(151 days)
Not Found
No
The summary describes a standard electronic apex locator with Bluetooth capability and does not mention any AI or ML features.
No.
The device is indicated for measurement of root canal length, which is a diagnostic function, not therapeutic.
Yes
The device is indicated for the "measurement of the length of the root canals," which is a form of diagnostic measurement, providing information about the condition or characteristics of the anatomical site.
No
The device description explicitly states it is a "dental apex locator" that measures depth by "electronic means" and has "Blue-Tooth Capability." This implies the presence of hardware components for measurement and communication, not just software.
Based on the provided information, the ApexNRG-Blue is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ApexNRG-Blue Function: The ApexNRG-Blue measures the length of root canals within the patient's mouth during a dental procedure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "measurement of the length of the root canals and related dental procedures," which is an in-vivo (within the living body) measurement.
Therefore, the ApexNRG-Blue is a medical device used in a clinical setting, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ApexNRG-Blue 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 Blue is a dental apex locator which has the ability to measure the depth of the root canal by electronic means. It has Blue-Tooth Capability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MedicNRG XFG Electronic Apex Locator (K063843), MedicNRG Electronic Apex Locator (K032743)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Ko71133
SEP 2 1 2007
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | Submitter
Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com |
|--------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | MedicNRG, Ltd.
PO Box 338, MP Gordon Valley
Kibbutz Afikim, Israel 15148 |
| | Mfq. Phone: | 972-4-675-4217 |
| | Contact Person: | Michal Zach, QA Manager |
| | Date: | April 11, 2007 |
| 2. | Device &
Classification
Name: | Locator, Root, Apex, Class 2, Product Code LQY, unclassified
ApexNRG XFR (Apex Locator) |
| 3. | Predicate Device: | MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG Electronic
Apex Locator (K032743) |
| 4. | Description: | The ApexNRG Blue is a dental apex locator which has the ability to measure
the depth of the root canal by electronic means. It has Blue-Tooth
Capability. |
| 5. | Intended Use: | The ApexNRG-Blue 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. |
| 6. | Comparison of
Technological
Characteristics: | With respect to technology and intended use, the Modified MedicNRG-Blue
(Apex Locator) is substantially equivalent to its predicate devices which are
the MedicNRG XFR Electronic Apex Locator & MedicNRG Electronic Apex
Locator. The primary difference is that the modified device provides Blue-
Tooth Capability. Based upon the testing results, MedicNRG believes these
differences do not raise additional safety of efficacy concerns. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 1 2007
MedicNRG, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K071133
Trade/Device Name: ApexNRG-Blue (Apex Locator) Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: II Product Code: LQY Dated: September 9, 2007 Received: September 17, 2007
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Sumner
Chia-Ling Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
X 07133
Device Name: ApexNRG-Blue (Apex Locator)
Indications For Use: The ApexNRG-Blue 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)
Super Qumor
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: Ko71133