(17 days)
Not Found
No
The description focuses on standard electrosurgical generator technology and microprocessor control, with no mention of AI or ML.
No
This device generates RF current for cutting and coagulation of tissue during surgery, which is a surgical tool function, not a therapeutic intervention aimed at treating disease or improving health outcomes.
No
This device is an electrosurgical generator used for cutting and coagulation of tissue, not for diagnosing medical conditions.
No
The device description clearly states it is a "high frequency generator" and a "microprocessor controlled, isolated output" device, indicating it is a hardware device that produces RF current.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures." This describes a surgical device used directly on a patient's tissue, not a device used to test samples (like blood, urine, or tissue biopsies) in vitro (outside the body).
- Device Description: The description reinforces this by stating it's a "high frequency generator designed for use in cutting and coagulating of tissue."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to surgically alter tissue directly.
N/A
Intended Use / Indications for Use
General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.
Product codes
GEI
Device Description
The Megadyne MEGA Power Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulating of tissue. The Generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Valleylab Force FXc (K944602)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 2 4 2005
050579
Section XV 510(k) Summary
February 9, 2005
A. Submitter's Name / Address
Ronda K. Magneson Manager, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Page 1 of 2
B. Contact Person
Primary: Ronda K. Magneson Manager of Regulatory Affairs / Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Alternate: Ihsan Samara Compliance Engineer 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): Mega Power Electrosurgical Generator
1
Page 2 of (2)
D. Device Name
Common Name:
Trade Name: Classification (if known):
Device, electrosurgical, cutting & coagulation & accessories MEGA Power 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
E. Predicate Device
Valleylab Force FXc (K944602).
F. Applicant Device Description
The Megadyne MEGA Power Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulating of tissue. The Generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.
G. Applicant Device Intended Use
General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.
H. Technological Characteristics
The operating principle of the proposed device is identical to the predicate device.
The proposed device conforms to the applicable sections of AAMI HF 18:2001, IEC 60601-1:2003 IEC 60601-2-2:1998 and IEC 60601-1-2:2001.
I. Safety information
Questions of safety and effectiveness are the same for this device as they are for the other electrosurgical generators on the market.
The proposed device conforms to the applicable sections of AAMI HF 18:2001, IEC 60601-1:2003 IEC 60601-2-2:1998 and IEC 60601-1-2:2001.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of a staff with two snakes coiled around it, and a pair of wings at the top.
MAR 2 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Megadyne Medical Products, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K050579
Trade/Device Name: MEGA Power™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 3, 2005 Reccived: March 7, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cholosale) to regars the Medical Device Amendments, or 10 commerce prior to May 20, 1978, the enaonance with the provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). alle Cosmetic rearly that do not require and controls provisions of the Act. The I ou may, merciole, manel the act include requirements for annual registration. Iisting of general controll pro receive, 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 If your device is classined (soc aborto) als. Existing major regulations affecting your device can Ifray be subject to suell additions, 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 r lease be advised that i Dri- 3 issuance over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I edetar statutes and regisments, including, but not limited to: registration and listing (21 Comply with an the Hot 87043FR Part 801); good manufacturing practice requirements as set OF IT att 6077, laboring (21 OFF egulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Mr. Mark Job
This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will allow you to begin marketing your avice of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device than premarket notification. The FDA inding of substantal equive and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), please
r the results of the man 2012 11:54 at has and as a regulation entitled If you desire specific advice for your device at (240) 276-0115. Also, please note the regulation entitled. contact the Office of Complanes at (210) 2017 - 12 (21CFR Part 807.97). You may obtain " Misbranding by reference to premance noutitean.org other general information on your responsions and its toll-free number (800) 638-2041 or and Manufacturers, International and Consumer Assistance arovedrh/industry/support/index.html.
Sincerely yours,
Elaine, M.D. Ph.D.
Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section IV Indications for Use Statement
510(k) Number (if known):
Device Name:
MEGA Power™
Indications for use:
General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use ___________
Concurrence of CDRH, Office of Device Evaluation (ODE)
Big
ion of G Restorative
rological Sciences
Kosos79
Megadyne Medical Products, Inc. Megadyne Medical Products, Integrosurgical Generator Page 8 of 74