Electrosurgical Generator and Accessories

K201224 · Medrange · GEI · Sep 18, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201224
• Device Name: Electrosurgical Generator and Accessories
• Applicant: Medrange
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.

Device Story

Electrosurgical generator 8070 provides high-frequency (HF) electrical power for surgical cutting and coagulation. Device accepts user input via front panel controls to select output function and power levels; output is activated by hand or foot switches. HF power is delivered to tissue via connected monopolar or bipolar handpieces. Used in clinical settings by healthcare professionals. Output enables precise tissue management during surgery, facilitating cutting or hemostasis.

Clinical Evidence

Bench testing only. Performance demonstrated via compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (HF surgical equipment safety), and IEC 60601-1-6 (usability). Testing followed FDA guidance for electrosurgical devices.

Technological Characteristics

HF generator producing 400-600 kHz current. System voltage 100-240VAC, 50/60Hz. Modes: Monopolar (4 cut, 8 coag) and Bipolar (4 modes). Max power: 320W (monopolar cut), 120W (monopolar coag), 240W (bipolar). Crest factors: 1.5-9.0. Waveforms: Sinusoidal constant/modulated, pulse/pause phases. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-1-6.

Indications for Use

Indicated for monopolar or bipolar surgery to achieve tissue cutting or coagulation. Intended for use with compatible monopolar handpieces/dispersive electrodes or bipolar handpieces and footswitches.

Regulatory Classification

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.

Predicate Devices

• MB 8010 Electrosurgical Unit (K102114)

Submission Summary (Full Text)

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September 18, 2020

Medrange Corporation Helen Xie RA Assistant 480 Apollo Street, Suite D. Brea. California 92821

Re: K201224

Trade/Device Name: Electrosurgical Generator and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI. Dated: August 19, 2020 Received: August 19, 2020

Dear Helen Xie:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] 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) K201224

#### Device Name

8070 Electrosurgical Generator and Accessories

Indications for Use (Describe)

The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.

Type of Use (*Select one or both, as applicable*)

| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image shows the title "510(k) Summary" in a large font. Below the title is a horizontal line, and below the line is the text "Traditional 510(k) Submission" in a smaller font. To the left of the title is a black graphic that resembles a stylized check mark or swoosh.

| Section | |
|---------|--|
| | |

| Version | 1.1f |
|---------|--------------------|
| Pages | 3 |
| Date | September 16, 2020 |

### 1. Submitter Information

| Company: | Medrange Corporation |
|----------|-------------------------------------------|
| Address: | Suite D, 480 Apollo Street, Brea CA 92821 |
| Contact: | Helen Xie |
| Phone: | 1(909) 859 - 9055 |
| Email: | [e-mail] |

## 2. Device Identification

| Common name: | Electrosurgical Generator and Accessories |
|--------------------------|------------------------------------------------------|
| Classification name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Trade name: | Accsurg™ Electrosurgical Workstation and Accessories |
| Model: | 8070 |
| Device Class: | Class II |
| Product Code: | GEI |
| 21CFR Regulation Number: | 878.4400 |

#### 3. Predicate Device

Product MB 8010 Electrosurgical Unit 510(K) K102114

## 4. Device Description

8070 is an Electrosurgical Generator with Monopolar Pure cut, Monopolar Bland Cut, Bipolar function. 8070 consists of HF generator and accessories. The device generates HF power, which is transmitted to the tissue through the output Pencil. Operator selects the output function and power with the front panel. The indicator is used to indicate the setup status and output status of the output is controlled by foot or hand switch.

#### 5. Indication for use

The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with Monopolar, handpiece and dispersive electrode or bipolar handpiece and footswitches.

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# 6. Substantial Equivalence Discussion

## Technological characteristics

| Device | Subject device | Predicate device |
|-------------------------------|---------------------------------------------------------------|----------------------------------------------------------------|
| Manufacturer | Medrange Corporation | Medrange Corporation |
| Model | 8070 | MB 8010 |
| 510(k) Number | K201224 | K102114 |
| Class | II | II |
| Product Code | GEI | GEI |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Mechanism of Action | The device generates high<br>Frequency current<br>400-600 kHz | The device generates high<br>Frequency current<br>416-1050 kHz |
| System Voltage | 100-240VAC- 50/60Hz | 100-240VAC- 50/60Hz |
| 4 Monopolar Cut Modes | | |
| Max. Power | 320 W (at 300Ω) | 300 W (at 300Ω) |
| Max. Voltage Output | 3800 | 2200 |
| Crest Factor | 1.5-2.5 | 1.8-2.5 |
| Wave Forms | Sinusoidal constant / modulated<br>Cut / Coag Pulse Phases | Sinusoidal constant / modulated |
| 8 Monopolar Coagulation Modes | | |
| Max. Power | 120 W (at 500Ω) | 100 W (at 500Ω) |
| Max. Voltage Output | 5800 | 9000 |
| Crest Factor | 4.4-8.7 | 7.0 |
| Wave Forms | Sinusoidal constant / modulated<br>Cut / Coag Pulse Phases | Sinusoidal constant / modulated |
| 4 Bipolar Modes | | |
| Max. Power | 240 W (at 100Ω) | 50 W (at 50Ω) |
| Max. Voltage Output | 900 | 280 |
| Crest Factor | 1.7-9 | 1.5-12.1 |
| Wave Forms | Sinusoidal constant / modulated<br>Pause Phases | Sinusoidal constant / modulated |

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## 7. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the 8070 and to show substantial equivalence to the predicate device (8070), Medrange completed successfully the following non-clinical performance tests:

| General Safety Testing | IEC 60601-1:2005+C1+C2+A1:2012 Medical electrical equipment, Part<br>1<br>General requirements for basic safety and essential performance |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EMC Safety Testing | IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment, Part<br>1-2<br>General requirements for basic safety and essential performance<br>Collateral Standard: Electromagnetic disturbances – Requirements and<br>tests |
| HF Safety Testing | IEC 60601-2-2:2017 Medical electrical equipment, Part 2-2<br>Particular requirements for the basic safety and essential performance of<br>high frequency - Surgical equipment and high frequency surgical<br>accessories |
| Performance Testing | Applicable parts of FDA Guidance Document “Premarket Notification<br>(510(k)) Submissions for Electrosurgical Devices for General Surgery”,<br>May 2016 |
| Usability Testing | IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part<br>1-6<br>General requirements for safety - Collateral Standard: Usability |

## 8. Statement of Substantial Equivalence

The 8070 has the same intended use as the 8010, and the same technological characteristics. The non-clinical test results, such as performance data, electrical safety and electromagnetic compatibility data have demonstrated the 8070 is as safe and effective as the predicate device. Therefore it is concluded, that the 8070 fulfills the requirements of a substantially equivalent device and that no new questions of safety and effectiveness were raised.