(438 days)
No
The device description and performance studies focus on the chemical composition and physical effects of the solution, with no mention of AI or ML.
Yes
The device is described as a "professional tooth desensitizer" intended for the "Treatment of Dental Hypersensitivity," which is a medical condition. Its "primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules." These characteristics align with the definition of a therapeutic device as it treats or alleviates a medical condition.
No
The device is a professional tooth desensitizer intended for treatment, not for diagnosing a condition. Its primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules, which is a therapeutic function.
No
The device description clearly states it is a solution composed of chemical ingredients provided in a squeezable dropper bottle, which is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Treatment of Dental Hypersensitivity". This is a therapeutic treatment applied directly to the tooth surface to alleviate a condition.
- Device Description: The device is a "professional tooth desensitizer" that works by "occluding open dentin tubules". This describes a physical mechanism of action within the body (or on the body surface).
- Lack of Diagnostic Purpose: There is no mention of this device being used to diagnose a condition, analyze a sample from the body for diagnostic purposes, or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is applied directly to the tooth for treatment.
N/A
Intended Use / Indications for Use
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
Product codes
PHR
Device Description
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant.
The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators (more information provided below) and the Instructions for Use (IFU).
The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
The dentist must clean and dry the affected tooth surface and then dispense 1-2 drops of solution into a disposable dappen dish. The material is applied directly to the tooth surface using Centrix supplied applicators (Centrix Benda Micro Fine Brushes). The tooth must be allowed to air dry and then if needed one or two reapplications can be administered at intervals of one week.
The packaging will labeled with lot number, expiration date and UDI barcode. The shelf life of the device is 24 months.
The device is packaged with applicators (Centrix Benda Micro Fine Brushes) that are classified as class I 510(k) exempt medical devices under regulation 21 CFR 872.3140, Product Code KXR. A quantity of applicators will be provided in a zip lock bag.
The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
Indicated Patient Age Range
over the age of 21. (adults)
Intended User / Care Setting
Dentist, professional use.
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)
Cytotoxicity (ISO 10993-5 (2009)): Testing was conducted on both the subject (Centrix) and predicate (Elevate) devices. Both were found "unsuitable for analysis" due to high precipitate generation, but the subject device performed identically to the predicate.
Skin Sensitization (ISO 10993-10 (2021)): Concluded that the subject device is NOT considered to be a contact skin sensitizer.
Irritation (ISO 10993-23 (2021)): Concluded that the subject device is considered to be a Non-Irritant to oral mucosa.
Systemic Toxicity (ISO 10993-11 (2017)): Acute Systemic Toxicity testing was conducted on both the subject and predicate devices. No signs of gross toxicity, adverse clinical effects, or abnormal behavior were observed. Both devices met requirements and performed identically.
Biological Evaluation/Risk Management (ISO 10993-1 (2018)): A Toxicological Risk Assessment report evaluated remaining biological endpoints (Acute, Subacute / Subchronic, Chronic Systemic Toxicity, Genotoxicity, Carcinogenicity). Conclusion: risk of adverse effects is low based on chemical ingredients, intended use, and predicate device information.
SEM Analysis of Subject and Predicate Devices (N/A): Summarizes comparison between Centrix SDF and Elevate SDF on human tooth samples. Both showed significant deposits of silver on the cut surface of the tooth and within the dentinal tubules. No discernable difference in silver deposition between subject and predicate devices.
Fluoride Release Testing (N/A): Evaluated fluoride release in SDF treated tooth cross sections comparing Centrix FluoroSilver Silver Diamine Fluoride 38% and Elevate Advantage Arrest SDF. The study confirmed the release of fluoride at the same rate with no statistical difference. Maximum fluoride concentrations were equivalent.
Dentin Permeability (N/A): Human molar teeth samples were evaluated to calculate the % reduction of dentin permeability. The results found that tooth samples treated with SDF reduced the dentin permeability by 97.5%.
Chemical Identity Testing: Mass Spectrometry (MS) (N/A): MS analysis found a strong match for chemical composition between the subject and predicate device, demonstrating compositional equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluoride Release: Subject 0.023 +/- 0.003 ppmF/mm², Predicate 0.024 +/- 0.006 ppmF/mm²
Dentin Permeability: Centrix % Reduction in Dentin Permeability 97.5% +/- 4.3%, Elevate % Reduction in Dentin Permeability 97.5% +/- 2.5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
October 27, 2023
Centrix Inc % Joseph Azary Chief Advisor & Compliance Officer Aztech Regulatory & Quality LLC 543 Long Hill Avenue Shelton, Connecticut 06484
Re: K222459
Trade/Device Name: Centrix FluoroSilver Silver Diamine Fluoride 38% Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: PHR Dated: August 12, 2022 Received: August 15, 2022
Dear Joseph Azary:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Bobak Shirmohammadi -2
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222459
Device Name
Centrix FluoroSilver Silver Diamine Fluoride 38%
Indications for Use (Describe) Treatment of Dental Hypersensitivity for use in adults over the age of 21.
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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4
K222459 510(k) Summary CENTRIX FLUOROSILVER SILVER DIAMINE FLUORIDE 38%
SUBMITTER/510(K) HOLDER 1.
Centrix Inc 770 River Road Shelton, CT 06484
Contact Name: Joseph Azary (Aztech Regulatory & Quality LLC) Email: jazary@erols.com Telephone: (203) 242-6670
Date Prepared: October 26, 2023
DEVICE NAME 2.
| Proprietary Name: | Centrix FluoroSilver Silver Diamine Fluoride 38% |
|---|---|
| Common/Usual Name: | Tooth Desensitizer |
| Classification Name: | Tooth Desensitizer |
| Classification Regulation: | 21 CFR 872.3260 |
| Product code: | PHR |
| Classification: | Class 2 |
| Medical Specialty (Panel): | Division of Dental and ENT devices |
3. PREDICATE DEVICES
- . Advantage Arrest (Elevate Oral Care aka ADP Silver Dental Arrest) K102973
5
4. DEVICE DESCRIPTION
The Centrix FluoroSilver is a professional tooth desensitizer that is composed of Aqueous Silver Diamine Fluoride, 38.3% to 43.2% w/v. The solution is composed of water, ammonia, fluoride, silver and a colorant.
The device is provided in a single 5 ml squeezable dropper bottle or a multi-pack which includes three 5 ml squeezable dropper bottles. Each variation is packaged in a preformed trav and includes applicators (more information provided below) and the Instructions for Use (IFU).
The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
The dentist must clean and dry the affected tooth surface and then dispense 1-2 drops of solution into a disposable dappen dish. The material is applied directly to the tooth surface using Centrix supplied applicators (Centrix Benda Micro Fine Brushes). The tooth must be allowed to air dry and then if needed one or two reapplications can be administered at intervals of one week.
The packaging will labeled with lot number, expiration date and UDI barcode. The shelf life of the device is 24 months.
The device is packaged with applicators (Centrix Benda Micro Fine Brushes) that are classified as class I 510(k) exempt medical devices under regulation 21 CFR 872.3140, Product Code KXR. A quantity of applicators will be provided in a zip lock bag.
The primary mode of action is to reduce dentinal hypersensitivity by occluding open dentin tubules by the formation of a precipitate.
| Parameter | Specification |
|---|---|
| Silver Diamine Fluoride (SDF) | 360 - 400 g/L |
| Fluoride | 50 - 60 g/L |
| pH | 8.5 - 9.5 |
| Density | 1.265 - 1.276 g/L |
Specifications
5. INDICATIONS FOR USE
Treatment of Dental Hypersensitivity for use in adults over the age of 21.
6
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The solution is applied to the tooth enamel to block dentinal tubules for the purpose of reducing tooth sensitivity. The solution precipitates upon application resulting in a physical blockage of dentinal tubules.
The subject device has equivalent indications for use, technical characteristics, mode of action, material composition (confirmed through chemical identity testing), SDF % and cytotoxicity results (comparative cytotoxicity testing) when compared to the selected predicate device.
Additionally, the subject device has a different colorant, uses different size bottles, and some minor differences in wording in labeling. These differences are minor and the overall similarities support the equivalence between the subject and predicate device.
| | Centrix
FluoroSilver
Silver Diamine
Fluoride 38% | Advantage Arrest | Discussion |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K222459 | K102973 | |
| Company | Centrix Inc | Elevate Oral Care
(named as ADP
Silver Dental Arrest
LLC in 510k) | |
| Classification Name | Cavity Varnish | Cavity Varnish | IDENTICAL |
| Common Name | Tooth Desensitizer | Tooth Desensitizer | IDENTICAL |
| Regulation Number | 872.3260 | 872.3260 | IDENTICAL |
| Product Code | PHR | PHR | IDENTICAL |
| Indications for Use | Treatment of Dental
Hypersensitivity for
use in adults over the
age of 21. | Treatment of dentinal
hypersensitivity.
For use in adult over
the age of 21. | IDENTICAL |
| Technical Method / Characteristics | Silver diamine
fluoride forms
precipitates with
calcium or phosphate
in the dentinal
tubules to block open
dentinal tubules. | Silver diamine
fluoride forms
precipitates with
calcium or phosphate
in the dentinal
tubules to block open
dentinal tubules. | IDENTICAL |
| Mode of Action | Tubule occlusion | Tubule occlusion | IDENTICAL |
| Material Composition | Silver diamine
fluoride
Purified Water | Silver diamine
fluoride
Purified Water | IDENTICAL |
Comparison Table
7
| | Fast Green FCF Dye
HPLC – Mass Spec | FD&C Blue 1
HPLC Mass Spec | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------|
| Chemical
Composition Profile | | | Nearly Identical
- Compositional
Equivalency |
| Color | Green | Blue / Violet | IDENTICAL |
| % SDF | 38% | 38% | IDENTICAL |
| Application | Liquid | Liquid | IDENTICAL |
| Rx / OTC | Rx | Rx | IDENTICAL |
| Packaging | Squeezable Dropper
Bottle
5 ml bottle
Three 5ml bottle kit
Applicator(s) | Squeezable Dropper
Bottle
8ml bottle
Three 3ml bottle kit | IDENTICAL
Packaging type
Different Size
bottles |
| Cytotoxicity | Yielded positive
cytotoxicity when
tested to ISO 10993-5 | Yielded positive
cytotoxicity when
tested to ISO 10993-5 | IDENTICAL |
| Fluoride Release | 0.023 +/- 0.003
ppmF/mm² | 0.024 +/- 0.006
ppmF/mm² | IDENTICAL
No statistical
difference
between
devices. |
| SEM Analysis | Silver deposition on dentin and in tubules
between Centrix SDF and Elevate SDF
showed no discernable difference based on
SEM analyses. | | IDENTICAL
No discernable
difference
between
devices. |
| Dentin Permeability | Dentin Permeability. Human molar teeth
samples were evaluated to calculate the %
reduction of dentin permeability using the
ratio of average treated volume of water
passing through the dentin divided by the
average baseline rate of flow.
The results found that tooth samples treated
with the subject and predicate device reduced
the dentin permeability by an average 97.5%.
Dentin permeability is thought to be related to
dentin sensitivity. Treatments that reduce
dentin permeability have been found to stop
pain due to dentin sensitivity.
Centrix % Reduction in Dentin Permeability
97.5% +/- 4.3%
Elevate % Reduction in Dentin Permeability
97.5% +/- 2.5% | | IDENTICAL |
8
7. PERFORMANCE TESTING
The following standards were either used as a reference and/or for testing of the subject device:
| Summary of Testing | ||
|---|---|---|
| Standard | Description of Test | Results |
| ISO 10993-5 (2009) | ||
| Cytotoxicity | Biological Evaluation of Medical | |
| Devices – Part 5: Tests for in vitro | ||
| cytotoxicity | Cytotoxicity testing was conducted on both | |
| the subject (Centrix) and predicate (Elevate) | ||
| devices. The testing found both the subject | ||
| device and predicate device samples were | ||
| "unsuitable for analysis" due to the high | ||
| level of precipitate generated when the test | ||
| articles were combined with culture media. | ||
| The subject device performed identically to | ||
| the predicate device. | ||
| ISO 10993-10 (2021) | Biological Evaluation of Medical | |
| Devices - Part 10: Tests for Skin | ||
| Sensitization | The testing concluded that the subject | |
| device is NOT considered to be a contact | ||
| skin sensitizer. | ||
| ISO 10993-23 (2021) | Biological Evaluation of Medical | |
| Devices – Part 23: Tests for Irritation | The testing concluded that the subject | |
| device is considered to be a Non-Irritant to | ||
| oral mucosa. | ||
| ISO 10993-11 (2017) | Biological Evaluation of Medical | |
| Devices – Part 11: Tests for Systemic | ||
| Toxicity | Acute Systemic Toxicity testing was | |
| conducted on both the subject device | ||
| (Centrix) and Predicate Device (Elevate). | ||
| The testing concluded that there were no | ||
| signs of gross toxicity, adverse clinical | ||
| effects, or abnormal behavior. No gross | ||
| abnormalities were noted after a 3 day | ||
| observation and necropsy. Both the subject | ||
| and predicate devices met the requirements | ||
| of the tests and performed identically. | ||
| ISO 10993-1 (2018) | Biological Evaluation of Medical | |
| Devices - Part 1: Evaluation and | ||
| Testing within a Risk Management | ||
| Process | The remaining biological endpoints of | |
| Acute, Subacute / Subchronic, Chronic | ||
| Systemic Toxicity, Genotoxicity and | ||
| Carcinogenicity were evaluated and | ||
| documented in a Toxicological Risk | ||
| Assessment report. The evaluation | ||
| concluded that information gathered in | ||
| published literature on the chemical | ||
| ingredients, intended use, predicate device | ||
| information that the risk of adverse effects | ||
| are low with respect to biological endpoints | ||
| of Acute, Subacute / Subchronic, Chronic | ||
| Systemic Toxicity, Genotoxicity and | ||
| Carcinogenicity. | ||
| N/A | SEM Analysis of Subject and | |
| Predicate Devices | The SEM report summarizes comparison | |
| between subject device (Centrix SDF) and | ||
| predicate device (Elevate SDF) on human | ||
| tooth samples. Both the subject and | ||
| predicate devices treated teeth samples have | ||
| significant deposits of silver on the cut | ||
| surface of the tooth and within the dentinal | ||
| tubules. There is no discernable difference | ||
| in the silver deposited on the tooth surface | ||
| and within the dentinal tubules as a result of | ||
| exposure to subject and predicate devices. | ||
| N/A | Fluoride Release Testing. Evaluation | |
| of fluoride release in SDF treated | ||
| tooth cross sections comparing | ||
| Centrix FluoroSilver Silver Diamine | ||
| Fluoride 38% and Predicate Device | ||
| (Elevate Advantage Arrest SDF) | The study confirmed the release of fluoride | |
| at the same rate with no statistical | ||
| difference between the groups. The | ||
| maximum fluoride concentrations were | ||
| equivalent. | ||
| Subject 0.023 +/- 0.003 ppmF/mm² | ||
| Predicate 0.024 +/- 0.006 ppmF/mm² | ||
| N/A | Dentin Permeability. Human molar | |
| teeth samples were evaluated to | ||
| calculate the % reduction of dentin | ||
| permeability using the ratio of | ||
| average treated volume of water | ||
| passing through the dentin divided by | ||
| the average baseline rate of flow. | The results found that tooth samples treated | |
| with SDF reduced the dentin permeability | ||
| by 97.5%. Dentin permeability is thought to | ||
| be related to dentin sensitivity. Treatments | ||
| that reduce dentin permeability have been | ||
| found to stop pain due to dentin sensitivity | ||
| N/A | Chemical Identity Testing: Mass | |
| Spectrometry (MS) performed on | ||
| subject and predicate device solutions | MS analysis found a strong match for | |
| chemical composition between the subject | ||
| and predicate device to demonstrate | ||
| compositional equivalency. |
Summary of Testing
9
8. SAFETY AND EFFICACY
The subject device is found to be equivalent to the predicate device based on comparative evaluation and testing. The overall safety and efficacy of FluoroSilver Silver Diamine Fluoride 38% usage for treating dentinal sensitivity has been demonstrated through testing conducted on the subject device, comparative testing between subject and predicate device and published literature.
9. CONCLUSION
Information presented supports substantial equivalence of the Centrix FluoroSilver Silver Diamine Fluoride 38% the predicate device based on similarities in intended use, design, principles of operation, performance specifications, and testing.
Centrix Inc believes that based on the indications for use, technological characteristics, and comparison to predicate devices the Centrix FluoroSilver Silver Diamine Fluoride 38% has been shown to be substantially equivalent to the predicate and have demonstrated that the device is as safe and as effective as the predicate.