(51 days)
No
The summary describes a standard electrosurgical unit and does not mention any AI or ML capabilities.
No.
The device is used for cutting and/or coagulating tissue, which are surgical procedures, not therapeutic ones.
No
The device's intended use is to deliver high-frequency electrical current for cutting and coagulation of tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is an "electrosurgical unit" which is a hardware device that delivers electrical current. The accessories are also hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and/or coagulation of tissue." This is a direct surgical intervention on living tissue, not a test performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description reinforces this by stating it delivers electrical current "to cut and/or coagulate tissue via various universal instruments."
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
This device is an electrosurgical unit, which is a type of surgical instrument used directly on a patient's body.
N/A
Intended Use / Indications for Use
The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Product codes
GEI
Device Description
The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.).
ESU Model VIO 3
The ESU is a standalone Unit that can be mounted/secured to a cart or on a ceiling mount (Note: An A/C power cord is provided with the device.). It can integrate a compatible Erbe argon plasma coagulator as well as be used in conjunction with other equipment. The Generator has a touch-screen monitor (i.e., an interactive display) that provides the user with an onscreen tutorial as well as settings and operational information. The ESU has automatic start and stop features. Also, when activated, the device has an audio and visual error system (i.e., malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered). The Unit has clearly defined cutting and coagulation modes based on various electrical waveforms and electrical parameters. Thermal effects on tissue can be different depending on the voltage, current, and the contact between electrode and tissue. With the available modes, the ESU provides physicians the flexibility in interventional applications. Finally, each mode has effect levels which can be finely adjusted by the physician in order to achieve the desired tissue effect.
Note: VIO stands for Variable Cut and Coagulation.
Accessories
Footswitches
Various types of single and double pedal Footswitches have been designed for the ESU Model VIO 3. Specifically, the Footswitches are used to activate the Generator. Some of the Footswitches have a ReMode button so that the physician can toggle between preset programs. Also, some Footswitches are equipped with a divider and/or bracket (i.e., a bar) so that the operator can, as desired, have better foot control.
Connecting Cables
Monopolar and Bipolar Cables are standard in the industry. They provide HF output from the Generator to associated instruments.
Fastening Sets
The Sets include connecting cables and hardware to attach the ESU to a Cart or Ceiling Mount.
VIO Cart
The Cart provides mobility for the ESU and associated Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Performance Evaluations/Testing
- Output/Mode Comparison
- Tissue Testing
- Contact Quality Monitoring (CQM)
- Capacitive Coupling (per Standard Number 60601-2-2)
- Accessory Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 22, 2019
Erbe Elektromedizin GmbH % Mr. Mark Job Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K190823
Trade/Device Name: Erbe ESU Model VIO 3 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: May 10, 2019 Received: May 9, 2019
Dear Mr. Job:
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.
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Jennifer R. Stevenson Acting Division 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
2
Indications for Use
510(k) Number (if known) K190823
Device Name Erbe's ESU Model VIO® 3 with Accessories
Indications for Use (Describe)
The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
| 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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3
510(k) SUMMARY [AS REQUIRED BY 21 CFR 807.92(C)]
| Submitted By: | Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
72072 Tuebingen
Germany
Tel: 0049-7071-755-0
Fax: 0049-7071-755-179 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Julia Weller
Specialist Regulatory Affairs |
| Date Prepared: | February 13, 2019 |
| Trade/Proprietary Name: | Erbe ESU Model VIO® 3 with Accessories |
| Common Name: | Electrosurgical Unit |
| Classification Name and Code: | Electrosurgical Cutting and Coagulation Device and
Accessories (21 CFR Part 878.4400) |
| Product Code: | GEI |
| Legally Marketed
Predicate Device: | Erbe ESU Model VIO® 300 D with Accessories, 510(k)
Number K083452 |
Device Description:
The Erbe ESU Model VIO® 3 with Accessories is an electrosurgical unit for the delivery of high frequency (HF) electrical current to cut and/or coagulate tissue via various universal instruments (e.g., electrodes, etc.).
ESU Model VIO 3
The ESU is a standalone Unit that can be mounted/secured to a cart or on a ceiling mount (Note: An A/C power cord is provided with the device.). It can integrate a compatible Erbe argon plasma coagulator as well as be used in conjunction with other equipment. The Generator has a touch-screen monitor (i.e., an interactive display) that provides the user with an onscreen tutorial as well as settings and operational information. The ESU has automatic start and stop features. Also, when activated, the device has an audio and visual error system (i.e., malfunctions or user errors are detected with medical personnel being alerted visually and/or by sound with, in some cases, no energy being delivered). The Unit has clearly defined cutting and coagulation modes based on various electrical waveforms and electrical parameters. Thermal effects on tissue can be different depending on the voltage, current, and the contact between electrode and tissue. With the available modes, the ESU provides physicians the flexibility in interventional applications. Finally, each mode has effect levels which can be finely adjusted by the physician in order to achieve the desired tissue effect.
Note: VIO stands for Variable Cut and Coagulation.
4
Accessories
Footswitches
Various types of single and double pedal Footswitches have been designed for the ESU Model VIO 3. Specifically, the Footswitches are used to activate the Generator. Some of the Footswitches have a ReMode button so that the physician can toggle between preset programs. Also, some Footswitches are equipped with a divider and/or bracket (i.e., a bar) so that the operator can, as desired, have better foot control.
Connecting Cables
Monopolar and Bipolar Cables are standard in the industry. They provide HF output from the Generator to associated instruments.
Fastening Sets
The Sets include connecting cables and hardware to attach the ESU to a Cart or Ceiling Mount.
- VIO Cart
The Cart provides mobility for the ESU and associated Accessories.
Indications for Use:
The Erbe Electrosurgical Unit (ESU/Generator) Model VIO® 3 with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):
| Characteristics | Current Predicate:
Erbe ESU Model VIO 300 D
with Accessories | Proposed:
Erbe ESU Model VIO 3 with
Accessories | Discussion |
|------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Erbe Elektromedizin GmbH
(Germany) | Erbe Elektromedizin GmbH
(Germany) | Same |
| 510(k) Number | K083452 | N/A | N/A |
| Trade/
Proprietary
Name | ERBE ESU Model VIO® 300
D with Accessories | Erbe ESU Model VIO® 3
with Accessories | New name |
| Indications for
Use | The ERBE ESU Model VIO
300 D with Accessories is
intended to deliver High
Frequency (HF) electrical
current for the cutting and/or
coagulation of tissue. | The Erbe Electrosurgical
Unit (ESU/Generator) Model
VIO® 3 with Accessories is
intended to deliver High
Frequency (HF) electrical
current for the cutting and/or
coagulation of tissue. | Same |
| Prescription or
OTC | Prescription | Prescription | Same |
| Frequency | 350 kHz | 350 kHz | Same |
| Maximum
Output Power | 370 Watts | 400 Watts | Slightly greater
maximum
output power
possible. |
| WiFi Feature | N/A | Available
(deactivated by default, for
service purposes only) | New feature. |
| Characteristics | Current Predicate:
Erbe ESU Model VIO 300 D
with Accessories | Proposed:
Erbe ESU Model VIO 3 with
Accessories | Discussion |
| Output
Modules /
Receptacles | · monopolar receptacle
· bipolar receptacles
· receptacle for neutral
electrodes | · monopolar receptacle
· bipolar receptacles
· universal receptacle
· receptacle for neutral
electrodes | Additional type
of receptacle
(universal
receptacle). |
| Modes | · Monopolar Cutting and
Coagulation Modes
· Bipolar Cutting and
Coagulation Modes
If connected to a compatible
Argon Plasma Coagulator:
· APC Modes
· argon-assisted Cutting and
Coagulation Modes | · Monopolar Cutting and
Coagulation Modes
· Bipolar Cutting and
Coagulation Modes
If connected to a compatible
Argon Plasma Coagulator:
· APC Modes
· argon-assisted Cutting and
Coagulation Modes | Same
(Note: Amount
of Modes
available is less
in the proposed
Unit than in the
predicate ESU) |
| Mode
Adjustment | Select voltage and set power
limitation | Select effect (comprises
defined power output and
voltage limitation) | Different. |
| User Interface
Screen | LED display and selection
buttons | Touchscreen display | Different type of
display. Both
displays provide
the user with an
onscreen
tutorials as well
as relevant
information. |
| Active
Accessories -
Cables | · return electrode connecting
cable
· monopolar connecting
cables | · return electrode connecting
cable
· monopolar connecting
cables
· bipolar connecting cables | Additional type
of cable (bipolar
connecting
cables). |
| Miscellaneous
Accessories -
Footswitches
and Cart | · one- and two-pedal
footswitches
(only compatible with ESU
Model VIO 300 D)
• Cart | · one- and two-pedal
footswitches
(only compatible with ESU
Model VIO 3)
· Cart | Proposed
footswitches
are only
compatible with
VIO 3. New
footswitch types
added. |
| Materials | Unit
Metal sheet, glass display
screen, plastics, wiring
Accessories
Insulation plastics, wiring,
metals, aluminum, rubber,
metal sheet | Unit
Metal sheet, glass display
screen, plastics, wiring
Accessories
Insulation plastics, wiring,
metals, aluminum, rubber,
metal sheet | Same |
| Condition
provided / Use
condition | · Non-sterile / reusable
(ESU and Footswitches)
· Sterile / reusable
(Cables) | · Non-sterile / reusable
(ESU and Footswitches)
· Sterile / reusable
(Cables) | Same |
5
Erbe Elektromedizin GmbH Traditional 510(k) for Erbe's ESU Model VIO® 3 with Accessories
Verification/Validation Activities (Including Applied/Certified Standards):
- ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and • ANSI AAMI A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)* *Other versions of this standard were also tested to and certified.
6
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*
- *Other versions of this standard were also tested to and certified.
- ANSI AAMI IEC 60601-2-2:2009 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surqical accessories*
- *Other versions of this standard were also tested to and certified.
- IEC 60529:2013 Degrees of Protection Provided by Enclosures (IP Code) .
- AAMI ANSI IEC 62304:2006 Medical device software Software life cycle processes .
- IEC 62366:2007 + A1:2014 Medical Devices Application of Usability Engineering to Medical Devices
- IEC 60601-1-6:2010 (Third Edition) + A1:2013 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, . labelling and information to be supplied - Part 1: General requirements
- . IEC 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
- . ANSI AAMI ST81:2004 Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices (only for cables)
- ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process (only for cables)
- . ISTA 2A:2011 Partial Simulation Performance Test - Packaged-Products 150lb (68kg) or Less
Performance Evaluations/Testing
- · Output/Mode Comparison
- · Tissue Testing
- · Contact Quality Monitoring (CQM)
- · Capacitive Coupling (per Standard Number 60601-2-2)
- · Accessory Testing
Conclusion:
The Erbe ESU Model VIO 3 with Accessories has the same intended use as well as essentially the same principles of operation and technological characteristics as the predicate devices in the previously cleared 510(k)s. Validation and verification activities in design control that includes testing/certification to designated standards (including electrical safety standards) and performance testing of the proposed devices has demonstrated substantial equivalence to the Erbe ESU Model VIO 300 D with Accessories (i.e., the predicate devices).