(20 days)
Not Found
No
The device description and intended use describe a passive, capacitive return electrode with no mention of computational analysis, algorithms, or learning capabilities.
No
The device is a patient return electrode used in electrosurgery, not a device directly applying therapy. Its function is to complete an electrical circuit to allow an electrosurgical generator to operate, which itself is used for therapeutic procedures (like cutting or coagulating tissue), but the return electrode itself is not the therapeutic component.
No
This device is described as a "reusable patient return electrode" for electrosurgical applications, not a device for diagnosing medical conditions. Its purpose is to complete an electrical circuit during surgery. While a "test wand" is mentioned for checking the electrode's integrity, this is a check of the device itself, not a diagnostic test of a patient.
No
The device description clearly details a physical hardware component (conductive material, dielectric plastic, cable) and its physical interaction with the patient and operating room table. There is no mention of software as the primary or sole component.
Based on the provided information, 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.
- Device Function: The MegaDyne reusable patient return electrode is a component used in electrosurgery. Its function is to safely return the electrical current from the patient back to the electrosurgical unit. It does not analyze any biological samples from the patient.
- Intended Use: The intended use clearly states it's a "general purpose return electrode in any electrosurgical application." This is a therapeutic/surgical application, not a diagnostic one.
- Device Description: The description details its construction and how it's used in the operating room, which aligns with a surgical device, not an IVD.
Therefore, the MegaDyne reusable patient return electrode falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MegaDyne 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 reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. An insulated and strain-relieved two conductor cable connects the device to a standard monopolar electrosurgical unit (ESU). The capacitive patient return electrode is large enough to extend at least half the length and the full width of a typical patient torso. Sizes for both adult and pediatric patients are available. This device is not intended to be attached to the patient. In typical use, this device will lay on an operating room table with the patient laying on top, on the side labeled "patient side". A disposable plastic sheath is placed over the device, which is replaced after each procedure, to allow for easy clean up between patients and to provide a second layer of dielectric protection. A test wand is available as an accessory. The test wand is intended to be used for periodic electrode inspections. The test wand identifies electrical deficiencies in the return electrode outer dielectric laver.
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
Adult and pediatric patients.
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 only current flow from the patient to the return electrode is via capacitive coupling. through the patient-side dielectric plastic sheet. This current density is designed 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 contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site. This device conforms with the applicable sections of AAMI HF-18/1993.
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
510(k) Summary
June 17, 1997
Submitter's Name/Address:
JUL - 8 1997
K 972273
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):
Electrode, Electrosurgical, Patient Return Undetermined 878.4400
Predicate Device:
PolyHesive patient return electrode, manufactured by Valleylab (K822572)
Device Description:
The MegaDyne reusable patient return electrode is constructed of a layer of conductive material, laminated between two sheets of dielectric plastic material. An insulated and strain-relieved two conductor cable connects the device to a standard monopolar electrosurgical unit (ESU). The capacitive patient return electrode is large enough to extend at least half the length and the full width of a typical patient torso. Sizes for both adult and pediatric patients are available.
This device is not intended to be attached to the patient. In typical use, this device will lay on an operating room table with the patient laying on top, on the side labeled "patient side".
MEGADYNE MEDICAL PRODUCTS, INC. 11506 South State Street Draper, Utah 84020 Phone (801) 576-9669 FAX (801) 576-9698 Toll Free (800) 747-6110
Page 26 of 56
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A disposable plastic sheath is placed over the device, which is replaced after each procedure, to allow for easy clean up between patients and to provide a second layer of dielectric protection.
A test wand is available as an accessory. The test wand is intended to be used for periodic electrode inspections. The test wand identifies electrical deficiencies in the return electrode outer dielectric laver.
Device Intended Use:
This device is intended to be used as a general purpose reusable patient return electrode for any standard ESU.
Safety information:
The only current flow from the patient to the return electrode is via capacitive coupling. through the patient-side dielectric plastic sheet. This current density is designed 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 contact area between the electrode and the patient allows for enough current flow for electrosurgery to be performed at the surgical site.
This device conforms with the applicable sections of AAMI HF-18/1993.
MEGADYNE MEDICAL PRODUCTS, INC. 11506 South State Street Draper, Utah 84020 Phone (801) 576-9669 FAX (801) 576-9698 Toll Free (800) 747-6110
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
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
JUL - 8 1997
Re : K972273 Patient Return Electrode Disposable Electrode Sheath Test Wand Regulatory Class: II Product Code: GEI Dated: June 17, 1997 Received: June 18, 1997
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are 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 devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major - « regulations affecting your devices 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 requirement, as set forth in the Quality System Regulation (QS) for Medical
3
Page 2 - Mr. John W. Smith
General regulation (21 CFR Part 820) and that, Devices: 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 devices 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.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, 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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
に
4
Indications for Use Statement
510(k) Number (if known):
Device Name:
MegaDyne reusable patient return electrode
Page 8 of 56
Indications for use:
.
The MegaDyne 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 | K972273 |
| 510(k) Number |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) |