ARC 400

K193591 · Bowa-Electronics GmbH & Co. KG · GEI · Apr 2, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193591
• Device Name: ARC 400
• Applicant: Bowa-Electronics GmbH & Co. KG
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 2, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.

Device Story

ARC 400 is an electrosurgical unit generating high-frequency (HF) electrical current (350 kHz / 1 MHz) for cutting and coagulating human tissue. Operated by surgeons in clinical settings, it functions with compatible monopolar or bipolar instruments and a neutral electrode. The device features 34 operational modes across four categories: monopolar cutting, monopolar coagulation, bipolar cutting, and bipolar coagulation. It transforms electrical input into controlled HF output, allowing precise tissue management to control bleeding or remove tissue. Healthcare providers select modes via the device interface to achieve desired surgical effects. The device benefits patients by providing versatile, controlled energy delivery for various surgical procedures.

Clinical Evidence

Bench testing only. Performance demonstrated through electrical safety testing (ES 60601-1), electromagnetic compatibility (IEC 60601-1-2), and adherence to IEC 60601-2-2 for high-frequency surgical equipment. Usability testing conducted per IEC 62366. Results confirm design inputs and performance specifications are met, supporting substantial equivalence to the predicate.

Technological Characteristics

Electrosurgical unit; 350 kHz / 1 MHz output frequency; 100-127 V system voltage. 34 modes: monopolar/bipolar cutting and coagulation. Max power 400W (monopolar/bipolar cut), 350W (bipolar coag), 250W (monopolar coag). Waveforms: sinusoidal constant, sinusoidal modulated, sinusoidal alternating, pulse modulated. Standards: ES 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62366.

Indications for Use

Indicated for surgical patients requiring monopolar or bipolar tissue cutting and coagulation.

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

• AUTOCON III 400 (K171717)

Reference Devices

• K953509
• K982743
• K173877

Submission Summary (Full Text)

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April 2, 2020

BOWA-electronics GmbH & Co. KG % Roxana CERNESCU Consultant QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K193591

Trade/Device Name: ARC 400 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 20, 2019 Received: April 2, 2020

Dear Roxana CERNESCU:

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 ([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) K193591

Device Name ARC 400 Electrosurgical Unit

Indications for Use (Describe)

The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.

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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# 510(k) Summary

# ARC 400 Electrosurgical Unit

# 1. Submission Sponsor

BOWA-electronic GmbH & Co. KG Heinrich-Hertz-Strasse 4 - 10 Gomaringen 72810 GERMANY Contact: Wolf-Ruediger FRITZ Title: Head of Quality Management / Regulatory Affairs Director

## 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail] Contact: Roxana CERNESCU Title: Senior Consultant QA/RA

# 3. Date Prepared

February 6, 2020

# 4. Device Identification

| Proprietary Name: | ARC 400 |
|-----------------------|----------------------------------------------------------------|
| Part Number: | 900-400 |
| Common/Usual Name: | Electrosurgical Device |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI |
| Class: | 2 |
| Classification Panel: | General & Plastic Surgery |

#### 5. Legally Marketed Predicate Device(s)

| Device name: | AUTOCON III 400 |
|----------------|------------------------|
| 510(k) number: | K171717 |
| Manufacturer: | KARL STORZ SE & Co. KG |

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## 6. Indication for Use Statement

The High Frequency (HF) device is intended exclusively for the generation of electrical power for monopolar and bipolar cutting and coagulation of tissue structures in surgical operations.

## 7. Device Description

The ARC 400 (REF: 900-400) is an electrosurgical device. It generates high frequency (HF) electrical current for the purpose of cutting (e.g. removing tissue) or coagulating (e.g. control bleeding) human tissue. It is used with compatible bipolar instruments (e.g. K953509) or with monopolar instruments (e.g. K982743) in combination with a neutral electrode (e.g. K173877).

The ARC 400 offers 34 modes that represent four main categories: monopolar cutting (12 modes), monopolar coagulation (9 modes), bipolar cutting (4 modes) and bipolar coagulation (9 modes).

#### 8. Substantial Equivalence Discussion

The following table compares the ARC 400 to the AUTOCON III 400 with respect to technological characteristics, principles of operation and performance. This forms the basis for the determination of substantial equivalence to the predicate device.

| Attribute | Subject Device | Predicate Device |
|---------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| | ARC 400 | AUTOCON III 400 |
| 510(k) Number | K193591 | K171717 |
| Manufacturer | BOWA-electronic GmbH & Co.<br>KG | KARL STORZ Endoscopy |
| 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>350 kHz / 1 MHz | The device generates high<br>frequency current<br>350 kHz / 1 MHz |
| System voltage | 100 - 127 V | 100 - 127 V |
| Monopolar Cutting Modes (12) | | |
| Max. Power | 400 W (at 200 Ω) | 400 W (at 200 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 1600 Vp | 1600 Vp |
| Crest Factor | 1.5, 3.5 | 1.5, 3.5 |
| Attribute | Subject Device | Predicate Device |
| | ARC 400 | AUTOCON III 400 |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant |
| | Sinusoidal Modulated | Sinusoidal Modulated |
| | Sinusoidal Alternating | Sinusoidal Alternating |
| | Cut/Coag/Pause Phases | Cut/Coag/Pause Phases |
| Monopolar Coagulation Modes (9) | | |
| Max. Power | 250W (at 500 Ω) | 250W (at 500 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 5000 Vp | 5000 Vp |
| Crest Factor | 1.6 - 7.4 | 1.6 - 7.4 |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant |
| | Sinusoidal Modulated | Sinusoidal Modulated |
| | Pulse Modulated | Pulse Modulated |
| Bipolar Cutting Modes (4) | | |
| Max. Power | 400 W (at 75 Ω) | 400 W (at 75 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 500 Vp | 500 Vp |
| Crest Factor | 1.5 – 1.6 | 1.5 - 1.6 |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant |
| Bipolar Coagulation Modes (9) | | |
| Max. Power | 350 W (at 25 Ω) | 350 W (at 25 Ω) |
| Output Frequency | 350 kHz | 350 kHz |
| Max. Voltage Output | 550 Vp | 550 Vp |
| Crest Factor | 1.5 – 3.8 | 1.5 - 3.8 |
| Wave Forms | Sinusoidal Constant | Sinusoidal Constant |
| | Pulse Modulated | Pulse Modulated |

## Table 5A - Comparison of Characteristics

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# 9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the ARC 400 and to show substantial equivalence to the predicate device (AUTOCON III 400), BOWA completed successfully the following non-clinical performance tests:

| Electrical safety testing | ES 60601-1 / 19-4 |
|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic Compatibility testing | IEC 60601-1-2 / 19-8 |
| Particular requirements for the basic safety and essential performance of high frequency surgical equipment | IEC 60601-2-2 / 6-389 |
| Performance testing | Applicable parts of FDA<br>Guidance Document<br>"Premarket Notification (510(k))<br>Submissions for Electrosurgical<br>Devices for General Surgery"<br>May 2016 |
| Usability testing | IEC 62366 / 5-114 |

The results confirm that the design inputs and performance specifications for the ARC 400 are met. The device passed the testing in accordance with FDA and international recognized standards, national standards, and internal requirements as shown above, supporting its safety and its substantial equivalence to the AUTOCON III 400.

# 10. Statement of Substantial Equivalence

The ARC 400 has the same intended use as the AUTOCON III 400, and the same technological characteristics. The non-clinical test results, such as performance data, electrical safety and electromagnetic compatibility data have demonstrated the ARC 400 is as safe and effective as the predicate device. Therefore it is concluded, that the ARC 400 fulfills the requirements of a substantially equivalent device and that no new questions of safety and effectiveness were raised.