(90 days)
No
The description focuses on electrical resistance measurement and microprocessor control, with no mention of AI/ML terms or related concepts like training/test data.
No.
The device determines the working length during endodontic treatment, but it does not directly treat a condition or disease.
Yes
Explanation: The device is described as supporting "the dentist in the determination of the working length during the endodontic treatment" by assessing "the electrical resistance of the tooth and surrounding tissues." This function of providing information for diagnosis (determining working length) during a medical procedure qualifies it as a diagnostic device.
No
The device description explicitly lists multiple hardware components, including the device itself, cables, an external tester, clips, a clamp, and a charger. The performance studies also include hardware requirements verification tests.
Based on the provided information, the Propex IQ® Apex Locator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "support the dentist in the determination of the working length during the endodontic treatment." This is a direct measurement taken in vivo (within the living patient's tooth and surrounding tissues) to guide a surgical procedure (endodontic treatment).
- Device Description: The device assesses "electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal." This is a physical measurement of electrical properties within the body, not an analysis of a sample taken from the body.
- Lack of Sample Analysis: IVD devices typically analyze samples taken from the human body (like blood, urine, tissue, etc.) to provide information about a patient's health or condition. This device does not analyze any such sample.
The Propex IQ® Apex Locator is a medical device used in vivo to assist in a dental procedure. It falls under the category of devices used for measurement and guidance during treatment, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
LQY
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
duly qualified dental practitioners / hospital environments, clinics or dental offices / professional healthcare facility environment
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)
- 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."
- Electrical safety: "The proposed Propex IQ® Apex Locator was tested for Electrical safety and Electromagnetic testing." Standard: "IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint) Medical electrical equipment - Part 1 : general requirements for safety". Results: "The proposed Propex IQ® Apex Locator conforms to the standard requirements."
- Electromagnetic compatibility: "The proposed Propex IQ® Apex Locator was tested for Electrical safety and Electromagnetic testing." Standard: "IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2 : General requirements for basic safety and essential performance - Collateral standard: electromagnetic compatibility Requirements and tests". Results: "The proposed Propex IQ® Apex Locator conforms to the 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"."
- Accuracy Testing with RAYPEX® 6 (K131907): Internal test method. Results: "It is shown that the performance of the proposed Propex IQ® Apex Locator is equivalent to that of primary predicate device RAYPEX6 (K131907) within the scope of this test."
- Accuracy Testing with Root ZX II Apex Locator (K071190): Internal test method. Results: "It is shown that the performance of the proposed Propex IQ® Apex Locator is equivalent to that of reference device: Root ZX II Apex Locator (K071190) within the scope of this test."
- Disinfectant Resistance Testing: Standard: "ISO 21530 (Dentistry -- Materials used for dental equipment surfaces -- Determination of resistance to chemical disinfectants)". Results: "Applicable device components were assessed for resistance to chemical disinfectants and the results support substantial equivalence."
- Information display latency: Internal test method. Results: "Device display latency in all modes was assessed and the results support substantial equivalence."
- Hardware requirements verification tests: Internal Test Methods. Results: "Verification testing of the device hardware requirements including: battery performance, audio alarm performance, temperature testing, liquid ingress resistance, and mating components connection cycling is included, and the results support substantial equivalence."
- Wireless coexistence: Standards: "AAMI TIR69: Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence". Results: "The proposed Propex IQ® Apex Locator maintained functional wireless performance in the presence of unintended signals."
- Usability Study: Standards/Guidance: "FDA Guidance: "Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff ANSI-AAMI_HE75:2009/ (R) 2013 Human factors engineering - Design of medical devices AAMI / ANSI / IEC 62366-1:2015 Medical devices -Part 1: Application of usability engineering to medical devices (General I (QS/RM)) IEC TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability". Results: "Usability Studies conducted showed that users were able to use the device correctly and safely without use error."
- Clinical Performance Data: "No human clinical data were included to support substantial equivalence."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K191806
Device Name Propex IQ® Apex Locator
Indications for Use (Describe)
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.
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
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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
-
- Reference Device: Root ZX II Apex Locator 510(k): K071190 Company Name: J. Morita Manufacturing Corp.
-
- Description of Device:
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:
4
- 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 | Proposed | ||
| Propex 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 connected | |||
| to the iPad application) | yes | yes | no |
| Uncombined, Connected (combined | |||
| with 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 Endo | |||
| IQ® App) | yes | yes | yes |
റ Indications for Use:
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.
5
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 Predicate | ||
| Device | |||
| RAYPEX® 6 (K131907) | Proposed Device | ||
| Propex IQ® Apex Locator | Similarities/Differences | ||
| Indication for | |||
| Use | RAYPEX® 6 is a microprocessor controlled | ||
| device used for locating the apex. | 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. | Both the proposed Propex | ||
| IQ® Apex Locator and the | |||
| primary predicate | |||
| RAYPEX® 6 (K131907) | |||
| are indicated to assist in the | |||
| determination of the length | |||
| of 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® is | ||
| designed to function in | |||
| combined mode with the | |||
| reference X-Smart IQ® | |||
| handpiece (K161213). | |||
| Combined mode facilitates | |||
| consolidation of working | |||
| steps when the X-Smart IQ® | |||
| Handpiece (K161213) is | |||
| used. | |||
| Use with Endo | |||
| IQ® App | |||
| (K161213) | Cannot be used with Endo IQ® App | ||
| (K161213) | Can be used in standalone mode without Endo | ||
| IQ® App (K161213) or with the Endo IQ® App | Endo IQ® App (K161213) | ||
| gives interactive | |||
| information (real time | |||
| graphs, images) and | |||
| access to pre- and post- | |||
| operation information. The | |||
| predicate device | |||
| (K131907) incorporates | |||
| interactive real-time | |||
| information in its integral | |||
| user interface display. | |||
| Table 5.2 Comparison between the primary predicate device, RA YPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator | |||
| Element | Primary Predicate | ||
| Device | |||
| RAYPEX® 6 (K131907) | Proposed Device | ||
| Propex IQ® Apex Locator | Similarities/Differences | ||
| Bluetooth | No Bluetooth functionality | Can be connected to Endo IQ® App (K161213) | |
| via Bluetooth and have Bluetooth function to | |||
| transfer the data to the Endo IQ® App | Bluetooth is used to connect | ||
| and transfer the data with Endo | |||
| IQ® App. The Endo IQ® App | |||
| (K161213) interactive | |||
| information (real time graphs, | |||
| images) and access to pre- and | |||
| post- operation information. | |||
| The predicate device | |||
| (K131907) incorporates | |||
| interactive real-time | |||
| information in its integral user | |||
| interface display. | |||
| Working | |||
| Environment | This product must be used in hospital | ||
| environments, clinics or dental offices by | |||
| qualified dental personnel. | This product must be used in professional | ||
| healthcare facility environment by qualified dental | |||
| personnel. | The proposed Propex IQ® | ||
| Apex Locator and the predicate | |||
| RAYPEX® 6 (K131907) are | |||
| both intended for use within | |||
| the same clinical environments. |
6
7
| Table 5.2 Comparison between the primary predicate device, RAYPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator | |||
|---|---|---|---|
| Element | PrimaryPredicate | ||
| Device | |||
| RAYPEX® 6 (K131907) | Proposed Device | ||
| Propex IQ® Apex | |||
| Locator | Similarities/Differences | ||
| Means of input | On/off pushbutton | ||
| Touch Panel | • On/off pushbutton | ||
| • Bluetooth button | |||
| • Endo IQ® App (K161213) | The proposed Propex IQ® Apex | ||
| Locator can be connected to | |||
| Endo IQ® App (K161213) via | |||
| Bluetooth. In Stand-alone mode | |||
| it can be used without Endo IQ® | |||
| App (K161213) using on/off | |||
| push buttons. The predicate | |||
| RAYPEX® 6 (K1311907) | |||
| incorporates an integral touch | |||
| screen user interface. | |||
| Patient contacting | |||
| components | |||
| material | |||
| composition | Lip Clip: Stainless steel | ||
| File Clip: Gold plated beryllium copper, glass filled nylon | Lip Clip: Stainless Steel | ||
| File Clip: Gold plated beryllium copper, glass | |||
| filled nylon | The proposed Propex® IQ Apex | ||
| Locator and the predicate device | |||
| (K131907) utilize the same | |||
| patient contacting accessory | |||
| components. | |||
| Power supply | Rechargeable Ni-MH battery | Rechargeable Ni-MH batteries | Both the proposed Propex® IQ |
| Apex locator and the predicate | |||
| device (K131907) utilize | |||
| rechargeable Ni-MH batteries. | |||
| Table 5.2 Comparison between the primary predicate device, RAYPEX® 6 (K131907), and the proposed, Propex IQ® Apex Locator | |||
| Element | Primary Predicate | ||
| Device | |||
| RAYPEX® 6 (K131907) | Proposed Device | ||
| Propex IQ® Apex | |||
| Locator | 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. |
| Adjustment | |||
| before | |||
| measurement | 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 Predicate | ||
| Device | |||
| RAYPEX® 6 (K131907) | Proposed | ||
| Device Propex | |||
| IQ® Apex | |||
| Locator | Similarities/Differences | ||
| Electronic | |||
| design | The electronic design utilizes | ||
| microcontroller based electronic circuit and | |||
| TFT color matrix graphic display. | The electronic design is based on a custom PCB | ||
| design with miniaturized electronic components. | |||
| A Bluetooth module is included for connectivity | |||
| with iPad. The audio-visual feedback to the user | |||
| is generated using a buzzer for sound emission | |||
| and multi-color LEDs for visual feedback. No | |||
| screen or graphic display is available on the | |||
| device, there are only multi-colored LEDs for | |||
| visual feedback. | The difference in electronic | ||
| design of two devices relates to | |||
| functionality, performance and | |||
| dimensions of the proposed | |||
| device. | |||
| Sterilization | Lip clip and file clip are user sterilized by | ||
| steam sterilization | Lip clip and file clip are user sterilized by | ||
| steam sterilization. | Both the proposed Propex® IQ | ||
| Apex Locator and the predicate | |||
| device utilize the same lip clip | |||
| and file clip accessory | |||
| components to facilitate the | |||
| estimation of the length of the | |||
| root canal space. These reusable | |||
| components are intended in both | |||
| cases as reusable accessories | |||
| which are end-user sterilized by | |||
| steam sterilization. |
8
9
10
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 IEC | ||
| 60601-1: 2012 reprint) Medical electrical | ||
| equipment - Part 1 : general requirements for | ||
| safety | The proposed Propex IQ® | |
| Apex Locator conforms to | ||
| the standard requirements. | ||
| Electromagneti | ||
| c compatibility | IEC 60601-1-2:2014 (Fourth Edition) | |
| Medical electrical equipment - Part 1-2 : | ||
| General requirements for basic safety and | ||
| essential performance - Collateral | ||
| standard: electromagnetic compatibility | ||
| Requirements and tests | The proposed Propex IQ® | |
| Apex Locator conforms to | ||
| the 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 |
| Accuracy | ||
| Testing with | ||
| RAYPEX® | ||
| 6 (K131907) | Internal test method | It is shown that the performance of the |
| proposed Propex IQ® Apex Locator is | ||
| equivalent to that of primary predicate | ||
| device RAYPEX6 (K131907) within the | ||
| scope of this test. |
11
| Table 5.4 Performance testing on the proposed Propex IQ® Apex Locator | |||||
|---|---|---|---|---|---|
| Test | Standard/Method | Results | |||
| Accuracy | |||||
| Testing with | |||||
| Root ZX II | |||||
| Apex | |||||
| Locator | |||||
| (K071190) | Internal test method | It is shown that the performance of the | |||
| proposed Propex IQ® Apex Locator is | |||||
| equivalent to that of reference device: Root | |||||
| ZX II Apex Locator (K071190) within the | |||||
| scope of this test. | |||||
| Disinfectant | |||||
| Resistance | |||||
| Testing | ISO 21530 (Dentistry -- | ||||
| Materials used for dental | |||||
| equipment surfaces -- | |||||
| Determination of resistance to | |||||
| chemical disinfectants) | Applicable device components were assessed | ||||
| for resistance to chemical disinfectants and | |||||
| the results support substantial equivalence. | |||||
| Information | |||||
| display | |||||
| latency | Internal test method | Device display latency in all modes was | |||
| assessed and the results support substantial | |||||
| equivalence. | |||||
| Hardware | |||||
| requirements | |||||
| verification | |||||
| tests. | Internal Test Methods | Verification testing of the device hardware | |||
| requirements including: battery performance, | |||||
| audio alarm performance, temperature testing, | |||||
| liquid ingress resistance, and mating | |||||
| components connection cycling is included, | |||||
| and the results support substantial | |||||
| equivalence. | |||||
| Wireless | |||||
| coexistence | AAMI TIR69: Risk | ||||
| Management of Radio- | |||||
| frequency Wireless | |||||
| Coexistence for Medical | |||||
| Devices and Systems | |||||
| ANSI C63.27-2017 American | |||||
| National Standard for | |||||
| Evaluation of Wireless | |||||
| Coexistence | The proposed Propex IQ® Apex Locator | ||||
| maintained functional wireless performance | |||||
| in the presence of unintended signals. |
12
| Table 5.5 Usability testing on the proposed Propex IQ® Apex Locator | ||
|---|---|---|
| Test | Standard/Guidance | Results |
| Usability | ||
| Study | FDA Guidance: "Applying Human Factors and | |
| Usability Engineering to Medical Devices - | ||
| Guidance for Industry and Food and Drug | ||
| Administration Staff ANSI-AAMI_HE75:2009/ (R) 2013 Human factors | ||
| engineering - Design of medical devices AAMI / ANSI / IEC 62366-1:2015 Medical devices | ||
| -Part 1: Application of usability engineering to | ||
| medical devices (General I (QS/RM)) IEC TR 62366-2:2016 Medical devices – Part 2: | ||
| Guidance on the application of usability engineering | ||
| to medical devices IEC 60601-1-6 Edition 3.1 2013-10 Medical | ||
| electrical equipment - Part 1-6: General | ||
| requirements for basic safety and essential | ||
| performance - Collateral standard: Usability | Usability Studies | |
| conducted showed | ||
| that users were able | ||
| to use the device | ||
| correctly and safely | ||
| without 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.