(54 days)
Not Found
No
The description focuses on the electrosurgical unit's modes, power settings, and electrical characteristics, with no mention of AI or ML. The performance studies are based on electrical safety, EMC, and bench testing of tissue effects and waveforms, not on data-driven algorithms.
Yes
The device delivers high-frequency electrical current for cutting and coagulation of tissue structures during surgery, which is a therapeutic action.
No
The device is an electrosurgical unit used for cutting and coagulating tissue during surgery, not for diagnosing conditions.
No
The device description explicitly states it consists of a generator, a foot switch, and a power cord, which are hardware components. It is an electrosurgical unit that generates high-frequency electrical current.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide a high frequency electrical current for monopolar and bipolar cutting and coagulation of tissue structures during surgical operations." This describes a device used on the patient during surgery, not a device used to test samples from the patient in a laboratory setting.
- Device Description: The description details an electrosurgical unit (ESU) that generates electrical current for cutting and coagulation. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the AUTOCON III 400 is a surgical device used for electrosurgery, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissue structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
- Electrical Safety and Electromagnetic Compatibility (EMC) Summary: The electrical safety and EMC data submitted for AUTOCON III 400 is in compliance 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 Guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery issued on August 15, 2016 for each major component and for the system.
- Electrosurgical Unit (ESU):
- Technical Specifications
- Output Waveform at the rated load
- Power Output at maximum and half-of-maximum intensity over the range of expected loads
- Miscellaneous Components/Accessories:
- Functional testing of accessories
- System Testing:
- Thermal Effects on Tissue (liver, kidney, muscle)
- Contact Quality Monitoring (CQM)
- Key results: Testing confirmed that comparable tissue effects and electrical waveforms could be achieved for all modes of operation.
- Electrosurgical Unit (ESU):
Clinical Performance Data:
Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was deemed sufficient to assess safety and effectiveness and establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AUTOCON II 400 (K062464), ERBE VIO 300D (K060484)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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1
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
2
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."
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."
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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 Avenue | |
| EI Segundo, CA 90245 | |
| Contact: | AnnaLisa Smullin |
| Regulatory Engineer | |
| Phone: (424) 218-8376 | |
| Fax: (424) 218-8519 | |
| Date of | |
| Preparation: | March 5, 2017 |
| Type of 510(k) | |
| Submission: | Traditional |
| Device | |
| Identification: | Trade Name: AUTOCON III 400 |
| Classification Name: Electrosurgical Generator | |
| Regulatory | |
| Class: | II |
| Product Code: | GEI |
| Regulation: | 21 CFR part 878.4400 (Electrosurgical cutting and coagulation device and |
| accessories) | |
| Predicate | |
| Device(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. | |
| Device | |
| Description: | 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. |
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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 STORZ | ||||
| Endoscopy | KARL STORZ | ||||
| Endoscopy | ERBE USA, Inc. | ||||
| Product Code | GEI | GEI | GEI | ||
| Energy | Monopolar, Bipolar | Monopolar, Bipolar | Monopolar, Bipolar | ||
| Neutral | |||||
| Electrode | Compatible FDA | ||||
| cleared Single or | |||||
| Split Electrodes | Compatible FDA | ||||
| cleared Single or | |||||
| Split Electrodes | Compatible FDA | ||||
| cleared Single or | |||||
| Split Electrodes | |||||
| Electrode | |||||
| Monitoring | |||||
| System | Yes | Yes | Yes | ||
| System Voltage | 100-127 V | 100-127 V | 100-120 V | ||
| Connection to | |||||
| KARL STORZ | |||||
| OR 1TM | Yes | Yes | No | ||
| Monopolar Cut Modes | |||||
| # of Modes | 13 | 6 | 7 | ||
| Max Power | 400W (at 200Ω) | 300W (at 500Ω) | 300W (at 500Ω) | ||
| Output | |||||
| Frequency | 350kHz | 350kHz | 350kHz | ||
| Max Voltage | |||||
| Output | 1600Vp | 1450Vp | 1550Vp | ||
| Crest Factor | 1.5, 3.5 | 1.4-3.8 | 1.4 | ||
| Wave Forms | -Sinusoidal Constant | -Sinusoidal Constant | -Sinusoidal Constant | ||
| -Sinusoidal | |||||
| Modulated | -Sinusoidal | ||||
| Modulated | -Sinusoidal | ||||
| Modulated | |||||
| -Sinusoidal | |||||
| Alternating | -Sinusoidal | ||||
| Alternating | -Sinusoidal | ||||
| Alternating | |||||
| Cut/Coag/Pause | |||||
| Phases | Cut/Coag/Pause | ||||
| Phases | Cut/Coag/Pause | ||||
| Phases | |||||
| Monopolar Coagulation Modes | |||||
| # of Modes | 11 | 3 | 8 | ||
| Max Power | 250W (at 500Ω) | 200W (at 500Ω) | 200W (at 500Ω) | ||
| Output | |||||
| Frequency | 350kHz | 350kHz | 350kHz | ||
| Max Voltage | |||||
| Output | 5000Vp | 4300Vp | 4300Vp | ||
| Crest Factor | 1.6-7.4 | 1.4-7.4 | 3.7-5.3 | ||
| Wave Forms | -Sinusoidal Constant | ||||
| -Sinusoidal | |||||
| Modulated | |||||
| -Pulse Modulated | -Sinusoidal Constant | ||||
| -Sinusoidal | |||||
| Modulated | |||||
| -Pulse Modulated | -Sinusoidal Constant | ||||
| -Sinusoidal | |||||
| Modulated | |||||
| -Pulse Modulated | |||||
| Bipolar Cut Modes | |||||
| # of Modes | 4 | 4 | 3 | ||
| Max Power | 400W (at 75Ω) | 370W (at 500Ω) | 370W (at 500Ω) | ||
| Output | |||||
| Frequency | 350kHz | 350kHz | 350kHz | ||
| Max Voltage | |||||
| Output | 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) | ||
| Output | |||||
| Frequency | 350kHz | 350kHz | 350kHz | ||
| Max Voltage | |||||
| Output | 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-Clinical | |||||
| Performance | |||||
| Data: | Electrical Safety and Electromagnetic Compatibility (EMC) Summary | ||||
| The electrical safety and EMC data submitted for AUTOCON III 400 is in | |||||
| compliance 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 Guidance | |||||
| Premarket Notification (510(k)) Submissions for Electrosurgical Devices | |||||
| for General Surgery issued on August 15, 2016 for each major component | |||||
| and for the system. | |||||
| • Electrosurgical Unit (ESU) | |||||
| o Technical Specifications |
5
Image /page/5/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 phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
KARL STORZ Premarket Notification AUTOCON III 400 007_510(k) Summary
6
Image /page/6/Picture/2 description: The image shows the logo for STORZ. The logo consists of the word "STORZ" in large, bold letters, with a circle in place of the letter "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is black and white.
KARL STORZ Premarket Notification AUTOCON III 400 007_510(k) Summary
| | o Output Waveform at the rated load
o Power Output at maximum and half-of-maximum intensity
over the range of expected loads |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • | Miscellaneous Components/Accessories
o Functional testing of accessories |
| • | System Testing
o Thermal Effects on Tissue (liver, kidney, muscle)
o Contact Quality Monitoring (CQM)
Testing confirmed that comparable tissue effects and electrical waveforms
could be achieved for all modes of operation. |
| Clinical
Performance
Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate devices. Non-clinical bench testing was
deemed sufficient to assess safety and effectiveness and establish
substantial equivalence. |
| Conclusion: | The conclusions drawn from the non-clinical tests such as the bench top
performance data, the software data, the electrical safety data, and the
electromagnetic compatibility data demonstrated that the subject device is
as safe as and as effective as the predicate devices. As such, we concluded
that the substantial equivalence of the subject and the predicate devices
has been met and the differences between the subject and the predicate
devices do not raise new questions of safety and effectiveness. |