(49 days)
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No
The document describes a passive patient return electrode for electrosurgery and does not mention any AI or ML components or functionalities.
No.
The device is a patient return electrode, designed to conduct electrosurgical energy back to the ESU, not deliver therapeutic energy or directly treat a disease or condition.
No
The device is described as a patient return electrode used to conduct electrosurgical energy back to an electrosurgical unit, not to diagnose medical conditions.
No
The device description clearly details a physical pad constructed of multiple layers of materials, including conductive material, urethane, and a viscoelastic polymer, connected by a cable. This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to conduct monopolar electrosurgical energy from a patient's tissue back to an electrosurgical unit. This is a therapeutic and surgical function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a physical pad designed to be placed on the operating surface with the patient lying on it. This is a device used on the patient during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro to diagnose a condition.
The device is clearly designed for use during electrosurgery, which is a medical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
This device is designed to be used whenever monopolar electrosurgery 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.
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 MegaSoft Universal Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two symmetric layers of a viscoelastic polymer called Akton® The Akton polymer is encapsulated by a layer of urethane film. One twoconductor cable 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 either side of the pad.
The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
patients weighing ≥ 0.8 lb (350 grams)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Megadyne has conducted extensive testing to ensure conformance to the following voluntary standards:
IEC 60601-1:2005, Medical electrical equipment, Part 1: General requirements for safety and essential performance
IEC 60601-2-2:2009, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
K133726 Paqe 1 of 3
JAN 2 4 2014
Section 4 510(k) Summary
December 4, 2013
A. Submitter's Name / Address
Ronda K. Magneson Director, Regulatory Affairs Megadyne Medical Products, Inc: 11506 South State Street Draper, UT 84020 (801) 576-9669 (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 rmagneson@megadyne.com (801) 576-9669 (801) 576-9698 fax
Alternate:
Katie Hoff Regulatory Affairs Specialist II Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 khoff(@megadyne.com (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
D. Device Name
| Common Name: | Device, electrosurgical, cutting & coagulation &
accessories |
|----------------------------|------------------------------------------------------------------------------------|
| Trade Name: | MegaSoft Universal Patient Return Electrode |
| Classification (if known): | 21 CFR 878.4400, Electrosurgical cutting and
coagulation device and accessories |
Megadyne Medical Products, Inc. 510(k): Mega Soft Universal Reusable Patient Return Electrode Page 12 of 64
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E. Predicate Devices
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The predicate device is Megadyne's Mega Soft Return Electrode Pad which was cleared for marketing via 510(k) # K080741 by FDA's Office of Device Evaluation on December 12, 2008
F. Applicant Device Description
The MegaSoft Universal Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two symmetric layers of a viscoelastic polymer called Akton® The Akton polymer is encapsulated by a layer of urethane film. One twoconductor cable 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 either side of the pad.
The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).
G. Applicant Device Intended Use
The intended use of the MegaSoft Universal Patient Return Electrode is to conduct monopolar electrosurgical energy from target tissue of a patient back to an electrosurgical unit (ESU), or generator.
This device is intended to be used whenever monopolar electrosurgy is indicated. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.
H. Technological Characteristics
The proposed device shares the same technological characteristics found in the Megadyne predicate devices.
I. Safety information
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The only current flow from the patient to the MegaSoft Universal Patient Return Electrode Pad is via capacitive coupling. This device is designed to be current limiting (