(274 days)
Not Found
No
The summary describes a device for measuring root canal length, focusing on its automatic and battery-operated nature. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is described as measuring the length of the root canal, which is a diagnostic or measurement function, not a therapeutic intervention.
Yes
The device is described as "measuring the length of the root canal" and helping to "locate a patient's anatomical root canal apex and obtain accurate root canal length measurements." These actions involve identifying and quantifying a physiological characteristic, which falls under the definition of diagnosis.
No
The device description explicitly states it is a "lightweight, fully-automatic, battery operated device," indicating it is a physical hardware device, not software only.
Based on the provided information, the i-ROOT device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body.
- i-ROOT Function: The i-ROOT device is used to measure the length of the root canal within the patient's body during a dental procedure. It interacts directly with the patient's anatomy.
Therefore, the i-ROOT is a medical device used in vivo (within the living body) and does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
Product codes (comma separated list FDA assigned to the subject device)
LQY
Device Description
The subject device is a lightweight, fully-automatic, battery operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements
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
dentist or oral surgeon
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The i-ROOT has been manufactured and tested to meet the safety requirements of IEC. The i-ROOT complies with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2001, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
The performance tests demonstrated that i-ROOT is as safe, as effective and performs in a substantially equivalent manner to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ±0.25mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Navi ROOT(K083901)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Kloused
ട്. 510(k) Summary
[as required by 807.92(c)]
NOV 1 8 2010
A. Applicant:
, 2 - 8
-Company name: S-Denti Co.,Ltd
-Address: 14F NO1407, Kolon Digital Tower Aston, 505-14, Gasan-dong, Geumcheon-gu, Seoul Korea -Tel:+82-2-2082-8828Fax:+82-2-2-2082-8829 web:www.s-denti.com
-Contact person: Peter Chung 412-687-3976
-Date: Dec 28th, 2009
B. Proprietary and Established Names:
Trade Name: i-ROOT Common Name:. Root Apex Locator Ragulation Name: Root Apex Locator Regulatory Classification: Unclassified, Dental, Product Code: LQY
C. Predicate device: Navi ROOT(K083901)
D. Device Description
The subject device is a lightweight, fully-automatic, battery operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements
E. Intended use
The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
F. Technological Characteristics:
The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 500 Hz and 5 KHz. The current between the file and mouth is measured at each of these frequencies, and compared, with readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.
G. Performance (Safety and Effectiveness Information)
The i-ROOT has been manufactured and tested to meet the safety requirements of IEC. The i-ROOT complies with IEC 60601-1 Medical electrical equipment - Part 1: General requirements for safety and IEC 60601-1-2:2001, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests.
I. Conclusion:
The performance tests demonstrated that i-ROOT is as safe, as effective and performs in a substantially equivalent manner to the predicate device
1
11.1 Comparison Table ________________________________________________________________________________________________________________________________________________________
| Product | i-ROOT | Navi ROOT |
|---|---|---|
| 510K No | K083901 | |
| Manufacturer | S-Denti Co.,Ltd | S-Denti Co.,Ltd |
| Intended Use | Measurement of the length of the | |
| root canal for the purpose of | ||
| performing root canals and related | ||
| dental procedures | Identical | |
| Method of calculating | Comparison of impedance at multi | |
| frequencies | Identical | |
| Electric Current | Input Current : DC 40 mA | |
| Patient auxiliary current : AC 10 mA | Less than 10pA | |
| Electrical Power | Lithium-ion Battery 8.2VDC(4.1VDCx2) | DC 4.5V(AA Battery 1.5Vx3EA) |
| Power consumption | 0.33VA | 180mW Max(150mW) |
| Measuring Voltage | 80mV | Identical |
| Frequencies used | ||
| for comparison | 500 Hz, 5 kHz | Identical |
| Time of use | 2000 Hr Continuous | Identical |
| Display | LCD | Identical |
| Accessory | Probe cord 1EA, Lip holder 5EA, | |
| File holder A 1EA, | ||
| File holder B 2EA, | ||
| AC adapter 1EA, | ||
| User manual 1EA, | ||
| USB Cable 1EA(optional), | ||
| PC software CD(optional) 1EA | Probe cord 1EA, | |
| File holder 2EA, | ||
| Accuracy | ±0.25mm | Identical |
| Storage condition |
- Temperature | -20 ~ 70℃ | -10 ~ 60 ℃ |
| - Humidity | 0 ~ 95% | 10 ~ 80RH% |
| Dimensions(LxWxH) | 110mm(W) x 100mm(D) x 117mm(H) | 153mm(W) x 138mm(D) x 44mm(H) |
| Weight | Approx. 372g ± 24g | 420g |
Conclusion
Based upon the intended use, and upon the similarity of product configuration and administration, it can be concluded the i-ROOTis substantially equivalent to the identified predicate device in terms of intended use, safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Tae Kye Nam S-Denti Company, Limited 505-14, Gasan-Dong, Geumcheon-Gu Seongnam-City, Seoul Republic of Korea 153-803
NOV 1 8 2010
Re: K100450
Trade/Device Name: i-ROOT Electronic Apex Locator Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LQY Dated: August 18, 2010 Received: October 25, 2010
Dear Mr. Nam:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Mr. Nam
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 100 450 ------------------------------------------------------------------------------------------------------------------------------------------
NOV 1 8 2010
Device Name: i-ROOT Electronic Apex Locator
Indications For Use:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . :
The i-ROOT is intended for measuring the length of the root canal for the purpose of performing root canals and related dental procedures
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)
Page 1 of 1
Susan Punny
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100460