(87 days)
Not Found
No
The device description and intended use describe a passive, reusable patient return electrode with no mention of computational or adaptive capabilities.
No
Explanation: A therapeutic device is used to treat or prevent a disease or condition. This device, a patient return electrode, is part of an electrosurgical system and its purpose is to safely return electrical current from the patient to the electrosurgical unit, not to provide therapy itself.
No
The device is described as a "reusable patient return electrode" for electrosurgical applications, which is a therapeutic rather than diagnostic function. Its purpose is to complete an electrical circuit during surgery, not to diagnose medical conditions.
No
The device description clearly states it is a physical electrode constructed of conductive and dielectric materials with a connecting cable, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MegaDyne Mega 2000™ is a patient return electrode used in electrosurgery. Its function is to safely return the electrical current from the patient back to the electrosurgical generator. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it's a "general purpose return electrode in any electrosurgical application." This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details its construction as a conductive material laminated between dielectric plastic, designed for placement under the patient's torso to facilitate the flow of electrical current. This aligns with the function of a return electrode, not an IVD.
The information provided about the device's function, intended use, and description all point to it being a surgical accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MegaDyne Mega 2000™ reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The MegaDyne Mega 2000™ reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. A two conductor cable to connect the device to a standard monopolar electrosurgical unit (ESU) is connected to the conductive layer of the electrode. This cable is insulated and strain-relieved well inside the device to prevent possible patient or user burns.
The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient.
A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.
The proposed device consists of the same device cleared in K972273, with some minor changes:
- The electrode sheath is no longer a single-use item. The sheath is to be . replaced on at least a daily basis (as a maximum interval between changes).
- Conformance to the minimum capacitance requirement of the ANSI / AAMI ● HF 18 standard is no longer claimed.
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): 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
q82826
510(k) Summary Section XIV
August 6, 1998
A. Sponsor's Name/Address
Matt Sansom Executive VP / COO MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 276-9669 (801) 576-9698 fax
B. Contact Person
John W. Smith Regulatory Consultant 328 M Street Salt Lake City, UT 84103 (801) 532-3334
C. Device Name
| Common Name: | Electrode, Electrosurgical, Patient Return |
|---|---|
| Trade Name: | Mega 2000™ |
| Classification | 21 CFR 878.4400, Electrosurgical cutting and |
| coagulation device and accessories |
D. Predicate Device
Reusable Patient Return Electrode, manufactured by MegaDyne. (K972273)
E. Applicant Device Description
The MegaDyne Mega 2000™ reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. A two conductor cable to connect the device to a standard monopolar electrosurgical unit (ESU) is connected to the conductive layer of the electrode. This cable is insulated and strain-relieved well inside the device to prevent possible patient or user burns.
The electrode is approximately 20'' x 36". This size is large enough to extend at least half the length and full width of the typical patient torso. The device is not intended to be attached to the patient.
1
A clear plastic sheath is placed over the device. This sheath, which is replaced at a minimum each day, provides a second layer of dielectric protection.
The proposed device consists of the same device cleared in K972273, with some minor changes:
- The electrode sheath is no longer a single-use item. The sheath is to be . replaced on at least a daily basis (as a maximum interval between changes).
- Conformance to the minimum capacitance requirement of the ANSI / AAMI ● HF 18 standard is no longer claimed.
F. Applicant Device Intended Use
This device is intended to be used as a general purpose reusable patient return electrode for any standard electrosurgical generator (ESU).
G. Technological Characteristics
The technological characteristics of the proposed device are identical to the predicate device.
H. Safety Information
The only current flow from the patient to the return electrode is via capacitive coupling, through the patient side of the electrode and the plastic sheath. The current density of this capacitively-coupled current flow is design to be less than 100 mA per square inch at an ESU output of 700 mA rms. This low current density prevents the patient from getting return electrode site burns.
The large capacitive contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site.
With the exception of the requirement for minimum capacitance, the device conforms with all applicable sections of ANSI / AAMI HF 18-1993.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
6 1998 NOV
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MegaDyne Medical Products, Inc. c/o Mr. John W. Smith Regulatory Consultant 328 M Street Salt Lake City, Utah 84103
K982826 Re: Mega 2000™ Trade Name: Requlatory Class: II Product Code: GEI Dated: August 06, 1998 Received: August 11, 1998
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
3
Page 2 - Mr. John W. Smith
Product Radiation Control provisions, or other Federal laws or regulations.
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 yours,
fucell
coll
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
Section IV Indications for Use Statement
510(k) Number (if known):
Device Name:
Mega 2000™
Indications for use:
The MegaDyne Mega 2000™ reusable patient return electrode is to be used as a general purpose return electrode in any electrosurgical application in which a standard monopolar electrosurgical generator is used.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K982826 |
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
MegaDyne Medical Products, Inc. 510(k): Mega 2000™ Reusable Patient Return Electrode