APEXNRG RIDER

K101177 · Medicnrg , Ltd. · LQY · Oct 8, 2010 · DE

Device Facts

• Record ID: K101177
• Device Name: APEXNRG RIDER
• Applicant: Medicnrg , Ltd.
• Product Code: LQY · DE
• Decision Date: Oct 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The ApexNRG Rider is intended for the measurement of the length of the root canal for purposes of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

Device Story

ApexNRG Rider is a dental apex locator measuring root canal depth electronically. Device inputs multi-frequency response signals (6.5 kHz and 1.3 kHz repetition rate) via probe; DSP technology processes signals using a fast algorithm to calculate distance to apex. Output displayed via 6-LED interface indicating distance in 0.25 mm increments. Used in dental clinics by trained professionals; can be used as a standalone unit or integrated with a dental handpiece. Provides real-time measurement to assist clinicians in determining working length during root canal therapy, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical performance testing, including EMC testing, electrical safety testing, and software validation.

Technological Characteristics

Electronic apex locator; multi-frequency response signal (6.5 kHz and 1.3 kHz square wave); DSP-based algorithm; 6-LED display; powered by single CR2450 battery; dimensions 67x34x19 mm; weight 26g; measuring voltage up to 15 mV; current <10 μA.

Indications for Use

Indicated for measurement of root canal length during endodontic procedures by trained dental professionals.

Predicate Devices

• MedicNRG DAL Apex Locator (K080113)

Submission Summary (Full Text)

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OCT 0 8 2010

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# 510(k) Summary of Safety & Effectiveness

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

- Submitter George J. Hattub 1. (a) Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 www.medicsense.com 1. (b) Manufacturer MedicNRG, Ltd. PO Box 338, MP Jordan Valley Address: Kibbutz Afikim, Israel 15148 Mfg. Phone: [phone] Contact Person: Michal Zach, QA Manager June 12, 2010 Date: 2. Device & Classification Locator, Root, Apex, Class 2, Product Code LQY, unclassified Name: ApexNRG Rider(Apex Locator) MedicNRG ApexDAL Apex Locator (K080113) Predicate Device: 3. Description: The ApexNRG Rider is a dental apex locator which has the ability to 4. measure the depth of the root canal by electronic means. The ApexNRG Rider is intended for the measurement of the length of the ક. Intended Use: root canal for purposes of performing root canals and related dental ﺮﮮ ۔ ۔ procedures, for use by a trained professional in general dentistry. With respect to technology and intended use, the Modified MedicNRG-Comparison of 6. Rider (Apex Locator) is substantially equivalent to its predicate device which Technological is the MedicNRG DAL Apex Locator. The primary difference is that the Characteristics: modified device can be used in conjunction with a dental handpiece or as a separate, external unit. Like its predicate device (K080113) it utilizes a multi-frequency response signal using DSP technology with a fast algorithm reducing the delay between calculation and display of measurement. The signals are generated as a response to multi-frequency signals having a 6.5 and 1.3 kHz repetition rate. The following table delineates the differences between the predicate device and the ApexNRG Rider

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| Device<br>Characteristic | Modified Device<br>ApexNRG Rider | Predicate<br>Device<br>Apex DAL<br>Electronic<br>Apex Locator | Comment | | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------|--|
| Intended Use | To measure the<br>length of the root<br>canal for the<br>purpose of<br>performing root<br>canals and related<br>dental procedures<br>for use by a trained<br>professional in<br>general dentistry | To measure<br>the length of<br>the root canal<br>for the<br>purpose of<br>performing<br>root canals<br>and related<br>dental<br>procedures<br>for use by a<br>trained<br>professional<br>in general<br>dentistry | same | | | | |
| Power Source | Single CR2450 V | AA 1.5 V | different | | | | |
| Electric<br>Current | Less than 10 μA | Less than 10 μA | same | | | | |
| Method of<br>calculating<br>location of root<br>canal apex | | Comparison of a<br>multi-frequency<br>response signal<br>using DSP<br>technology with a<br>different algorithm<br>reducing the delay<br>between calculation<br>and display of<br>measurement. The<br>signals are<br>generated as a<br>response to multi-<br>frequency signals<br>having a 6.5 and<br>1.3 kHz repetition<br>rate. The<br>frequencies used<br>for comparison 6.5<br>kHz - 1.3 kHz<br>Square Wave with<br>3 cycles used for<br>measurement. | | Comparison<br>of a multi-<br>frequency<br>response<br>signal using<br>DSP<br>technology<br>with a<br>different<br>algorithm<br>reducing the<br>delay<br>between<br>calculation<br>and display of<br>measurement.<br>The signals<br>are generated<br>as a response<br>to multi-<br>frequency<br>signals having<br>a 6.5 and 1.3<br>kHz repetition<br>rate. The<br>frequencies<br>used for<br>comparison<br>6.5 kHz - 1.3<br>kHz Square<br>Wave with 3<br>cycles used<br>for<br>measurement. | | same | |

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| Frequencies<br>used for<br>comparison | 6.5 kHz - 1.3 kHz<br>Square Wave | 6.5 kHz - 1.3 kHz Square<br>Wave | same |
|---------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| Number of<br>cycles used for<br>measurement | 3 | 3 | same |
| Display | 6 LED- Distance<br>provided every 0.25<br>mm from 0.5 mm<br>to the apex. | 8 LED-<br>Distance<br>provided<br>every 0.25<br>mm from 0.5<br>mm to the<br>apex. | Same |
| Adjustment<br>before<br>measurement | Not required | Not required | Same |
| Measuring<br>Voltage | Up to 15 mV | Up to 15 mV | Same |
| Weight | 26 grams | 50 grams | Same |
| Dimensions | L:67 x W: 34 x H:<br>19 mm | L: 87 x W: 60<br>x H: 18 mm | Same |

Based upon the testing results, MedicNRG believes this difference does not raise additional safety of efficacy concerns.

#### 7. Testing

The determination of substantial equivalence is based on an assessment of non-clinical performance data. This testing consisted EMC and Electrical Testing as well as Software Validation. The results of this testing supported a determination of substantial equivalence.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medicnrg, Limited C/O Mr. George Hattub Medicsense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

OCT 0 8 2010

Re: K101177

Trade/Device Name: ApexNRG Rider (Apex Locator) Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LQY . Dated: August 24, 2010 Received: August 30, 2010

Dear Mr. Hattub:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2- Mr. Hattub

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: ApexNRG Rider (Apex Locator)

Indications For Use: The ApexNRG Rider is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General പ്രവ്യൂട്ടുപ്പ്മി of 1 infection Control, Dental Devices

510(k) Number: K01177