(237 days)
Not Found
No
The description mentions "microprocessor controlled" and "automatic adjustments" based on analyzing the signal, but there is no mention of AI, ML, or related terms, nor any description of training or test data sets which are typical for AI/ML devices.
No
The device is described as an apex locator, intended for precisely locating the apex of the root canal, which is a diagnostic or navigational function for a dental procedure, not a therapeutic intervention itself.
Yes
The device is intended for "locating the apex of the root canal," which is a diagnostic function because it identifies and determines the position of a specific anatomical landmark within the tooth.
No
The device description explicitly states it is a "microprocessor controlled device" and mentions "automatic adjustments are made if needed," implying hardware components beyond just software. The performance studies also include safety, EMC, biocompatibility, and sterilization testing, which are typically associated with physical medical devices, not software-only ones.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "locating the apex of root canal." This is a procedure performed directly on a patient's tooth, not on a sample of human origin in vitro (outside the body).
- Device Description: The description details a device used with endodontic files within the root canal of a tooth. This is an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to assist in a dental procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Apex Locator, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.
Product codes (comma separated list FDA assigned to the subject device)
LQY
Device Description
Apex Locator, DPEX III is an apex locator intended for precise localization of root canal apex.
Operation of Apex Locator, DPEX III is fully automatic, no manual calibrations or adjustments are required. The measuring signal is analyzed, and automatic adjustments are made if needed. The device may operate within different conditions in the root canal. Apex Locator, DPEX III may only be used with stainless steel or nickel titanium endodontic files. The scale indication on the apex locator screen does not represent a distinct length or distance in mm or other linear units. It merely indicates the file progression towards the apex.
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
Hospital environment, clinics or dental offices by qualified dental personnel.
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)
Performance Comparison Test:
The comparison testing on Apex Locator. DPEX III and the predicate device (RAYPEX 6 (K131907) was performed to compare the measurement performance of locating apex root using extracted tooth. The result obtained with the Apex Locator, DPEX III is clinically acceptable since they are equivalent to the results of the predicate device.
Safety and EMC Test:
-
- IEC 60601-1: 2005+CORR.1 (2006)+CORR.2(2007)+AM1(2012) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance – Collateral standards: electromagnetic compatibility – Test and requirements
The safety and EMC testing confirm that the subject device complies with the same FDA recognized safety and EMC standards as the primary predicate device. All of the predetermined acceptance criteria were met.
Biocompatibility Test:
-
- Cytotoxicity Tests (ISO10993-5)
-
- Skin Irritation Test (ISO10993-10)
-
- Oral Mucosa Irritation Test (ISO10993-10)
-
- Skin Sensitization Test (ISO10993-10)
The test result shows that the subject device complies with the same FDA recognized biocompatibility standards as predict device. All of the pre-determined acceptance criteria were met.
Sterilization Validation:
-
- ISO 17665-1:2006, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices (Sterility)
-
- ISO 11737-2:2009, Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the validation of a sterilization process. (Sterility)
-
- ANSI AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
The steam sterilization validation study supports the labeling of sterilization method for the accessories subject to be sterilized at the clinical site.
All of the pre-determined acceptance criteria were met.
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Guilin Woodpecker Medical Instrument Co., Ltd. % Charlie Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K181087
Trade/Device Name: Apex Locator, DPEX III Regulatory Class: Unclassified Product Code: LQY Dated: September 8, 2018 Received: September 19, 2018
Dear Charlie Mack:
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/cdrl/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.
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
December 18, 2018
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mary S. Mary S. Runner -S3 Runner -S3 Date: 2018.12.18
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181087
Device Name Apex Locator, DPEX III
Indications for Use (Describe)
Apex Locator, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a red rectangle with rounded corners. Inside the rectangle is the logo for Woodpecker. The logo consists of a white woodpecker graphic on the left and the word "WOODPECKER" in white text on the right. There is a registered trademark symbol below the woodpecker.
Guilin Woodpecker Medical Instrument Co., Ltd.
510(k) Summary (21 CFR §807.92) 510(k) assigned number K181087
Submitter Information:
| Submitter Name: | Guilin Woodpecker Medical Instrument Co., Ltd. |
|---|---|
| Address: | Information Industrial Park, Guilin National High-Tech Zone, |
| Guilin City, Guangxi Province, P.R. China 541004 | |
| Contact Person: | Mr. Xunxian Wu |
| President | |
| charliemack@irc-us.com | |
| 931-625-4938 | |
| Date of Preparation: | December 15, 2018 |
| Trade Name: | Apex Locator, DPEX III |
|---|---|
| Common Name: | Root apex locator |
| Regulation Number: | Pre-Amendment |
| Regulation Name: | locator, root apex |
| Regulatory Class: | Unclassified |
| Product Code: | LQY |
| Classification Panel: | Dental |
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Image /page/4/Picture/0 description: The image is a logo for Woodpecker. The logo is white text on a red background. To the left of the text is a white outline of a woodpecker.
Primary Predicate Device
| Trade Name: | RAYPEX 6 |
|---|---|
| 510(k) Reference: | K131907 |
| Common Name: | Root apex locator |
| Regulation Number: | Pre-Amendment |
| Regulation Name: | locator, root apex |
| Regulatory Class: | Unclassified |
| Product Code: | LQY |
| Classification Panel: | Dental |
Purpose of Submission
This is a new submission of an apex root locator.
Device Description
Apex Locator, DPEX III is an apex locator intended for precise localization of root canal apex.
Operation of Apex Locator, DPEX III is fully automatic, no manual calibrations or adjustments are required. The measuring signal is analyzed, and automatic adjustments are made if needed. The device may operate within different conditions in the root canal. Apex Locator, DPEX III may only be used with stainless steel or nickel titanium endodontic files. The scale indication on the apex locator screen does not represent a distinct length or distance in mm or other linear units. It merely indicates the file progression towards the apex.
5
Image /page/5/Picture/0 description: The image is a logo for Woodpecker. The logo features a white woodpecker on the left side of the image. To the right of the woodpecker is the word "WOODPECKER" in white, bold letters. The background of the logo is red.
Indications for Use
Apex Locator, DPEX III is a microprocessor- controlled device used for locating the apex of root canal.
| SUBJECT
Indications for Use | PRIMARY
PREDICATE Device
(K131907)
Indications for Use |
|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Apex Locator, DPEX III is a microprocessor-
controlled device used for locating the apex of
root canal. | Rapex 6 is a microprocessor-controlled
device used for locating the apex. |
All the labeling and characteristics of the submitted Apex Locator, DPEX III is the same as the primary predicate device and most typical apex locators currently on the market. The submitted device and predicate both are used in routine procedures.
The basic design of the submitted device specifications is substantially the same as the predicate, with differences in the display, weight, and frequencies used for measurements. Testing validates that the performance of the Apex Locator, DPEX III is comparable to the predicate device.
Sterilization validation and performance testing has verified that the submitted device is safe for use.
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Image /page/6/Picture/0 description: The image is a logo for Woodpecker. The logo features a white woodpecker icon on the left and the word "WOODPECKER" in white on the right. The background is a red rectangle with rounded corners.
Technological Characteristics
Technological characteristics of the subject and predicate devices are equivalent. The subject device Apex Locator, DPEX III achieves its intended use based on the same technology and principles of operation as the predicate device, Rapex 6 apex locator.
| Characteristics | Subject Device | Primary Predicate Device |
|---|---|---|
| Device Trade Name | Apex Locator, DPEX III | Apex Locator, RAYPEX 6 |
| 510K Applicant | GUILIN WOODPECKER MEDICAL | |
| INSTRUMENT CO., LTD | DENTSPLY International | |
| 510(K) Number | K181087 | K131907 |
| Regulation Number | Unclassified | Unclassified |
| Product Code | LQY | LQY |
| Classification Name | Root Apex Locator | Root Apex Locator |
| OTC or Prescription | Prescription Use | Prescription Use |
| Medical Specialty | Dental | Dental |
| Indications for Use | DPEX III is a microprocessor-controlled | |
| device used for locating the apex of root | ||
| canal. | RAYPEX 6 is a microprocessor- | |
| controlled device used for locating | ||
| the apex. | ||
| Electrical Power | Rechargeable lithium battery(3.7V) | Rechargeable NiMH |
| batteries(2.4V) | ||
| Adapter | Input: AC100-240V 50/60Hz | |
| Output: DC5V 1A | Input: AC100-240V 50/60Hz | |
| Output: DC5V 1A | ||
| Display | Custom colorized 4.5" LCD | 3.5" colorized TFT |
| Measuring Voltage | Nominal - doesn't exceed 200mV AC | Nominal - doesn't exceed 200mV |
| AC | ||
| Frequencies used | ||
| for measurements | 400Hz & 8kHz | 500Hz & 8kHz |
| Method of | ||
| calculation | The ratio of impedance at two | |
| frequencies | The ratio of impedance at two | |
| frequencies |
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Image /page/7/Picture/0 description: The image is a logo for Woodpecker. The logo features a stylized woodpecker bird in white, with the word "WOODPECKER" in white text to the right of the bird. The logo is set against a red background. There is a registered trademark symbol below the bird.
| Characteristics | Subject Device | Primary Predicate Device |
|---|---|---|
| Accessory | Measuring wire, File clip, Lip hook, Touch probe, Adapter, Tester | Measuring wire, File clip, Lip hook, Touch probe, Adapter, Tester |
| Weight | 385g | 350g |
| Operating Environment | Hospital environment, clinics or dental offices by qualified dental personnel. | Hospital environment, clinics or dental offices by qualified dental personnel |
| Button | Three push buttons: |
- ON/OFF
- Sound adjustment
- Demonstration function | One push button:
ON/OFF
-Touchscreen |
| Sound Indication | Piezo transducer with sound level control (high, medium, low, mute) | A speaker which enables:
-the sound level adjustment from mute to the high sound level
-tone selection |
| Automatic Turn off function | The device turns off automatically after 5 minutes of the idle state. | The device turns off automatically after 5 minutes of an idle state. |
| Calibration | Not required | Not required |
| Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 |
The submitted Apex Locator DPEX III uses the same technology to determine the apex of the root, using two frequencies that are alternated, with the ratios of the impedance measurement to determine the apex of the root canal. Both the subject device and the predicate Rapex 6 use a sound alert when the file is near the apex. The Apex Locator DPEX III uses a different high frequency, but testing reveals that there is no performance difference between the predicate and submitted device.
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Image /page/8/Picture/0 description: The image is a logo for Woodpecker. The logo features a white woodpecker on the left side of the image. To the right of the woodpecker is the word "WOODPECKER" in white, all on a red background.
Summary of Performance Tests
The following performance testing was performed to demonstrate substantial equivalence of the subject device Apex Locator DPEX III and applicable standards:
Non-clinical Test
Performance Comparison Test:
The comparison testing on Apex Locator. DPEX III and the predicate device (RAYPEX 6 (K131907) was performed to compare the measurement performance of locating apex root using extracted tooth. The result obtained with the Apex Locator, DPEX III is clinically acceptable since they are equivalent to the results of the predicate device.
Safety and EMC Test:
-
- IEC 60601-1: 2005+CORR.1 (2006)+CORR.2(2007)+AM1(2012) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2: 2014 Medical devices part 1-2: General requirements for basic safety and essential performance – Collateral standards: electromagnetic compatibility – Test and requirements
The safety and EMC testing confirm that the subject device complies with the same FDA recognized safety and EMC standards as the primary predicate device. All of the predetermined acceptance criteria were met.
Biocompatibility Test:
-
- Cytotoxicity Tests (ISO10993-5)
-
- Skin Irritation Test (ISO10993-10)
-
- Oral Mucosa Irritation Test (ISO10993-10)
-
- Skin Sensitization Test (ISO10993-10)
The test result shows that the subject device complies with the same FDA recognized biocompatibility standards as predict device. All of the pre-determined acceptance criteria were met.
9
Image /page/9/Picture/0 description: The image is a logo for Woodpecker. The logo is red with white text and a white woodpecker. The woodpecker is on the left side of the logo, and the text "WOODPECKER" is on the right side of the logo.
Sterilization Validation:
-
- ISO 17665-1:2006, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices (Sterility)
-
- ISO 11737-2:2009, Sterilization of medical devices -- Microbiological methods --Part 2: Tests of sterility performed in the validation of a sterilization process. (Sterility)
-
- ANSI AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
The steam sterilization validation study supports the labeling of sterilization method for the accessories subject to be sterilized at the clinical site.
All of the pre-determined acceptance criteria were met.
Clinical Test
No clinical study is included in this submission.
Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, and performance testing, the subject Apex Locator, DPEX III has demonstrated to be substantially equivalent to the primary predicate Rapex 6 Apex Locator.