(101 days)
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.
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).
Here's a breakdown of the acceptance criteria and the study information for the ARC 400 Electrosurgical Unit, based on the provided document.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific clinical acceptance criteria in the way an AI/ML device might. Therefore, the "acceptance criteria" here are generally performance specifications that align with the predicate device and established standards.
1. Table of Acceptance Criteria and Reported Device Performance
Instead of specific numerical "acceptance criteria" for clinical performance, this device demonstrates substantial equivalence by matching or exceeding the technological characteristics and performance of its predicate device, the AUTOCON III 400. The "reported device performance" are the specifications of the ARC 400.
| Attribute | Acceptance Criteria (Predicate Device: AUTOCON III 400) | Reported Device Performance (Subject Device: ARC 400) |
|---|---|---|
| Mechanism of Action | Generates high-frequency current (350 kHz / 1 MHz) | Generates high-frequency current (350 kHz / 1 MHz) |
| System Voltage | 100 - 127 V | 100 - 127 V |
| Monopolar Cutting Modes | ||
| 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 |
| Wave Forms | Sinusoidal Constant, Sinusoidal Modulated, Sinusoidal Alternating, Cut/Coag/Pause Phases | Sinusoidal Constant, Sinusoidal Modulated, Sinusoidal Alternating, Cut/Coag/Pause Phases |
| Monopolar Coagulation Modes | ||
| 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 Modulated, Pulse Modulated | Sinusoidal Constant, Sinusoidal Modulated, Pulse Modulated |
| Bipolar Cutting Modes | ||
| 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 | ||
| 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, Pulse Modulated | Sinusoidal Constant, Pulse Modulated |
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical performance testing for an electrosurgical unit, not an AI/ML device. Therefore, the concept of a "test set" for clinical data or image data isn't directly applicable in the same way. The testing involves engineering and performance validations, such as:
- 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 Guidance Document "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" May 2016
- Usability testing: IEC 62366 / 5-114
The "sample size" would refer to the number of devices tested or the number of test runs conducted within these engineering and performance evaluations. The document does not specify these exact numbers.
Data provenance (country of origin, retrospective/prospective) is not applicable here as the tests are non-clinical engineering and performance tests, not clinical data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided and is not typically relevant for the type of non-clinical testing described for an electrosurgical unit. The "ground truth" for these tests is defined by established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not provided and is not typically relevant for the type of non-clinical testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating human reader performance, particularly with AI assistance, which is not applicable to this electrosurgical unit.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not Applicable. This is an electrosurgical unit, not an AI algorithm. Its performance is intrinsically "standalone" in the sense that it generates electrical current based on user settings, but it is not an algorithm that performs diagnostic or assistive tasks.
7. The Type of Ground Truth Used
The "ground truth" for the ARC 400 is based on established engineering standards, international and national recognized standards (e.g., IEC 60601 series), and the performance specifications of the legally marketed predicate device (AUTOCON III 400). The device is tested to ensure it meets these defined technical parameters.
8. The Sample Size for the Training Set
Not Applicable. This is an electrosurgical unit, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As explained above, this device does not utilize a training set in the context of AI/ML.
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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 (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) 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: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com 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.KG | KARL STORZ Endoscopy |
| Product Code | GEI | GEI |
| Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Mechanism of Action | The device generates highfrequency current350 kHz / 1 MHz | The device generates highfrequency current350 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 FDAGuidance Document"Premarket Notification (510(k))Submissions for ElectrosurgicalDevices for General Surgery"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.
§ 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.