(90 days)
Not Found
No
The description focuses on electrical resistance measurement and microprocessor control, with no mention of AI or ML terms or concepts.
No.
The device is used to determine the working length during endodontic treatment by assessing electrical resistance, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device "support[s] the determination of the working length during the endodontic treatment" by assessing "the electrical resistance of the tooth and surrounding tissues." This function provides information about the patient's physiological state to aid in diagnosis and treatment planning, aligning with the definition of a diagnostic device.
No
The device description explicitly lists hardware components such as a Power Adapter, USB cable, Measuring cable A, File clip, Lip hook, and Measuring cable C. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device "assess[es] the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal." This is a measurement taken directly within the body (in vivo), not on a sample taken from the body (in vitro).
- Intended Use: The intended use is to "support the determination of the working length during the endodontic treatment," which is a clinical procedure performed on a patient.
Therefore, the BOMEDENT Apex locator and WISMY Apex locator are considered medical devices used in a clinical setting, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Product codes (comma separated list FDA assigned to the subject device)
LOY
Device Description
The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components:
(1) Power Adapter
(2) USB cable
(3) Measuring cable A
(4) File clip
(5) Lip hook
(6) Measuring cable C (Optional)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / Root Canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
duly qualified dental practitioners.
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)
Accuracy Testing
Internal test method. It shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806) within the scope of this test. The tests shown substantial equivalence between the subject device and the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
ChangZhou BoMedent Medical Technology Co., Ltd Zhang Lili Quality Manager No.9 Changyang Road, West Taihu Science & Technology Industrial Park, Changzhou, Jiangsu 213100 CHINA
Re: K203836
Trade/Device Name: BOMEDENT Apex locator, WISMY Apex locator Regulatory Class: Unclassified Product Code: LOY Dated: December 18, 2020 Received: December 30, 2020
Dear Zhang Lili:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
March 30, 2021
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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203836
Device Name BOMEDENT Apex locator, WISMY Apex locator
Indications for Use (Describe)
BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Type of Use (Select one or both, as applicable)
| ☑ Construction Use (Both OFF-Site & On-Site) | ☐ On-Site Construction Use (OFF-Site) |
|---|---|
| ------------------------------------------------------------- | -------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K203836 - 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 18 December 2020
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | ChangZhou BoMedent Medical Technology Co.,Ltd |
|---|---|
| Address: | No.9 Changyang Road,West Taihu Science & Technology |
| Industrial Park, Changzhou, Jiangsu China. | |
| Contact person: | Zhang Lili |
| Title: | Quality Manager |
| E-mail: | qm@bome-dent.com |
| Tel: | +86-0519-88991980 |
2. Device Identification
| Trade/Device Name: | BOMEDENT Apex locator, WISMY Apex locator |
|---|---|
| Models: | iRoot apex, Wispex |
| Common name: | Locator, Root Apex |
| Regulation Number: | N/A |
| Regulation Name: | N/A |
| Regulation Class: | Unclassified |
| Panel: | Dental |
| Product Code: | LQY |
3. Primary Predicate
| 510(K) number: | K191806 |
|---|---|
| Device Name: | Propex IQ® Apex Locator |
| Manufacturer: | Dentsply Sirona |
| Common name | Locator, Root Apex |
| Regulation Number: | N/A |
| Regulation Name: | N/A |
| Regulation Class: | Unclassified |
| Panel: | Dental |
| Product Code: | LQY |
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4. Device Description
The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components:
(1) Power Adapter(2) USB cable(3) Measuring cable A4) File clip(5) Lip hook
- (6) Measuring cable C (Optional)
5. Indication for use
BOMEDENT Apex locator and WISMY Apex locator support the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
5
ditional 510(k) Submission of Apex locat
ﻭ
Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performanc
effectiveness, performance safety as the predicate device as summarized in the following table
| SE
Comparisons | Proposed Devices | Primary Predicate
Device
K191806 | Similarities/Differences | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | BOMEDENT Apex locator
support the dentist in the
determination of the
working length during the
endodontic treatment. The
use of this product is
intended exclusively for duly
qualified dental
practitioners. | WISMY Apex locator
support the dentist in the
determination of the
working length during the
endodontic treatment. The
use of this product is
intended exclusively for duly
qualified dental
practitioners. | Propex IQ® Apex Locator
supports the dentist in the
determination of the
working length during the
endodontic treatment. The
use of this product is
intended exclusively for duly
qualified dental
practitioners. | Same. Both the proposed
devices and the predicate
device are indicated to
assist in the determination
of the length of the root
canal space. |
| Dimensions | Length: 110 mm
Width: 65 mm
Height: 20 mm | Length: 94 mm
Width: 60 mm
Height: 13 mm | Length: 75 mm
Width: 46 mm
Height: 20 mm | the proposed devices and
the predicate device are
different appearance,
however, this do not affect
the safety or substantial
equivalence. |
| Cable length | • Charger cable: 1.1m
• Measurement cables:
1.6 m
• File clip cable: 0.2 m | • Charger cable: 1.1m
• Measurement cables:
1.6 m
• File clip cable: 0.2 m | • Charger cable: 2 m
• Propex IQ® and X-Smart
IQ®
Measurement cables: 1.3 m
• Propex IQ® File clip FCA:
0.15 m | These cables are same
function with different
length. |
| Weight | 185g | 85g | 80 g (0.18 lbs) | the proposed devices and
the predicate device are
different weight,
however, this do not affect
the safety or substantial
equivalence. |
006_510(k) Summar
6
| Traditional 510(k) Submission of Apex locator | Patient
contacting
components
material
composition
Material | Power supply | Charger | Bluetooth | Means of input | Display |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Lip Clip: Stainless Steel
File Clip: Silicone and
stainless steel | Rechargeable Li-ion battery
Capacity 950mAh,3.7V | • Power supply:
100-240 VAC
• Frequency:
50 - 60 Hz
• Nominal power output:
0.15A
• Electrical safety class:
Class II | No Bluetooth function | • Touch screen
• Foldable main unit | 3.5" TFT Wide angle of
view LCD |
| | Lip Clip: Stainless Steel
File Clip: Silicone and
stainless steel | Rechargeable Li-ion battery
Capacity 950mAh,3.7V | • Power supply:
100-240 VAC
• Frequency:
50 - 60 Hz
• Nominal power output:
0.15A
• Electrical safety class:
Class II | No Bluetooth function | • Select key
•Volume key
•Power key | 2.8" TFT Color LCD |
| BoMedent | Lip Clip: Stainless Steel
File Clip: Gold plated
beryllium copper, glass
filled nylon | Rechargeable 2x AAA Ni-MH
Batteries:
Minimum capacity 750 mAh
1.2 VDC nominal;
INTERNALLY POWERED
DEVICE | • Power supply:
100-240 VAC
• Frequency:
50 - 60 Hz
• Nominal power output:
5.5 VA
• Electrical safety class:
Class II | Can be connected to Endo
IQ® App (K161213)
via Bluetooth and have
Bluetooth function to
transfer the data to the
Endo IQ® App | • On/off pushbutton
• Bluetooth button
• Endo IQ® App (K161213) | No display on the device,
only multi-color LEDs
to indicate status during the
working length
determination |
| | Material of Lip Clip is same.
Material of File Clip are
different. File Clip of
propose device meets
biocompatibility and sterile
verification. | Proposed devices powered
by rechargeable Li-ion
battery that meet the
requirements of IEC
62133:2013 | Same safety level. | Proposed devices are
without Bluetooth function | Proposed devices are
without Bluetooth button,
other means of input are
similar | Proposed devices' screen
display the file progression
along the root canal. |
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006_510(k) Summary
7
| Traditional 510(k) Submission of Apex locator | BoMedent | |||
|---|---|---|---|---|
| Adjustment | ||||
| before | ||||
| measurement | In the menu of Ref Point, | |||
| the reference position can | ||||
| be | ||||
| adjusted from 0.0 – 1.2. | adjust to set position of | |||
| apex reference point. The | ||||
| range is 0-2. | Not required | Proposed devices can | ||
| adjust reference point | ||||
| Calibration | Not required | Not required | Not required | Same |
| Sterilization | Lip clip and file clip are user | |||
| sterilized by | ||||
| steam sterilization. | Lip clip and file clip are user | |||
| sterilized by | ||||
| steam sterilization. | Lip clip and file clip are user | |||
| sterilized by | ||||
| steam sterilization. | Same | |||
| 3. Performance Data | ||||
| Clinical test: | Clinical testing is not required. | |||
| Non-clinical data | ||||
| The proposed BOMEDENT Apex locator and WISMY Apex locator comply with: | ||||
| 1. IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential | ||||
| Safety and performance: |
C 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essentia formance of dental equipm performance. ਨ।
Electromagnetic Compatibility
ectromagnetic Compatibility:
Collateral Standard: Electromagnetic disturbances-Requirements and તં
8
| Traditional 510(k) Submission of Apex locator | BoMedent |
|---|---|
| 4. IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications | |
| Biocompatibility: | |
| 5. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | |
| 6. ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | |
| Software Verification and Validation: | |
| FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002". | |
| Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | |
| Performance Testing: | |
| Accuracy Testing | |
| Internal test method. It shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806) within the scope of this test. The tests shown substantial equivalence between the subject device and the predicate. | |
| Cleaning, Low Level Disinfection, and Sterilization validation of the components of the subject device per the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2. | |
| 9. Conclusion | |
| Information included in this premarket notification supports the substantial equivalence of the proposed BOMEDENT Apex locator and WISMY Apex locator. The proposed device has the identical intended use as the primary predicate device cleared under premarket notification K191806. The proposed BOMEDENT Apex locator and WISMY Apex locator also have similar indications for use and incorporates the same fundamental technology as the primary predicate device (K191806). Performance, safety, and software validation test data demonstrate the performance of the subject BOMEDENT Apex locator and WISMY Apex locator against its design, functional, and safety requirements. The results of the testing support a determination of substantial equivalence. |
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