(14 days)
The Gold Vac pencils, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgioal effect.
The CONMED GoldVac "Integrated Smoke Evacuation Pencils a sterile, single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is intended for general electrosurgical applications and when used in conjunction withan effective smoke evacuation system, for removing smoke generated by electrosurgery. The integration of the pencil and the smoke attachment allows a single device to be used. The device is constructed of themoplastics well known throughout the industry in the manufacture of medical devices. The device won known integratival pencil with an integrated pathway for smoke removal. This pathway forms an airway from the tip to the rear of the pencil. The pencil is connected to tubing which will be attached to the rear of a variety of smoke evacuation systems. The smoke is then filtered by smoke evacuation system preventing personnel exposure to this surgical smoke. The device will be packaged singly for sterile distribution. The CONMED GoldVac "Integrated Smoke Evacuation Pencil incorporates an extendable "smoke tube" which is housed within the electrosurgical pencil. The pencil is connected to the 10 feet of tubing which connects the pencil to the smoke evacuation system.
The provided text describes the CONMED® GoldVac™ Integrated Smoke Evacuation Pencil, an electrosurgical pencil with integrated smoke evacuation. The information focuses on its substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria for a novel AI/software device. Therefore, many of the requested categories are not applicable to this submission.
Here's a breakdown of the available information and areas where the requested details are not present:
Acceptance Criteria and Device Performance
The submission focuses on establishing substantial equivalence to predicate devices rather than defining and meeting specific analytical or clinical performance acceptance criteria for a new type of device. The "performance testing" section describes general bench testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrosurgical Function: No effect or changes to the function of the electrosurgical pencil. | "tests conducted with the device have shown no effect or changes to the function of the electrosurgical pencil." |
| Smoke Removal: Removal of smoke similar to predicate devices. | "The removal of smoke was similar to that of the two independent devices." |
| Design does not impede electrosurgical function: No obstruction of the electrosurgical function by the smoke intake nozzle. | "The nozzle or intake portion of the device has been designed so as to not impede the operation of the electrosurgical function of the pencil and provides for intake of the surgical smoke for filtering." |
| Compliance with standards: ANSI/AAMI HF-18, IEC 60601-2-2, ISO 14971, ISO 10993. | "The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, 60601-2-2, Risk Management ISO 14971 and Biocompatibility ISO 10993." (This indicates design intent and compliance, not necessarily specific test results for each standard in this summary.) |
Study Information (Not Applicable for this type of submission)
The provided document describes a 510(k) submission for an electrosurgical pencil, a hardware device, not an AI or software device. Therefore, information regarding sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not included and are not expected for this type of medical device submission.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a hardware device submission focused on substantial equivalence. Performance testing mentioned is "bench testing" without details on sample size or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Bench testing" on the device was performed to confirm its function.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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| Submitted by: | CONMED Electrosurgery Division14603 East Fremont AvenueCentennial, CO 80112 USATelephone: 303-269-8224Facsimile: 303-699-9854 | JUN 25 2008 |
|---|---|---|
| Contact Person: | Shawn Riedel | |
| Date Prepared: | 25 April 2008 | |
| Proprietary Name: | CONMED® GoldVac™ Integrated Smoke Evacuation Pencil | |
| Common Name: | Electrosurgical pencil accessory for surgical smoke evacuation | |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories21 CFR 878.440079 GEI | |
| Predicate Device: | This product is similar in design, composition, and function to theConMed Smoke Evacuation Attachment of 510(k) NotificationK982309 cleared August 5, 1998, as well as the ElectrosurgicalPencil K791137 cleared July 24, 1979. |
Device Description: The CONMED GoldVac "Integrated Smoke Evacuation Pencils a sterile, single use integrated electrosurgical pencil and smoke evacuation handpiece. The device is intended for general electrosurgical applications and when used in conjunction withan effective smoke evacuation system, for removing smoke generated by electrosurgery.
The integration of the pencil and the smoke attachment allows a single device to be used. The need for smoke removal is demonstrated in numerous studies documenting the effects of surgical smoke. It has been well documented the smoke produced from electrosurgery contains carbonized tissue, airborne particles, and various chemicals and gases. The Occupational Health And Safety Administration has issued recommendations that surgical smoke be removed and properly filtered by a smoke evacuation system as close to the surgical site as possible. The traditional surgical mask has been determined to be not adequate for personal protection. The device is constructed of themoplastics well known throughout the industry in the manufacture of medical devices. The device won known integratival pencil with an integrated pathway for smoke removal. This pathway forms an airway from the tip to the rear of the pencil. The pencil is connected to tubing which will be attached to the rear of a variety of smoke evacuation systems. The smoke is then filtered by smoke evacuation system preventing personnel exposure to this surgical smoke. The device will be packaged singly for sterile distribution.
GoldVac Integrated Smoke Pencil
Section 4 Page 1 of 2
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The CONMED GoldVac "Integrated Smoke Evacuation Pencil incorporates an extendable "smoke tube" which is housed within the electrosurgical pencil. The pencil is connected to the 10 feet of tubing which connects the pencil to the smoke evacuation system.
Technological Characteristics: The CONMED GoldVac "Integrated Smoke Evacuation Pencils are simply an integration of the electrosurgical pencil and the smoke evacuation attachment. The only visible difference is this integration and the addition of a "smoke tube" which can be positioned near the tip of the electrode for maximum smoke removal or farther back for maximum accessibility and visibility.
The tubing houses the cord set to eliminate clutter at the surgical site and swivels to allow for a maximum range of motion.
The technological characteristics of the electrosurgical pencil remain the same. As with the predicate device, CUT, COAG, and smoke evacuations are contained in one device, limiting the need for several devices present at the surgical site that perform these functions independently of each other.
The proposed device is equivalent to the identified predicate devices with respect to technological characteristics and function. The device has been designed to comply with the applicable sections of ANSI/AAMI American National Standard for Electrosurgical Devices HF-18, the International Electrotechnical Commission Standard for Electrosurgical Devices, 60601-2-2, Risk Management ISO 14971 and Biocompatibility ISO 10993.
- There are no changes to the generator and therefore no changes to the . accompanying software.
- The operator controls the use of the device; �
- The generator provides alarms for conditions that could pose a risk to the patient; .
- The operator sets the appropriate mode and output settings for the device. .
Performance testing: Bench testing on the subject device has shown the device to perform as intended with the same or similar results as a predicate device. No particular requirements peculiar to this smoke performance exist in the standards but tests conducted with the device have shown no effect or changes to the function of the electrosurgical pencil. The removal of smoke was similar to that of the two independent devices. The nozzle or intake portion of the device has been designed so as to not impede the operation of the electrosurgical function of the pencil and provides for intake of the surgical smoke for filtering
Intended Use: The GoldVac pencils, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.
Summary: The CONMED GoldVac "Integrated Smoke Evacuation Pencil is equivalent to the identified predicate devices. In addition, it is equivalent in its intended use and indications for use.
GoldVac Integrated Smoke Pencil
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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 consists of a stylized caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted as a stylized bird with outstretched wings, and the text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 5 2008
ConMed Corporation % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K081634
Trade/Device Name: CONMED® GoldVac™ Integrated Smoke Evacuation Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 3, 2008 Received: June 11, 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 the reporting 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 M. Mulhern
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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Indications for Use
510(k) Number (if known): KOB1634
Device Name: CONMED GoldVac Integrated Smoke Evacuation Pencil
Indications for Use:
The Gold Vac pencils, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgioal effect.
Prescription Use (Part 21 CFR 801 Subpart D
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
from
(Division Sign-Off) Division of General. Restorative,
and Neurological Devices
510(k) Number K081634
Page .
§ 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.