 post marketing 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 Implantable Dental Devices Team 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) K200099
Device Name s-Clean SQ-SL Implant System Mini
Indications for Use (Describe)
s-Clean SQ-SL Implant System Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one 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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Image /page/3/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that appears to be a stylized flame or abstract design. The text is clear and legible, suggesting it may be a logo or brand name.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
510(K) Summary K200099
Submitter
Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: s-Clean SO-SL Implant System Mini ●
- Common Name: Dental Implant System
- Classification Name: implant, endosseous, root-form
- Product Code: DZE
- Secondary Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3640
- Device Class: Class II
- . Date Prepared: 01/08/2020
Predicate Devices:
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●
Reference Predicates
- K161689, OSSTEM Implant System Abutment by Osstem Implant Co. Ltd ●
- K171027, Dentis Dental Implant System by Dentis Co., Ltd. ●
- K171694, s-Clean TiN Coating Abutments ●
Indication for Use:
s-Clean SQ-SL Implant System Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
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Image /page/4/Picture/0 description: The image shows the text "Dentis Co., Ltd." in a bold, sans-serif font. The text is arranged on a single line, with the company name followed by the abbreviation "Co." and "Ltd.". The text is black against a white background.
Image /page/4/Picture/1 description: The image shows the logo for DENTIS. The logo features an orange abstract shape on the left, resembling a stylized flame or a curved shape with a circle at the top. To the right of the shape, the word "DENTIS" is written in a bold, sans-serif font. The overall design is clean and modern.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806
Device Description:
s-Clean SQ-SL Implant System Mini is composed of Fixture and Abutments. s-Clean SQ-SL Implant System Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.
Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The dimensions are as following:
| No. | Device Name | Dimension Ranges |
|---|---|---|
| 1 | s-Clean SQ-SL Fixture | Ø 3.7, 4.1mm (D) X 7.0, 7.5, 9.5, 11.5 and 13.5mm (L) |
Tolerance of dimension shall be within ± 1% range.
The s-Clean SQ-SL Implant System Mini Abutments are composed as below;
s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Mini Fixture Cover Screw
The dimensions of abutments are as following:
| No. | Device Name | Dimension Ranges | Angulation |
|---|---|---|---|
| 1 | s-Clean Sole Abutment S-Line | Ø 4.0 and 5.0mm (D) X 11.2, 12.2, 13.2mm (L) | 0° |
| 2 | s-Clean TiN Half Coating Sole Abutment S-Line | Ø 4.0 and 5.0mm (D) X 11.2, 12.2, 13.2mm (L) | 0° |
| 3 | s-Clean Mini Fixture Cover Screw | Ø 3.1mm (D) X 5.4mm (L) | 0° |
The Abutments have below featured:
| Name | Uses | Surface | Connection |
|---|---|---|---|
| s-Clean Sole Abutment S-Line | N/A | Internal Hex | |
| s-Clean TiN Half Coating SoleAbutment S-Line | The Abutment is connected with fixture and itsupports prosthesis which restores tooth function. | TiN-Coating | Internal Hex |
| s-Clean Mini Fixture CoverScrew | It is used for protecting inner hole and connectingpart with exposed upper part of structure duringthe healing period after inserting dental implantfixture | N/A | ScrewRetained |
Tolerance of dimension for Abutments shall be within ± 1% range.
s-Clean SQ-SL Fixture and s-Clean Mini Fixture Cover Screw are provided sterilized. And the other Abutments are provided non-sterilized.
s-Clean SO-SL Fixture is enclosed with s-Clean Mini Fixture Cover Screw in a set packing. s-Clean Mini Fixture Cover Screw is also provided separately.
Materials:
- The fixtures and s-Clean Mini Fixture Cover Screw are fabricated from Pure titanium of ASTM F67 ●
- . The s-Clean Sole Abutment S-Line and s-Clean TiN Half Coating Sole Abutment S-Line are fabricated from Ti-6Al-4V of ASTM F136
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Image /page/5/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a curved check mark with a circle at the top. The logo is simple and professional, likely representing a dental-related business.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
Summaries of Technological Characteristics
| s-Clean SQ-SL Fixture | Subject Device | Primary Predicate Device | |
|---|---|---|---|
| 510(k) Number | N/A | K153639 | |
| Trade Name | s-Clean SQ-SL Implant System Mini | OneQ-SL s-Clean Implant System | |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | |
| Design(Fixture Type) | Image: s-Clean SQ-SL Implant System Mini- Internal Hex-connected- Submerged Fixture- Bone level- Tapered body- 3 sided cutting edge with self-tapping | Image: OneQ-SL s-Clean Implant System- Internal Hex-connected- Submerged Fixture- Bone Level- Tapered & straight body- 3 sided cutting edge with self-tapping | |
| FixtureDiameter(Ø) | 3.7, 4.1mm | 3.7, 3.9, 4.2, 4.7, 5.2, 6.0, 7.0, 8.0mm | |
| Fixture Length | 7, 7.5, 9.5, 11.5, 13.5mm | 7, 8, 9, 10, 12, 14mm | |
| Indication forUse | s-Clean SQ-SL Implant System Mini isindicated for use in partially or fully edentulousmandibles and maxillae, in support of single ormultiple unit restorations including; cementedretained, screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixed bridgework. Thissystem is dedicated for one and two stagesurgical procedures. This system is intendedfor delayed loading. | The OneQ-SL s-Clean Implant System isindicated for use in partially or fully edentulousmandibles and maxillae, in support of single ormultiple unit restoration including;cemented retained, screw retained, oroverdenture restoration, and terminal orintermediate abutment support for fixedbridgework. This system is dedicated for oneand two stage surgical procedures and notdedicated for immediate loading. This systemis intended for delayed loading. | |
| SurfaceTreatment | SLA | SLA | |
| Material | CP Titanium Grade 4(ASTM F67) | CP Titanium Grade 4(ASTM F67) | |
| Sterilization | Gamma Sterilization | Gamma Sterilization | |
| Product Code | DZE, NHA | DZE | |
| Shelf Life | 8 years | ||
| BriefComparison | s-Clean SQ-SL Implant System Mini has same device characteristics with the Primarypredicate devices, OneQ-SL s-Clean Implant System (K153639) such as indications forUse, material, functions, general shape (Design), manufacturing process, dimensions,structure, shelf life and surface treatment.Any differences do not affect the clinical performance and efficacy. |
s-Clean SO-SL Fixture
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Image /page/6/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic. The graphic is a curved shape with a circle at the top.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
s-Clean Sole Abutment S-Line
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) | N/A | K171027 | K161689 |
| Trade Name | s-Clean SQ-SL ImplantSystem Mini | Dentis Dental ImplantSystem s-Clean SoleAbutment | OSSTEM Implant System- Abutment |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | OSSTEM Implant Co.,Ltd. |
| Product Name | s-Clean Sole Abutment S-Line | s-Clean Sole Abutment | Rigid Abutment |
| Design | Image: s-Clean SQ-SL Implant System Mini | Image: Dentis Dental Implant System s-Clean Sole Abutment | Image: OSSTEM Implant System - Abutment |
| Dimension | Ø 4.0, 5.0mm (D) X 11.2,12.2, 13.2mm (L) | Ø 4.5, 4.8, 5.5, 6.0, 6.5mm(D) X12.5,13.0,13.5,14.,15.0,16.0,17.0mm (L) | Ø 4.0, 4.6, 5.0, 6.0, 7.0mm(D) X 10, 10.4, 11, 11.4,11.5, 11.9, 12, 12.4, 12.5,12.9, 13, 13.4, 13.5, 13.9,14, 14.4, 14.5, 14.9, 15,15.4, 15.5, 15.9, 16, 16.4,17, 17.4mm (L) |
| Angulation | N/A | N/A | N/A |
| Material | Ti-6Al-4V ELI(ASTM F136) | Ti-6Al-4V ELI(ASTM F136) | Titanium Alloy(Ti-6Al-4V) |
| Sterilization | Steam sterilization by user | Steam sterilization by user | Steam sterilization by user |
| Product Code | NHA | NHA | NHA |
| Brief Comparison | The subject device has no difference from the predicate device that affects the clinicalperformance and efficacy. Dimensional specification of the subject device falls intothe range of the reference device. |
s-Clean TiN Half Coating Sole Abutment S-Line
| Subject Device | Reference Device | Reference Device | |
|---|---|---|---|
| 510(k) | N/A | K171694 | K161689 |
| Trade Name | s-Clean SQ-SL ImplantSystem Mini | s-Clean TiN CoatingAbutments | OSSTEM Implant System -Abutment |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | OSSTEM Implant Co., Ltd. |
| Product Name | s-Clean TiN Half CoatingSole Abutment S-Line | s-Clean TiN Partial CoatingSole Abutment | Rigid Abutment |
| Design | Image: s-Clean TiN Half Coating Sole Abutment S-Line | Image: s-Clean TiN Partial Coating Sole Abutment | Image: Rigid Abutment |
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Image /page/7/Picture/0 description: The image contains the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient, with the bottom being a darker orange and the top being a lighter orange.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
| Dimension | Ø 4.0, 5.0mm (D) X 11.2, 12.2, 13.2mm (L) | Ø 4.5, 5.5, 6.0 and 6.5mm (D) x 11, 11.5, 12.0, 12.5, 13.5, 14.5, 15.5mm (L) | Ø 4.0, 4.6, 5.0, 6.0, 7.0mm (D) X 10, 10.4, 11, 11.4, 11.5, 11.9, 12, 12.4, 12.5, 12.9, 13, 13.4, 13.5, 13.9, 14, 14.4, 14.5, 14.9, 15, 15.4, 15.5, 15.9, 16, 16.4, 17, 17.4mm (L) |
|---|---|---|---|
| Angulation | N/A | N/A | N/A |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Titanium Alloy (Ti-6Al-4V) |
| Surface Treatment | TiN Coating | TiN Coating | Non-Coating |
| Sterilization | Steam sterilization by user | Steam sterilization by user | Steam sterilization by user |
| Product Code | NHA | NHA | NHA |
| Brief Comparison | The subject device has no difference from the predicate device that affects the clinical performance and efficacy. Dimensional specification of the subject device falls into the range of the reference device. |
s-C lean Mini Fixture Cover Screw
| Subject Device | Primary Predicate deviece | |
|---|---|---|
| 510(k) | N/A | K153639 |
| Trade Name | s-Clean SQ-SL Implant System Mini | OneQ-SL s-Clean Implant System |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. |
| Design | Image: Subject Device Design | Image: Primary Predicate Device Design |
| Dimension | Ø 3.1mm (D) X 5.4mm (L) | Ø 3.6mm (D) X 5.9mm (L) |
| Angulation | N/A | N/A |
| Material | CP Titanium Grade 4(ASTM F67) | CP Titanium Grade 4(ASTM F67) |
| Sterilization | Gamma Sterilization | Gamma Sterilization |
| Product Code | NHA | NHA |
| BriefComparison | The subject device is a bit smaller than the predicate device in its diameter and length.This device (cover screw) is to seal the fixture opening from the exposure to thesurrounding tissue during the healing process. Thus, the measurement is not animportant factor to the device performance but the fitness accuracy to the fixtureopening is. The dimensional difference is ignorable. |
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Image /page/8/Picture/0 description: The image contains the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that appears to be a stylized flame or swirl. The text and graphic are aligned horizontally. The overall impression is that of a company logo.
Non-Clinical Test Data
Below tests were performed for predicate devices and leveraged for the subject device:
- . Sterilization Validation Test on Fixtures according to ISO 11137-1,2,3 referenced in K153639
- . End User Sterilization Validation Test Report on Abutments according to ANSVAAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K171027
- . Shelf Life Test on Fixtures according to ASTM F1980 referenced in K153639
- . Biocompatibility testing on fixtures according to ISO 10993-1:2009. ISO 10993-3:2014. ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639
- Biocompatibility testing on Abutments according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171027
- . Biocompatibility testing on TiN Coating Abutments according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K171694
- . Bacterial Endotoxin Test Report on Fixtures according to ANSI/AAMI ST72:2011, USP <161>, and USP <85> referenced in K192688
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device. The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Conclusion
s-Clean SQ-SL Implant System Mini constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, s-Clean SQ-SL Implant System Mini and its predicates are substantially equivalent.
§ 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.