(257 days)
Not Found
Not Found
No
The description details a comparison of impedance values to a stored database, which is a rule-based or lookup system, not indicative of AI/ML. There is no mention of learning, training, or complex pattern recognition.
No
The device is used to estimate the position of an endodontic file for diagnostic purposes, not to treat or cure a disease or condition. Its function is to provide information to the dentist, which can then guide their therapeutic actions.
Yes
The device is used to "estimate the position an endodontic file in the root canal" and provides "readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen," which are measurements or indications used to aid in diagnosis or treatment planning.
No
The device description explicitly mentions "Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip." and "The software inside the Endopex V compares the impedance values being read between its two electrodes". This indicates the device includes hardware components (electrodes and the system that reads impedance values) in addition to the software.
Based on the provided information, the Endopex V is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The Endopex V measures electrical impedance within the root canal and oral cavity of a living patient. It does not analyze a sample (like blood, urine, or tissue) that has been removed from the body.
- The device interacts directly with the patient. The electrodes are placed in contact with the patient's tooth and oral cavity. IVDs typically analyze samples in a laboratory setting or using a device that interacts with the sample, not the patient directly.
- The intended use is for estimating the position of a file in situ. This is a procedural aid during a dental procedure, not a diagnostic test performed on a biological sample.
The Endopex V is a medical device used in a clinical setting to assist a dentist during an endodontic procedure. It falls under the category of devices used for measurement or guidance during treatment, rather than for diagnosing a condition by analyzing a biological sample.
N/A
Intended Use / Indications for Use
The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.
Product codes
LQY
Device Description
Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip. The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal, oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentist
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the text "DEC - 3 2003" at the top. Below this text is a logo that reads "A Sepro International". The logo is stylized with a swirling design on the left and a world map on the right.
Aseptico Inc. 8333 216th Street SE Woodinville, Washington 98072 Phone: 425.487.3157 Fax: 360.668.8722
510(k) Summary
Contact: Grant Ramaley
Date Prepared: March 17, 2003
Trade of Proprietary Name: Aseptico Endopex V Model Number AEU-40
Classification Name: Unclassified
Product Code: LQY - Locator, Root Apex
Endopex V operating principals
Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip.
The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.
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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 eagle with three stripes extending from its back, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Mr. Grant Ramaley Quality and Regulatory Affairs Manager Aseptico Incorporated 8333 216th Street SE Woodinville, Washington 98072
Re: K030895
Trade/Device Name: Endopex V Model AEU-40 Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LQY Dated: February 3, 2003 Received: September 4, 2003
Dear Mr. Ramaley:
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 marketcd 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 Fedcral 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. Ramaley
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 vour 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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours.
Susan Runor
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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Page 1 of 1
510(k) Number (if known): K030895
Device Name: ENDOPEX V Model AEU-40
Indications For Use:
The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801 109)
OR
Over-The-Countern Use
(Optional Format 1-2-96)
Robert S. Betz, DDS for Dr. Susan Runner
Division of Anesthesiology, General Hospital, Infection Contro
510(k) Number: K030875