CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR by CONMED CORPORATION

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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the CONMED System 2450 ESU, focusing on the acceptance criteria and the study that proves the device meets those criteria:

The provided document is a 510(k) Premarket Notification for the CONMED System 2450 ESU. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant standards. It does not contain information about a clinical study or performance data against specific acceptance criteria in the manner one would typically find for an AI/CADe device.

The "acceptance criteria" presented are primarily compliance with recognized electrical and medical device safety standards, and the "study" is the conformity to these standards and validation of software.

Here's the breakdown based on your request, with an emphasis on what information is not present:

Acceptance Criteria and Device Performance (Based on the provided document)

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Electrical Safety Standards	Designed to comply with: - ANSI/AAMI HF-18 - IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-4, 60601-1-8, 60601-2-2 - UL60601-1
Risk Management	Designed to comply with: - ISO 14971
Biocompatibility	Designed to comply with: - ISO 10993
Software Validation	Validated and verified according to internal ConMed procedures and FDA guidance "General Principles of Software Validation." - Level of concern: "Moderate" - System Level Hazard Analysis, peer review of software design, software module testing performed.
Output Characteristics	Output characteristics are "equivalent to the values for other previously cleared electrosurgical generators."
Operational Control	Operator controls device use and sets mode/output.
Safety Features	Device provides alarms for risky conditions.

Detailed Breakdown of Missing Information for an AI/CADe Device:

Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This is an electrosurgical unit, not an AI/CADe device that uses a "test set" of patient data for performance evaluation. The "tests" relate to electrical and software validation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No such ground truth establishment is described for this type of device. Electrical and software validation involves engineering and quality control experts, but not in the context of diagnostic "ground truth."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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/Not provided. This device is an electrosurgical generator, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. The "software valuation" described is for the operational software of the electrosurgical unit, not a diagnostic algorithm. The device itself is "standalone" in that it performs its intended function (cutting/coagulation) without AI assistance, but this is a fundamental difference in the type of device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided in the traditional sense. For this device, "ground truth" would relate to the correct functioning of the electrosurgical current delivery, safety mechanisms, and adherence to electrical engineering specifications, validated through laboratory testing and engineering analysis rather than medical consensus or pathology.
The sample size for the training set:
- Not applicable/Not provided. This device does not use machine learning or AI models developed with "training sets" of data.
How the ground truth for the training set was established:
- Not applicable/Not provided.

In summary:

The provided 510(k) submission for the CONMED System 2450 ESU demonstrates its safety and effectiveness primarily through showing substantial equivalence to previously cleared predicate devices and by stating compliance with relevant national and international electrical safety, risk management, and biocompatibility standards. It also details the software validation procedures undertaken to ensure its proper functioning.

The document does not describe clinical performance studies, AI algorithm validation, or the use of patient data sets for training or testing, as it is an electrosurgical generator and not a diagnostic AI/CADe device. The "acceptance criteria" are compliance with engineering standards and safe operational characteristics.

Summary

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2 = 2 8 2005

sa002

510(k) Premarket Notification CONMED System 2450 ESU

Summary of Safety and Effectiveness

Submitted by:	CONMED Electrosurgery Division14603 East Fremont AvenueCentennial, CO 80112 USATelephone: 303-699-7600Facsimile: 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 accessories21 CFR 878.440079 GEI
Predicate Device:	CONMED Sabre 2400 ESU, K905654, cleared March 18, 1991CONMED System 5000 ESU, K020186, cleared April 12, 2002Valleylab 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. ●

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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.

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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

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510(k) Number (if known): K 0 52 00 9

Device Name: _________________________________________________________________________________________________________________________________________________________________ CONMED SYSTEM 2450 ESU

Indications for Use:

Prescription Use
(Per 21 CFR 801.109)

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

Regulation Number and Section

§ 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.