(81 days)
Not Found
No
The description details a standard electrosurgical handpiece with manual switching, and there is no mention of AI or ML in the provided text.
Yes.
The device's intended use is for "cutting and coagulation at the operative site" using electrosurgical current to "produce the therapeutic affect," which describes a function aimed at treating or alleviating a medical condition.
No
Explanation: The device description states its purpose is for "cutting and coagulation" using electrosurgical current, not for diagnosing conditions or diseases.
No
The device description clearly outlines a physical handpiece with a cable, electrode tip, and switching buttons, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is an electrosurgical accessory handpiece used to deliver RF electrosurgical current for cutting and coagulation at the operative site. It directly interacts with the patient's tissue during surgery.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens taken from the patient. The device's function is therapeutic (cutting and coagulation), not diagnostic based on laboratory analysis.
Therefore, based on the intended use and device description, this is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.
Product codes
GEI
Device Description
This pencil has applications in general surgical procedures to provide a means of cutting and coagulation using electrosurgical current. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to an electrode tip at the distal end of the handpiece is provided with various electrode types and cable lengths and acts as a hand-switching conduit in delivering the HF energy from the electrosurgical generator unit through an electrode to produce the therapeutic affect. Current is activated by the cut/coagulation switching element buttons on the handpiece. The devices will be distributed sterile for single-use applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
operative site.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Summary of Safety and Effectiveness
| Submitted by: | CONMED Electrosurgery Division
14603 East Fremont Avenue
Centennial, CO 80112 USA
Telephone: 303-699-7600
Facsimile: 303-699-9854 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pamela L. Vetter |
| Date Prepared: | July 8, 2004 |
| Proprietary Name: | ValuPen TM, Profile® and other trade names as established |
| Common Name: | Disposable Electrosurgical Pencil |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories (21 CFR
878.4400)
79 GEI |
| Predicate Device: | Disposable Electrosurgical Pencils
510(k) # K936304 |
Device Description: This pencil has applications in general surgical procedures to provide a means of cutting and coagulation using electrosurgical current. The device consists of a cable for connection to the output of an electrosurgical generator unit, to carry high-frequency (HF) electrosurgical current to an electrode tip at the distal end of the handpiece is provided with various electrode types and cable lengths and acts as a hand-switching conduit in delivering the HF energy from the electrosurgical generator unit through an electrode to produce the therapeutic affect. Current is activated by the cut/coagulation switching element buttons on the handpiece. The devices will be distributed sterile for single-use applications.
Intended Use of Device: Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.
Technological Characteristics: The proposed device is equivalent to the identified predicate device 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, IEC 60601-2-2, Sterilization of health care products – Requirements for validation and routine control – Radiation Sterilization, ISO 11137 and Biocompatibility, ISO 10993.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2004
Ms. Pamela Vetter Regulatory Affairs Manager ConMed Electrosurgery 14603 East Fremont Avenue Centennial, Colorado 80112
Re: K041868
Trade/Device Name: Disposable Electrosurgical Pencil Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 8, 2004 Received: July 9, 2004
Dear Ms. Vetter:
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.
2
Page 2 - Ms. Pamela Vetter
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Disposable Electrosurgical Pencil Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Single-use hand-switching electrosurgical accessory handpiece used in conjunction with an electrosurgical generator for delivery of RF electrosurgical current through an electrode for cutting and coagulation at the operative site.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_K04 / 868