(23 days)
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.
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.
The provided text is a 510(k) Summary for a medical device (Beamer AVEO™ Filter Integrated Argon Probes) and does not describe a study involving acceptance criteria for an AI/ML powered device. Instead, it details the substantial equivalence of the new device to a predicate device, focusing on changes in mechanical design and integration of components.
Therefore, I cannot provide the requested information as the document does not contain details about:
- Acceptance criteria and device performance table for an AI/ML device.
- Sample sizes for test sets, data provenance, number of experts, or adjudication methods for ground truth.
- MRMC studies, standalone algorithm performance, or ground truth types, training set size, or ground truth establishment for an AI/ML model.
The document discusses performance testing for the physical device, such as thermal effects on tissue and mechanical tests (flow rate, insertion/retraction, tensile strength), and states that "All test results were acceptable." However, it does not provide specific acceptance criteria or detailed results of those tests. It also mentions biocompatibility testing confirming material safety.
The core of this submission is a claim of substantial equivalence for a non-AI/ML medical device, based on similar materials, processes, packaging, and technological characteristics to a predicate device, with minor modifications (like an integrated filter and a new connector).
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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.
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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; BeamerAVEO™ 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 | ProductCode | Trade Name | Manufacturer |
|---|---|---|---|
| K081644 | GEI | ConMed Beamer® ArgonProbe | 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 DeviceConMed Beamer Argon /SideFire Probes | Modified DeviceBeamer AVEO Filter Integrated ArgonProbes / SideFire Probe |
|---|---|---|
| 510(k) | K081644 | K221945 |
| Manufacturer | ConMed Corporation | ConMed Corporation |
| Regulatory Description | Electrosurgical cutting andcoagulation device and accessories. | Same |
| Product Code | GEI | GEI |
| Brief Description | The Beamer Argon Probes areflexible, single patient use deviceswhich deliver argon for non-contactcoagulation. The probes have twoconfigurations - axial fire probesand a sidefire probe. The axialprobes are offered in several lengthand diameters to accommodatevarious endoscope types. The distalend of all the probes has a ceramictip which provides a thermalinsulation barrier for the tubing toprevent heat degradation duringcoagulation. | The Beamer AVEO™ Filter Integrated ArgonProbes and Beamer AVEO™ Filter IntegratedArgon SideFire Probe are flexible, singlepatient use devices which deliver argon fornon-contact coagulation when used inconjunction with the Beamer AVEO™ System(Beamer AVEO™ Electrosurgical Generatorand Beamer AVEO™ Argon Module). Theprobes are offered in two configuration - axialfire probes and a sidefire probe. The axialprobes are offered in various sizes. The distalend of all the probes has a ceramic tip |
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| Elements | Predicate DeviceConMed Beamer Argon /SideFire Probes | Modified DeviceBeamer AVEO Filter Integrated ArgonProbes / SideFire Probe |
|---|---|---|
| IntendedUse/Indications for Use | The Beamer Argon Probes areintended to be used for argonenhanced coagulation of tissue. | The Beamer AVEO™ Argon Probes areintended to be used for argon enhancedcoagulation 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 thefinished device | In-line Filter |
| Gas Flow | 1.8 mm: 0.3 L/min – 0.6 L/min2.3 mm: 0.4 L/min – 0.8 L/min3.2 mm: 0.5 L/min – 1.0 L/min | Same |
| Connector | Pin plug style connector, whichconnects to connecting cable | Connector (connect directly to BeamerAVEOTM 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.
§ 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.