(85 days)
The Viora V10 system is intended for dermatological procedures.
The V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V20 system is intended for dermatological procedures. The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V30 system is intended for dermatological procedures. The V30 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The V-FR Handpiece is fractional Bi-polar radiofrequency (RF) Handpiece is supported by Viora's V10, V20 and V30 systems.
V30: Multi-application, multi-technology platform device intended for use in dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel.
V20: dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. Cooled by deionized water
V10: based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel.
The FDA 510(k) clearance letter and summary for the Viora V30, V20, V10 Systems and V-FR Handpiece (K201064) provides information about the device's substantial equivalence to predicate devices, but it does not include acceptance criteria or the specifics of a study proving the device meets those criteria in the typical sense of a clinical performance study with predefined endpoints and statistical analysis.
Instead, the document focuses on demonstrating substantial equivalence through:
- Comparison of technological characteristics with predicate devices.
- Non-clinical testing, including electrical safety, electromagnetic compatibility, performance bench tests, biocompatibility, and software verification/validation.
- An animal study to evaluate safety and effectiveness for the indicated use.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document in the traditional format. However, I can provide the available information:
1. Table of "Acceptance Criteria" (interpreted as performance standards and study findings) and Reported Device Performance:
| Category | Acceptance Criteria (from performance standards / study goals) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1:2012 | Device was determined to be in conformance with IEC 60601-1:2012. |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2:2014 | Device was determined to be in conformance with IEC 60601-1-2:2014. |
| Non-Laser Light Source (V20, V30) | Conformance to IEC 60601-2-57:2011 | V20, V30 systems determined to be in conformance with IEC 60601-2-57:2011. |
| Surgical Laser (V20, V30) | Conformance to IEC 60601-2-22:2007 | V20, V30 systems determined to be in conformance with IEC 60601-2-22:2007. |
| Laser Product Safety (V20, V30) | Conformance to IEC 60825-1:2014 | V20, V30 systems determined to be in conformance with IEC 60825-1:2014. |
| General Performance | Performs per device specifications; safe and effective as cleared predicate devices (Bench testing goal) | Bench testing demonstrated that the V-FR Handpiece performs per its device specifications and is as safe and effective as the cleared predicate devices. All performance testing demonstrated it performs according to specifications and functions as intended. |
| Biocompatibility (V-FR tip) | Meet requirements of ISO 10993-1 for surface device contacting breached/compromised skin in limited duration (Cytotoxicity, Irritation, Sensitization tests) | Results showed that the V-FR tip materials meet the requirement of ISO 10993-1 for indicated contact type. |
| Software Functionality | Software verification and validation testing results found acceptable for release (Software goal) | Software verification and validation testing was conducted, and results demonstrated that testing results were found acceptable for software release. |
| Animal Study (Safety/Effectiveness) | Evaluate safety and effectiveness for dermatological procedures requiring ablation and resurfacing of the skin; no device-related serious adverse events | Action of V-FR handpiece (coagulation and ablation of epidermis/superficial dermis) was confirmed. Histopathological evaluation indicated well-circumscribed coagulation necrosis limited to treated tissue, with intact skin in-between. Healing initiated from intact areas without adjacent tissue complications (inflammation, thrombosis). Clear, consistent, time-related progressive healing without adverse reactions. No device-related serious adverse events. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Animal Study): "female domestic pigs (Sus scrofa domestica)" were used, but the specific number (sample size) is not provided.
- Data Provenance: The animal study was "prospective" as described, but the country of origin of the data is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document mentions "Histopathological evaluation of the tissue samples" but does not specify the number or qualifications of experts performing this evaluation in the animal study.
4. Adjudication Method for the Test Set:
- The document does not describe an adjudication method for the animal study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study involving human readers and AI assistance was mentioned or conducted, as this device (V-FR Handpiece) is a fractional radiofrequency device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This is not applicable as the device is a physical medical device (RF handpiece) and not an AI algorithm. Its performance is evaluated through bench testing and animal studies.
7. Type of Ground Truth Used (Animal Study):
- Histopathology/Histopathological evaluation: This involved examining skin biopsies for depth/width of ablated tissue, coagulative necrosis, and signs of healing/complications.
- Macroscopic evaluation: Local reactions were evaluated grossly.
8. Sample Size for the Training Set:
- Not applicable/Not provided: This device does not involve an AI algorithm with a distinct "training set" in the context of machine learning. The "training" for the device, if one considers it, would be its design, engineering, and manufacturing based on existing medical device knowledge and standards.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable: As noted above, there is no AI training set in the context of this device. Ground truth for the device's design and functionality would stem from established medical physics, dermatology principles, and engineering standards.
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Image /page/0/Picture/0 description: The image shows 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.
July 15, 2020
Viora Ltd. Simona Krant QA/RA Director 6 Hagavish Street Neanya, 4250706 Israel
Re: K201064
Trade/Device Name: V30 System, V20 System, V10 System, V-FR Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX, ISA, GEX, GEI Dated: March 31. 2020 Received: April 21, 2020
Dear Simona Krant:
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.
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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201064
Device Name V30, V20, V10 systems V-FR handpiece
Indications for Use (Describe)
The Viora V10 system is intended for dermatological procedures.
The V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V20 system is intended for dermatological procedures. The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V30 system is intended for dermatological procedures. The V30 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
| 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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Shape the Fu 510(k) K201064
510(k) - Summary
Device
Page 1 of 6
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
| Submitter Nameand Address: | Viora Ltd.6 Hagavish StreetNetanya, Israel 4250706Israel |
|---|---|
| Contact Person: | Ms. Simona F. KrantQA/RA DirectorEmail: Simona@Vioramed.comPhone Number: +972 9955 1344Fax Number: +972 9955 1345 |
| EstablishmentRegistrationNumber: | 3005695724 |
| Date Prepared: | July 14, 2020 |
| Device TradeName(s): | V-FR Handpiece compatible with V30, V20, V10 Systems |
| Device CommonName: | Multi-application RF, IPL and Laser device, RF based applicator |
| Classification: | Name: Electrosurgical cutting and coagulation device andaccessories and Laser surgical instrument for use in general andplastic surgery and in dermatology.Product code: PBX, ISA, GEI, GEX (for V30 system)PBX, ISA GEI, GEX (for V20 system)PBX, ISA, GEI (for V10 system)Regulation No: 21CFR878.4400, 21CFR878.4810Class: IIPanel: General and plastic surgery devices |
| PredicateDevice(s): | Viora V30 system (K162363)Viora V20 system (K152611)Viora V10 system (K150035)Syneron Medical Matrix RF Applicator (K090025) |
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Image /page/4/Picture/0 description: The image shows the logo for VIORA, a company with the tagline "Shape the Future." Below the logo is the text "510(k) K201064". The logo features the company name in a bold, sans-serif font, with a stylized graphic above it. The graphic appears to be a curved line that resembles a strand of hair.
Device description
| System | Description | Applications | 510(k) Clearance |
|---|---|---|---|
| V30 | Multi-application, multi-technology platform device intended for use in dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. | Nd:YAG (V30) | November 18, 2016 (K162363). |
| V20 | dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel.Cooled by deionized water | For V20 & V30:V-ST, V-IPL, V- and V-FORM (with BC Small, Medium and Large applicators) | February 19, 2016 (K152611) &November 18, 2016 (K162363). |
| V10 | based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel. | V-ST and V-FORM (with BC Small and Large applicators) | May 1, 2015 (K150035) &November 18, 2016 (K162363). |
The V-FR Handpiece is fractional Bi-polar radiofrequency (RF) Handpiece is supported by Viora's V10, V20 and V30 systems.
Indication for Use for V-FC Handpiece compatible with V30, V20, V10 Systems
The Viora V10 system is intended for dermatological procedures.
The V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V20 system is intended for dermatological procedures.
The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
The Viora V30 system is intended for dermatological procedures.
The V30 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.
Predicate Devices
The predicate device to Viora systems V10, V20 and V30 are the cleared V10, V20 and V30 systems themselves (please refer to the table below) and the V-FR handpiece is Syneron Medical Matrix RF Applicator that was cleared for marketing on January 8, 2010 (K090025).
| Device name | 510k No. | Date of Clearance |
|---|---|---|
| Viora V10 | K150035 | Cleared on May 1, 2015 |
| Viora V20 | K152611 | Cleared on February 19, 2016 |
| Viora V30 | K162363 | Cleared on November 18, 2016 |
| Syneron Medical Matrix RF Applicator | K090025 | Cleared on January 8, 2010 |
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Image /page/5/Picture/0 description: The image shows the logo for VIORA, with the tagline "Shape the Future" underneath. Above the company name is a stylized graphic that resembles a needle and thread. Below the logo is the text "510(k) K201064", which likely refers to a medical device clearance or approval number.
Page 3 of 6
Substantial Equivalence to Predicate Device
| Comparison Parameter | Subject Device:V10,V20 and V30 systems with V-FR Handpiece | Predicate Device:Matrix RF Applicator Syneron Medical Ltd. | Characteristic Comparison(same/different) |
|---|---|---|---|
| Device Class | Class II | Class II | Same |
| ClassificationPanel | General and PlasticSurgery devices | General and PlasticSurgery devices | Same |
| Product code | PBX, ISA , GEI (V10,V20 & V30)GEX (V20 & V30) | GEI | Same for FR Technology |
| Regulation number | 21CFR878.4400 (V10,V20 & V30)21CFR878.4810 (V20 & V30) | 21CFR878.4400 | Same |
| Regulation description | Laser Surgical Instrument for Use in General and plasticsurgery and in dermatology.Electrosurgical cutting and coagulation device and accessories | Electrosurgical cutting and coagulation device andaccessories. | Same |
| Device main components | Cleared V10,V20 and V30 systems with:V-FC Handpiece, connector, cable handpiece. | • Matrix RF Applicator, connector, cable handpiece• Disposable, sterilized treatment tips• Disposable, sterilized test tips | Same |
| Supported technologies | The cleared V10,V20 and V30 systems -with V-FRHandpiece, are supported with RF technology | Matrix RF Applicator is supported with RF technology | Same |
| Intended use andindication for use | The V10,V20 and V30 systems with V-FC Handpiece areintended for dermatological procedures requiring ablation andresurfacing of the skin circulation and temporary reduction inthe appearance of cellulite. | The Matrix RF Applicator is intended for use indermatological procedures, requiring ablation andresurfacing of the skin, and for the treatment of facialwrinkles, circulation and temporary reduction in theappearance of cellulite | Similar, V-FR does not treatfacial wrinkles |
| System user interface | V10 & V20: 8.1-inch touch screenV30:10.4-inch touch screen | High-resolution color, 15" LCD V30:10.4-inch touchscreen | Different but equivalent |
| Handpiece dimensions: | 18x16cm | 15x16cm | Different but equivalent |
| Handpiece weight | 0.4 kg | 0.5 kg | Different but equivalent |
| Electricalrequirements: | 100-240 V~ 10A 50/60 Hz (V10,V20 & V30)100-120 V~ 10A 50/60 Hz (V20 & V30)Single Phase | 100-230 VAC ±10%; 3A; 50/60HzSingle Phase | Same |
| Software | The V10,V20 and V30 systems software supports the V-FRHandpieces.The software was verified and validated according to the FDAguidance. | According to 510(k) summary K090025, the softwarewas verified and validatedaccording to the FDA guidance | Same |
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Image /page/6/Picture/0 description: The image shows the logo for VIORA, a company with the tagline "Shape the Future." The logo features the company name in a bold, sans-serif font, with a stylized graphic above the name. Below the logo is the text "510(k) K201064", which likely refers to a regulatory submission or approval number.
Summary of technologic characteristics
The technological differences between Viora V-FR Handpiece compatible with V30, V20, V10 Systems and the predicate device Matrix RF Applicator Syneron Medical Ltd. do not raise any new questions of safety or effectiveness.
The non-clinical testing, software verification and validation testing and animal study were performed to evaluate the performance of V-FR Handpiece compatible with V30, V20, V10 Systems.
Based on comparison of the technological characteristics of the devices and results of the performance testing, V-FR Handpiece compatible with V30, V20, V10 Systems is substantially equivalent to the predicate device Matrix RF Applicator Syneron Medical Ltd. for requested intended use."
In conclusion, the V-FC Handpiece compatible with V30, V20, V10 Systems is substantially equivalent to its predicate device. Therefore, we concluded that the Matrix RF Applicator Syneron Medical Ltd. for the V-FR Handpiece compatible with V30, V20, V10 Systems appears to be an adequate predicate for this submission.
Performance standards
The V-FC Handpiece compatible with V30, V20, V10 Systems comply with the following performance standards:
| System Relevance | Standard Number | Part Title |
|---|---|---|
| V10,V20,V30 | IEC 60601-1:2012 | Medical Electrical Equipment Part 1:GeneralRequirements for Basic Safety and EssentialPerformance |
| V10,V20,V30 | IEC 60601-1-2: 2014 | Medical Electrical Equipment Part 1-2:GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard: ElectromagneticCompatibility – Requirements and Tests. |
| V20,V30 | IEC 60601-2-57:2011 | Particular Requirements for The Basic Safety andEssential Performance of Non-Laser Light SourceEquipment Intended for Therapeutic, Diagnostic,Monitoring and Cosmetic/Aesthetic Use. |
| V20,V30 | IEC 60601-2-22:2007 | Particular Requirements for Basic Safety AndEssential Performance of Surgical, Cosmetic,Therapeutic and Diagnostic Laser Equipment. |
| V20,V30 | IEC 60825-1:2014 | Safety of Laser Products Part 1: EquipmentClassification. And Requirements |
Electrical Safety and Electromagnetic Compatibility:
The V-FR Handpiece compatible with V30, V20, V10 Systems was determined to be in conformance with applicable IEC standards as described in the above table.
Performance Bench Tests:
Bench testing demonstrated that the V-FR Handpiece compatible with V30, V20, V10 Systems performs per its device specifications and are as safe and effective as the cleared predicate devices.
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Image /page/7/Picture/1 description: The image shows the logo for VIORA, a company that is shaping the future. The logo features a stylized symbol above the word "VIORA" in a bold, sans-serif font. Below "VIORA" is the tagline "Shape the Future" in a smaller, lighter font. The text "510(k) K201064" is located at the bottom of the image.
Biocompatibility:
The materials and biocompatibility characteristics of Viora V10, V30 systems remains the same as approved (K150035, K152611, and K162363 respectively). Addition biocompatibility tests were performed according to ISO 10993-1 for the V-FR tip - Cytotoxicity test, Irritation test, Sensitization test. Results showed that the V-FR tip materials meet the requirement of the ISO 10993-1 for surface device that contacts breached or compromised surface in limited contact duration with the skin.
Software:
Software verification and validation testing was conducted, and results demonstrated that testing results were found acceptable for software release.
All performance testing demonstrated that the V-FR Handpiece compatible with V30, V20, V10 Systems performs according to specifications and functions as intended.
Pre-Clinical (Animal) study
The Animal prospective study was conducted to evaluate the safety and effectiveness of the V-FR Handpiece compatible with V30, V20, V10 Systems for dermatological procedures requiring ablation and resurfacing of the skin.
The study was comprised female domestic pigs (Sus scrofa domestica), each subjected to multiple topical exposures of fractional radio frequency pulses via the V-FR handpiece connected to Viora V10, V20, V30 systems by which different settings, such as depth of penetration, pulse energy and duration.
Animals were evaluated macroscopically for local reaction at Day 0, Day 3, Day 7 and at study's termination 14 days post Activation. Skin biopsies were harvested on the same days and evaluated for depth/width of the ablated tissue and coagulative necrosis.
Action of the V-FR handpiece (i.e., a fractional radiofrequency system) was confirmed in this study to consist of coagulation and ablation of the epidermis and the superficial dermis. Histopathological evaluation of the tissue samples indicated that, there was a well circumscribed condensation of the epidermis (i.e., coagulation necrosis), strictly limited only to small "islets" of the treated tissue, leaving intact skin in-between these islets. The healing was confirmed to be initiated from these intact skin areas resulting in lack of any evidence for adjacent tissue complications (i.e., inflammation, thrombosis). Histopathological evaluation of the activation sites indicated a clear and consistent time-related progressive change in the morphologic aspect of the sites, generally reflecting trend for healing without associated adverse reaction. This trend was evident in all combinations of type of programs / energy settings / pulse durations. Ablations were mainly restricting pod to the high-power settings (i.e. 8 & 10.) and coagulated necrosis was noted in all type of setting combinations on the day of application.
The results of the animal study demonstrated the favorable safety and effectiveness profile for the Viora V10, V20, V30 systems for the indicated use for ablation and resurfacing of the skin with no device related serious adverse events.
All performance testing demonstrated that the V-FR Handpiece compatible with V30, V20, V10 Systems performs according to specifications and functions as intended.
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Image /page/8/Picture/0 description: The image shows the logo for VIORA, with the tagline "Shape the Future" underneath. Below the logo and tagline, the text "510(k) K201064" is displayed. The logo features a stylized, abstract design above the company name.
Conclusion:
The technological differences between subject and predicate devices do not raise any new questions of safety or effectiveness. The non-clinical testing, software verification testing and animal study were performed to evaluate the performance of Viora V10, V20, V30 system with V-FR Handpiece.
Based on comparison of the technological characteristics of the devices and results of the performance testing, Viora V10, V20, V30 system with V-FR Handpiece are substantially equivalent to the predicate devices for requested intended use.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.