(25 days)
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 Dental Pain Eraser DPE-C300 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-C300 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 intended for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients. The modified Dental Pain Eraser DPE-C300 is a multi-use device to be used in a dental/orthodontic facility.
This document describes a 510(k) premarket notification for the "Dental Pain Eraser DPE-C300," which is a non-invasive electrical stimulation device for temporary dental anesthesia. The primary purpose of this submission is to demonstrate that a modified version of the device, intended for multi-use, is substantially equivalent to a predicate single-use device (K182947). Therefore, the study focuses on validating the reprocessing (cleaning and disinfection) and durability for multi-use, rather than clinical efficacy studies of the pain relief itself.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantifiable manner for the overall "performance" of the device in terms of pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device, particularly regarding its new multi-use characteristic. The "reported device performance" in this context refers to the successful outcomes of the nonclinical tests designed to support the multi-use claim.
| Acceptance Criteria Category | Specific Criteria/Focus | Reported Device Performance |
|---|---|---|
| Cleaning and Disinfection Validation | Adherence to standards for reprocessing medical devices. | "The results of the collective testing demonstrate that differences between the modified Dental Pain Eraser DPE-C300 as a multi-use device and the predicate as a single-use device do not raise different questions of safety or effectiveness." |
| Residual Cytotoxicity Testing | Ensuring no harmful residues remain after disinfection. | Implied to be met as part of "Disinfecting Validation/Residual Cytotoxicity Testing" and the overall conclusion of no new safety/effectiveness questions. |
| Cycle Testing | Durability and consistent performance over multiple uses. | "meet the established specifications necessary for consistent performance during its intended use." (Specific quantitative cycles not provided in summary). |
| Tip Assembly Pull Testing | Mechanical integrity of the tip assembly. | "meet the established specifications necessary for consistent performance during its intended use." (Specific quantitative force not provided in summary). |
| Biocompatibility | Compliance with relevant ISO standards and FDA guidance. | "Biocompatibility testing was performed per ISO 10993-1 and FDA Guidance Document... issued June 16, 2016." (No specific results provided in summary, but implied compliance). |
| Electrical Safety & EMC | Compliance with IEC 60601 series and ANSI/AAMI NS4:2013 | "Compliant with applicable requirements of: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304, ANSI/AAMI NS4:2013." (General statement of compliance without specific test results in summary). |
| Risk Management & Usability | Compliance with ISO 14971 and IEC 62366-1 | "Compliant with applicable requirements of: IEC 62366-1:2015, Medical devices. Part 1: Application of usability engineering to medical devices ISO 14971:2012, Medical Devices. Application of Risk Management to Medical Devices." (General statement of compliance without specific details). |
| Output Specifications (Voltage, Current, etc.) | Identical to predicate device. | All output specifications (patient leakage current, output modes, waveform, shape, voltage, current, pulse duration, frequency, charge, power density, burst mode, on/off time) for the proposed device are listed as identical to the predicate device. |
| General Physical Characteristics | Identical to predicate device (except multi-use capability). | Indications for Use, Intended User/Patient Population, Use Environment, Product Code, Classification, Manufacturer, Power Source, Method of Line Current Isolation, Indicator Display, Therapy Range, Weight, Unit Body Dimensions, Materials and Construction, Ingress Protection Rating are all stated as "N/A (same)" as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Clinical testing was not required to establish substantial equivalence."
Therefore, there is no "test set" in the context of clinical performance data. The "tests" performed were nonclinical (bench testing) for cleaning, disinfection, cycle testing, and pull testing. The sample sizes for these specific bench tests are not provided in the summary. Data provenance is implied to be from Synapse Dental's internal testing as part of their 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set was used to establish ground truth for clinical efficacy. The evaluation was based on nonclinical bench testing and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a direct-use electrical stimulation device, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable, as the device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used
For the nonclinical tests (cleaning, disinfection, cycle, pull), the "ground truth" was established by compliance with regulatory standards and pre-established specifications for those specific engineering and microbiological tests. For example, for cleaning and disinfection, it would be the absence of detectable bioburden or remaining residues, meeting the criteria outlined in AAMI TIR standards. For cycle and pull testing, it would be the structural integrity and continued function after a specified number of cycles or under a specified load.
For the substantial equivalence claim, the overarching "ground truth" is that the modified multi-use device performs equivalently to the predicate single-use device without raising new safety or effectiveness concerns, justified by the nonclinical testing results.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2020
Synapse Dental % Valerie Defiesta-Ng Vice President, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, California 95110
Re: K193570
Trade/Device Name: Dental Pain Eraser Regulatory Class: Unclassified Product Code: LWM Dated: December 20, 2019 Received: December 23, 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.
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
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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 Quality Center for Devices and Radiological Health
Enclosure
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510(k) Notification K193570
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: December 20, 2019
DEVICE INFORMATION [807.92(a)(2)]
Classification: Unclassified, Pre-Amendment
Product Code: LWM
Trade Name: Dental Pain Eraser DPE-C300
Generic/Common Name: Device, Electrical Dental Anesthesia
PREDICATE DEVICE(S) [807.92(a)(3)]
Dental Pain Eraser DPE-C300 (K182947)
DEVICE DESCRIPTION [807.92(a)(4)]
The Dental Pain Eraser DPE-C300 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-C300 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
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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 intended for the alleviation of oral pain for pediatric (10 years through 22 years of age) and adult patients. The modified Dental Pain Eraser DPE-C300 is a multi-use device to be used in a dental/orthodontic facility.
INDICATIONS FOR USE [807.92(a)(5)]
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.
SUBSTANTIAL EQUIVALENCE
The modified Dental Pain Eraser DPE-C300 is substantially equivalent to the predicate device with regard to function and physical characteristics. The difference as a multi-use device versus a single-use device does not raise any different issues of safety or effectiveness. Thus, the modified Dental Pain Eraser DPE-C300 is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
Synapse performed a cleaning and disinfecting validation in accordance with the following standards:
- o Guidance for Industry and Food and Drug Administration Staff, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Document Issued on March 17, 2015, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluations.
- 0 AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.
- o AAMI TIR12-30:2011/(R)2016. A compendium of processes. materials, test methods, and acceptance criteria for cleaning reusable medical devices, December 15, 2016.
- Guidance for Industry and FDA Reviewers, Content and Format of Premarket o Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants." FDA CDRH, January 3, 2000.
- ASTM E1837-96 (2014), Standard Test Method to Determine Efficacy of Disinfection 0 Processes for Reusable Medical Devices (Simulated Use Test).
The results of the collective testing demonstrate that differences between the modified Dental Pain Eraser DPE-C300 as a multi-use device and the predicate as a single-use device do not raise different questions of safety or effectiveness and that the modified Dental Pain Eraser DPE-C300 is substantially equivalent to the predicate Dental Pain Eraser DPE-C300 (K182947).
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Nonclinical Testing Summary [807.92(b)(1)]:
The nonclinical, bench testing included:
- Cleaning Validation ●
- o Disinfecting Validation/Residual Cytotoxicity Testing
- o Cycle Testing
- Tip Assembly Pull Testing ●
The collective results of the nonclinical testing demonstrate that the cleaning and disinfection processes, in conjunction with the cycle and pull testing performed meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Dental Pain Eraser DPE-C300 does not raise new questions of safety or effectiveness when used as a multi-use device when compared to the predicate device.
Clinical Testing Summary [807.92(b)(2)]:
Clinical testing was not required to establish substantial equivalence
CONCLUSIONS [807.92(b)(3)]
Extensive nonclinical 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 meets the requirements of a multi-use device. The Dental Pain Eraser is substantially equivalent to the predicate device.
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| K193570 | |||
|---|---|---|---|
| Table 1: Substantial Equivalence Table | |||
| Characteristic | Dental Pain EraserDPE-C300(Proposed Device) | Dental Pain EraserDPE-C300(Predicate Device) | Rationale for Substantial Equivalence |
| 510(k) Number | TBD | K182947 | |
| Indications for Use | The Dental Pain Eraser DPE-C300 isintended to provide temporary dentalanesthesia (pain relief) and is indicated foruse before, during, or after dental andorthodontic procedures, and other sources oforal pain. It is intended for use bydental/orthodontic professionals for thealleviation of oral pain. | The Dental Pain Eraser DPE-C300 isintended to provide temporary dentalanesthesia (pain relief) and is indicated foruse before, during, or after dental andorthodontic procedures, and other sources oforal pain. It is intended for use bydental/orthodontic professionals for thealleviation of oral pain. | N/A (same) |
| Intended User or PatientPopulation | The Dental Pain Eraser is intended for use bydental/orthodontic professionals for thealleviation of oral pain in their pediatric (10years through 22 years of age) and adultpatients. | The Dental Pain Eraser is intended for use bydental/orthodontic professionals for thealleviation of oral pain in their pediatric (10years through 22 years of age) and adultpatients. | N/A (same) |
| Use Environment | Professional Dental/Orthodontic Facility | Professional Dental/Orthodontic Facility | N/A (same) |
| Single-use or Multi-use | Multi-use | Single-use | The change in use does not raise differentquestions of safety and effectiveness asdemonstrated by the cleaning, disinfectionand performance 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 (3) 393/309 Silver Oxide Button CellBatteries | Three (3) 393/309 Silver Oxide Button CellBatteries | N/A (same) |
| Method of Line CurrentIsolation | Not connected to the line | Not connected to the line | N/A (same) |
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| Rationale for Substantial Equivalence | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dental Pain EraserDPE-C300(Predicate Device) | DC ~ 0μA AC<10mA | DC~0μA AC<10mA | 0μA | 1(As requested per Q180245, see Table 2 forthe Output Specifications) | 2 | Alternating | Not isolated | Voltage | Firmware | No | No | Yes | N/A (same) | ||
| Dental Pain EraserDPE-C300(Proposed Device) | DC ~ 0μA AC<10mA | DC~0μA AC<10mA | 0μA | 1(As requested per Q180245, see Table 2 forthe Output Specifications) | 2 | Alternating | Not isolated | Voltage | Firmware | No | No | Yes | N/A (same) | ||
| Table 1: Substantial Equivalence Table (Cont.) | Characteristic | Patient Leakage Current | ○ Normal Condition (μA) | ○ Single Fault Condition (μA) | Average DC current through electrodes when device is on but no pulses are being applied (μA) | Number of Output Modes | Number of Output Channels | • Synchronous or Alternating? | • Method of Channel Isolation | Regulated Current or Regulated Voltage? | Software/Firmware/Microprocessor Control? | Automatic Overload Trip? | Automatic No-Load Trip? | Automatic Shut Off? |
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| Characteristic | Dental Pain EraserDPE-C300(Proposed Device) | Dental Pain EraserDPE-C300(Predicate Device) | Rationale for Substantial Equivalence |
|---|---|---|---|
| Indicator DisplayOn/Off Status? | Yes | Yes | N/A (same) |
| Low Battery? | No | No | N/A (same) |
| Voltage/Current Level? | No | No | N/A (same) |
| Therapy Range (minutes) | 5 minutes Max | 5 minutes Max | N/A (same) |
| Compliance with VoluntaryStandards | Compliant with applicable requirements of:IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304ANSI/AAMI NS4:2013, TranscutaneousElectrical Nerve StimulatorsISO 7405: Second edition 2008-12-15,Dentistry - Evaluation of biocompatibility ofmedical devices used in dentistry [Including:Amendment 1 (2013)].ISO 10993-1:2009, Biological evaluation ofmedical devices - Part 1: Evaluation andtesting within a risk management process | Compliant with applicable requirements of:IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304ANSI/AAMI NS4:2013, TranscutaneousElectrical Nerve StimulatorsISO 7405: Second edition 2008-12-15,Dentistry - Evaluation of biocompatibility ofmedical devices used in dentistry [Including:Amendment 1 (2013)].ISO 10993-1:2009, Biological evaluation ofmedical devices - Part 1: Evaluation andtesting within a risk management process | |
| Table 1: Substantial Equivalence Table (Cont.) | K193570 | ||
| Dental Pain EraserDPE-C300(Proposed Device) | Dental Pain EraserDPE-C300(Predicate Device) | ||
| Characteristic | Rationale for Substantial Equivalence | ||
| Compliance with VoluntaryStandards (continued) | IEC 62366-1:2015, Medical devices. Part 1:Application of usability engineering tomedical devicesISO 14971:2012, Medical Devices.Application of Risk Management to MedicalDevices | IEC 62366-1:2015, Medical devices. Part 1:Application of usability engineering tomedical devicesISO 14971:2012, Medical Devices.Application of Risk Management to MedicalDevices | N/A (same) |
| Compliance with 21 CFR Part898? | Not applicable | Not applicable | |
| Weight (oz.) | 0.423oz | 0.423oz | N/A (same) |
| Unit Body Dimensions (in.)Two Electrode Probes:Dimensions (in.) | Pen-shaped ~0.5" to ~1.04" Diameter,Length ~6.27"0.118" Diameter, 0.157", Center to centerspacing | Pen-shaped ~0.5" to ~1.04" Diameter,Length ~6.27"0.118" Diameter, 0.157", Center to centerspacing | N/A (same) |
| Materials and Construction | |||
| Patient Contacting MaterialsWithin the Mouth | Tip Assembly with Electrodes:• Lustran 348 WT012002 (ABS)• Clariant SB7M665060, GREY• 303 Stainless Steel | Tip Assembly with Electrodes:• Lustran 348 WT012002 (ABS)• Clariant SB7M665060, GREY• 303 Stainless Steel | N/A (same) |
| Biocompatible | Biocompatibility testing was performed perISO 10993-1 and FDA Guidance Document,"Use of 10993-1, 'Biological Evaluation ofmedical devices - Part 1: Evaluation andtesting within a risk management process',"issued June 16, 2016. | Biocompatibility testing was performed perISO 10993-1 and FDA Guidance Document,"Use of 10993-1, 'Biological Evaluation ofmedical devices - Part 1: Evaluation andtesting within a risk management process',"issued June 16, 2016. | |
| Ingress Protection Rating | IP21 | IP21 | N/A (same) |
| Description | Dental Pain EraserDPE-C300(Proposed Device) | Dental Pain EraserDPE-C300(Predicate Device) | |
| Mode or Program Name | Only one Mode | Only one Mode | |
| Indication for Use | Pulsing Light | Pulsing Light | |
| Waveform (e.g., pulsed monophasic, biphasic) | Complex, Biphasic, Charge Neutral (See Detailed Description) | Complex, Biphasic, Charge Neutral (See Detailed Description) | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | |
| Pole Configuration (e.g., 2-pole, 4-pole) - For interferentialcurrent only | NA | NA | |
| Maximum Output Voltage (V) (+/- 10%) | 2.08@ 500Ω2.74@ 1kΩ4.24@ 10kΩ | 2.08@ 500Ω2.74@ 1kΩ4.24@ 10kΩ | |
| Maximum Output Current (mA) (+/-10%) | 4.16@ 500Ω2.74@ 1kΩ0.42@ 10kΩ | 4.16@ 500Ω2.74@ 1kΩ0.42@ 10kΩ | |
| Duration of primary (depolarizing) phase (ms) | |||
| High Frequency Pulse duration (μs) | 50μs on, 50μs off | 50μs on, 50μs off | |
| High Frequency (Hz) [or Rate (pps)] | 10kHz | 10kHz | |
| Slow Frequency Pulse Duration | 1Hz | 1Hz | |
| For multiphasicwaveforms only: | Symmetrical phases? | Yes | Yes |
| Phase Duration (include units), (staterange, if applicable), (both phases, ifasymmetrical) | 0.999s | 0.999s | |
| Net Charge (microcoulombs (μC) per cycle) (If zero, statemethod of achieving zero net charge.) | 0μC. Positive current through the load for0.999s, then negative going current for0.999s and repeat. | 0μC. Positive current through the load for0.999s, then negative going current for0.999s and repeat. | |
| Table 2: Comparison of Output Specifications (Cont.) | |||
| Description | Dental Pain EraserDPE-C300(Proposed Device) | Dental Pain EraserDPE-C300(Predicate Device) | |
| Maximum Phase Charge (μC) | 2.77μC @ 1kΩ | 2.77μC @ 1kΩ | |
| Maximum Current Density (mA/cm², r.m.s.) | 68.5mA/cm² @ 1kΩ, assuming 4mm²electrode contact area | 68.5mA/cm² @ 1kΩ, assuming 4mm²electrode contact area | |
| Maximum Average Current (average absolutevalue - mA) | 0mA @ 1kΩ | 0mA @ 1kΩ | |
| Maximum Average Power Density (W/cm²), (using smallestelectrode conductive surface area) | 0.187W/cm² @ 1kΩ | 0.187W/cm² @ 1kΩ | |
| Burst Mode(i.e., pulse trains):(a) Pulses per burst | 15 | 15 | |
| (b) Bursts per second | 333 | 333 | |
| (c) Burst duration (seconds) | 3ms | 3ms | |
| (d) Duty Cycle: Line (b) x Line (c) | 0.999s | 0.999s | |
| ON Time (seconds) | 0.2498s | 0.2498s | |
| OFF Time (seconds) | 0.7493s | 0.7493s | |
| Additional Features (specify, if applicable) | Device can be turned off by the user or itturns off automatically after 5 minutes,whichever time is shortest | Device can be turned off by the user or itturns off automatically after 5 minutes,whichever time is shortest |
0(k) SUMMARY (CONT
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10(k) SUMMARY (CONT
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