(63 days)
Not Found
No
The device description and intended use are for a simple electrosurgical electrode, and there is no mention of AI or ML in the provided text.
No
The device is described as an electrosurgical electrode used for cutting and coagulation during surgical procedures, which are interventional actions rather than therapeutic ones aimed at restoring health.
No
The device is an electrosurgical electrode used for cutting and coagulation during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical electrode made of stainless steel with insulation, designed to conduct energy from an electrosurgical unit. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical procedures which requires electrosurgical cutting and/or coagulation." This describes a device used during a surgical procedure on a patient's tissue, not a device used to test samples outside of the body to diagnose a condition.
- Device Description: The description details a surgical electrode that conducts energy to tissue. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to perform a surgical action (cutting and coagulation) directly on tissue.
N/A
Intended Use / Indications for Use
This device is intended to be used in any application which requires electrosurgical cutting or coagulation.
The MegaDyne uncoated electrode is indicated for use in any surgical procedure which requires electrosurgical cutting and/or coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The MegaDyne uncoated electrosurgical electrode is very similar to other, commercially available, stainless steel electrodes. It is used in various electrosurgical procedures, in conjunction with a hand- or foot-activated "pencil", which is connected to a standard electrosurgical unit (ESU).
The device consists of a formed stainless steel rod, insulated over most of its length by polyolefin insulation. The flat, or blade, end of the electrode conducts energy from a standard high-frequency electrosurgical generator to the target tissue. The round end fits into a standard electrosurgical handpiece. Various electrode configurations, such as blade, needle, and ball ends are available in assorted lengths from 2.5" to 8" overall. The blade, needle, and ball configurations are all identical to currently available uncoated stainless steel electrodes on the U.S. market.
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)
The Electrosurgical Electrode conforms with the relevant clause of ANSI / AAMI HF18 -1993: 4.3.5.4, Dielectric withstand of accessories.
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
Image /page/0/Picture/0 description: The image shows a logo with the letters "MMP" in a bold, sans-serif font. The letters are arranged horizontally and enclosed within an oval shape. The logo appears to be a low-resolution image, with some pixelation and jagged edges visible. The overall impression is of a simple, recognizable brand mark.
K973346
NOV - 7 1997
510(k) Summary
September 4, 1997
Submitter's Name/Address:
John W. Smith Director of Regulatory Affairs / Quality Assurance MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669
(801) 576-9698 fax
Contact Person:
Same as above
Device Name:
Common Name: Trade Name: Classification (if known): Electrosurgical Electrode Not Yet Determined 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
Predicate Device:
Electrosurgical Blade, manufactured by National Wire and Stamping (K861495)
Applicant Device Description:
The MegaDyne uncoated electrosurgical electrode is very similar to other, commercially available, stainless steel electrodes. It is used in various electrosurgical procedures, in conjunction with a hand- or foot-activated "pencil", which is connected to a standard electrosurgical unit (ESU).
The device consists of a formed stainless steel rod, insulated over most of its length by polyolefin insulation. The flat, or blade, end of the electrode conducts energy from a standard high-frequency electrosurgical generator to the target tissue. The round end fits into a standard electrosurgical handpiece. Various electrode configurations, such as blade, needle, and ball ends are available in assorted lengths from 2.5" to 8" overall. The blade, needle, and ball configurations are all identical to currently available uncoated stainless steel electrodes on the U.S. market.
MegaDyne Uncoated Blade 510(k)
Page 18 of 29
MEGADYNE MEDICAL PRODUCTS, INC. 11506 South State Street Draper, Utah 84020 Phone (801) 576-9669 FAX (801) 576-9698 Toll Free (800) 747-6110
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "MMP" in a stylized, bold font. The letters are arranged horizontally within an oval shape. The logo has a distressed or textured appearance, giving it a vintage or worn look. The background is white, and the letters are black.
Applicant Device Intended Use:
This device is intended to be used in any application which requires electrosurgical cutting or coagulation.
ਸ
Technological Characteristics:
| Component/ Feature | MegaDyne's
Electrosurgical
Electrode | Predicate Device:
Electrosurgical Blade
(K861495) |
|-------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended use | to be used in any
application which
requires electrosurgical
cutting or coagulation | same |
| Electrode Material | 300 series stainless steel | same |
| Insulation Material | Polyolefin | unknown |
| Configurations available | Blade, needle, and ball
end electrode | same |
| Compatibility | Standard 3/32" shaft | same |
| Single use | yes | same |
| Conforms with ANSI / AAMI HF
18 - 1993 | yes | unknown |
Performance Data:
The Electrosurgical Electrode conforms with the relevant clause of ANSI / AAMI HF18 -1993: 4.3.5.4, Dielectric withstand of accessories.
MEGADYNE MEDICAL PRODUCTS, INC. 11506 South State Street Draper, Utah 84020 Phone (801) 576-9669 FAX (801) 576-9698 Toll Free (800) 747-6110
MegaDyne Uncoated Blade 510(k)
Page 19 of 29
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans. The text "AN SERVICES USA" is also included in the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John W. Smith 'Director of Regulatory Affairs and Quality Assurance MegaDyne Medical Products, Inc. 11506 South State Street Draper, Utah 84020
NOV - 7 1997
Re: K973346 Trade Name: Electrosurgical Electrode Regulatory Class: II Product Code: GEI Dated: September 3, 1997 Received: September 5, 1997
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. John W. Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
KaJ3342
Device Name:
Electrosurgical Electrode
Indications for use:
The MegaDyne uncoated electrode is indicated for use in any surgical procedure which requires electrosurgical cutting and/or coagulation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K973346 |
|---|---|
| --------------- | --------- |
| Prescription Use ✗
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------------------------------- | ---- | ----------------------------- |
MegaDyne Uncoated Blade 510(k)
Page 8 of 29