(54 days)
The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations.
The AUTOCON III 400 is an electrosurgical unit (ESU) that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. AUTOCON III 400 offers a total of 37 different modes that can be divided into 4 main categories: Monopolar cutting (13 modes), monopolar coagulation (11 modes), bipolar cutting (4 modes), and bipolar coagulation (9 modes). The various modes in each category represent different settings that provide controlled cutting and coagulation. Each mode can be defined by the waveform type, power, crest factor, and duty cycle which correspond to different tissue effects. AUTOCON III 400 consists of a generator, a foot switch, and a power cord. A touchscreen user interface displays the connection status of accessories and peripherals and allows the user to select modes, power settings, effect, and various other settings. AUTOCON III 400 has a bipolar socket, a monopolar socket, and neutral electrode socket for the instruments and accessories with which the generator is compatible. Contact quality indicators are displayed to indicate if the neutral electrodes are correctly connected or not.
The KARL STORZ Endoscopy-America, Inc. AUTOCON III 400 is an electrosurgical generator designed for monopolar and bipolar cutting and coagulation of tissue during surgical operations. The submission focuses on non-clinical performance data to demonstrate substantial equivalence to its predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format for direct comparison of numerical thresholds. Instead, it details the type of non-clinical tests performed and concludes that the device performed comparably to its predicate devices. The study aimed to demonstrate substantial equivalence, meaning the AUTOCON III 400 performs as safely and effectively as the predicate devices. The reported performance is an affirmation of compliance with recognized standards and comparable results in bench testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | In compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Electromagnetic Compatibility (EMC) | In compliance with IEC 60601-1-2. |
| Performance Testing (Bench Top) | Comparative verification testing performed per FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued on August 15, 2016." |
| ESU Technical Specifications | Output Waveform at the rated load was tested. |
| ESU Power Output | Power Output at maximum and half-of-maximum intensity over the range of expected loads was tested. |
| Miscellaneous Components/Accessories | Functional testing of accessories was conducted. |
| System Testing | Thermal Effects on Tissue (liver, kidney, muscle) were observed. Contact Quality Monitoring (CQM) was tested. Testing confirmed that comparable tissue effects and electrical waveforms could be achieved for all modes of operation. |
| Conclusion of Equivalence | The non-clinical tests demonstrated that the subject device is as safe as and as effective as the predicate devices. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench-top testing and does not specify a numerical sample size for the "test set" in terms of patient data or clinical cases. The testing was focused on the device itself and its interaction with proxy materials (e.g., tissue samples like liver, kidney, muscle).
- Data Provenance: The data is based on non-clinical, bench-top testing performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. The document does not specify the country of origin of the data beyond the manufacturer's location in El Segundo, CA, USA, and the regulatory body (FDA) in the USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This was a non-clinical, bench-top study evaluating the technical performance and safety of an electrosurgical unit against regulatory standards and predicate devices, not a study requiring expert clinical ground truth on patient outcomes or diagnoses.
4. Adjudication Method for the Test Set:
Not applicable. Since there was no clinical data or assessment by human readers/experts for a diagnostic or treatment outcome, no adjudication method was used. The evaluation was based on objective measurements and comparison to recognized standards and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The AUTOCON III 400 is an electrosurgical generator, and its evaluation focused on electrical safety, electromagnetic compatibility, and bench-top performance, not on interpretation by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was performed in the sense that the device's performance was evaluated based on its technical specifications and physical effects, without direct human intervention in the "performance" during the tests outside of operating the device for the bench tests. The tests assessed the device's output, waveform, power, and thermal effects on tissue, which are intrinsic properties of the algorithm/hardware. This was a "device-only" performance assessment in a controlled bench setting.
7. Type of Ground Truth Used:
The "ground truth" for this study was established through:
- Compliance with recognized electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2).
- Comparison to the performance of legally marketed predicate devices (AUTOCON II 400 and ERBE VIO 300D) as defined by the FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery."
- Objective measurements of technical specifications (e.g., output waveform, power output, thermal effects on tissue) to demonstrate "comparable tissue effects and electrical waveforms" to the predicate devices.
8. Sample Size for the Training Set:
Not applicable. This device is an electrosurgical generator, not an AI/ML-based device that typically requires a training set of data. The "design" and "settings" of the device are based on engineering principles and intended surgical effects, not on learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set was used for this type of medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2017
KARL STORZ Endoscopy-America, Inc. % Dawn Tibodeau Third Party 510(k) Project Coordinator TÜV SÜD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
Re: K171717
Trade/Device Name: Autocon III 400 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 26, 2017 Received: July 31, 2017
Dear Dawn Tibodeau:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
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For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) Not yet assigned K171717
Device Name AUTOCON III 400
Indications for Use (Describe)
The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
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KARL STORZ Premarket Notification AUTOCON III 400 007_510(k) Summary
7. 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy-America, Inc. |
|---|---|
| 2151 E. Grand AvenueEI Segundo, CA 90245 | |
| Contact: | AnnaLisa SmullinRegulatory EngineerPhone: (424) 218-8376Fax: (424) 218-8519 |
| Date ofPreparation: | March 5, 2017 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: AUTOCON III 400Classification Name: Electrosurgical Generator |
| RegulatoryClass: | II |
| Product Code: | GEI |
| Regulation: | 21 CFR part 878.4400 (Electrosurgical cutting and coagulation device andaccessories) |
| PredicateDevice(s): | Primary Predicate Device: AUTOCON II 400 (K062464)Second Predicate Device: ERBE VIO 300D (K060484)These predicate devices have not been subject to a design-related recall. |
| DeviceDescription: | The AUTOCON III 400 is an electrosurgical unit (ESU) that generatesHigh Frequency (HF) electrical current to cut and/or coagulate tissue.AUTOCON III 400 offers a total of 37 different modes that can be dividedinto 4 main categories: Monopolar cutting (13 modes), monopolarcoagulation (11 modes), bipolar cutting (4 modes), and bipolarcoagulation (9 modes). The various modes in each category representdifferent settings that provide controlled cutting and coagulation. Eachmode can be defined by the waveform type, power, crest factor, and dutycycle which correspond to different tissue effects. |
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Image /page/4/Picture/2 description: The image shows the logo for Karl Storz Endoskope. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The letter "O" in the word "STORZ" is stylized as a circle with a smaller circle inside.
KARL STORZ Premarket Notification AUTOCON III 400 007_510(k) Summary
| AUTOCON III 400 consists of a generator, a foot switch, and a power cord. A touchscreen user interface displays the connection status of accessories and peripherals and allows the user to select modes, power settings, effect, and various other settings. AUTOCON III 400 has a bipolar socket, a monopolar socket, and neutral electrode socket for the instruments and accessories with which the generator is compatible. Contact quality indicators are displayed to indicate if the neutral electrodes are correctly connected or not. | |||||
|---|---|---|---|---|---|
| Intended Use: | The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation. | ||||
| Indications For Use: | The AUTOCON III 400 is intended for use by qualified surgeons to provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations. | ||||
| Technological Characteristics: | The subject and predicate devices are electrosurgical generators used to cut and coagulate tissue. The technological differences between the systems are described in the table below. | ||||
| AUTOCON III 400(Proposed) | AUTOCON II 400(K062464) | ERBE VIO 300D(K060484) | |||
| Manufacturer | KARL STORZEndoscopy | KARL STORZEndoscopy | ERBE USA, Inc. | ||
| Product Code | GEI | GEI | GEI | ||
| Energy | Monopolar, Bipolar | Monopolar, Bipolar | Monopolar, Bipolar | ||
| NeutralElectrode | Compatible FDAcleared Single orSplit Electrodes | Compatible FDAcleared Single orSplit Electrodes | Compatible FDAcleared Single orSplit Electrodes | ||
| ElectrodeMonitoringSystem | Yes | Yes | Yes | ||
| System Voltage | 100-127 V | 100-127 V | 100-120 V | ||
| Connection toKARL STORZOR 1TM | Yes | Yes | No | ||
| Monopolar Cut Modes | |||||
| # of Modes | 13 | 6 | 7 | ||
| Max Power | 400W (at 200Ω) | 300W (at 500Ω) | 300W (at 500Ω) | ||
| OutputFrequency | 350kHz | 350kHz | 350kHz | ||
| Max VoltageOutput | 1600Vp | 1450Vp | 1550Vp | ||
| Crest Factor | 1.5, 3.5 | 1.4-3.8 | 1.4 | ||
| Wave Forms | -Sinusoidal Constant | -Sinusoidal Constant | -Sinusoidal Constant | ||
| -SinusoidalModulated | -SinusoidalModulated | -SinusoidalModulated | |||
| -SinusoidalAlternating | -SinusoidalAlternating | -SinusoidalAlternating | |||
| Cut/Coag/PausePhases | Cut/Coag/PausePhases | Cut/Coag/PausePhases | |||
| Monopolar Coagulation Modes | |||||
| # of Modes | 11 | 3 | 8 | ||
| Max Power | 250W (at 500Ω) | 200W (at 500Ω) | 200W (at 500Ω) | ||
| OutputFrequency | 350kHz | 350kHz | 350kHz | ||
| Max VoltageOutput | 5000Vp | 4300Vp | 4300Vp | ||
| Crest Factor | 1.6-7.4 | 1.4-7.4 | 3.7-5.3 | ||
| Wave Forms | -Sinusoidal Constant-SinusoidalModulated-Pulse Modulated | -Sinusoidal Constant-SinusoidalModulated-Pulse Modulated | -Sinusoidal Constant-SinusoidalModulated-Pulse Modulated | ||
| Bipolar Cut Modes | |||||
| # of Modes | 4 | 4 | 3 | ||
| Max Power | 400W (at 75Ω) | 370W (at 500Ω) | 370W (at 500Ω) | ||
| OutputFrequency | 350kHz | 350kHz | 350kHz | ||
| Max VoltageOutput | 500Vp | 740Vp | 770Vp | ||
| Crest Factor | 1.5-1.6 | 1.4 | 1.4 | ||
| Wave Forms | -Sinusoidal Constant | -Sinusoidal Constant | -Sinusoidal Constant | ||
| Bipolar Coagulation Modes | |||||
| # of Modes | 9 | 5 | 5 | ||
| Max Power | 350W (at 25Ω) | 200W (at 50Ω) | 200W (at 50Ω) | ||
| OutputFrequency | 350kHz | 350kHz | 350kHz | ||
| Max VoltageOutput | 550Vp | 190Vp | 560Vp | ||
| Crest Factor | 1.5-3.8 | 1.4 | 1.4-3.8 | ||
| Wave Forms | -Sinusoidal Constant-Pulse Modulated | -Sinusoidal Constant-Pulse Modulated | -Sinusoidal Constant-Pulse Modulated | ||
| Non-ClinicalPerformanceData: | Electrical Safety and Electromagnetic Compatibility (EMC) Summary | ||||
| The electrical safety and EMC data submitted for AUTOCON III 400 is incompliance with the following FDA recognized standards: | |||||
| • IEC 60601-1 | |||||
| • IEC 60601-1-2 | |||||
| • IEC 60601-2-2 | |||||
| Performance Testing – Bench Top Summary | |||||
| Comparative verification testing has been performed per FDA GuidancePremarket Notification (510(k)) Submissions for Electrosurgical Devices | |||||
| for General Surgery issued on August 15, 2016 for each major componentand for the system. | |||||
| • Electrosurgical Unit (ESU) | |||||
| o Technical Specifications |
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KARL STORZ Premarket Notification AUTOCON III 400 007_510(k) Summary
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KARL STORZ Premarket Notification AUTOCON III 400 007_510(k) Summary
| o Output Waveform at the rated loado Power Output at maximum and half-of-maximum intensityover the range of expected loads | |
|---|---|
| • | Miscellaneous Components/Accessorieso Functional testing of accessories |
| • | System Testingo Thermal Effects on Tissue (liver, kidney, muscle)o Contact Quality Monitoring (CQM)Testing confirmed that comparable tissue effects and electrical waveformscould be achieved for all modes of operation. |
| ClinicalPerformanceData: | Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wasdeemed sufficient to assess safety and effectiveness and establishsubstantial equivalence. |
| Conclusion: | The conclusions drawn from the non-clinical tests such as the bench topperformance data, the software data, the electrical safety data, and theelectromagnetic compatibility data demonstrated that the subject device isas safe as and as effective as the predicate devices. As such, we concludedthat the substantial equivalence of the subject and the predicate deviceshas been met and the differences between the subject and the predicatedevices do not raise new questions of safety and effectiveness. |
§ 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.