(88 days)
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A²s in a 60 s period occur.
Nissha Medical Technologies Neutral Electrodes - Boston Scientific:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4TM and 1A/1B Radiofrequency Generators".
A neutral electrode is a non-sterile non-active dispersive conductor intended to be fastened to a patient and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for single-use.
This document describes the premarket notification for Nissha Medical Technologies Neutral Electrodes. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data in the context of clinical efficacy or diagnostic accuracy.
Therefore, many of the requested data points (such as acceptance criteria for specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth establishment) are typically associated with performance studies for diagnostic or AI-driven medical devices, which are not detailed in this submission for a neutral electrode.
However, based on the provided text, I can extract information related to non-clinical performance and substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the format typically seen for diagnostic device studies. Instead, it states that the device "passed all the testing in accordance with internal requirements, and international standards." The performance is reported in terms of compliance with these standards.
| Standard/Test | Description of Acceptance | Reported Device Performance |
|---|---|---|
| IEC 60601-2-2:2017 (relevant requirements) | Compliance with "Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" | Passed tests for Thermal performance, Contact impedance, Adhesion, Shelf-life, Cord attachment, Cord connector, and Cord insulation. |
| IEC 60601-1 (relevant requirements) | Compliance with general requirements for basic safety and essential performance of medical electrical equipment. | Passed. |
| ISO 10993-1 (Biocompatibility) | Confirmation that finished devices are biocompatible and do not induce new risks. | Confirmed biocompatible. |
| ISO 10993-5 (Cytotoxicity) | Acceptable level of cytotoxicity. | Showed a slight reactivity (implies within acceptable limits for clearance). |
| ISO 10993-10 (Skin Irritation and Sensitization) | No adverse results for skin irritation and sensitization. | Showed no adverse results. |
| Shelf-Life Testing (per IEC 60601-2-2, subclause 201.15.101.8) | Demonstrated shelf-life based on accelerated aging and subsequent electrical safety testing. | Demonstrated a shelf-life of 24 months. |
2. Sample Sizes used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this is a non-clinical performance testing submission for an accessory device, not a diagnostic or AI-driven device with a traditional "test set" from patient data. The testing would have involved a sufficient number of device samples to demonstrate compliance with standards.
- Data Provenance: The data is from non-clinical laboratory testing conducted by Nissha Medical Technologies Ltd. (United Kingdom).
3. Number of Experts used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a non-clinical engineering and safety compliance submission for an electrosurgical accessory. The "ground truth" for these tests are the established parameters and thresholds within the cited international standards (e.g., maximum temperature rise, impedance limits). No human experts were involved in establishing a "ground truth" for interpretation of data in the way radiologists or pathologists would for imaging-based devices.
4. Adjudication Method for the Test Set
Not applicable, for the reasons stated above. Compliance with engineering standards is typically determined by measurement against predefined limits, not human adjudication of subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a neutral electrode accessory for electrosurgery, not a diagnostic or AI-assisted interpretation device. Therefore, there is no human-in-the-loop performance improvement to measure with AI.
6. Standalone Performance Study
Yes, the non-clinical performance testing described (thermal performance, contact impedance, adhesion, shelf-life, cord attachment, cord connector, cord insulation, biocompatibility) represents standalone performance without human input beyond operating the test equipment. The purpose was to demonstrate the device's inherent safety and performance characteristics against established engineering and biological standards.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical performance testing is based on:
- International Standards: Specific criteria and limits defined in IEC 60601-2-2:2017, IEC 60601-1, ISO 10993-1, ISO 10993-5, and ISO 10993-10. These standards provide the established benchmarks for safety and performance of such devices.
- Internal Requirements and Specifications: The manufacturer's own design inputs and specifications, which are expected to align with the international standards.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products.
February 23, 2021
Nissha Medical Technologies LTD Marcel Salchner Director of European Quality, Regulatory & Innovation Torbay Business Park, Woodview Road Paignton, Devon TQ4 7HP United Kingdom
Re: K203494
Trade/Device Name: Nissha Medical Technologies Neutral Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 29, 2020 Received: December 30, 2020
Dear Marcel Salchner:
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 Actinclude 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
{1}------------------------------------------------
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-devices/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 (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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203494
Device Name
Nissha Medical Technologies Neutral Electrodes
Indications for Use (Describe)
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur.
Nissha Medical Technologies Neutral Electrodes - Boston Scientific:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HF-generator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4™ and 1A/1B Radiofrequency Generators".
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" written in smaller, light gray letters. The logo is simple and modern.
510(k) Summary
Nissha Medical Technologies Neutral Electrodes
1) Submission Sponsor/Correspondent
Nissha Medical Technologies Ltd. Torbay Business Park, Woodview Road Paignton, Devon TQ4 7HP United Kingdom Establishment Registration Number: 3008933393 Contact: Marcel Salchner Title: Director of European Quality, Regulatory & Innovation Phone: +43 512 219313 Email: msalchner@nisshamedical.com
- Date Prepared 2020-12-29
3) Device Identification
Trade Name: Nissha Medical Technologies Neutral Electrodes Common Name: Neutral Electrodes Classification Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Device Class: Class II Review Panel: General & Plastic Surgery
4) Legally Marketed Predicate Device(s)
| Manufacturer | BOWA-electronicsGmbH & Co. KG |
|---|---|
| Trade Name | BOWA NeutralElectrodes |
| 510(k) Number | K173877Primary predicate |
5) Indication for Use Statement
Nissha Medical Technologies Neutral Electrodes - SWAROPLATE:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HFgenerator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The SWAROPLATE neutral electrodes of Nissha Medical Technologies are not intended for use in High Current Mode. These are applications with high current and / or long activation periods where heating factors of more than 30 A2s in a 60 s period occur.
002_510(k)_Summary
{4}------------------------------------------------
Nissha Medical Technologies Neutral Electrodes - 510(k) Submission
Nissha Medical Technologies Neutral Electrodes - Boston Scientific:
Neutral electrodes are an accessory for monopolar HF-surgery and represent the large area and low impedance contact with the patient's skin required for returning the electric current to the HFgenerator. Neutral electrodes are self-adhesive, ready-to-use disposable products.
The Boston Scientific Neutral Electrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REF DGP-PM2-5, and REF DGP-PM2-25 are intended to be used in combination with the devices "Boston Scientific G4TM and 1A/1B Radiofrequency Generators''.
6) Device Description
A neutral electrode is a non-sterile non-active dispersive conductor intended to be fastened to a patient and connected to an electrosurgical diathermy generator, to create a circuit for the return of electrical current to the generator after its emission to perform electrosurgery on the patient. It is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may or may not include a return cable(s). This medical device is intended for single-use.
7) Substantial Equivalence Discussion
The following table compares the Nissha Medical Technologies Neutral Electrodes to the predicate devices with respect to intended use, indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.
| Manufacturer | BOWA-electronicsGmbH & Co. KG | Nissha MedicalTechnologies Ltd. | Device Comparison |
|---|---|---|---|
| Trade Name | BOWA NeutralElectrodes | Nissha Medical TechnologiesNeutral Electrodes | N/A |
| 510(k)Number | K173877 | K203494 | N/A |
| Product Code | GEI | GEI | Same |
| RegulationNumber | 21 CFR 878.4400 | 21 CFR 878.4400 | Same |
| RegulationName | Electrosurgicalcutting andcoagulation deviceand accessories | Electrosurgicalcutting andcoagulation deviceand accessories | Same |
| Indications forUse | Disposable neutralelectrodes are selfadhesive, ready-touse and single-useproducts and arean accessory for HFsurgery inmonopolarapplications. Theelectrodes | Nissha Medical TechnologiesNeutral Electrodes -SWAROPLATE:Neutral electrodes are anaccessory for monopolar HF-surgery and represent thelarge area and low impedancecontact with the patient's skinrequired for returning theelectric current to the HF- | Wording isdifferent, but theIntended Use isidentical |
| Manufacturer | BOWA-electronicsGmbH & Co. KG | Nissha MedicalTechnologies Ltd. | Device Comparison |
| complete theelectrical circuitbetween thepatient and the HFgenerator on thepassive side. | generator. Neutral electrodesare self-adhesive, ready-to-use disposable products.The SWAROPLATE neutralelectrodes of Nissha MedicalTechnologies are not intendedfor use in High Current Mode.These are applications withhigh current and / or longactivation periods whereheating factors of more than30 A²s in a 60 s period occur.Nissha Medical TechnologiesNeutral Electrodes – BostonScientific:Neutral electrodes are anaccessory for monopolar HF-surgery and represent thelarge area and low impedancecontact with the patient's skinrequired for returning theelectric current to the HF-generator. Neutral electrodesare self-adhesive, ready-to-use disposable products.The Boston Scientific NeutralElectrodes REF DGP-PMC2-5, REF DGP-PMC2-25, REFDGP-PM2-5, and REF DGP-PM2-25 are intended to beused in combination with thedevices "Boston ScientificG4TM and 1A/1BRadiofrequency Generators". | ||
| Prescription orOTC | Prescription | Prescription | Same |
| Neutral electrodesserve to return thecurrent from thepatient to theelectrosurgical unit(ESU) during HFsurgery inmonopolarapplication. | Neutral electrodesserve to return thecurrent from thepatient to theelectrosurgical unit(ESU) during HFsurgery inmonopolarapplication. | ||
| Mechanism ofAction | Same | ||
| TechnologyOverview | Multi-layer device | Multi-layer device | Similar |
| Manufacturer | BOWA-electronicsGmbH & Co. KG | Nissha MedicalTechnologies Ltd. | Device Comparison |
| Backing materialConductive layerConductiveadhesive hydrogelCover material | Backing materialConductive layerConductiveadhesive hydrogelCover material | ||
| Population | Neonates, Children,Adults | Neonates, Children,Adults | Same |
| AnatomicalLocation | Muscular or wellvascularizedconvex skin site, asclose as possible tothe operating field | Muscular or wellvascularizedconvex skin site, asclose as possible tothe operating field | Same |
| >15kg (33lbs)Adults | >15kg (33lbs)Adults | ||
| Weight rangeaccording toIEC 60601-2-2 | >5kg (11lbs)Children and AdultsBetween 5 and15kg (11 to 33lbs)Children<5kg (11lbs)Neonates | >5kg (11lbs)Children and AdultsBetween 5 and15kg (11 to 33lbs)Children<5kg (11lbs)Neonates | Same |
| Conductivearea | 140 cm² Adults110 cm² Childrenand Adults70 cm² Children40 cm² Neonates | 128-170 cm² Adults105 - 110 cm² Childrenand Adults71 - 72 cm² Children32-37 cm² Neonates | Similar |
| 140 cm² not limited | Adults not limited | ||
| Power | 110 cm² not limited70 cm² limited to200W40 cm² limited to100W | Children and Adults notlimitedChildren limited to 250WNeonates limited to 150W | Similar |
| Material | Conductivelaminate:Al-foil / PET andmedical gradehydrogelBacking: PE-foamCover: release liner | Conductivelaminate:Al-foil / PET andmedical gradehydrogelBacking: PE-foamCover: release liner | Same |
| Cable length for pre-wired electrodes | 3 meters | 3 meters | Same |
Table 1 - Comparison of Characteristics
002 510(k) Summary
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is written in large, bold, blue letters. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" in smaller, gray letters.
Nissha Medical Technologies Neutral Electrodes – 510(k) Submission
002_510(k)_Summary
3
{6}------------------------------------------------
Image /page/6/Picture/6 description: The image shows the logo for Nissha Medical Technologies. The word "NISSHA" is in large, blue, sans-serif font. Below the word "NISSHA" are the words "MEDICAL TECHNOLOGIES" in a smaller, gray, sans-serif font.
Nissha Medical Technologies Neutral Electrodes – 510(k) Submission
002_510(k)_Summary
4
{7}------------------------------------------------
| Image: NISSHA logo | ||
|---|---|---|
| MEDICAL | TECHNOLOGIES |
Nissha Medical Technologies Neutral Electrodes - 510(k) Submission
| Manufacturer | BOWA-electronicsGmbH & Co. KG | Nissha MedicalTechnologies Ltd. | Device Comparison |
|---|---|---|---|
| Sterile | Non-sterile | Non-sterile | Same |
| Single-Use /disposable | Yes | Yes | Same |
| Shelf Life | 36 months | 24 months | Similar |
| Complies withISO 10993-1; 10993-5 and 10993-10 | Yes | Yes | Same |
| Complies withrelevantclauses of IEC60601-2-2 | Yes | Yes | Same |
| ElectricalSafety TestingPassed | Yes | Yes | Same |
| Compatibilitywith HFGenerators(ESU) | Yes, if ESU isequipped with aCQM System whichfulfils IEC 60601-1 | Yes, several ESUs have beenevaluated for compatibilityand a "Declaration ofCompatibility" is availablefor end-users. | Similar |
| Packaging | Sealed pouch | Sealed pouch | Same |
| Accessory | For electrodesprovided withoutcable, reusable cableavailable | For electrodesprovided withoutcable, reusable cableavailable | Same |
8) Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of Nissha Medical Technologies Neutral Electrodes and in showing substantial equivalence to the predicate devices, Nissha Medical Technologies completed several non-clinical performance tests. The Nissha Medical Technologies Neutral Electrodes meet all the requirements for overall design, biocompatibility and electrical safety with results confirming that the design output meets the design inputs and specifications for the devices.
The Nissha Medical Technologies Neutral Electrodes passed all the testing in accordance with internal requirements, and international standards shown below to support substantial equivalence of the predicate devices:
· The device passed performance testing conducted according to standard IEC 60601-2-2:2017 "Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories" and IEC 60601-1, relevant requirements. The testing conducted included: Thermal performance, Contact impedance, Adhesion, Shelf-life, Cord attachment, Cord connector and Cord insulation.
· Biocompatibility testing per ISO 10993-1 confirmed that the finished devices are biocompatible, and do not induce new risks. Testing per ISO 10993-5 Cytotoxicity was showing a slight reactivity, and ISO 10993-10 (Skin Irritation and Sensitization) was showing no adverse results.
002_510(k)_Summary
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image contains the logo for Nissha Medical Technologies. The word "NISSHA" is in large, blue, sans-serif font. Below the word "NISSHA" is the phrase "MEDICAL TECHNOLOGIES" in a smaller, gray, sans-serif font. The logo is simple and modern.
· Shelf Life Testing – According to accelerated aging of the Nissha Medical Technologies Neutral Electrodes and subsequent electrical safety testing, as it is required in subclause 201.15.101.8 of the standard IEC 60601-2-2, it has been demonstrated that the Nissha Medical Technologies Neutral Electrodes can be labeled with a shelf-life of 24 months.
9) Clinical Performance Data
No human clinical testing is required to support the medical device as the intended use is equivalent to the predicate devices. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
10) Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. All the comparisons described in this document clearly show that the neutral electrodes from Nissha Medical Technologies are substantially equivalent to the competitor products from BOWA. Despite small differences in detail, all products comply with the state of the art and are suitable for the 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.