Propex IQ® Apex Locator supports the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Device Description

The proposed Propex IQ® Apex Locator is a microprocessor-controlled device that supports the dentist during endodontic treatments for the determination of the file to the reference point for endodontic working length determination. To do so, the proposed Propex IQ® Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed Propex IQ® Apex Locator product configuration consists of the following components:

The proposed Propex IO® Apex Locator
The proposed Propex IQ® Apex Locator Measurement cable
The Proposed X-Smart IO® Measurement Cable
The proposed Propex IQ® Apex Locator External Tester
The Propex IQ® Disposable Barrier Sleeve
The proposed Propex IQ® Lip clip
The proposed Propex IQ® File clip
The proposed Propex IQ® Clamp
Propex IQ® Charger and AC Adapter Plugs

AI/ML Overview

The document describes the Dentsply Sirona Propex IQ Apex Locator and its non-clinical performance data to demonstrate substantial equivalence to its predicate devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Identical materials and fabrication methods to predicate device.	The patient contacting part (lip clip) is composed of identical materials and fabricated using the same methods as the primary predicate device (K131907).
Electrical Safety	Conformance to IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + A1:2012.	The proposed Propex IQ® Apex Locator conforms to the standard requirements.
Electromagnetic Compatibility (EMC)	Conformance to IEC 60601-1-2:2014.	The proposed Propex IQ® Apex Locator conforms to the standard requirements.
Software Verification & Validation	Conformance to IEC 62304:2015 and FDA guidance "General Principles of Software Validation".	Software Verification and Validation tests were conducted in accordance with the specified standards and guidance.
Accuracy Testing (vs. RAYPEX® 6)	Performance equivalent to primary predicate device RAYPEX® 6 (K131907).	The performance of the proposed Propex IQ® Apex Locator is equivalent to that of the primary predicate device RAYPEX® 6 (K131907).
Accuracy Testing (vs. Root ZX II)	Performance equivalent to reference device Root ZX II Apex Locator (K071190).	The performance of the proposed Propex IQ® Apex Locator is equivalent to that of the reference device: Root ZX II Apex Locator (K071190).
Disinfectant Resistance	Resistance to chemical disinfectants supporting substantial equivalence.	Applicable device components were assessed for resistance to chemical disinfectants and the results support substantial equivalence.
Information Display Latency	Latency supporting substantial equivalence.	Device display latency in all modes was assessed and the results support substantial equivalence.
Hardware Requirements Verification (Battery, Audio, Temp, Ingress, Mating Components)	Performance meeting device hardware requirements.	Verification testing of hardware requirements (battery performance, audio alarm, temperature, liquid ingress, mating components connection cycling) was included, and results support substantial equivalence.
Wireless Coexistence	Maintained functional wireless performance in the presence of unintended signals.	The proposed Propex IQ® Apex Locator maintained functional wireless performance in the presence of unintended signals.
Usability Study	Users able to use the device correctly and safely without use error.	Usability Studies conducted showed that users were able to use the device correctly and safely without use error.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the "Accuracy Testing" or "Disinfectant Resistance Testing." It refers to "Internal test method" for accuracy, suggesting it was conducted in a controlled lab or in-house environment rather than a clinical setting. Given the nature of the device (apex locator), the "test set" for accuracy would likely involve extracted teeth or simulated root canals.

The data provenance is non-clinical performance data, primarily from internal testing and conformance to international standards. There is no mention of country of origin for the data; it is assumed to be performed by the manufacturer, Dentsply Sirona. The tests are retrospective in the sense that they are conducted on a developed device to prove its performance against established standards and predicates.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not specify the number or qualifications of experts used to establish ground truth for the non-clinical tests. For "Accuracy Testing," the "ground truth" would likely be the actual measured length of the root canal established by precise laboratory methods or a gold-standard manual measurement. This might involve trained technicians or dental professionals, but their specific roles and numbers are not detailed.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as this was a non-clinical study focused on direct measurement and conformance to standards, not subjective interpretation.

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 comparative effectiveness study was mentioned. The device is not an AI-assisted diagnostic tool; it is an apex locator, a measurement device for determining root canal length. There is no "human reader" component in the context of interpretation or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The accuracy testing on the Propex IQ Apex Locator and its comparison with predicate devices served as a standalone performance assessment of the device's ability to measure root canal length. The device itself operates to provide a measurement, and its performance was evaluated independently.

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth would be the actual physical measurements of root canal length, likely established by high-precision manual or digital methods that are considered the gold standard for such measurements in dental research (e.g., direct visualization after sectioning, or radiographic measurements validated post-extraction). The document states "Internal test method," implying a controlled experimental setup to determine true root canal length.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is not described as being based on machine learning or AI that requires training data. It is a measurement device based on electrical resistance principles.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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October 3, 2019

Dentsply Sirona Karl Nittinger Director, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401

Re: K191806

Trade/Device Name: Propex IQ Apex Locator Regulatory Class: Unclassified Product Code: LQY Dated: September 4, 2019 Received: September 5, 2019

Dear Karl Nittinger:

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.

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

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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,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191806

Device Name Propex IQ® Apex Locator

Indications for Use (Describe)

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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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/3/Picture/1 description: The image contains the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a leaf or a curved letter 'S', rendered in a dark gray color. To the right of the shape are the words "Dentsply" stacked on top of "Sirona", both in a simple, sans-serif font and a light gray color.

SECTION 5. 510(k) SUMMARY

for K191806 Propex IQ® Apex Locator

1. Submitter Information:

Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: September 20, 2019

2 Device Name:

Propex IQ® Apex Locator Proprietary Name: .
- Classification Name: Locator, Root Apex
CFR Number: N/A .
Device Class: Unclassified ●
Product Code: LOY .

3. Primary Predicate Device:

Primary Predicate Device Name: RAYPEX® 6 ●
510(k): K131907
Company Name: Dentsply Sirona

Reference Devices:

Reference Device: X-Smart IQ® 1. 510(k): K161213 Company Name: Dentsply Sirona
1. Reference Device: Root ZX II Apex Locator 510(k): K071190 Company Name: J. Morita Manufacturing Corp.
1. Description of Device:

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The proposed Propex IO® Apex Locator ●
The proposed Propex IQ® Apex Locator Measurement cable
The Proposed X-Smart IO® Measurement Cable
. The proposed Propex IQ® Apex Locator External Tester
The Propex IQ® Disposable Barrier Sleeve
The proposed Propex IQ® Lip clip
The proposed Propex IQ® File clip
The proposed Propex IQ® Clamp
Propex IQ® Charger and AC Adapter Plugs

Modes of Operation:

The proposed Propex IQ® Apex Locator can be used with X-Smart IQ® Handpiece (K161213) and/or Endo IQ® App (K161213) in different modes. Summary of different modes of operations of the proposed Propex IQ® Apex Locator along with its interaction with X-Smart IQ®Handpiece (K161213) and Endo IQ® App (K161213) is summarized in the Table 5.1 below ("Yes" indicates that the device or components is utilized in the referenced Mode, "No" indicates that it is not utilized in the referenced Mode):

Table 5.1 Summary of the different modes of Operation of the proposed Propex IQ®
Apex Locator
Mode	ProposedPropex IQ®Apex Locator	X-Smart IQ®Handpiece	Endo IQ®App
Uncombined, Unconnected(Stand-Alone)	yes	no	no
Combined, Unconnected(combined with X-Smart IQ®Handpiece) (stand-alone connectedto the iPad application)	yes	yes	no
Uncombined, Connected (combinedwith X-Smart IQ® Handpiece) (stand-alone, connected to the Endo IQ®App)	yes	no	yes
Combined, Connected(combined to X-Smart IQ®Handpiece and connected to the EndoIQ® App)	yes	yes	yes

റ Indications for Use:

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6. Substantial Equivalence:

Table 5.2 compares the proposed device, Propex IQ® Apex Locator, and the primary predicate device, RAYPEX 6®. Technological similarities and differences are as follows:

Table 5.2 Comparison between the primary predicate device, RAYPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator
Element	Primary PredicateDeviceRAYPEX® 6 (K131907)	Proposed DevicePropex IQ® Apex Locator	Similarities/Differences
Indication forUse	RAYPEX® 6 is a microprocessor controlleddevice used for locating the apex.	Propex IQ® Apex Locator supports the dentist in thedetermination of the working length during theendodontic treatment. The use of this product isintended exclusively for duly qualified dentalpractitioners.	Both the proposed PropexIQ® Apex Locator and theprimary predicateRAYPEX® 6 (K131907)are indicated to assist in thedetermination of the lengthof the root canal space.
Use with X-Smart IQ®Handpiece(Product code:EBW, K161213)	Cannot be used with any hand-piece	Can be used with only X-Smart IQ® Handpiece(K161213) (in combined mode).	The proposed Propex IQ® isdesigned to function incombined mode with thereference X-Smart IQ®handpiece (K161213).Combined mode facilitatesconsolidation of workingsteps when the X-Smart IQ®Handpiece (K161213) isused.
Use with EndoIQ® App(K161213)	Cannot be used with Endo IQ® App(K161213)	Can be used in standalone mode without EndoIQ® App (K161213) or with the Endo IQ® App	Endo IQ® App (K161213)gives interactiveinformation (real timegraphs, images) andaccess to pre- and post-operation information. Thepredicate device(K131907) incorporatesinteractive real-timeinformation in its integraluser interface display.
Table 5.2 Comparison between the primary predicate device, RA YPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator
Element	Primary PredicateDeviceRAYPEX® 6 (K131907)	Proposed DevicePropex IQ® Apex Locator	Similarities/Differences
Bluetooth	No Bluetooth functionality	Can be connected to Endo IQ® App (K161213)via Bluetooth and have Bluetooth function totransfer the data to the Endo IQ® App	Bluetooth is used to connectand transfer the data with EndoIQ® App. The Endo IQ® App(K161213) interactiveinformation (real time graphs,images) and access to pre- andpost- operation information.The predicate device(K131907) incorporatesinteractive real-timeinformation in its integral userinterface display.
WorkingEnvironment	This product must be used in hospitalenvironments, clinics or dental offices byqualified dental personnel.	This product must be used in professionalhealthcare facility environment by qualified dentalpersonnel.	The proposed Propex IQ®Apex Locator and the predicateRAYPEX® 6 (K131907) areboth intended for use withinthe same clinical environments.

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Table 5.2 Comparison between the primary predicate device, RAYPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator
Element	PrimaryPredicateDeviceRAYPEX® 6 (K131907)	Proposed DevicePropex IQ® ApexLocator	Similarities/Differences
Means of input	On/off pushbuttonTouch Panel	• On/off pushbutton• Bluetooth button• Endo IQ® App (K161213)	The proposed Propex IQ® ApexLocator can be connected toEndo IQ® App (K161213) viaBluetooth. In Stand-alone modeit can be used without Endo IQ®App (K161213) using on/offpush buttons. The predicateRAYPEX® 6 (K1311907)incorporates an integral touchscreen user interface.
Patient contactingcomponentsmaterialcomposition	Lip Clip: Stainless steelFile Clip: Gold plated beryllium copper, glass filled nylon	Lip Clip: Stainless SteelFile Clip: Gold plated beryllium copper, glassfilled nylon	The proposed Propex® IQ ApexLocator and the predicate device(K131907) utilize the samepatient contacting accessorycomponents.
Power supply	Rechargeable Ni-MH battery	Rechargeable Ni-MH batteries	Both the proposed Propex® IQApex locator and the predicatedevice (K131907) utilizerechargeable Ni-MH batteries.
Table 5.2 Comparison between the primary predicate device, RAYPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator
Element	Primary PredicateDeviceRAYPEX® 6 (K131907)	Proposed DevicePropex IQ® ApexLocator	Similarities/Differences
Display	3.5 inch color display.	No display on the device, only multi-color LEDs to indicate status during the working length determination.	Different user interface, no screen in Propex IQ® Apex Locator. When working in unconnected mode, the proposed Propex IQ® Apex Locator gives an indication of estimated file position using visual signals (the color of the central LED) and auditory signals. When connected to Endo IQ® App (K161213), the larger display of the iPad® will display the file progression along the root canal in the form of colored bars.
Adjustmentbeforemeasurement	Not required	Not required	Neither the proposed Propex IQ® Apex Locator nor the predicate device (K131907) require adjustment prior to estimation of the length of the root canal space.
Calibration	Not required	Not required	Neither the proposed Propex IQ® Locator nor the predicate RAYPEX® 6 (K131907) require calibration prior to estimation of the length of the root canal space.
Table 5.2 Comparison between the primary predicate device, RAYPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator
Element	Primary PredicateDeviceRAYPEX® 6 (K131907)	ProposedDevice PropexIQ® ApexLocator	Similarities/Differences
Electronicdesign	The electronic design utilizesmicrocontroller based electronic circuit andTFT color matrix graphic display.	The electronic design is based on a custom PCBdesign with miniaturized electronic components.A Bluetooth module is included for connectivitywith iPad. The audio-visual feedback to the useris generated using a buzzer for sound emissionand multi-color LEDs for visual feedback. Noscreen or graphic display is available on thedevice, there are only multi-colored LEDs forvisual feedback.	The difference in electronicdesign of two devices relates tofunctionality, performance anddimensions of the proposeddevice.
Sterilization	Lip clip and file clip are user sterilized bysteam sterilization	Lip clip and file clip are user sterilized bysteam sterilization.	Both the proposed Propex® IQApex Locator and the predicatedevice utilize the same lip clipand file clip accessorycomponents to facilitate theestimation of the length of theroot canal space. These reusablecomponents are intended in bothcases as reusable accessorieswhich are end-user sterilized bysteam sterilization.

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7. Summary of Non-Clinical Performance Data

Biocompatibility: The patient contacting part of the proposed Propex IQ® Apex Locator (the lip clip component) is composed of identical materials and fabricated using the same methods as the same component used with the primary predicate device (K131907). Therefore, no new biocompatibility data is included in support of substantial equivalence.

Electromagnetic compatibility and electrical safety:

The proposed Propex IQ® Apex Locator was tested for Electrical safety and Electromagnetic testing. Table 5.3 below summarizes EMC and Electrical safety testing.

Table 5.3 Summary of Electrical safety and Electromagnetic compatibility
Test	Standard	Results
Electrical safety	IEC 60601-1:2005 (Third Edition) + CORR.1:2006 + CORR. 2:2007 + A1:2012 (or IEC60601-1: 2012 reprint) Medical electricalequipment - Part 1 : general requirements forsafety	The proposed Propex IQ®Apex Locator conforms tothe standard requirements.
Electromagnetic compatibility	IEC 60601-1-2:2014 (Fourth Edition)Medical electrical equipment - Part 1-2 :General requirements for basic safety andessential performance - Collateralstandard: electromagnetic compatibilityRequirements and tests	The proposed Propex IQ®Apex Locator conforms tothe standard requirements.

Software Verification and Validation: Software Verification and Validation tests were conducted in accordance with IEC 62304:2015 and FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".

Performance Testing: In addition to biocompatibility, electrical safety, EMC and software testing, the following non-clinical tests are included in support of substantial equivalence.:

Table 5.4 Performance testing on the proposed Propex IQ® Apex Locator
Test	Standard/Method	Results
AccuracyTesting withRAYPEX®6 (K131907)	Internal test method	It is shown that the performance of theproposed Propex IQ® Apex Locator isequivalent to that of primary predicatedevice RAYPEX6 (K131907) within thescope of this test.

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Table 5.4 Performance testing on the proposed Propex IQ® Apex Locator
Test	Standard/Method	Results
AccuracyTesting withRoot ZX IIApexLocator(K071190)	Internal test method	It is shown that the performance of theproposed Propex IQ® Apex Locator isequivalent to that of reference device: RootZX II Apex Locator (K071190) within thescope of this test.
DisinfectantResistanceTesting	ISO 21530 (Dentistry --Materials used for dentalequipment surfaces --Determination of resistance tochemical disinfectants)	Applicable device components were assessedfor resistance to chemical disinfectants andthe results support substantial equivalence.
Informationdisplaylatency	Internal test method	Device display latency in all modes wasassessed and the results support substantialequivalence.
Hardwarerequirementsverificationtests.	Internal Test Methods	Verification testing of the device hardwarerequirements including: battery performance,audio alarm performance, temperature testing,liquid ingress resistance, and matingcomponents connection cycling is included,and the results support substantialequivalence.
Wirelesscoexistence	AAMI TIR69: RiskManagement of Radio-frequency WirelessCoexistence for MedicalDevices and SystemsANSI C63.27-2017 AmericanNational Standard forEvaluation of WirelessCoexistence	The proposed Propex IQ® Apex Locatormaintained functional wireless performancein the presence of unintended signals.

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Table 5.5 Usability testing on the proposed Propex IQ® Apex Locator
Test	Standard/Guidance	Results
UsabilityStudy	FDA Guidance: "Applying Human Factors andUsability Engineering to Medical Devices -Guidance for Industry and Food and DrugAdministration Staff ANSI-AAMI_HE75:2009/ (R) 2013 Human factorsengineering - Design of medical devices AAMI / ANSI / IEC 62366-1:2015 Medical devices-Part 1: Application of usability engineering tomedical devices (General I (QS/RM)) IEC TR 62366-2:2016 Medical devices – Part 2:Guidance on the application of usability engineeringto medical devices IEC 60601-1-6 Edition 3.1 2013-10 Medicalelectrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability	Usability Studiesconducted showedthat users were ableto use the devicecorrectly and safelywithout use error.

Clinical Performance Data 8.

No human clinical data were included to support substantial equivalence.

Conclusion Regarding Substantial Equivalence 9.
Information included in this premarket notification supports the substantial equivalence of the proposed Propex IQ® Apex Locator. The proposed device has the identical intended use as the primary predicate device cleared under premarket notification K131907. The proposed Propex IQ® Apex Locator also has similar indications for use and incorporates the same fundamental technology as the primary predicate device (K131907).

Performance, safety, and software validation test data demonstrate the performance of the subject Propex IQ® Apex Locator device against its design, functional, and safety requirements. The results of the testing support a determination of substantial equivalence.

Regulation Number and Section

N/A