(118 days)
Not Found
No
The summary describes a standard electrosurgical electrode with a special tip geometry for use with a specific generator mode. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is used to perform cutting and coagulation in surgical procedures using radio frequency (RF) current, which directly treats soft tissue.
No
Explanation: The device is described as an electrosurgical electrode intended for cutting and coagulation of soft tissue. Its function is to deliver RF current for surgical procedures, not to diagnose conditions.
No
The device is a physical electrosurgical electrode, a hardware component used in conjunction with an electrosurgical unit. The description details its material, coating, insulation, and various tip configurations, all of which are physical attributes. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are used to "conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures." This describes a device used in vivo (within a living organism) for surgical intervention.
- Device Description: The description details a surgical tool used in conjunction with an electrosurgical pencil and generator to perform cutting and cauterization on soft tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any testing of samples or analysis of biological materials in vitro.
Therefore, the E-Z Clean electrosurgical electrode is a surgical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Megadyne E-Z Clean electrosurgical electrode is a monopolar electrosurgical electrode that is coated with polytetrafluoroethylene (PTFE). It is insulated over the majority of its exposed length. It is intended for general electrosurgical use, and is designed to fit into and work in conjunction with an industry standard hand- or footactivated electrosurgical pencil which is connected to an electrosurgical unit or ESU. This device is supplied sterile and is not intended to be reused.
The E-Z Clean electrosurgical electrodes are available in a number of tip configurations and lengths. Tips such as standard blades, modified blades, needles, blunt needles, ball-ends, and others are typical.
Some tip configurations (ACE blades) contain a slightly different geometry that will enhance the affects of the generator's Advanced Cutting Effect (ACE) Mode. In this mode, the blade will make skin incisions without the blanching or thermal damage commonly seen with standard electrosurgery. The new E-Z Clean ACE Blade provides a wound site that will heal similar to a scalpel wound (comparable Histopathology) when used in conjunction with the ACE mode. When not being used to perform skin incisions the ACE Blade functions as a standard E-Z Clean blade in all cutting and coagulating modes.
This submission also includes the option of a guard or nosecone on some configurations of electrodes. This nose cone provides additional dielectric protection at the junction where the E-Z Clean electrosurgical electrode is connected to an electrosurgical pencil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.
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.
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
16091791
Section 5 510(k) Summary
June 24, 2008
OCT 2 1 2008
- A. Submitter's Name / Address
Ronda K. Magneson Director, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
B. Contact Person
Primary: Ronda K. Magneson Director of Regulatory Affairs Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Alternate: Ihsan Samara Quality Manager Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
C. Megadyne's Manufacturing Facility
Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Megadyne Medical Products, Inc. 510(k): E-Z Clean electrosurgical electrodes Page 11 of 105
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D. Device Name
| Common Name: | Device, electrosurgical, cutting & coagulation &
accessories |
|----------------------------|------------------------------------------------------------------------------------|
| Trade Name: | E-Z Clean electrosurgical electrodes |
| Classification (if known): | 21 CFR 878.4400, Electrosurgical cutting and
coagulation device and accessories |
E. Predicate Devices
The predicate devices include American Medical Products' E-Z Clean Cautery Tip which was cleared for marketing via 510(k) # K862221 by FDA's Office of Device Evaluation on August 11, 1986; and Utah Medical Products' Epitome® Scalpel electrode with ZapGuard™ which was cleared for marketing via 510(k) #K960255 on March 27, 1996.
F. Applicant Device Description
The Megadyne E-Z Clean electrosurgical electrode is a monopolar electrosurgical electrode that is coated with polytetrafluoroethylene (PTFE). It is insulated over the majority of its exposed length. It is intended for general electrosurgical use, and is designed to fit into and work in conjunction with an industry standard hand- or footactivated electrosurgical pencil which is connected to an electrosurgical unit or ESU. This device is supplied sterile and is not intended to be reused.
The E-Z Clean electrosurgical electrodes are available in a number of tip configurations and lengths. Tips such as standard blades, modified blades, needles, blunt needles, ball-ends, and others are typical.
Some tip configurations (ACE blades) contain a slightly different geometry that will enhance the affects of the generator's Advanced Cutting Effect (ACE) Mode. In this mode, the blade will make skin incisions without the blanching or thermal damage commonly seen with standard electrosurgery. The new E-Z Clean ACE Blade provides a wound site that will heal similar to a scalpel wound (comparable Histopathology) when used in conjunction with the ACE mode. When not being used to perform skin incisions the ACE Blade functions as a standard E-Z Clean blade in all cutting and coagulating modes.
This submission also includes the option of a guard or nosecone on some configurations of electrodes. This nose cone provides additional dielectric protection at the junction where the E-Z Clean electrosurgical electrode is connected to an electrosurgical pencil.
G. Applicant Device Intended Use
E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the electrosurgical generator to target soft
Megadyne Medical Products, Inc. 510(k): E-Z Clean electrosurgical electrodes Page 12 of 105
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Image /page/2/Picture/0 description: The image contains handwritten text, with the characters "K081791" visible on the left side, underlined. To the right of this, there are additional handwritten symbols and numbers, including what appears to be a "3" and other indistinct markings. The overall impression is that of a document or note containing a mix of alphanumeric characters and symbols.
tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.
H. Technological Characteristics
The proposed device shares the same technological characteristics found in the predicate devices. It is an electrosurgical electrode intended for electrosurgical cutting and coagulation.
I. Safety information
Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other electrosurgical electrodes on the market. There are no new technologies incorporated into the device.
Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.
Megadyne Medical Products, Inc. 510(k): E-Z Clean electrosurgical electrodes Page 13 of 105
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Megadyne Medical Products, Inc. % Ms. Ronda K. Magneson Director, Regualtory Affairs 11506 South State Street Draper, Utah 84020
OCT 2 1 2008
Re: K081791
Trade/Device Name: E-Z Clean electrosurgical electrosurgical electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 9, 2008 Received: October 10, 2008
Dear Ms. Magneson:
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.
4
Page 2 - Ms. Ronda K. Magneson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KOSi791
$\sigma$ ( $\omega$ $\hat{t}$ )
Section 4 Indications for Use Statement
510(k) Number (if known): K081791
Device Name:
E-Z Clean electrosurgical electrodes
Indications for use:
E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mitred Sormen
(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices
510(k) Number K081791
Prescription Use V
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Megadyne Medical Products, Inc. 510(k): E-Z Clean electrosurgical electrodes
Page 10 of 105