(126 days)
CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.
The CONMED® Surefit™ Dual Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The CONMED® Surefit™ Dual Dispersive Electrode is to be used on any patient where full skin contact and a suitable placement site can be obtained. Use of this product for unintended applications could lead to an unsafe condition.
The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids.
The provided text is a 510(k) summary for a medical device called the CONMED® Surefit™ Dual Dispersive Electrode. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance results in the context of an AI/ML model for diagnostic or predictive purposes.
Therefore, the specific information requested in the prompt regarding acceptance criteria, studies, sample sizes, expert involvement, and ground truth for an AI/ML model is not present in this document.
However, I can extract the information related to the device's assessment methods:
Acceptance Criteria and Device Performance:
Since this is a submission for a dispersive electrode, the "acceptance criteria" discussed are related to meeting established standards for electrosurgical accessories, rather than performance metrics like sensitivity or specificity for an AI model.
| Acceptance Criteria (Standards Conformance) | Reported Device Performance (Implied) |
|---|---|
| IEC 60601-2-2:2009 Edition 5.0 (Medical Electrical Equipment) | The device's performance conforms to the requirements of this standard. |
| ISO 10993-5: 1999 (Biological Evaluation - Cytotoxicity) | Biological safety of selected components assured through material selection and conformance to this standard. |
| ISO 10993-10: 2002/Amd 1:2006 (Biological Evaluation - Irritation & Hypersensitivity) | Biological safety of selected components assured through material selection and conformance to this standard. |
Explanation of Missing Information:
- Sample sized used for the test set and the data provenance: Not applicable. The document describes compliance with standards, not a test set for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI/ML diagnostic or predictive device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable in the context of an AI/ML model. The "ground truth" here is the adherence to established engineering and biocompatibility standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Key takeaway: This document is a regulatory submission for a medical device that relies on established engineering and biocompatibility standards for its safety and effectiveness, not on an AI/ML model that would have the types of studies described in the prompt. The "acceptance criteria" are therefore compliance with these standards.
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Image /page/0/Picture/0 description: The image shows the logo for Conmed Electrosurgery. The logo consists of a stylized graphic to the left of the word "CONMED" in all caps. Below the word "CONMED" is the word "ELECTROSURGERY" in all caps. The graphic is a square with a curved shape inside of it.
Klooch
510k Summary of Safety and Effectiveness
CONMED® Surefit™ Dual Dispersive Electrode
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. ConMed Electrosurgery is hereby submitting the 510(s) Summary of Safety and Effectiveness for the 510(k) Number _______________________________________________________________________________________________________________________________ as of January 6, 2010.
A. Submitter
ConMed Electrosurgery 14603 E. Fremont Ave. Centennial, Colorado 80112
MAY 1 4 2010
B. Company Contact
Shawn Riedel Vice President, Quality Assurance and Regulatory Affairs 14603 E. Fremont Ave. Centennial, Colorado 80112
Phone: 303-269-8224 Fax: 303-699-9854 e-mail: shawn riedel@es.conmed.com
C. Device Name
| Trade Name: | CONMED® SurefitTM Dual Dispersive Electrode | ||
|---|---|---|---|
| Common Name: | Electrosurgical unit and accessories | ||
| Classification Name: | Electrosurgical Cutting and Coagulation Device and accessories | ||
| Regulation Number: | 21 CFR 878.4400 | Class II | 79 GEI |
| Panel: | General and Plastic Surgery |
D. Predicate Device Name
CONMED® Surefit™ Dual Dispersive Electrode ConMed Electrosurgery 510(k) K002002
E. Device Description
The CONMED® Surefit™ Dual Dispersive Electrode is a single use, non-sterile dispersive electrode with a pre-attached cord. The purpose of the return electrode is to complete the electrosurgical circuit between the generator, the active electrode, and the patient. The CONMED® Surefit™ Dual Dispersive Electrode is to be used on any patient where full skin
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contact and a suitable placement site can be obtained. Use of this product for unintended applications could lead to an unsafe condition.
The surface of the conductive area is covered with a soft, conformable hydro-gel conductive adhesive. The pad also has a non-conductive border adhesive surrounding the entire conductive area to isolated the conductive area from surgical fluids.
F. Intended Use
The CONMED® Surefit™ Dual Dispersive Electrodes is intended for use in surgical procedures in which Electrosurgery equipment with contact quality monitoring system is used.
G. Indications for Use
CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin
H. Technological Characteristics
The technological characteristics of the proposed device are identical to the predicate device.
Safety Information ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
Questions of safety and effectiveness are the same for this device as they are for the predicated devices and other patient return electrodes on the market. There are no new technologies incorporated into the device.
J. Biocompatibility
The biological safety of selected components of the CONMED® Surefit™ Dual Dispersive Electrode has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. These were selected on the basis of Part 1 of ISO 10993-1, "Biological Evaluation of Medical Devices."
K. Performance Testing
Where applicable, specific testing performed was in conformance with the requirements of the following standards:
IEC 60601-2-2:2009 Edition 5.0 2009-02, Medical Electrical Equipment Part 2-2 ISO 10993-5: 1999 Biological Evaluation of Medical Devices - Part 5 Tests for cytotoxicity, in vitro methods
ISO 10993-10: 2002/Amd 1:2006 Biological Evaluation of Medical Devices - Tests for Irritation and delayed-type hypersensitivity
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
MAY 1 4 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Conmed Corporation % Mr. Shawn Riedel Vice President, Quality Assurance and Regulatory Affairs 14603 E. Fermont Avenue Centennial, Colorado 80112
Re: K100047
Trade/Device Name: CONMED® Surefit™ Dual Dispersive Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: April 15, 2010 Received: April 16, 2010
Dear Mr. Riedel:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Shawn Riedel
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CONMED® Surefit™ Dual Dispersive Electrode
Indications for Use:
CONMED® Surefit™ Dual Dispersive Electrodes are designed for use with only those electrosurgical generators equipped with contact quality monitoring systems (i.e. REM™, ARM™, and NESSY, ™etc.) during electrosurgery and provides a path for, RF energy produced at the active electrode to return to the generator. The Surefit™ Dual Dispersive Electrode is for use with all patient populations providing there is sufficient surface area to ensure full contact of the electrode with the patient's skin.
Prescription Use X (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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Pestorative Devices
Page _ of _
510(k) Number K100047
§ 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.