(14 days)
Not Found
No
The summary describes a physical electrosurgical pencil with integrated smoke evacuation, focusing on mechanical function and materials. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an "Integrated Smoke Evacuation Pencil" used to remove smoke plume and conduct electrosurgical current, but it is not intended to directly treat or diagnose a disease or condition for therapeutic purposes. It's an accessory to a surgical procedure.
No
The device is an electrosurgical pencil designed to remove smoke plume during surgery, not to diagnose a condition or disease.
No
The device description clearly describes a physical, sterile, single-use integrated electrosurgical pencil and smoke evacuation handpiece constructed of thermoplastics, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an electrosurgical pencil used to apply current to the operative site for surgical effects and to remove surgical smoke. It operates directly on the patient's tissue during surgery.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is entirely focused on surgical intervention and smoke removal.
Therefore, the CONMED GoldVac "Integrated Smoke Evacuation Pencils" is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
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.
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
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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
| Submitted by: | CONMED Electrosurgery Division
14603 East Fremont Avenue
Centennial, CO 80112 USA
Telephone: 303-269-8224
Facsimile: 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 accessories
21 CFR 878.4400
79 GEI | |
| Predicate Device: | This product is similar in design, composition, and function to the
ConMed Smoke Evacuation Attachment of 510(k) Notification
K982309 cleared August 5, 1998, as well as the Electrosurgical
Pencil 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
1
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
2
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.
3
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
4
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 .