(274 days)
Not Found
No
The description focuses on the physical construction and function of a patient return electrode for electrosurgery, with no mention of AI or ML capabilities.
No
The primary function of this device is to conduct electrosurgical energy and reduce the risk of pressure injury, not to provide therapeutic treatment for an ailment or condition.
No
The device is described as an electrosurgical accessory used to return electrosurgical energy to the generator and reduce pressure-related injury during surgery. Its function is therapeutic/supportive, not diagnostic.
No
The device description clearly outlines a physical product constructed of multiple material layers, including conductive material, urethane, and a viscoelastic polymer, with connecting cables. This is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to conduct monopolar electrosurgical energy from the patient back to the electrosurgical unit and reduce the risk of pressure-related injury. This is a therapeutic and safety function related to a surgical procedure.
- Device Description: The description details the physical construction of a patient return electrode, which is a component used in electrosurgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing biological samples outside the body to gain diagnostic or other medical information. This device operates on the patient during a surgical procedure.
N/A
Intended Use / Indications for Use
This device is designed to be used whenever monopolar electrosurgy is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. At the same time the product reduces the risk of pressure related injury due to immobility during surgery.
Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Mega Soft Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric lavers of a viscoelastic polymer called Akton . (The top layer of polymer is thinner than the bottom layer.) The Akton polymer is encapsulated by a layer of urethane film. One or two two-conductor cables connects the conductive layer of the device to a two conductor DetachaCable". The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on top, on the side labeled "patient side".
The adult-size device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x 1/2". The pediatricsize device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.
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
The pediatric-size device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.
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.
K021077, K031285, K994428, K063161
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
DEC 1 6 2008
510(k) Summary Section 5
December 15, 2008
A. Submitter's Name / Address
Ronda K. Magneson Director, Regulatory Affairs Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 276-9669 (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) 276-9669 (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
D. Device Name
Common Name:
Device, electrosurgical, cutting & coagulation & accessories
Trade Name:
Classification (if known):
21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
Mega Soft Patient Return Electrode
Megadyne Medical Products, Inc. 510(k): Mega Soft Reusable Patient Return Electrode Page 11 of 54
1
E. Predicate Devices
The predicate devices include:
Megadyne's Mega 2000™ Soft Patient Return Electrode Pad which was cleared for marketing via 510(k) # K021077 by FDA's Office of Device Evaluation on April 17, 2002;
Megadyne's Mega 2000™ Soft Dual Cord Patient Return Electrode Pad which was cleared for marketing via 510(k) # K031285 by FDA's Office of Device Evaluation on May 19, 2003;
Valleylabs E7512 Neonatal REM Polyhesive II Patient Return which was cleared for marketing via 510(k) #K994428 by FDA's Office of Device Evaluation on March 7, 2000; and
Leonard Lang's Skintact® Cool Contact Electrosurgical Grounding Plates with NH 04 gel which was cleared for marketing via 510(k) # K063161 by FDA's Office of Device Evaluation on November 26, 2006.
F. Applicant Device Description
The Mega Soft Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric lavers of a viscoelastic polymer called Akton . (The top layer of polymer is thinner than the bottom layer.) The Akton polymer is encapsulated by a layer of urethane film. One or two two-conductor cables connects the conductive layer of the device to a two conductor DetachaCable". The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on top, on the side labeled "patient side".
The adult-size device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x 1/2". The pediatricsize device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.
G. Applicant Device Intended Use
The intended use of the Mega Soft Patient Return Electrode is to conduct monopolar electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator. At the same time, the product reduces the risk of pressure related injury due to immobility during surgery.
This device is intended to be used whenever monopolar electrosurgy is indicated. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not indicated for RF ablation.
Megadyne Medical Products, Inc.
510(k): Mega Soft Reusable Patient Return Electrode
Page 12 of 54
2
H. Technological Characteristics
The proposed device shares the same technological characteristics found in the Megadyne predicate devices.
I. Safety information
Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other patient return 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): Mega Soft Reusable Patient Return Electrode Page 13 of 54
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, rendered in a stylized manner.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DFC 1 6 2008
Megadyne Medical Products, Inc. % Ms. Ronda K. Magneson Director. Regulatory Affairs 11506 South State Street Draper, Utah 84020
Re: K080741
Trade/Device Name: Mega Soft® Reusable Patient Return Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 10, 2008 Received: December 12, 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 Compliation 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 Prosmarket 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 vours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 Indications for Use Statement
K080741 510(k) Number (if known):
Device Name:
Mega Soft® Reusable Patient Return Electrode
Indications for use:
This device is designed to be used whenever monopolar electrosurgy is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. At the same time the product reduces the risk of pressure related injury due to immobility during surgery.
Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R. Gode for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K080741
Prescription Use V
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Megadyne Medical Products, Inc. 510(k): Mega Soft Reusable Patient Return Electrode
Page 10 of 54