(242 days)
No
The document describes a standard electrosurgical generator and argon module. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies focus on electrical safety, thermal effects, and substantial equivalence to predicate devices, not on AI/ML performance metrics.
Yes
The device is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation of tissue, which are therapeutic interventions.
No.
The device is described as an electrosurgical generator intended for cutting, coagulation, and argon beam assisted coagulation of tissue, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is comprised of an Electrosurgical Generator, Argon Module control, cart, and accessories (wired foot pedal, pressure reducer), which are all hardware components.
Based on the provided information, the Beamer AVEO™ Electrosurgical Generator System with Accessories is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation of tissue." This describes a device used directly on or in the human body for surgical procedures.
- Device Description: The description reinforces this by stating it's used "in surgical procedures" and "at the operative site."
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, or tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The Beamer AVEO System does not perform this function.
The Beamer AVEO System is an electrosurgical device used for therapeutic purposes during surgery.
N/A
Intended Use / Indications for Use
The Beamer AVEO™ Electrosurgical Generator System with Accessories is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation of tissue. The Beamer AVEO™ System is used in conjunction with compatible applicators or probes.
Product codes
GEI
Device Description
The Beamer AVEO™ Electrosurgical Generator and Argon Module (aka Beamer AVEO System / Beamer AVEO Electrosurgical System) is an electrosurgical generator that is used in surgical procedures and uses High-Frequency (HF) current through an accessory electrode for cutting and coagulation at the operative site. It is also intended to be used for enhanced control of bleeding by the delivery of HF electrosurgical current in combination with Argon gas through a compatible accessory. The Beamer AVEO System can be used for all patient types, conditions where electrosurgery is relevant, on all parts of human body.
The Beamer AVEO System is comprised of an Electrosurgical Generator (AVEO-ESU), Argon Module control (AVEO-ABC), Beamer AVEO cart and accessories (wired foot pedal, pressure reducer). A Graphical User Interface (GUI) and associated footswitches are provided for user interaction. Monopolar instruments, bipolar instruments, Argon probes, and a footswitch are connected to the AVEO system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
on all parts of human body.
Indicated Patient Age Range
all patient types
Intended User / Care Setting
Not Found
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 testing demonstrates that the Beamer AVEO System is substantially equivalent to the predicate device with regard to its intended use, materials, technology, and performance. Testing demonstrates the devices comply with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2, and IEC 60601-1-2. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Beamer AVEO system are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Beamer AVEO System outweigh the residual risks.
Thermal Effects on Tissue testing was conducted on Beamer AVEO™ Electrosurgical Generator and Argon Module per FDA Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery". The test was conducted on three different tissues (Liver, Muscle and Kidney) in triplicate at the minimum, default and maximum settings. The test results and analysis showed that the thermal effects on tissues of the Beamer AVEO™ Electrosurgical Generator and Argon Module are substantially equivalent to the predicate and reference devices. All test results were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
August 26, 2022
ConMed Corporation Ms. Kavita Amin, MSRA Sr. Specialist, Regulatory Affairs 525 French Road Utica, New York 13502
Re: K214058
Trade/Device Name: Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 29, 2021 Received: July 1, 2022
Dear Ms. Amin:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 medical devices and radiation-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,
for
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
2
Indications for Use
510(k) Number (if known) K214058
Device Name
Beamer AVEO Electrosurgical Generator and Argon Module
Indications for Use (Describe)
The Beamer AVEO™ Electrosurgical Generator System with Accessories is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation of tissue. The Beamer AVEO™ System is used in conjunction with compatible applicators or probes.
| 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) |
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3
510(k) SUMMARY
Beamer AVEO™ Electrosurgical Generator and Argon Module
Submitter Name and Address:
ConMed Corporation 525 French Road Utica, NY -13502 USA
Contact Person Name and Telephone:
Ms. Kavita Amin, MSRA Sr Specialist, Regulatory Affairs ConMed Advanced Endoscopic Technologies
525 French Road Utica, NY-13502 Telephone: 508-948-2084 Email address: kavitaamin@conmed.com
Date of Summary Prepared: August 23, 2022
Name of the device:
| Trade Name: | Beamer AVEO™ |
|---|---|
| Device Name: | Beamer AVEO™ Electrosurgical Generator; Beamer AVEO™ Argon |
| Module | |
| Common Name: | Beamer AVEO™ System, AVEO System |
| Classification Name: | Class II |
| Product Code: | GEI |
Predicate Device:
The information presented in this submission demonstrates the Beamer AVEO™ Electrosurgical Generator and Argon Module is substantially equivalent in function to its predicate device, VIO 300D, and reference device, ConMed Beamer System . The list of predicate and reference devices are provided in Table 1 below.
| 510(k) Number | Product
Code | Trade Name | Manufacturer | |
|---------------------|-----------------|------------|----------------------|------------|
| Predicate
Device | K083452 | GEI | VIO 300D | Erbe |
| Reference
Device | K081678 | GEI | ConMed Beamer System | KLS Martin |
Table 1: List of Predicate and Reference Devices
4
Device Description:
The Beamer AVEO™ Electrosurgical Generator and Argon Module (aka Beamer AVEO System / Beamer AVEO Electrosurgical System) is an electrosurgical generator that is used in surgical procedures and uses High-Frequency (HF) current through an accessory electrode for cutting and coagulation at the operative site. It is also intended to be used for enhanced control of bleeding by the delivery of HF electrosurgical current in combination with Argon gas through a compatible accessory. The Beamer AVEO System can be used for all patient types, conditions where electrosurgery is relevant, on all parts of human body.
The Beamer AVEO System is comprised of an Electrosurgical Generator (AVEO-ESU), Argon Module control (AVEO-ABC), Beamer AVEO cart and accessories (wired foot pedal, pressure reducer). A Graphical User Interface (GUI) and associated footswitches are provided for user interaction. Monopolar instruments, bipolar instruments, Argon probes, and a footswitch are connected to the AVEO system.
Indications for Use:
The Beamer AVEO™ Electrosurgical Generator System with Accessories is intended to deliver electrosurgical current and Argon gas for the cutting, coagulation and argon beam assisted coagulation of tissue. The Beamer AVEO™ System is used in conjunction with compatible applicators or probes.
Summary of Technological Characteristics:
The subject device is similar in design as the predicate and reference devices. The subject device has the same intended use as the predicate and reference devices. The Beamer AVEO System is comprised of an electrosurgical unit and argon unit as the predicate device. All three systems use same technology of high frequency energy for cutting and coagulation of tissue.
Substantial Equivalence:
Table 2 provides the similarities and differences between the predicate and reference devices. The modifications made to the subject device do not raise any risk to safety or effectiveness. Supporting information per this premarket submission confirms that the Beamer AVEO Electrosurgical Generator is safe and effective for its intended use and is substantially equivalent in design, intended use, principals of operation, and technical characteristics to the predicate and reference devices.
| Features | Subject Device:
Beamer AVEO System | Predicate Device:
ERBE VIO 300 D / ERBE
APC 2 | Reference Device:
ConMed Beamer
System CE600 |
|---------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------------------|
| 510(k) | K214058 | K083452 / K024047 | K081678 |
| Duty Cycle | Non-continuous
10 seconds/ 30 seconds | Non-continuous
10 seconds/ 30 seconds | Non-continuous
10 seconds/ 30 seconds |
| Energy Type | High Frequency (HF), Argon | High Frequency (HF), Argon | High Frequency (HF), Argon |
| Output | Monopolar, Bipolar, Argon | Monopolar, Bipolar, Argon | Monopolar, Bipolar, Argon |
| Electrical Safety
Compliance | IEC 60601-1, Ed. 3.1
IEC 60601-1-2, Ed. 4.0
IEC 60601-2-2, Ed. 6.0 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 |
| Table 2: Substantial Equivalence | |||||
|---|---|---|---|---|---|
| ---------------------------------- | -- | -- | -- | -- | -- |
5
| Features | Subject Device:
Beamer AVEO System | Predicate Device:
ERBE VIO 300 D / ERBE
APC 2 | Reference Device:
ConMed Beamer
System CE600 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display | The Beamer AVEO ESU
is designed with a 7"
touch screen LCD
display. The screen
displays program, mode,
power settings, argon
flow rate, argon tank
status, neutral electrode
status and contact
quality (dual-foil
electrodes), user
programs, and visual
indications. | The VIO 300 D is designed
with a backlit dual color
screen controlled via
selection buttons located on
either side of the screen. The
screen displays program,
mode, power settings, | The ConMed Beamer
System CE600 is
designed with an 8"
screen containing
push buttons and
rotary switch (knob) for
navigation. The screen
displays program,
mode, power settings,
argon flow rate, argon
tank status, neutral
electrode status and
contact quality (dual-
foil electrodes), user
programs, and visual
indications. |
| Foot Pedal
Connections | Accommodates the
following foot pedal
connections:
Dual | Accommodates the following
foot pedal connections:
– Dual
Single | Accommodates the
following foot pedal
connections:
– Dual
– Single |
| Purge | The Beamer AVEO
System provides a purge
function of 3 LPM ± 20%
for 4 seconds. | The VIO 300 D with
connected APC 2 module
provides a 3-second purge
with flow rate dependent upon
the type of instrument
connected to the APC 2. | The Beamer System
CE600 provides a
purge function of 3
LPM ± 20% for 3
seconds. |
| Modes | The Display screen has
indicators / icons to
identify the selected
program, power settings
for each mode,
instrument used and the
selected argon gas flow
rate. | The Display screen has
indicators / icons to identify
the selected program, power
settings for each mode, and
the selected argon gas flow
rate. | The Display screen
has indicators / icons
to identify the selected
program, power
settings for each mode
and the selected argon
gas flow rate. |
| Programmable
settings | The Beamer AVEO
System is designed to
allow users to create,
recall, modify, and
delete user-defined
programs. | The VIO 300 D is designed to
allow users to create, recall,
modify, and delete user-
defined programs. | The Beamer System
CE600 is designed to
allow users to create,
recall, modify, and
delete user-defined
programs. |
| Features | Subject Device:
Beamer AVEO System | Predicate Device:
ERBE VIO 300 D / ERBE APC 2 | Reference Device:
ConMed Beamer
System CE600 |
| Instrument
Connections | The Beamer AVEO
System accommodates
the following instrument
connections:
– Monopolar (Bovie-
type, 3-prong, 4mm)
– Bipolar (coaxial, 2-
prong)
– Argon (ConMed
proprietary design) | The ERBE VIO 300 D
accommodates the following
instrument connections:
– Monopolar
– Bipolar
Argon (via APC Module) | The ConMed Beamer
System CE600
accommodates the
following instrument
connections:
– Monopolar (Bovie-
type, 3-prong,
4mm)
– Bipolar (coaxial, 2-
prong)
– Argon (Luer
connection) |
6
Performance Testing:
Performance testing demonstrates that the Beamer AVEO System is substantially equivalent to the predicate device with regard to its intended use, materials, technology, and performance. Testing demonstrates the devices comply with the applicable sections of AAMI/ANSI ES60601-1, IEC 60601-2-2, and IEC 60601-1-2. Risk management activities in accordance with ISO 14971 demonstrate the risks associated with the use of the Beamer AVEO system are mitigated to an acceptable level. Analyses of these activities conclude the benefits associated with the use of the Beamer AVEO System outweigh the residual risks.
Thermal Effects on Tissue testing was conducted on Beamer AVEO™ Electrosurgical Generator and Argon Module per FDA Guidance, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery". The test was conducted on three different tissues (Liver, Muscle and Kidney) in triplicate at the minimum, default and maximum settings. The test results and analysis showed that the thermal effects on tissues of the Beamer AVEO™ Electrosurgical Generator and Argon Module are substantially equivalent to the predicate and reference devices. All test results were acceptable.
Conclusion:
The subject device is substantially equivalent to the commercially available marketed device, ConMed Beamer System and Erbe VIO 300D. The modifications expressed in this 510(k) Premarket Notification do not change the intended use, nor alter the fundamental scientific technology of the device, and do not raise any new issues of safety and effectiveness.