(67 days)
The NSK Precision Apex Locator is intended for the measurement of 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.
The NSK Precision Apex Locator is a dental medical device which has the ability to measure the depth of the root canal by electronic means.
The provided text is a 510(k) Summary and the FDA's acceptance letter for the NSK Precision Apex Locator. It does not contain the detailed information needed to answer the questions regarding acceptance criteria and a specific study proving the device meets those criteria.
The 510(k) Summary (document {0}) outlines the device's intended use and claims substantial equivalence to a predicate device. It briefly mentions "testing results" as a basis for believing a difference in display technology does not raise additional safety or efficacy concerns, but it does not describe the specific acceptance criteria or the study methodology in detail.
The FDA letter (documents {1}, {2}, {3}) confirms the substantial equivalence determination but also does not provide the study details.
Therefore, I cannot provide the requested information based on the given text. The text does not elaborate on:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method.
- Whether a multi reader multi case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone performance study was done.
- Type of ground truth used for the test set.
- Sample size for the training set.
- How the ground truth for the training set was established.
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Image /page/0/Picture/1 description: The image shows handwritten text in two rows. The first row contains the text "Ko5 3235", which appears to be a combination of letters and numbers. The second row contains the text "f. 1 of i", which appears to be a combination of letters and symbols. The text is written in black ink on a white background.
510(k) Summary of Safety & Effectiveness
Pursuant to CFR 807.92, the following 510(k) Summary is provided:
| 1. (a) | SubmitterAddress: | MedicSense, Ltd.Galdani Bldg58b Amal St.Kiriat Arie, Petach Tikya, Israel 47103www.medicsense.com |
|---|---|---|
| 1. (b) | ManufacturerAddress: | NSK Nakanishi, Inc.700 Shimohinata, Kanuma-shiTochigi-ken, Japan 322-8666 |
| Mfg. Phone: | 1-289-64-3422 | |
| Contact Person: | Masato Hamada, North America Manager | |
| Date: | November 13, 2005 | |
| 2. | Device &ClassificationName: | Locator, Root, Apex, Class 2, Product Code LQY, unclassifiedNSK Precision Apex Locator (PAL) |
| 3. | Predicate Device: | MedicNRG Electronic Apex Locator (K032743) |
| 4. | Description: | The NSK Precision Apex Locator is a dental medical device which has theability to measure the depth of the root canal by electronic means. |
| 5. | Intended Use: | The NSK Precision Apex Locator is intended for the measurement of thelength of the root canal for purposes of performing root canals and relateddental procedures, for use by a trained professional in general dentistry. |
| 6. | Comparison ofTechnologicalCharacteristics: | With respect to technology and intended use, the NSK Precision ApexLocator is substantially equivalent to its predicate device which is theMedicNRG Electronic Apex Locator. The primary difference is that the NSKdevice utilizes a LCD display whereas the NRG device utilizes a LEDdisplay. Based upon testing results, NSK believes this difference does notraise additional safety of efficacy concerns. |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2006
Mr. George Hattub Senior Staff Consultant MedicSense, U.S.A. 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K053235
Trade/Device Name: NSK Precision Apex Locator Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: November 15, 2005 Received: November 23, 2005
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 mav, 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 docs 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 (OS) 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,
Anthony D. Watson for
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
KOS 3235 510(k) Number (if known):
Device Name: NSK Precision Apex Locator
Indications For Use: The NSK Precision Apex Locator is intended for the measurement of 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.
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)
Robert Betz DDS for Dr. Susan Runner
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