(294 days)
Not Found
No
The document describes a standard electronic apex locator and its accessories, with no mention of AI or ML capabilities. The performance studies focus on accuracy and substantial equivalence to a predicate device, which is typical for non-AI/ML devices.
No
The device measures the length of the root canal for diagnostic/measurement purposes during a dental procedure, but it does not directly perform a therapeutic function on the patient.
Yes
The device is described as an "Electronic Apex Locator" intended for "measuring the length of the root canal." Measuring a physiological parameter like the length of a root canal for the purpose of a dental procedure constitutes a diagnostic function.
No
The device description explicitly lists hardware components: "main unit and lip clip, Cable assembly and 2 kinds of File holder." This indicates it is not a software-only device.
Based on the provided information, the i-ROOT 100 mini is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure the length of the root canal for the purpose of performing root canals and related dental procedures. This is a direct measurement within the patient's body (in vivo), not an analysis of a sample taken from the body (in vitro).
- Device Description: The device is an Electronic Apex Locator used to treat patients. It consists of components used directly with the patient during a dental procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on samples outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The i-ROOT 100 mini's function is a direct measurement within the patient's anatomy during a procedure.
N/A
Intended Use / Indications for Use
The i-ROOT 100 mini 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
i-ROOT 100 mini is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
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
Not Found
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 production and inspection is followed by our documented procedures based on our quality systems - ISO 9001/ ISO 13485/ Medical Device Directives 93/42/EC, which have been assessed by the third party certification bodies of SGS Certification.
The performance tests demonstrated that the i-Root 100 mini is substantially equivalent to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy(±0.5mm)
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.
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
K112153 : iRoot 100 mini
510(k) Summary
[as required by 807.92(c)]
A. Applicant:
-Company name: S-Denti Co.,Ltd
-Address: Rm.607, Byucksan Digital Valley 6, 481-4, Gasan-dong, Geumcheon-gu, Seoul, 153-803, Korea
Tel : +82-2-2627-3765~7 Fax : +82-2-2627-3768web : www.s-denti.com
-Contact person: Peter Chung 412-687-3976
-Date: July 7th, 2011
B. Proprietary and Established Names:
Trade Name: i-ROOT 100 mini
Common Name:. Root Apex Locator
Ragulation Name: Root Apex Locator
Regulatory Classification: Unclassified, Dental,
Product Code: LQY
C. Predicate device: i- ROOT(K100450)
D. Device Description
i-ROOT 100 mini is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main unit and lip clip, Cable assembly and 2 kinds of File holder.
E. Intended use
The i-ROOT 100 mini 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 I-ROOT 100 mini is identical with predicate device in the following contents;
Buzzer volume ,Signal, Graph , Intended Use, Frequencies used(500 Hz, 5 Wz ±0.002 kkz), Patient auxiliary current(less than AC 10 µA), Accuracy(±0.5mm) and Power consumption (less than 0.27VA)
● Difference is as follows;
Predicate device(i-ROOT) uses the built-in rechargeable Lithium-ion batteries (4.1V x 2 pcs) but i-ROOT 100mini uses the alkaline disposable batteries (1.5V AA x 3 pcs).
G. Performance (Safety and Effectiveness Information)
The production and inspection is followed by our documented procedures based on our quality systems - ISO 9001/ ISO 13485/ Medical Device Directives 93/42/EC, which have been assessed by the third party certification bodies of SGS Certification.
I. Conclusion:
The performance tests demonstrated that the i-Root 100 mini is substantially equivalent to the predicate device
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
S-Denti Company, LTD. C/O Mr. Peter Chung 300 Atwood Pittsburgh, Pennsylvania 15213
APR 2 6 2012
Re: K112153
Trade/Device Name: i-ROOT 100 mini Electronic Apex Locator Regulation Number: None Regulation Name: None · Regulatory Class: Unclassified Product Code: LQY Dated: March 10, 2012 Received: March 16, 2012
Dear Mr. Chung:
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.
2
Page 2 - Mr. Chung
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
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Indications for Use
510(k) Number (if known):_K || 2|53
Device Name: i-ROOT 100 mini Electronic Apex Locator
Indications For Use:
..............................................................................................................................................................................
The i-ROOT 100 mini is intended for measuring the length of 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)
Susan Pursine
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K112153
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