(164 days)
Not Found
No
The summary describes a standard electronic apex locator and does not mention any AI/ML terms, image processing, or data-driven performance metrics typically associated with AI/ML devices.
No
The device is used for measurement of the length of root canals, which is a diagnostic/measurement function, not a therapeutic one. It assists a professional in performing procedures but does not directly treat a condition.
Yes
The ApexNRG Rider measures the length of root canals to assist in dental procedures, which is a form of diagnosis in dentistry.
No
The device description explicitly states it is a "dental apex locator which has the ability to measure the depth of the root canal by electronic means," implying hardware components are involved in the measurement process. The performance studies also mention "EMC and Electrical Testing," which are typically associated with hardware devices.
Based on the provided information, the ApexNRG Rider is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure the length of root canals and related dental procedures in vivo (within the patient's body). IVDs are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples.
- Device Description: The device measures the depth of the root canal electronically, which is a direct measurement within the patient's mouth.
- Anatomical Site: The anatomical site is the root canal, which is part of the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens or performing tests on samples taken from the patient.
Therefore, the ApexNRG Rider is a medical device used for a diagnostic procedure performed directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LQY
Device Description
The ApexNRG Rider is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional in general dentistry
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
OCT 0 8 2010
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string appears to be "K101177". The characters are written in black ink on a white background. The handwriting is somewhat messy, but the characters are still legible.
14,
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: 972-4-675-4217 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
1
| Device
Characteristic | Modified Device
ApexNRG Rider | Predicate
Device
Apex DAL
Electronic
Apex Locator | Comment | | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|------|--|
| Intended Use | To measure the
length of the root
canal for the
purpose of
performing root
canals and related
dental procedures
for use by a trained
professional in
general dentistry | To measure
the length of
the root canal
for the
purpose of
performing
root canals
and related
dental
procedures
for use by a
trained
professional
in general
dentistry | same | | | | |
| Power Source | Single CR2450 V | AA 1.5 V | different | | | | |
| Electric
Current | Less than 10 μA | Less than 10 μA | same | | | | |
| Method of
calculating
location of root
canal apex | | Comparison of a
multi-frequency
response signal
using DSP
technology with a
different 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
frequencies used
for comparison 6.5
kHz - 1.3 kHz
Square Wave with
3 cycles used for
measurement. | | Comparison
of a multi-
frequency
response
signal using
DSP
technology
with a
different
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
frequencies
used for
comparison
6.5 kHz - 1.3
kHz Square
Wave with 3
cycles used
for
measurement. | | same | |
2
| Frequencies
used for
comparison | 6.5 kHz - 1.3 kHz
Square Wave | 6.5 kHz - 1.3 kHz Square
Wave | same |
|---------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| Number of
cycles used for
measurement | 3 | 3 | same |
| Display | 6 LED- Distance
provided every 0.25
mm from 0.5 mm
to the apex. | 8 LED-
Distance
provided
every 0.25
mm from 0.5
mm to the
apex. | Same |
| Adjustment
before
measurement | Not required | Not required | Same |
| Measuring
Voltage | Up to 15 mV | Up to 15 mV | Same |
| Weight | 26 grams | 50 grams | Same |
| Dimensions | L:67 x W: 34 x H:
19 mm | L: 87 x W: 60
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, bold design.
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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