(151 days)
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.
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.
This 510(k) summary (K071133) for the ApexNRG-Blue (Apex Locator) does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Here's an breakdown of the requested information based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
Unfortunately, the provided 510(k) summary does not explicitly state any specific acceptance criteria (e.g., accuracy thresholds, precision ranges) or numerical performance metrics for the ApexNRG-Blue. The document primarily focuses on establishing "substantial equivalence" to predicate devices based on technological characteristics and intended use.
The only statement related to performance is: "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns." This implies testing was done, but the results and the criteria used to evaluate them are not presented.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample size for a test set or the provenance of any data. It mentions "testing results" in a general sense but provides no details about the datasets used for these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention any experts, ground truth establishment, or their qualifications in the context of a performance study.
4. Adjudication Method
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text.
6. Standalone Performance Study
While the statement "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns" implies some form of testing was conducted on the device's performance, the document does not present the results of a standalone (algorithm only without human-in-the-loop performance) study. The focus is on the device's technical characteristics and similarity to predicate devices.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. The device described is an "Apex Locator," which is a hardware device for measuring root canal length, implying direct measurement rather than a machine learning algorithm that would require training data.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set, the document does not describe how ground truth for a training set was established.
Summary of what is present:
- Device Name: ApexNRG-Blue (Apex Locator)
- Intended Use: Measurement of the length of root canals for dental procedures by a trained professional.
- Predicate Devices: MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG Electronic Apex Locator (K032743).
- Primary Difference from Predicate: Blue-Tooth Capability.
- Conclusion (regarding performance): "Based upon the testing results, MedicNRG believes these differences do not raise additional safety of efficacy concerns."
In conclusion, this 510(k) summary primarily addresses substantial equivalence based on technological characteristics and intended use, rather than detailing a specific performance study with explicit acceptance criteria, robust sample sizes, or detailed ground truth methodologies that would be typical for a device with an AI/ML component or complex imaging analysis. The device, an "Apex Locator," is likely a direct measurement tool, and its safety and efficacy would be evaluated through different means than a typical AI-driven diagnostic device.
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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) | 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 |
| Mfq. Phone: | 972-4-675-4217 | |
| Contact Person: | Michal Zach, QA Manager | |
| Date: | April 11, 2007 | |
| 2. | Device &ClassificationName: | Locator, Root, Apex, Class 2, Product Code LQY, unclassifiedApexNRG XFR (Apex Locator) |
| 3. | Predicate Device: | MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG ElectronicApex Locator (K032743) |
| 4. | Description: | The ApexNRG Blue is a dental apex locator which has the ability to measurethe depth of the root canal by electronic means. It has Blue-ToothCapability. |
| 5. | Intended Use: | The ApexNRG-Blue is intended for the measurement of the length of theroot canal for purposes of performing root canals and related dentalprocedures, for use by a trained professional in general dentistry. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology and intended use, the Modified MedicNRG-Blue(Apex Locator) is substantially equivalent to its predicate devices which arethe MedicNRG XFR Electronic Apex Locator & MedicNRG Electronic ApexLocator. The primary difference is that the modified device provides Blue-Tooth Capability. Based upon the testing results, MedicNRG believes thesedifferences do not raise additional safety of efficacy concerns. |
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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.
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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 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
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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
N/A