(55 days)
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications. The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible. Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables.
The provided document describes a Special 510(k) for an updated electrosurgical unit (ESU), the ERBE ESU Model VIO dV with Accessories. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics for an AI algorithm.
Therefore, many of the requested elements regarding acceptance criteria for device performance, sample sizes for test and training sets, expert involvement, and ground truth establishment are not applicable to this type of device submission. The focus here is on design control, verification, and validation against recognized consensus standards, and demonstrating that the modifications do not raise new questions of safety or effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of a 510(k) for an ESU based on substantial equivalence. The submission focuses on demonstrating that the modified device's performance, as verified through design controls and testing to recognized consensus standards, is equivalent to the predicate device. Specific numerical "acceptance criteria" and "reported device performance" in terms of clinical accuracy metrics (like sensitivity, specificity, F1-score for AI) are not provided nor typically required for this type of medical device.
- The document states: "The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards"." This implies adherence to established engineering and safety standards relevant to ESUs, which serve as the "acceptance criteria" for the device's technical functionality and safety.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This information is relevant for studies involving data-driven algorithms (like AI/ML) where test sets are used to evaluate model performance on unseen data. This document describes a hardware device (electrosurgical unit), not a data-driven algorithm requiring a test set in that sense. Testing would involve engineering verification and validation on physical units to ensure compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the context of expert consensus is typically used for AI/ML performance evaluation. For an ESU, the "truth" is its ability to safely and effectively cut and coagulate tissue as specified by engineering standards, verified through testing, not through expert-labeled data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used in studies where multiple human readers or algorithms produce outputs that need to be resolved to establish a definitive ground truth. This is not relevant to the verification and validation of an ESU's hardware and software against engineering standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are used to evaluate the impact of AI assistance on human reader performance, typically in diagnostic imaging. This device is an electrosurgical unit, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to the performance of an AI algorithm independently. The device described is a medical instrument (ESU) that operates under human control, not an autonomous AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML context. For this device, the "ground truth" for verification and validation would be adherence to recognized consensus standards for electrical safety, electromagnetic compatibility, performance characteristics (e.g., power output, voltage curves for different modes), and functional specifications. This is established through objective measurements and compliance with regulatory standards.
8. The sample size for the training set
- Not applicable. This information is relevant for machine learning algorithms. The ESU is a hardware device with programmed functionalities, not a system that is "trained" on a dataset in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. As above, the concept of a "training set" and "ground truth" for it is not relevant to this ESU's design and approval process.
Summary of Device Acceptance / Study Information from the Document:
- Acceptance Criteria Basis: The primary "acceptance criteria" for this Special 510(k) submission are based on demonstrating substantial equivalence to the predicate device (ERBE ESU Model VIO 300 D) and compliance with FDA's "Recognized Consensus Standards."
- Study Proving Acceptance: The study conducted was a design control process involving:
- Design and development planning: (Page 3)
- Design input: (Page 3)
- Design review: (Page 3)
- Design verification/design output: (Page 3)
- Design validation: (Page 3)
- Design transfer: (Page 3)
- Design change control: (Page 3)
- Specific evidence of meeting acceptance criteria:
- "The ERBE ESU Model VIO dV with Accessories has been verified or validated in design control." (Page 3)
- "The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards"." (Page 3)
- The conclusion explicitly states: "The ERBE ESU Model VIO dV with Accessories has the same intended use, principles of operation and technological characteristics as the predicate device... The subject device has been verified or validated in design control. In conclusion, there are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices." (Page 3)
- Nature of Testing: The document indicates that animal or clinical performance testing was not considered necessary (Page 3), reinforcing that the acceptance was based on engineering verification, validation, and standard compliance, demonstrating equivalence to a lawfully marketed predicate device.
In essence, the "study" for this device was its robust design and development process, including verification and validation activities conducted according to established procedures and adherence to recognized consensus standards, which collectively demonstrated its safety and effectiveness as being substantially equivalent to the predicate device.
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ERBE USA Incorporated Special 510(k) for ERBE ESU Model VIO dV with Accessories
Page 1 of 3 October 2013
| Owner/Operator: | ERBE USA Incorporated2225 Northwest ParkwayMarietta, GA 30067 |
|---|---|
| Trade (Proprietary) Name: | ERBE ESU Model VIO dV with Accessories |
| Common Name: | Electrosurgical Unit (ESU/Generator) |
| Classification Name, Number, andProduct Code: | Electrosurgical, Cutting & Coagulation &Accessories; 21 CFR 878.4400; GEI |
| Legally Marketed Predicate Device: | ERBE ESU Model VIO 300 D with Accessories,510(k) Number K083452Note: VIO stands for Variable Cut andCoagulation. |
510(k) SUMMARY [As Required by 21 CFR 807.92(c)]
Description of the Device:
The ERBE ESU Model VIO dV with Accessories is an ElectroSurgical Unit that generates High Frequency (HF) electrical current to cut and/or coagulate tissue. It is a stand-alone generator. The ESU has five clearly defined Cutting and Coagulation Modes with different electrical waveforms and electrical parameters, which are programmed with defined Effect levels. Each Effect level corresponds to a specific voltage. The Modes provide the physician flexibility in interventional applications. Thus the Unit may be used for a broad array of surgical applications.
The ESU user interface consists primarily of a touchscreen surrounded by a small number of physical controls, such as a power switch and connection points for the instruments and accessories with which the generator is compatible.
Various hand instruments and neutral electrodes from ERBE and different manufacturers may be attached to and operated by the generator. The standard Accessories for the ESU consist of reusable Footswitches as well as Monopolar and Bipolar Cables
Intended Use:
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) current for the cutting and/or coagulation of tissue.
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ERBE USA Incorporated Special 510(k) for ERBE ESU Model VIO dV with Accessories
Page 2 of 3 October 2013
Summary of the Technological Characteristics:
Similarities between modified and predicate devices:
Unit
The ERBE ESU Model VIO dV has the same intended use, the same basic technology, protective circuits, and uses the same basic accessories as the predicate ESU (ERBE Model VIO 300 D). Also, the Modes available in the ERBE ESU Model VIO dV ESU [i.e. Auto Cut, Dry Cut, Swift Coag, Forced Coag, and Bipolar Soft Coag with and without Auto Stop] are the same in the predicate. Both generators have user interface displays to select modes, power settings, etc. and have the AutoStop function. Also, both units have audio and visual error monitoring.
The subject ESU and the predicate device both are manufactured by ERBE Elektromedizin GmbH in Germany and are supplied as non-sterile and are reusable. The packaging is also the same for both devices with similar labeling (e.g. Outer Package Label, User Manual, etc.).
Accessories:
The one pedal and two pedal footswitches are the same for both the subject and the predicate devices. The packaging is also the same with similar labeling.
Differences between modified and predicate devices:
The ERBE ESU Model VIO dV differs from the predicate ERBE ESU Model VIO 300 D as follows:
| Subject device | Predicate device |
|---|---|
| - the unit has a square shape(408 x 163 x 380 mm)with rounded front panel | - the unit is of 'cake slice' shape(425 x 211 x 462 mm)with square front panel |
| - the ESU has a 10" Touchscreen color monitor display | - it has 6" button and LED color monitor display |
| - it has 4 HF receptacles in the front panel(2 monopolar and 2 bipolar) withinstrument recognition on both themonopolar and bipolar receptacles. | - it has 3 HF receptacles in the front panel(monopolar, bipolar, multifunction) |
| - it has a receptacle for a CAN-bus for a remote controller | - it has no receptacle for a CAN-bus for a remote controller |
| - it has no receptacle for an APC unit | - it has a receptacle for an APC unit |
| - it has a firewall function | - it has no firewall function |
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Page 3 of 3
ERBE USA Incorporated Special 510(k) for ERBE ESU Model VIO dV with Accessories
October 2013
| - it has no programming capabilities- it ha a recall function- the modes that are present are theprincipal ones to perform essentialcutting and coagulating activities.Auto Cut, Dry Cut, Swift Coag, ForcedCoag., Soft Coag, Soft Coag withAutoStop,,No new modes are added. | - it has 99 program possibilities- it has no recall function- the predicate has a wide range of modessuch as Auto Cut, High Cut, Dry Cut, DryCut °, Precise Cut, Soft Coag, Soft Coagwith AutoStop, Swift Coag, Swift Coag °,Classic Coag, Forced Coag, SprayCoag, Precise Coag, Twin Coag, BipolarCut, Bipolar Cut +, Bipolar Precise Cut,Endo Cut Q, Endo Cut I, Bipolar SoftCoag +, Bipolar Forced Coag, BiClamp,Bipolar Precise Coag, Precise APC,Forced APC, Pulsed APC, Argon-assisted High Cut, Argon-assisted AUTOCut, Argon-assisted Dry Cut, Argon-assisted Dry Cut °, Argon-assisted SwiftCoag, Argon-assisted Swift Coag °,Argon-assisted Soft Coag, Argon-assisted Forced Coag and Argon-assisted Twin Coag (Note: Only some ofthese Modes are standard with thepredicate device.). |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
The ERBE ESU Model VIO dV with Accessories has been verified or validated in design control.
ERBE Elektromedizin GmbH, in accordance with established procedures, directs and controls design activities. These procedures involve design and development planning, design input, design review, design verification/design output, design validation, design transfer, as well as design change control. The activities provide the oversight and forum for project approval, formal management/design review, evaluation, and final project approval. This work is documented within design review and the approvals are documented as part of the current change control system.
The ERBE ESU Model VIO dV with Accessories was tested to FDA's "Recognized Consensus Standards". Animal or clinical performance testing was not considered necessarv.
Conclusion:
The ERBE ESU Model VIO dV with Accessories has the same intended use, principles of operation and technological characteristics as the predicate device in the previously cleared 510(k)s. The subject device has been verified or validated in design control. In conclusion, there are no issues with the subject device that would raise additional safety or efficacy issues, when compared to the predicate devices.
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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized emblem with three curved shapes, resembling a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ERBE USA Incorporated Mr. John Tartal Ouality Assurance/Regulatory Affairs Director 2225 Northwest Parkway Marietta, Georgia 30067
December 11, 2013
Re: K133180
Trade/Device Name: ERBE ESU Model VIO dV with Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 11, 2013 Received: November 12, 2013
Dear Mr. Tartal:
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 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 (reporting of medical . device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. John Tartal
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forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K133180 510(k) Number (if known):
Device Name: ERBE ESU Model VIO dV with Accessories
Indications For Use:
ﺍﻟﻤﺴﻴﺴﻴﺔ ﺍﻟﺘﺤﺘﻮﻱ ﺍﻟﻤﻮﺗﻮﻓﻴﺎ
The ERBE ESU Model VIO dV with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Prescription Use 2 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/5/Figure/10 description: The image shows a document sign-off for the Division of Surgical Devices. The 510(k) number is K133180. The document is signed by Long H. Chen-A on December 10, 2013. The document is for BSA.
001_4 Indications for Use Statement
004 - 1
§ 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.