(368 days)
No
The summary describes a dental abutment and its manufacturing process, with no mention of AI or ML technology.
No
The Zirconia Base is an abutment for dental prosthetics, which provides support for restorations like copings or crowns. While it's used in a medical context, it's a structural component rather than a device designed to directly treat or cure a disease or condition. Its function is mechanical support.
No
The device, a Zirconia Base abutment, is designed to provide support for prosthetic restorations (like copings or crowns) on dental implants, not to diagnose a condition or disease.
No
The device description clearly states it is a physical abutment made of zirconia and used in conjunction with other physical components (implants, crowns, cement). The submission focuses on manufacturing workflows and material equivalence, not software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an abutment placed over dental implants to support prosthetic restorations. This is a medical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details the physical components and how they are used to create a dental prosthesis. This aligns with the function of a medical device.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Using reagents or assays
The device is a component of a dental implant system, which is a type of medical device used for restoring dental function and aesthetics.
N/A
Intended Use / Indications for Use
Indications for Use for Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The Zirconia Base abutment is used as two-piece abutment, where the base is premanufactured from zirconia and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The top half and base pieces are cemented together to form the final abutment
This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Mechanical testing: In order to demonstrate the substantial equivalence regarding the mechanical strength of the system, the dynamic fatigue test was performed using the new restoration material, in accordance with ISO 14801 and FDA guidance document "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The performance bench test carried out with the Zirconia Bases and IPS e.max Press demonstrates that the new material is substantially equivalent to the previously cleared materials.
MR Compatibility testing: The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for primary predicate devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per primary predicate devices.
Sterilization validation: Sterilization of the Zirconia Abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135-1 Sterilization of Health Care Products -Ethylene Oxide - Part 1: Requirements For Development, Validation and Routine Control of a Sterilization Process For Medical Devices. A minimum Sterility Assurance Level (SAL) of 1 x 10-6 has been validated. Steam sterilization have been performed according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The worst case device in conjunction with lithum dissilicate restoration material (IPS) was already validated for steam sterilization, using the parameters described in IFU, under reference device evaluation (K163194).
Biocompatibility: A biological assessment was performed according to ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016. No new issues of biocompatibility are raised for the Zirconia Bases when compared to primary predicate and restoration and cement materials when compared to reference devices (K223638). Therefore, no additional biocompatibility testing was required.
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
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
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 & 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.
JJGC Industria e Comercio de Materiais Dentarios S.A. % Jennifer Jackson Director of Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K222026
Trade/Device Name: Neodent Implant System - Zirconia Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2023 Received: June 14, 2023
Dear Jennifer Jackson:
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.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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
Indications for Use
510(k) Number (if known) K222026
Device Name
Neodent Implant System - Zirconia Implant System
Indications for Use (Describe) Indications for Use for Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
| 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
| 510(k) Summary | |
|---|---|
| ADMINISTRATIVE INFORMATION | |
| Sponsor | JJGC Indústria e Comércio de Materiais Dentários SA |
| (dba Neodent) | |
| Av. Juscelino Kubitschek de Oliveira, 3291 | |
| Curitiba, Parana, Brazil 81270-200 | |
| Registration No.: 3008261720 | |
| Owner/Operator No.: 10031702 | |
| Contact Person | Jennifer M. Jackson, MS |
| Director of Regulatory Affairs, | |
| Straumann USA | |
| E-mail: jennifer.jackson@straumann.com | |
| Telephone (978) 747-2509 | |
| Date Prepared | July 13, 2023 |
| Preparer / Alternate Contact | Mariana Hartmann |
| Regulatory Affairs Leader | |
| E-mail: mariana.hartmann@neodent.com | |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | |
| Common Name | Neodent Implant System - Zirconia Implant System |
| Endosseous dental implant abutment | |
| Classification Name | Endosseous dental implant abutment |
| Classification Regulations | |
| Product Code | |
| Classification Panel | |
| Reviewing Branch | 21 CFR 872.3630, Class II |
| NHA | |
| Dental Products Panel | |
| Dental Devices Branch | |
| PREDICATE DEVICE INFORMATION | |
| Primary Predicate Device | K201491 – Neodent Implant System – Zirconia Implant |
| System, JJGC Indústria e Comércio de Materiais | |
| Dentários S.A; | |
| Reference Device | K142890 – Institut Straumann AG – Straumann® |
| Variobase™ Abutments | |
| K163194 - Neodent Implant System - GM Line, JJGC | |
| Indústria e Comércio de Materiais Dentários S.A |
4
K223638 - Neodent Implant System - Helix Short Implant System; JJGC Indústria e Comércio de Materiais Dentários S.A.
INDICATIONS FOR USE
Indications for Use Zirconia Bases:
The Zirconia Base is an abutment placed over Neodent Zirconia Implants in order to provide support for patient-specific prosthetic restorations, such as copings or crowns. It may be used for cement- or screw retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.
SUBJECT DEVICE DESCRIPTIONS
The Zirconia Base abutment is used as two-piece abutment, where the base is premanufactured from zirconia and the top half is created via burn out coping or a digital workflow with CAD/CAM at a validated milling center. The top half and base pieces are cemented together to form the final abutment
This submission aims to introduce the conventional workflow for obtaining prostheses manually designed by the technician using the Zirconia Bases, already cleared under K201491. With that, the introduction of one more restoration material (IPS e.max® Press) for the top half confection is necessary. The conventional workflow, using the IPS e.max® Press as restoration material along with the suggested cement materials is equivalent to the design workflow indicated for reference device (K142890). The table below details the restorative material introduced and the cement materials involved in the conventional workflow for the Zirconia Bases:
| Top Half Material | Cement Material | |
|---|---|---|
| Material Name | IPS e.max® Press | Ivoclar Multilink |
| Raw Material | Lithium Dissilicate | Lithium Dissilicate |
| 510(k) | K120053 | K130436 |
The subject and primary predicate devices (K201491) have identical Indications for Use statements, providing the support for patient-specific prosthetic restorations. They also present the same raw material, technological characteristics (design and gingival height), reuse indication, sterilization method and sterile barrier.
Regarding the restoration material, focus of this submission, the IPS e.max® Press used to create the top half under the subject device are already cleared in the same configuration under K142890 (reference device). The Ivoclar Multilink cement material has also been previously cleared to be used together with IPS e.max restoration materials, under K223638 (reference device), with the intention to prepare a prosthetic restoration under implantable devices.
The results of the comparison between the subject, predicate and reference devices using the IPS e.max restoration materials along with the cement materials demonstrate that they are substantially equivalent.
5
TECHNOLOGICAL CHARACTERISTIC COMPARISON TABLE
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | |
|---|---|---|---|---|
| Neodent Implant System – Zirconia Implant System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K201491 | |||
| Neodent Implant System | ||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K142890 | |||
| Straumann® Variobase™ Abutments | ||||
| Institut Straumann AG | ||||
| Indications for Use | The Zirconia Base is an abutment placed over | |||
| Neodent Zirconia Implants in order to provide | ||||
| support for patient-specific prosthetic restorations, | ||||
| such as copings or crowns. It may be used for | ||||
| cement- or screw retained single unit restorations. | ||||
| All digitally designed copings and/or crowns to be | ||||
| used with the Neodent Zirconia Base Abutment | ||||
| System are intended to be sent to Straumann for | ||||
| manufacture at a validated milling center. | The Zirconia Base is an abutment placed over Neodent | |||
| Zirconia Implants in order to provide support for patient- | ||||
| specific prosthetic restorations, such as copings or | ||||
| crowns. It may be used for cement- or screw retained | ||||
| single unit restorations. All digitally designed copings | ||||
| and/or crowns to be used with the Neodent Zirconia | ||||
| Base Abutment System are intended to be sent to | ||||
| Straumann for manufacture at a validated milling center. | Identical | |||
| Implant to | ||||
| abutment interface | Straight internal connection | |||
| indexing features (Zilock) | Straight internal connection | |||
| indexing features (Zilock) | Identical | |||
| Gingival Height | 1.5 and 2.5 mm | 1.5 and 2.5 mm | Identical | |
| Reusable | No | No | Identical | |
| Material | Zirconia Base: Yttrium-stabilized zirconium dioxide | |||
| (Y-TZP). | ||||
| Screw: Titanium alloy, according to ASTM F136 | ||||
| standard. | Zirconia Base: Yttrium-stabilized zirconium dioxide (Y- | |||
| TZP). | ||||
| Screw: Titanium alloy, according to ASTM F136 standard. | Identical | |||
| Design workflow | Digital Workflow: Zirconia Base library on Dental | |||
| Wings and 3Shape. | ||||
| Conventional Workflow: manually designed by the | ||||
| technician | Digital Workflow: Zirconia Base library on Dental Wings | |||
| and 3Shape. | Digital Workflow: CARES® Visual. | |||
| Conventional Workflow: manually designed by the | ||||
| technician | Equivalent | |||
| The digital workflow remains the | ||||
| same and the conventional workflow | ||||
| is done manually as the reference | ||||
| predicate device. | ||||
| Manufacturing | ||||
| workflow | Digital Workflow: Straumann Milling Center | |||
| Conventional Workflow: in-lab (traditional | ||||
| pressing) | Digital Workflow: Straumann Milling Center | Digital Workflow: Straumann Milling Center | ||
| Conventional Workflow: in-lab (traditional casting or | ||||
| pressing) | Equivalent | |||
| The digital workflow remains the | ||||
| same and the conventional workflow | ||||
| (subject of this submission) is the | ||||
| same of the reference predicate | ||||
| device (traditional pressing). |
6
Traditional 510(k) Submission
K222026 - Neodent Implant System – Zirconia Implant System
| SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERENCE DEVICE | EQUIVALENCE DISCUSSION | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neodent Implant System – Zirconia Implant System | |||||||||||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K201491 | ||||||||||||
| Neodent Implant System | |||||||||||||
| JJGC Indústria e Comércio de Materiais Dentários S.A. | K142890 | ||||||||||||
| Straumann® Variobase™ Abutments | |||||||||||||
| Institut Straumann AG | Equivalent | ||||||||||||
| Restoration Material | Digital Workflow: | Digital Workflow: | Digital Workflow: | The digital workflow remains the | |||||||||
| same when compared to primary | |||||||||||||
| predicate device. The change of this | |||||||||||||
| submission is related to | |||||||||||||
| conventional workflow and | |||||||||||||
| inclusion of IPS e.max Press | |||||||||||||
| indication to Zirconia Bases. | |||||||||||||
| However, when compared to | |||||||||||||
| reference predicate device, the | |||||||||||||
| restorative material (IPS e.max | |||||||||||||
| Press) is equivalent. | |||||||||||||
| Material | Minimum wall | ||||||||||||
| thickness | Minimum | ||||||||||||
| angulation | Maximum | ||||||||||||
| angulation | Material | Minimum wall | |||||||||||
| thickness | Minimum | ||||||||||||
| angulation | Maximum | ||||||||||||
| angulation | Material | Minimum wall | |||||||||||
| thickness | Minimum | ||||||||||||
| angulation | Maximum | ||||||||||||
| angulation | |||||||||||||
| 3M ESPE Lava | |||||||||||||
| Plus Zirconia | 0.7 mm | 3M ESPE Lava Plus | |||||||||||
| Zirconia | 0.7 mm | Zerion | 0.4 mm | ||||||||||
| Zirconia (Zerion | |||||||||||||
| LT) | 0.4 mm | 0° | 30° | Zirconia (Zerion LT) | 0.4 mm | 0° | 30° | IPS e.max CAD | 0.9 mm | 0° | 30° | ||
| Zirconia (Zerion | |||||||||||||
| UTML) | 0.5 mm | Zirconia (Zerion | |||||||||||
| UTML) | 0.5 mm | Coron | 0.3 mm | 30° | |||||||||
| Polycon ae | 0.5 mm | ||||||||||||
| Conventional Workflow: | Conventional Workflow: | ||||||||||||
| Material | Minimum wall | ||||||||||||
| thickness | Minimum | ||||||||||||
| angulation | Maximum | ||||||||||||
| angulation | Material | Minimum wall | |||||||||||
| thickness | Minimum | ||||||||||||
| angulation | Maximum | ||||||||||||
| angulation | |||||||||||||
| IPS e.max Press | 0.9 mm | 0° | 30° | IPS e.max Press (in-lab pressing) | 0.9 mm | 0° | 30° | ||||||
| Type 4 dental | |||||||||||||
| metals (ISO 22674) | |||||||||||||
| (In-lab casting). | 0.5 mm | 0° | 30° | ||||||||||
| Sterilization Method | Provided sterile via Ethylene Oxide to an SAL of 10-6. | ||||||||||||
| End user sterilized via moist heat following | |||||||||||||
| cementation of coping and before use. | Provided sterile via Ethylene Oxide to an SAL of 10-6. End | ||||||||||||
| user sterilized via moist heat following cementation of | |||||||||||||
| coping and before use. | Identical |
7
PERFORMANCE DATA
Mechanical testing
In order to demonstrate the substantial equivalence regarding the mechanical strength of the system, the dynamic fatigue test was performed using the new restoration material, in accordance with ISO 14801 and FDA guidance document "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". The performance bench test carried out with the Zirconia Bases and IPS e.max Press demonstrates that the new material is substantially equivalent to the previously cleared materials.
MR Compatibility testing
The MR compatibility was performed to access the risk of exposing patients who have implantable medical devices. An assessment was made to demonstrate that the subject devices do not configure a new worst case and can be represented by the previously conducted studies reviewed for primary predicate devices, since both have the same raw material and similar dimensions. The subject devices are therefore MR conditional devices and a patient treated with the subject devices can be safely scanned observing the parameters previously established per primary predicate devices.
Sterilization validation
Sterilization of the Zirconia Abutments via ethylene oxide gas using the overkill method has been performed according to the requirements of ISO 11135-1 Sterilization of Health Care Products -Ethylene Oxide - Part 1: Requirements For Development, Validation and Routine Control of a Sterilization Process For Medical Devices. A minimum Sterility Assurance Level (SAL) of 1 x 10° has been validated.
Steam sterilization have been performed according to ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The worst case device in conjunction with lithum dissilicate restoration material (IPS) was already validated for steam sterilization, using the parameters described in IFU, under reference device evaluation (K163194).
Biocompatibility
A biological assessment was performed according to ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993- 1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016. No new issues of biocompatibility are raised for the Zirconia Bases when compared to primary predicate and restoration and cement materials when compared to reference devices (K223638). Therefore, no additional biocompatibility testing was required.
CONCLUSION
The results of the comparison between the subject and predicates devices demonstrate that they are substantially equivalent.