(30 days)
No
The summary describes a standard electronic apex locator and makes no mention of AI, ML, or related concepts.
No
The device is used for measurement within the root canal, not for treating or preventing a disease or condition. Its function is diagnostic/assessment, not therapeutic.
No
The device is an apex locator used to measure the length of root canals, which is a measurement function rather than a diagnostic one as it doesn't identify the presence or absence of a disease or condition.
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 the presence of hardware components for electronic measurement.
Based on the provided information, the Apex DAL 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.
- Apex DAL Function: The Apex DAL measures the length of root canals within the patient's body using electronic means. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for measuring root canal length and related dental procedures, which are performed directly on the patient.
Therefore, the Apex DAL is a medical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Apex DAL is intended for the measurement of the length of the root canals 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 Apex DAL 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
MedicNRG Blue Apex Locator (K071133)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K 080113
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 | |
| | Mfg. Phone: | 972-4-675-4217 | |
| | Contact Person: | Michal Zach, QA Manager | |
| | Date: | January 5, 2008 | |
| 2. | Device &
Classification
Name: | Locator, Root, Apex, Class 2, Product Code LQY, unclassified
Apex DAL (Apex Locator) | |
| 3. | Predicate Device: | MedicNRG Blue Apex Locator (K071133) | |
| | | Earlier devices are:
MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG Electronic
Apex Locator (K032743) | |
| 4. | Description: | The Apex DAL is a dental apex locator which has the ability to measure the
depth of the root canal by electronic means. | |
| 5. | Intended Use: | The Apex DAL 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- D/
(Apex Locator) is substantially equivalent to its predicate device which is the
MedicNRG Blue Apex Locator. The primary difference is that the modified
device provides does not Bluetooth Wireless Capability | |
| | | Like its predicate and earlier devices (K063843, & K032743) with which the
device measured the tissue's changing response to the test signal between
the electrodes as the file is advancing toward the apex, and with the second
generation of Medic NRG's apex locator (K071133) it utilizes 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
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. | |
| | | Based upon the testing results, MedicNRG believes this difference does
raise additional safety of efficacy concerns. | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 15 2008
MedicNRG, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K080113
Trade/Device Name: Apex DAL (Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LOY Dated: January 13, 2008 Received: January 16, 2008
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 vours.
Susan Burns
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
11380113 510(k) Number (if known):
Device Name: Apex DAL (Apex Locator)
Indications For Use: The Apex DAL 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 Quars
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
KOXO)13 510(k) Number: _______________________________________________________________________________________________________________________________________________________________