(131 days)
Not Found
No
The device description and performance studies focus on electrical stimulation (TENS) and usability testing, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to provide temporary dental anesthesia (pain relief) by numbing nerve pain with electrical stimulation, which directly addresses a health condition (pain relief) and thus is a therapeutic function.
No
The device is described as an "electrical stimulation device that is used to numb the nerve pain" and provides "temporary dental anesthesia (pain relief)." Its intended use is for "alleviation of oral pain," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "non-invasive electrical stimulation device" with "two metal electrodes" and a shape similar to a toothbrush, indicating it is a physical hardware device that delivers electrical current.
Based on the provided information, the Dental Pain Eraser DPE-T300 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Dental Pain Eraser DPE-T300 is a non-invasive electrical stimulation device that applies current to the gums or skin to alleviate pain. It does not analyze any biological specimens.
- Intended Use: The intended use is for temporary dental anesthesia (pain relief) by applying electrical stimulation, not for diagnostic purposes based on analyzing samples.
Therefore, the Dental Pain Eraser DPE-T300 falls under the category of a therapeutic or pain management device, not an IVD.
N/A
Intended Use / Indications for Use
The Dental Pain Eraser DPE-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatric (10 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.
Product codes
LWM
Device Description
The Dental Pain Eraser DPE-T300 is a non-invasive electrical stimulation device that is used to numb the nerve pain associated with orthodontic procedures and to dull the pain of canker sores often developed inside the mouths of patients wearing braces or retainers. This method of treatment is referred to as Transcutaneous Electrical Nerve Stimulation (TENS).
The Dental Pain Eraser DPE-T300 has a shape and size similar to a common toothbrush, except that in place of the bristles are two metal electrodes. In operation, the device is turned on for 30 seconds to 10 minutes, the two electrodes are rubbed gently up and down the gums above the patient's aching tooth or on the intact skin around the canker sore. Current flowing between the electrodes through the gum anesthetizes the nearby nerves thus alleviating pain. The Dental Pain Eraser is for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients for treatment at home who are under the care of a dental/orthodontic professional. Pediatric patients 10 through 12 years of age must be supervised by an adult.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity (gums, intact skin around canker sore)
Indicated Patient Age Range
Pediatric (10 years through 22 years of age) and adult patients. Pediatric patients 10 through 12 years of age must be supervised by an adult.
Intended User / Care Setting
Under the care of a dental/orthodontic professional / treatment at home.
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
Human factors usability testing was conducted to confirm that representative users can use the device safely and effectively without supervision from a healthcare professional. The representative group used in this Usability study was fifteen (15) Adult (18 + years of age) and fifteen (15) Pediatric patients, of which fourteen (14) were Male and sixteen (16) were Female. Pediatric patients 8 - 11 years of age required parental/guardian supervision and patients 12 - 17 years of age were asked to work with their guardian to the degree they would at home. Each participant was given a realistic task scenario to perform with the DPE-T300 on an anatomical model. The participants were rated on task completion performance, interviewed and asked follow-up questions about the task, and asked knowledge-based questions on the system documentation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Nonclinical Testing Summary
Sample Size: Not Applicable
Key Results: Synapse performed safety testing in accordance with IEC 60601-1-11, Edition 2.0, 2015-01, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard Requirements for medical electrical equipment and medical electrical systems use in the home healthcare environment demonstrating basic safety and essential performance for the lay or the trained healthcare personnel. In addition, the Dental Pain Eraser DPE-T300 was tested for ingress protection (IP) code IP24 in accordance with IEC 60529, Edition 2.2, 2013-08, Degrees of protection provided by enclosures (IP code).
Study Type: Clinical/Usability Testing Summary
Sample Size: Fifteen (15) Adult (18 + years of age) and fifteen (15) Pediatric patients (14 Male, 16 Female).
Key Results: Usability testing demonstrated that the DPE-T300 could be used by representative users under simulated use conditions without producing patterns of failures that could result in negative clinical impact to patients or harm to users. The test also included verifying the Instructions for Use, packaging, and labeling for effectiveness and ensuring that the use-related risks of the DPE-T300 were mitigated. Overall, task completion rates were high for removing the device from the package, holding the device in the correct orientation, turning on the device, moving the electrodes in the recommended motion/around affected area, and removing the electrodes after the recommended duration. The tasks that most patients completed with issues or did not complete were clearing excess moisture or saliva from gums, cleaning the entire device, and ensuring the blue indicator light is pulsing to signal device is ready for use. None of the observed task errors, close calls, or failures fell into the category of undesirable or intolerable risk. The majority of the use-related risk errors were related to the IFU layout and organization. Many use errors were attributed to patients not reading the IFU or having difficulty picking out particular instructions or warnings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dental Pain Eraser DPE-C300 (K182947)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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January 14, 2020
Synapse Dental % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkawy, Suite 250 San Jose, California 95110
Re: K192429
Trade/Device Name: Dental Pain Eraser Regulatory Class: Unclassified Product Code: LWM Dated: December 16, 2019 Received: December 17, 2019
Dear Valerie Defiesta-Ng:
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.
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
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 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 medical devices and radiation-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.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192429
Device Name Dental Pain Eraser DPE-T300
Indications for Use (Describe)
The Dental Pain Eraser DPE-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatic (10 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.
| 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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3
510(k) SUMMARY
510(k) Notification K192429
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Synapse Dental 67 Phenix Avenue Cranston, RI 02920 USA Phone: 401-932-9877 Fax: 401-464-8903
Contact Person:
Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose. CA 95110 USA
Date Prepared: January 13, 2020
DEVICE INFORMATION [807.92(A)(2)]
Trade Name: Dental Pain Eraser DPE-T300
Generic/Common Name: Device, Electrical Dental Anesthesia
Device, Electrical Dental Anesthesia
Classification: Unclassified, Pre-Amendment
Product Code: LWM
PREDICATE DEVICE(S) [807.92(A)(3)]
Dental Pain Eraser DPE-C300 (K182947)
DEVICE DESCRIPTION [807.92(A)(4)]
The Dental Pain Eraser DPE-T300 is a non-invasive electrical stimulation device that is used to numb the nerve pain associated with orthodontic procedures and to dull the pain of canker sores often developed inside the mouths of patients wearing braces or retainers. This method of treatment is referred to as Transcutaneous Electrical Nerve Stimulation (TENS).
The Dental Pain Eraser DPE-T300 has a shape and size similar to a common toothbrush, except that in place of the bristles are two metal electrodes. In operation, the device is turned on for 30
4
510(k) SUMMARY (CONT.)
seconds to 10 minutes, the two electrodes are rubbed gently up and down the gums above the patient's aching tooth or on the intact skin around the canker sore. Current flowing between the electrodes through the gum anesthetizes the nearby nerves thus alleviating pain. The Dental Pain Eraser is for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients for treatment at home who are under the care of a dental/orthodontic professional. Pediatric patients 10 through 12 years of age must be supervised by an adult.
INDICATIONS FOR USE [807.92(a)(5)]
The Dental Pain Eraser DPE-T300 is intended to provide temporary dental anesthesia (pain relief). It is intended for prescriptive use only for the alleviation of oral pain for use by pediatric (10 years through 22 years of age) and adult patients for treatment at home. Pediatric patients 10 through 12 years of age must be supervised by an adult.
SUBSTANTIAL EQUIVALENCE
The Dental Pain Eraser DPE-T300 is substantially equivalent to the predicate device with regard to function and physical characteristics. Any differences in the technological characteristics between the devices do not raise any different issues of safety or effectiveness. Thus, the proposed Dental Pain Eraser DPE-T300 is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary bench and usability testing were conducted on the Dental Pain Eraser to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)] Nonclinical Testing Summary
Synapse performed safety testing in accordance with IEC 60601-1-11, Edition 2.0, 2015-01, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard Requirements for medical electrical equipment and medical electrical systems use in the home healthcare environment demonstrating basic safety and essential performance for the lay or the trained healthcare personnel. In addition, the Dental Pain Eraser DPE-T300 was tested for ingress protection (IP) code IP24 in accordance with IEC 60529, Edition 2.2, 2013-08, Degrees of protection provided by enclosures (IP code).
[807.92(b)(2)] Clinical/Usability Testing Summary
Human factors usability testing was conducted to additionally confirm that representative users can use the device safely and effectively without supervision from a healthcare professional. This testing was performed in accordance with recommendations in FDA's Guidance Document titled, "Applying Human Factors and Usability Engineering to Medical Devices," issued February 03, 2016, and IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices.
The Synapse Dental Pain Eraser (DPE-T300) underwent usability testing to demonstrate that the DPE-T300 could be used by representative users under simulated use conditions without producing patterns of failures that could result in negative clinical impact to patients or harm to users. The test also included verifying the Instructions for Use, packaging, and labeling for effectiveness and ensuring that the use-related risks of the DPE-T300 were mitigated. Synapse initially proposed that the DPE-T300 be indicated for pediatric patients 8 – 11 years of age with
5
510(k) SUMMARY (CONT.)
parental supervision, pediatric patients 12 - 22 years of age without adult supervision, and adult patients. Therefore, the representative group used in this Usability study was fifteen (15) Adult (18 + years of age) and fifteen (15) Pediatric patients, of which fourteen (14) were Male and sixteen (16) were Female. Pediatric patients 8 - 11 years of age required parental/guardian supervision and patients 12 - 17 years of age were asked to work with their guardian to the degree they would at home. Each participant was given a realistic task scenario to perform with the DPE-T300 on an anatomical model. The participants were rated on task completion performance, interviewed and asked follow-up questions about the task, and asked knowledgebased questions on the system documentation.
Overall, task completion rates were high for removing the device from the package, holding the device in the correct orientation, turning on the device, moving the electrodes in the recommended motion/around affected area, and removing the electrodes after the recommended duration. The tasks that most patients completed with issues or did not complete were clearing excess moisture or saliva from gums, cleaning the entire device, and ensuring the blue indicator light is pulsing to signal device is ready for use. None of the observed task errors, close calls, or failures fell into the category of undesirable or intolerable risk. The majority of the use-related risk errors were related to the IFU layout and organization. Many use errors were attributed to patients not reading the IFU or having difficulty picking out particular instructions or warnings. While serious use errors were committed, the likelihood of occurrence for these are incredible and further reduction of the residual risk is not possible or practical, and the device's benefits outweigh its residual risks. The pre-screening and training by the dentist/orthodontist that occurs with the prescription of the device will also further lower the potential for harm. The test results indicate that the goals of the validation studies were met and that the use-related safety issues associated with the DPE-T300 have been adequately mitigated, and no new risks have been identified.
CONCLUSION [807.92(B)(3)]
Extensive nonclinical and usability testing has been performed on the Dental Pain Eraser to evaluate the overall performance of the device. The collective results confirm that the Dental Pain Eraser meets its specifications and exhibits the required characteristics for its intended use in alleviating pain and as such is substantially equivalent to the predicate device. The Dental Pain Eraser DPE-T300 is substantially equivalent to the predicate device.
6
| | Dental Pain Eraser
DPE-T300 | Dental Pain Eraser
DPE-C300 | |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | (Proposed Device) | (Predicate Device) | Rationale for Substantial Equivalence |
| 510(k) Number | TBD | K182947 | |
| Indications for Use | The Dental Pain Eraser DPE-T300 is
intended to provide temporary dental
anesthesia (pain relief). It is intended for
prescriptive use only for the alleviation of
oral pain for use by pediatric (10 years
through 22 years of age) and adult patients
for treatment at home. Pediatric patients 10
through 12 years of age must be supervised
by an adult. | The Dental Pain Eraser DPE-C300 is
intended to provide temporary dental
anesthesia (pain relief) and is indicated for
use before, during, or after dental and
orthodontic procedures, and other sources of
oral pain. It is intended for use by
dental/orthodontic professionals for the
alleviation of oral pain. | The change in Indications for Use statement
does not raise different questions of safety
and effectiveness and is supported by the
appropriate IEC 60601-1-11 and usability
testing. |
| Intended User or Patient
Population | The Dental Pain Eraser is for the alleviation
of oral pain for use by pediatric (10 years
through 22 years of age) and adult patients
for treatment at home who are under the care
of a dental/orthodontic professional.
Pediatric patients 10 through 12 years of age
must be supervised by an adult. | The Dental Pain Eraser is intended for use by
dental/orthodontic professionals for the
alleviation of oral pain in their pediatric (10
years through 22 years of age) and adult
patients. | The change in Intended Use does not raise
different questions of safety and
effectiveness and is supported by the
appropriate IEC 60601-1-11 and usability
testing. |
| Use Environment | Home | Professional Dental/Orthodontic Facility | The difference in use environment does not
raise different questions of safety and
effectiveness and is supported by the
usability testing. |
| Product Code | LWM | LWM | N/A (same) |
| Classification | Unclassified, Pre-amendment | Unclassified, Pre-amendment | N/A (same) |
| Manufacturer | Synapse Dental | Synapse Dental | N/A (same) |
| Power Source(s) | Three 393/309 Silver Oxide Button Cell
Batteries | Three 393/309 Silver Oxide Button Cell
Batteries | N/A (same) |
| Method of Line Current
Isolation | Not connected to the line | Not connected to the line | N/A (same) |
| | Dental Pain Eraser
DPE-T300
(Proposed Device) | Dental Pain Eraser
DPE-C300
(Predicate Device) | Rationale for Substantial Equivalence |
| Characteristic | | | |
| Patient Leakage Current | | | |
| Normal Condition ( $\mu$ A) | DC ~ 0 $\mu$ A AC