(14 days)
The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.
The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.
The Beamer Snare Probe consists of connectors for attachment to the output of an Argon Beam Coagulation Unit. The device also consists of catheter tubing for delivering argon gas to the operative site within the patient, as well as an internal wire to carry high frequency (HF) electrosurgical current to the electrosurgical snare. The snare probe device is provided in two lengths 160 cm and 230 cm for use in flexible bronchoscopes, gastroscopes, colonoscopes and duodenoscopes.
The electrosurgical snare is provided in a symmetrical loop (braided or monofilament oval) in sizes of 15mm and 30mm and can be positioned back into the catheter tube, such that it does not contact the patient's tissue during the argon beam coagulation procedure.
The Beamer Argon Snare Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The proximal end of the stainless steel wire is locked into the connector be The distal end of the wire is soldered to a snare shaped wire located at the distal end of the probe. In its retracted position the snare wire is in electric contact to a tungsten electrode. The distal end of the Beamer Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The tungsten electrode remains recessed in the ceramic tip such that there is no tissue contact during the argon beam coagulation procedure.
There are five configurations of the Beamer Argon Snare Probe. The probes vary in length and loop configuration to accommodate the procedure performed by the physician. The Beamer Argon Snare Probes are provided sterile by ethylene oxide and are single use only.
The provided text describes the ConMed Endoscopic Technologies Beamer™ Argon Snare Probe, a medical device for electrosurgical cutting and coagulation. It's a 510(k) summary, aiming to demonstrate substantial equivalence to legally marketed predicate devices rather than proving specific performance against acceptance criteria through a detailed clinical study.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from 'testing passed') | Reported Device Performance |
|---|---|---|
| Performance Testing | Functional equivalence to predicate devices for gas and electrosurgical current delivery, snare operation, and safety during use with a Beamer system generator. | "All testing passed the predetermined performance specifications." This indicates the device met its internal design and functional requirements. Specific numerical targets or detailed results are not provided in this 510(k) summary. The comparison is against predicate devices in "intended use, technological characteristics and materials." |
| Biocompatibility | Compliance with biocompatibility standards to ensure patient safety (e.g., non-toxic, non-irritating, non-sensitizing). | "Biocompatibility... have been performed to demonstrate equivalence of the Beamer Argon Snare Probes to their predicate devices." This implies the device materials are safe for human contact as per established medical device standards. Specific tests or results are not listed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify any sample sizes for a clinical test set. The testing mentioned is "Biocompatibility and bench testing." These typically involve material testing and functional evaluations in a lab setting, not human clinical trials. Thus, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided as the submission describes bench and biocompatibility testing, not a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as the submission describes bench and biocompatibility testing, not a clinical study requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through bench and biocompatibility testing against predicate devices, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical electrosurgical probe, not an AI-driven algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in AI/imaging studies (e.g., expert consensus, pathology, outcome data) is not applicable here. For bench testing, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet. For biocompatibility, it refers to regulatory standards for material safety.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not a machine learning model, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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ConMed Endoscopic Technologies Beamer™ Argon Snare Probe
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Image /page/0/Picture/1 description: The image shows the logo for CONMED Endoscopic Technologies. Above the logo is the text "K081580". The logo is black and white and features the word "CONMED" in large, bold letters. Below the word "CONMED" is the text "ENDOSCOPIC TECHNOLOGIES" in smaller letters.
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8000 8 I Nin
510(k) Summary of Safety and Effectiveness
- ConMed Endoscopic Technologies, Inc. Sponsor Name: 1. 129 Concord Road Billerica, MA 01821 Telephone: 978-964-4232 Contact Individual: Karen Provencher Sr. Regulatory Affairs Specialist
- ConMed Beamer™ Argon Snare Probe 2. Device Name:
Identification of Predicate or Legally Marketed Device: 3.
ConMed Optimizer Snare cleared under K820430 on April 8, 1982 Olympus SD Electrosurgical Snare cleared under K902735 on August 2, 1990
ConMed ABC Probes for Flexible Endoscopes cleared in K990586 on May 17, 1999
ERBE Argon Plasma Coagulator cleared in K013348 on October 26, 2001
4. Device Description:
The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.
The Beamer Snare Probe consists of connectors for attachment to the output of an Argon Beam Coagulation Unit. The device also consists of catheter tubing for delivering argon gas to the operative site within the patient, as well as an internal wire to carry high frequency (HF) electrosurgical current to the electrosurgical snare. The snare probe device is provided in two lengths 160 cm and 230 cm for use in flexible bronchoscopes, gastroscopes, colonoscopes and duodenoscopes.
The electrosurgical snare is provided in a symmetrical loop (braided or monofilament oval) in sizes of 15mm and 30mm and can be positioned back into the catheter tube, such that it does not contact the patient's tissue during the argon beam coagulation procedure.
The Beamer Argon Snare Probe consists of a stainless steel wire that extends from the probe connector to the distal end of the probe. The
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ConMed Endoscopic Technologies Beamer™ Argon Snare Probe
t
proximal end of the stainless steel wire is locked into the connector be The distal end of the wire is soldered to a snare shaped wire located at the distal end of the probe. In its retracted position the snare wire is in electric contact to a tungsten electrode. The distal end of the Beamer Probe has a ceramic tip which provides a thermal insulation barrier for the tubing to prevent heat degradation during coagulation. The tungsten electrode remains recessed in the ceramic tip such that there is no tissue contact during the argon beam coagulation procedure.
There are five configurations of the Beamer Argon Snare Probe. The probes vary in length and loop configuration to accommodate the procedure performed by the physician. The Beamer Argon Snare Probes are provided sterile by ethylene oxide and are single use only.
5. Intended Use:
The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.
Comparison of Technological Characteristics: 6.
The Beamer Snare Probes are substantially equivalent to the predicate devices both in intended use, technological characteristics and materials.
7. Performance Testing:
Biocompatibility and bench testing have been performed to demonstrate equivalence of the Beamer Argon Snare Probes to their predicate devices. All testing passed the predetermined performance specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the image. The text is in a circular format around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
ConMed Corporation % Intertek Testing Services Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K081580
Trade/Device Name: Beamer™ Argon Snare Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 03, 2008 Received: June 05, 2008
Dear Mr. Lehtonen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark on Mil
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/1 description: The image shows the logo for Conmed Endoscopic Technologies. The logo features a stylized graphic to the left of the word "CONMED" in large, bold letters. Below "CONMED" are the words "ENDOSCOPIC TECHNOLOGIES" in a smaller font. The letters are all in black.
C. INDICATION FOR USE
11 - 11
510(k) Number (if known)_KO81580
Device Name: Beamer™ Argon Snare Probe
Indication for Use:
The Beamer Argon Snare Probe is used in conjunction with the Beamer system generator for the delivery of gas and electrosurgical current through a flexible endoscope to an electrode wire snare at the operative site.
| Prescription Use(Per 21 CFR 801 Subpart D) | X | AND/OR | Over the Counter Use(Per 21 CFR 801 Subpart C) |
|---|---|---|---|
| ------------------------------------------------ | --- | -------- | ---------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K081580 |
|---|---|
| --------------- | --------- |
| Page 1 of 1 | |
|---|---|
| 13 of 187 |
§ 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.