(23 days)
Not Found
No
The summary describes a standard electrosurgical device for argon enhanced coagulation and does not mention any AI or ML components or functionalities.
Yes
The device is used for argon enhanced coagulation of tissue, which involves treating or altering biological tissue for medical purposes. This falls under the definition of a therapeutic device.
No
The device is described as being used for "argon enhanced coagulation of tissue," and its function is to "deliver argon for non-contact coagulation." This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a flexible, single-patient use device with physical components like a ceramic tip and tubing, designed to deliver argon for coagulation. This indicates a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "argon enhanced coagulation of tissue." This is a therapeutic procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as delivering argon for "non-contact coagulation." This further reinforces its role in a therapeutic intervention.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
In summary, the Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe are devices used for a therapeutic procedure (tissue coagulation) and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe are intended to be used for argon enhanced coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Beamer AVEOTM Argon Probes and Argon SideFire Probe are flexible, single patient use devices which deliver argon for non-contact coagulation when used in conjunction with the Beamer AVEOTM Electrosurgical Generator (ESU) and Argon (ABC) Module. The axial probes are offered in several lengths and diameters to accommodate various endoscope types. The distal end of all the probes has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation.
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
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 for the modified device includes thermal effects on tissue per FDA Guidance on Electrosurgery and mechanical tests (such as flow rate, insertion and retraction, and tensile strength) were conducted per ConMed Procedures. All test results were acceptable.
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.
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 28, 2022
Conmed Corporation Ms. Kavita Amin, MSRA Sr Specialist, Regulatory Affairs ConMed Advanced Endoscopic Technologies 525 French Road Utica, New York 13502
Re: K221945
Trade/Device Name: Beamer AVEO™ FILTER INTEGRATED ARGON PROBE; Beamer AVEO™ FILTER INTEGRATED ARGON SIDEFIRE PROBE
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 30, 2022 Received: July 5, 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.
1
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 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
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Indications for Use
510(k) Number (if known)
Device Name
Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe
Indications for Use (Describe)
The Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe are intended to be used for argon enhanced 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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510(k) Summary
Beamer AVEO™ Filter Integrated Argon Probes Beamer AVEOTM Filter Integrated Argon SideFire Probe
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:
July 26, 2022
Name of the device:
| Trade Name: | Beamer AVEO™ FILTER INTEGRATED ARGON PROBE; Beamer
AVEO™ FILTER INTEGRATED ARGON SIDEFIRE PROBE |
|----------------------|----------------------------------------------------------------------------------------------------|
| Common Name: | Beamer AVEO™ Argon Probes |
| Classification Name: | Class II |
| Product Code: | GEI |
Predicate Device:
The Beamer AVEOTM Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probes are substantially equivalent in function and its intended use as its predicate as listed in Table 1 below.
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|-------------------------------|--------------------|
| K081644 | GEI | ConMed Beamer® Argon
Probe | ConMed Corporation |
Table 1: Predicate Device
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Device Description:
The Beamer AVEOTM Argon Probes and Argon SideFire Probe are flexible, single patient use devices which deliver argon for non-contact coagulation when used in conjunction with the Beamer AVEOTM Electrosurgical Generator (ESU) and Argon (ABC) Module. The axial probes are offered in several lengths and diameters to accommodate various endoscope types. The distal end of all the probes has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation.
Indications for Use:
The Beamer AVEOTM Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe are intended to be used for argon enhanced coagulation of tissue.
Substantial Equivalence Comparison:
The modified devices, Beamer AVEO™ Filter Integrated Argon Probes and Beamer AVEO™ Filter Integrated Argon SideFire Probe (Beamer AVEO™ Argon Probes) has the same manufacturing process as the predicate device with the addition of in-line filter prior to packaging and sterilization. The packaging material has been slightly modified to increase robustness of packaging. The modified devices are manufactured with similar material specification and processing steps as the predicate device. The addition of in-line filter to the Beamer AVEO Argon Probes and Argon SideFire Probe provide an ease of use to the end-user. The modified devices also include a connector that provides a simple, easy, and unique connection with the Beamer capital equipment. The table below shows the Substantial Equivalence comparison between the predicate and modified device.
| Elements | Predicate Device
ConMed Beamer Argon /
SideFire Probes | Modified Device
Beamer AVEO Filter Integrated Argon
Probes / SideFire Probe |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K081644 | K221945 |
| Manufacturer | ConMed Corporation | ConMed Corporation |
| Regulatory Description | Electrosurgical cutting and
coagulation device and accessories. | Same |
| Product Code | GEI | GEI |
| Brief Description | The Beamer Argon Probes are
flexible, single patient use devices
which deliver argon for non-contact
coagulation. The probes have two
configurations - axial fire probes
and a sidefire probe. The axial
probes are offered in several length
and diameters to accommodate
various endoscope types. The distal
end of all the probes has a ceramic
tip which provides a thermal
insulation barrier for the tubing to
prevent heat degradation during
coagulation. | The Beamer AVEO™ Filter Integrated Argon
Probes and Beamer AVEO™ Filter Integrated
Argon SideFire Probe are flexible, single
patient use devices which deliver argon for
non-contact coagulation when used in
conjunction with the Beamer AVEO™ System
(Beamer AVEO™ Electrosurgical Generator
and Beamer AVEO™ Argon Module). The
probes are offered in two configuration - axial
fire probes and a sidefire probe. The axial
probes are offered in various sizes. The distal
end of all the probes has a ceramic tip |
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| Elements | Predicate Device
ConMed Beamer Argon /
SideFire Probes | Modified Device
Beamer AVEO Filter Integrated Argon
Probes / SideFire Probe |
|-------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for Use | The Beamer Argon Probes are
intended to be used for argon
enhanced coagulation of tissue. | The Beamer AVEO™ Argon Probes are
intended to be used for argon enhanced
coagulation of tissue. |
| Features | | |
| Outside Diameter | 1.8 mm, 2.3 mm, 3.2 mm | Same |
| Probe Length | 180 cm, 230 cm, 320 cm | Same |
| Overall Length | 180 cm, 230 cm, 320 cm | 430 cm, 480 cm, 570 cm |
| Filter | Filter supplied separately with the
finished device | In-line Filter |
| Gas Flow | 1.8 mm: 0.3 L/min – 0.6 L/min
2.3 mm: 0.4 L/min – 0.8 L/min
3.2 mm: 0.5 L/min – 1.0 L/min | Same |
| Connector | Pin plug style connector, which
connects to connecting cable | Connector (connect directly to Beamer
AVEOTM Argon Module (AVEO-ABC)) |
| Configuration | Sterile, Single-Use | Same |
| Sterilization Method | Ethylene Oxide | Same |
Summary of Technological Characteristics:
The modified devices use the same technological characteristics as the predicate devices except for the following:
- The predicate device uses a reusable extension cable however, the modified devices ● incorporate an extension tubing as part of a single-use device
- The predicate device is supplied with a separate filter however the modified devices are ● supplied with an integrated filter for the ease of use
- The predicate device connects to the ESU via a separate Pin Plug Connector however, the . modified devices have an integrated single connector that is used to connect the probes with the capital equipment.
Performance Testing:
The modified devices, Beamer AVEO™ Argon Probes, are comprised of similar materials, processes, and packaging as the predicate device (K081644). The sterilization method (EtO) remains unaltered between these devices. The biocompatibility testing conducted on the modified devices confirms the use of materials as safe and effective for its intended purpose.
Performance testing for the modified device includes thermal effects on tissue per FDA Guidance on Electrosurgery and mechanical tests (such as flow rate, insertion and retraction, and tensile strength) were conducted per ConMed Procedures. All test results were acceptable.
Conclusion:
Based on the Performance Testing, Substantial Equivalence Comparison, and Technological Characteristics, the modified devices, Beamer AVEO™ Filter Integrated Argon Probes and
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Beamer AVEO™ Filter Integrated Argon SideFire Probe (Beamer AVEO™ Argon Probes), are substantially equivalent to the commercially available marketed device, ConMed Beamer® Argon Probes. The modifications expressed in this 510(k) Premarket Notification do not change the intended use, nor alter the fundamental scientific technology of the device. The modified devices are as safe and as effective as the predicate device.