(30 days)
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.
The Apex DAL is a dental apex locator which has the ability to measure the depth of the root canal by electronic means.
The provided text is a 510(k) summary and FDA clearance letter for a dental apex locator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance: This information is not present in the provided text.
- Sample size used for the test set and data provenance: No details regarding a test set, its sample size, or data origin are mentioned.
- Number of experts used to establish ground truth and their qualifications: The document does not describe any ground truth establishment for a test set or the experts involved.
- Adjudication method: No adjudication method is mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: The text does not refer to any such study or human reader improvement with AI assistance.
- Standalone performance study: While the device is "algorithm only" in the sense it measures electronically, no dedicated standalone performance study with specific metrics is detailed. The comparison focuses on technological characteristics rather than performance metrics against a gold standard.
- Type of ground truth used: No ground truth type (e.g., pathology, outcomes data) is specified for any performance evaluation.
- Sample size for the training set: There is no mention of a training set or its sample size.
- How ground truth for the training set was established: Correspondingly, no information on ground truth establishment for a training set is provided.
The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices, rather than detailed performance study results against specific acceptance criteria. It mentions that the manufacturer "believes this difference does [not] raise additional safety of efficacy concerns" based upon "testing results," but these results are not elaborated upon in the provided summary.
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K 080113
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | George J. HattubMedicSense, USA291 Hillside AvenueSomerset, MA 02726www.medicsense.com | |
|---|---|---|---|
| 1. (b) | ManufacturerAddress: | MedicNRG, Ltd.PO Box 338, MP Gordon ValleyKibbutz Afikim, Israel 15148 | |
| Mfg. Phone: | 972-4-675-4217 | ||
| Contact Person: | Michal Zach, QA Manager | ||
| Date: | January 5, 2008 | ||
| 2. | Device &ClassificationName: | Locator, Root, Apex, Class 2, Product Code LQY, unclassifiedApex DAL (Apex Locator) | |
| 3. | Predicate Device: | MedicNRG Blue Apex Locator (K071133) | |
| Earlier devices are:MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG ElectronicApex Locator (K032743) | |||
| 4. | Description: | The Apex DAL is a dental apex locator which has the ability to measure thedepth of the root canal by electronic means. | |
| 5. | Intended Use: | The Apex DAL is intended for the measurement of the length of the rootcanal for purposes of performing root canals and related dental proceduresfor use by a trained professional in general dentistry. | |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology and intended use, the Modified MedicNRG- D/(Apex Locator) is substantially equivalent to its predicate device which is theMedicNRG Blue Apex Locator. The primary difference is that the modifieddevice provides does not Bluetooth Wireless Capability | |
| Like its predicate and earlier devices (K063843, & K032743) with which thedevice measured the tissue's changing response to the test signal betweenthe electrodes as the file is advancing toward the apex, and with the secondgeneration of Medic NRG's apex locator (K071133) it utilizes a multi-frequency response signal using DSP technology with a different algorithmreducing the delay between calculation and display of measurement. Thesignals are generated as a response to multi-frequency signals having aand 1.3 kHz repetition rate. The frequencies used for comparison 6.5 kHz1.3 kHz Square Wave with 3 cycles used for measurement. | |||
| Based upon the testing results, MedicNRG believes this difference doesraise additional safety of efficacy concerns. |
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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.
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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); 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
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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
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KOXO)13 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
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