(117 days)
CONMED® Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® 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® Macrolyte® 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® Macrolyte® 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.
There are 9 models of the CONMED® Macrolyte® Dispersive Electrode.
The provided document is a 510(k) summary for the CONMED® Macrolyte® Dispersive Electrode. It details the device's description, intended use, and technological characteristics, and states that its safety and effectiveness are established by comparison to a predicate device.
However, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trials or performance validation reports.
Instead, it relies on the concept of "substantial equivalence" to a predicate device (CONMED® Macrolyte® Dispersive Electrode, 510(k) K100686), and conformance with recognized standards.
Therefore, I cannot populate the table or answer most of the questions using the provided text. I can only infer what information is not present.
Here's what I can glean or explicitly state based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in the document. The document states that "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." This implies that the acceptance criteria are implicitly met by being substantially equivalent to the predicate, rather than through a dedicated performance study with explicit metrics.
2. Sample size used for the test set and the data provenance
- Not provided in the document. There is no mention of a test set, sample size, or data provenance for a study proving acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No test set or ground truth establishment by experts is described for performance evaluation.
4. Adjudication method for the test set
- Not applicable. No test set or adjudication method is described.
5. 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
- No. This device is an electrosurgical dispersive electrode, not an AI-powered diagnostic device. Therefore, an MRMC study with human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is hardware (an electrosurgical electrode), not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used
- Not applicable. No specific ground truth is mentioned as the basis for performance evaluation beyond comparison to a predicate device and adherence to industry standards for electrosurgical equipment (IEC 60601-2-2) and biocompatibility (ISO 10993).
8. The sample size for the training set
- Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth establishment for it is mentioned.
Summary based on the provided text:
The document primarily focuses on establishing "substantial equivalence" to a previously cleared predicate device and conformity to relevant electrical and biocompatibility standards. It does not describe a new performance study with specific acceptance criteria that the device was tested against.
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Image /page/0/Picture/0 description: The image shows the logo for Conmed Electrosurgery. The logo features a stylized graphic to the left of the text "CONMED" in large, bold letters. Below the text "CONMED" is the word "ELECTROSURGERY" in a smaller font. The logo is black and white.
K120476 PAGE I OF 2
JUN 1 2 2012
510k Summary of Safety and Effectiveness
CONMED® Macrolyte® 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 February 8, 2012.
A. Submitter
ConMed Electrosurgery 14603 E. Fremont Ave. Centennial, Colorado 80112
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: shawnriedel@conmed.com
C. Device Name
| Trade Name: | CONMED® Macrolyte® 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® Macrolyte® Dispersive Electrode ConMed Electrosurgery 510(k) K100686
E. Device Description
The CONMED® Macrolyte® 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® Macrolyte® 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.
There are 9 models of the CONMED® Macrolyte® Dispersive Electrode.
F. Intended Use
The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
G. Indications for Use
CONMED® Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® 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. Both devices are intended for single use.
-Safety Information
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® Macrolyte® 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Conmed Corporation % Mr. Shawn Riedel VP. Quality Assurance and Regulatory Affairs 14603 East Fremont Avenue Centennial, Colorado 80112
JUN 1 2 2012
Re: K120476.
Trade Name: CONMED® Macrolyte® Dispersive Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: May 22, 2012 Received: May 25, 2012
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, listing 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/CDRH0ffices/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/ReportaProblem/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 yours,
Mark A. Millman
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® Macrolyte® Dispersive Electrode
Indications for Use:
CONMED® Macrolyte® Dispersive Electrodes are designed for use with electrosurgical generators during electrosurgery and provide a path for, RF energy produced at the active electrode to return to the generator. The CONMED® Macrolyte® 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 Restorative Devices
Page of
510(k) Number K120476
§ 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.