(108 days)
Not Found
No
The description focuses on electrical impedance measurement and display of distance, with no mention of AI/ML algorithms or data processing beyond basic signal interpretation.
Yes.
The device is an apex locator, which is a piece of equipment used to measure working length during root canal treatment, assisting the dentist in determining the working length for endodontic treatment. This direct application in a medical procedure aimed at treating a condition (root canal treatment) makes it a therapeutic device.
Yes
The "Intended Use" explicitly states that the device is to "support the dentist in the determination of the working the endodontic treatment," which is a diagnostic function to determine a specific parameter for treatment.
No
The device description explicitly lists multiple hardware components including a main unit, measurement wires, clips, hooks, a probe, an adapter, and a tester. It also mentions a built-in battery and LCD screen.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support the dentist in the determination of the working the endodontic treatment." This is a measurement and guidance function during a clinical procedure performed directly on the patient.
- Device Description: The device is an "Apex locator" used for "working length measurement during root canal treatment." It measures the distance between a file tip and a reference point within the root canal. This is a physical measurement within the patient's body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not analyze any bodily specimens. It interacts directly with the patient's tooth and surrounding tissues during a procedure.
The device is a medical device used in vivo (within the living body) to assist in a dental procedure.
N/A
Intended Use / Indications for Use
support the dentist in the determination of the working 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)
LQY
Device Description
Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.
The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.
The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.
Main unit: measure and display working length.
Measurement wire A: connect file clip and lip hook with main unit.
Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)
File clip: Connect to file.
Lip hook: hook patient's lip.
Touch Probe: promote to measure molar.
Power Adapter: use for charging.
Tester: use for checking whether the device is normal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Clinical test:
Clinical testing is not required.
Non-clinical data
The subject devices Apex Locator (Model: AL-Pex, AL-Pex+) comply with: Safety and performance:
-
- AAMI ES60601-1:2005+AMD1:2012+AMD2:2021 Medical electrical equipment Part 1:
General requirements for basic safety and essential performance.
- AAMI ES60601-1:2005+AMD1:2012+AMD2:2021 Medical electrical equipment Part 1:
IEC 60601-1:2005,AMD1:2012,AMD2:2020 Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance.
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for 2. the basic safety and essential performance of dental equipment
Electromagnetic Compatibility:
IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment-Part1-2: General 3. requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility:
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation 5.
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Accuracy verification
Internal method 7.
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final 8. 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
Reprocess
-
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 12:2020 Designing, testing, andlabeling medical devicesintended for processingby health care facilities:A guide for device manufacturers
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
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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
December 22, 2023
Changzhou Haili Medical Co., Ltd. Wang Xiaofang Quality manager Hutang Science Technology Industrial Park, Wujin District Changzhou, Jiangsu 213000 CHINA
Re: K232717
Trade/Device Name: Apex Locator (AL-Pex), Apex Locator (AL-Pex+) Regulatory Class: Unclassified Product Code: LQY Dated: November 22, 2023 Received: November 22, 2023
Dear Wang Xiaofang:
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 (the 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 available 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.
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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Michael E. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K232717
Device Name
Apex Locator (AL-Pex); Apex Locator (AL-Pex+)
Indications for Use (Describe)
support the dentist in the determination of the working 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)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows a logo with the text "HaiLi". The "H" is stylized with a blue gradient and a curved line running through it. The rest of the text, "aiLi", is in a bold, sans-serif font and is colored black. The logo appears to be for a company or organization named HaiLi.
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: November 20, 2023
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Changzhou Haili Medical Co., Ltd. |
|---|---|
| Address: | Hutang Science Technology Industrial Park, Wujin District, |
| Changzhou, Jiangsu, 213000 China | |
| Contact person: | Wang Xiaofang |
| Title: | Quality manager |
| E-mail: | vips@hailimedical.com |
| Tel: | +86-15251985980 |
2. Device Identification
| 510(K) number: | K232717 |
|---|---|
| Trade/Device Name: | Apex Locator (Model: AL-Pex, AL-Pex+) |
| Common name: | Locator, Root Apex |
| Regulation Number: | N/A |
| Regulation Name: | Locator, Root Apex |
| Regulation Class: | Unclassified |
| Panel: | Dental |
| Product Code: | LQY |
3. Predicate Device
| 510(K) number: | K203836 (Primary predicate) |
|---|---|
| Device Name: | BOMEDENT Apex locator (Model: iRoot apex) |
| Manufacturer: | ChangZhou BoMedent Medical Technology Co.,Ltd |
| Common name | Locator, Root Apex |
| Regulation Number: | N/A |
| Regulation Name: | Locator, Root Apex |
| Regulation Class: | Unclassified |
| Panel: | Dental |
| Product Code: | LQY |
-
- Device Description
5
Image /page/5/Picture/1 description: The image shows a logo for a company called "Haili". The logo consists of a stylized letter "H" in blue, with a curved line running through it. To the right of the "H" is the company name "Haili" in black, block letters. The logo has a modern and professional look.
Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.
The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.
The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.
Main unit: measure and display working length.
Measurement wire A: connect file clip and lip hook with main unit.
Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)
File clip: Connect to file.
Lip hook: hook patient's lip.
Touch Probe: promote to measure molar.
Power Adapter: use for charging.
Tester: use for checking whether the device is normal.
5. Indication for use
support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
6. Summary of the device compared to the predicate device
Compared to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device, summarized comparison information is listed in the following table:
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Image /page/6/Picture/1 description: The image shows the logo for "HaiLi". The logo consists of a stylized blue letter "H" with a wave-like design running through it. To the right of the "H" is the text "aiLi" in black, with a bold, sans-serif font.
| SE | Subject Devices
K232717 | | Predicate Device
K203836 | |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparisons | Apex locator
(Model: AL-Pex) | Apex locator
(Model: AL-Pex+) | BOMEDENT Apex locator | Similarities/Differences |
| Indication for
Use | 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. | 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. | 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. | Same |
| Dimensions | Length: 116 mm
Width: 67 mm
Height: 20 mm | Length: 116 mm
Width: 67 mm
Height: 20 mm | Length: 110 mm
Width: 65 mm
Height: 20 mm | The subject devices and
the predicate device are
different appearance,
however, this do not
affect the safety or
substantial equivalence. |
| Cable length | Measurement cable A:1.5m
Measurement cable B:1.5m
File clip cable:0.2m | | Charger cable:1.1m
Measurement cables:1.6 m
File clip cable: 0.2 m | These cables are same
function with different
length. |
| Weight | 182g | 188g | 185g | The subject devices and
the predicate device are
different weight,
however, this do not
affect the safety or
substantial equivalence. |
| Accuracy | ±0.5mm | ±0.5mm | ±0.5mm | Same |
| Patient
contacting | Lip hook: Stainless Steel | Lip hook: Stainless Steel | Lip hook: Stainless Steel | Same |
| components | File Clip: Stainless Steel, Nylon and Silicone | File Clip: Stainless Steel, Nylon and Silicone | File Clip: Silicone and
stainless steel | Materials of File Clip are
different. File Clip of the |
| material
composition
Material | | | subject device meets
biocompatibility
requirements. | |
| | Probe: Stainless Steel and Silicone | N/A | Probe of the subject
device meets
biocompatibility
requirements. | |
| Power supply | Rechargeable Li-ion battery
Capacity 1000 mAh,3.7V | Rechargeable Li-ion
battery
Capacity 950mAh,3.7V | The battery capacity is
different. The battery of
subject device meet
standard UL1642:2012
and IEC 62133-2. | |
| Battery
Charger | Input:100-240V AC 50/60Hz 0.2 A
output: DC 5V 1A | Input:100-240V AC
50-60Hz 0.15 A
output:DC 5V 1A | The input current is
different. The battery
charger meet
IEC 60601-1 ANSI/AAMI
ES60601-1 CSA
CAN/CSA-C22.2 NO.
60601-1:14
standard, this do not
affect the safety or
substantial equivalence. | |
| Bluetooth | No Bluetooth function | No Bluetooth function | Same | |
| Display | 3.5" TFT LCD | 3.5" TFT Wide angle of
view LCD | Same | |
| Reference
point | In the menu of Ref Point, the reference point can be
adjusted from 0.0 – 2.0 | In the menu of Ref Point,
the reference point can be
adjusted from 0.0 – 1.2. | the reference point can
be adjusted by user
(dentist). This do not
affect the safety or
substantial equivalence. | |
| Sterilization | Lip hook, File clip and Probe are user sterilized by
steam sterilization | Lip hook and File clip are
user sterilized by | The subject devices
include a probe, it is | |
| | | steam sterilization | required sterilization,
sterilization validation
were conducted. | |
| Electrical
Safety | AAMI ES60601-1:2005+AMD1:2012+AMD2:2021
IEC 60601-1:2005,AMD1:2012,AMD2:2020
IEC 80601-2-60:2019 | IEC 60601-1:2012
IEC 80601-2-60:2019 | The standards were
updated, we conducted
the tests according to
new version. | |
| EMC | IEC 60601-1-2:2014+AMD:2020 | IEC 60601-1-2:2014 | The standards were
updated, we conducted
the tests according to
new version. | |
| Biocompatibility | ISO 10993-5:2009
ISO 10993-10:2021
ISO 10993-11:2021 | ISO 10993-5:2009
ISO 10993-10:2010 | The standards were
updated, we conducted
the tests according to
new version. | |
510(k) Summary
7
Traditional 510(k) Submission of Apex Locator
Image /page/7/Picture/1 description: The image shows the logo for "HaiLi". The logo consists of a stylized blue letter "H" with a wave-like design running through it, followed by the text "aiLi" in black. The font used for "aiLi" is bold and sans-serif.
K232717
510(k) Summary
Page 4 of Page 7
8
Image /page/8/Picture/1 description: The image shows the logo for HaiLi. The logo consists of a stylized blue letter H on the left, followed by the text "aiLi" in black. The letter H is made up of two curved lines that intersect in the middle, creating a modern and dynamic look. The text "aiLi" is in a bold, sans-serif font, with the letters closely spaced together.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing so no safety and effectiveness issues relating to the system come into conclusion.
9
Image /page/9/Picture/1 description: The image shows a logo for a company called "HaiLi". The logo consists of a stylized letter "H" in blue, with a curved line running through it. To the right of the "H" is the company name, "HaiLi", in black, block letters. The logo is simple and modern, and the colors are eye-catching.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The subject devices Apex Locator (Model: AL-Pex, AL-Pex+) comply with: Safety and performance:
-
- AAMI ES60601-1:2005+AMD1:2012+AMD2:2021 Medical electrical equipment Part 1:
General requirements for basic safety and essential performance.
- AAMI ES60601-1:2005+AMD1:2012+AMD2:2021 Medical electrical equipment Part 1:
IEC 60601-1:2005,AMD1:2012,AMD2:2020 Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance.
IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for 2. the basic safety and essential performance of dental equipment
Electromagnetic Compatibility:
IEC 60601-1-2:2014+AMD1:2020 Medical electrical equipment-Part1-2: General 3. requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility:
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation 5.
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Accuracy verification
Internal method 7.
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final 8. 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
Reprocess
10
Image /page/10/Picture/1 description: The image shows a logo with the text "HaiLi". The "H" is stylized with a blue color and a curved line running through it. The rest of the text, "aiLi", is in black and appears to be in a bold, sans-serif font. The logo has a clean and modern design.
-
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 12:2020 Designing, testing, andlabeling medical devicesintended for processingby health care facilities:A guide for device manufacturers
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicated device.