(65 days)
Not Found
No
The document describes a standard electrosurgical generator with basic cutting and coagulation modes, and there is no mention of AI, ML, or related concepts.
Yes
The device is described as producing a "therapeutic effect" through electrosurgical cutting and coagulation at the operative site.
No
Explanation: The device is described as an electrosurgical generator used for cutting and coagulation at an operative site, which are therapeutic actions, not diagnostic ones. It supplies electrosurgical current to produce a "therapeutic effect."
No
The device description clearly states it is an "electrosurgical generator unit" which is a hardware component that supplies high-frequency current. It also mentions "accessory handpieces" and "accessory electrode," which are also hardware. The summary does not indicate that the device is solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site." This describes a therapeutic device used for surgical procedures, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the electrosurgical generator's function in applying RF current for cutting and coagulation of tissue. This is a direct intervention on the patient's body, not an analysis of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or providing diagnostic information.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The System 2450 is an electrosurgical generator with the basic modes of operation being conventional electrosurgical cutting and coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result. The device consists of an electrosurgical generator unit to supply high frequency (HF) electrosurgical current to accessory handpieces to produce the therapeutic effect. The device utilizes previously cleared/marketed and required accessories.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
CONMED Sabre 2400 ESU, K905654, CONMED System 5000 ESU, K020186, Valleylab Force FX™ ESU, K944602
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
2 = 2 8 2005
sa002
510(k) Premarket Notification CONMED System 2450 ESU
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 21, 2005 |
| Proprietary Name: | CONMED System 2450 ESU |
| Common Name: | Electrosurgical Unit and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories
21 CFR 878.4400
79 GEI |
| Predicate Device: | CONMED Sabre 2400 ESU, K905654, cleared March 18, 1991
CONMED System 5000 ESU, K020186, cleared April 12, 2002
Valleylab Force FX™ ESU. K944602. cleared June 5. 1995 |
Device Description: The System 2450 is an electrosurgical generator with the basic modes of operation being conventional electrosurgical cutting and coagulation. When cutting, the edge of the electrode is drawn across the tissue while electrosurgical energy is being applied. When coagulating, the accessory electrode may be held in contact with the tissue for desiccation or separated from the tissue by distance for fulguration to achieve the desired result. The device consists of an electrosurgical generator unit to supply high frequency (HF) electrosurgical current to accessory handpieces to produce the therapeutic effect. The device utilizes previously cleared/marketed and required accessories.
Intended Use of Device: The System 2450 is a general-purpose electrosurgical generator used in coniunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory electrode for cutting and coagulation at the operative site.
Technological Characteristics: 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, IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-1-8, 60601-1-8, 60601-2-2, Underwriter's Laboratory UL60601-1, Risk Management ISO 14971 and Biocompatibility ISO 10993.
Software for the System 2450 ESU will be validated in accordance with internal ConMed Electrosurgery procedures including the FDA guidance "General Principles of Software Validation". The level of concern for the ConMed System 2450 is "Moderate" as defined in the FDA guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This is based on the following considerations:
- . The System 2450 software will be validated and verified according to documented procedures, which include, but are not limited to System Level Hazard Analysis, peer review of software design and software module testing. All validation and verification activities will be completed prior to commercial distribution;
- . Output characteristics are equivalent to the values for other previously cleared electrosurgical generators;
- . The operator controls the use of the device;
- The device provides alarms for conditions that could pose a risk to the patient; .
- The operator sets the appropriate mode and output settings for the device. ●
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines representing the body and head.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2005
Ms. Pamela Vetter Manager of Regulatory Affairs CONMED Electrosurgery 14603 East Fremont Avenue Centennial, Colorado 80112
Re: K052009
Trade/Device Name: CONMED SYSTEM 2450 ESU Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 21, 2005 Received: July 25, 2005
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
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 (240) 276-0115. 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,
Mark McMillken
Mark N. Melkerson Acting 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): K 0 52 00 9
Device Name: _________________________________________________________________________________________________________________________________________________________________ CONMED SYSTEM 2450 ESU
Indications for Use:
General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of RF (radio frequency) electrosurgical current through an accessory 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)
Mark A. Mikkelsen
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number