(26 days)
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No
The description focuses on the physical construction and electrical properties of a patient return electrode pad, with no mention of AI or ML algorithms for data processing, analysis, or decision-making. The infrared camera mention is for temperature recording during testing, not for device operation.
No
The device is described as a general-purpose return electrode for electrosurgical generators and a pressure reduction pad, which are not therapeutic functions.
No
The device is a patient return electrode pad used in electrosurgery for current dispersion, not for diagnosing conditions.
No
The device description clearly outlines a physical hardware component (conductive material, urethane, viscoelastic polymer, cables) and its construction, indicating it is not solely software.
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 Mega 2000 Soft Dual Cord Patient Return Electrode Pad is a device used during surgical procedures involving electrosurgery. Its function is to safely return the electrical current from the patient to the electrosurgical generator, preventing burns. It also serves as a pressure reduction pad.
- Intended Use: The intended use clearly states it's a "general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad, in any surgical application." This is a device used on the patient's body during a procedure, not for testing samples from the body.
- Device Description: The description details the physical construction and how it connects to an electrosurgical unit, reinforcing its role in the surgical process.
- Performance Studies: The performance studies focus on safety aspects related to electrical current return (temperature rise, impedance) and pressure reduction, not on diagnostic testing of biological samples.
Therefore, the Mega 2000 Soft Dual Cord Patient Return Electrode Pad is a surgical accessory used in vivo (on the living body) during electrosurgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad, in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.
Product codes
GEI
Device Description
The Mega 2000 Soft Dual Cord is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric layers of a viscoelastic polymer. (The top layer of polymer is thinner than the bottom layer.) The polymer is encapsulated by a layer of urethane film. Two cables connect the conductive layer of the device to two DetachaCable(s)". The DetachaCable(s) are connected to a standard monopolar electrosurgical unit (ESU). The device cables are insulated and strain-relieved well inside the device to prevent patient or user burns.
The 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 ½".
In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".
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
Not Found
Intended User / Care Setting
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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)
Maximum Safe Temperature Rise:
Maximum Safe Temperature Rise was demonstrated, using the method specified by the standard, with human volunteers and two electrosurgical generators. The device is well within the requirements of the standard. (Ref. Appendix A.)
Electrode Contact Impedance:
Conformance with the minimum capacitance requirement was demonstrated through bench testing. Device capacitance was evaluated under several different test setups intended to simulate clinical use. (Ref. Appendix B.)
Both proposed and predicate device performed similarly during the above testing. This device conforms to the applicable sections of AAMI HF-18/2001, under test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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
尚 KO31285
MAY 1 9 2003
Section XIV 510(k) Summary
April 14, 2003
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
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. Device Name
| Common Name: | Electrode, Electrosurgical, Patient Return |
|---|---|
| Trade Name: | Mega 2000 Soft Dual Cord Patient Return Electrode Pad |
| Classification (if known): | 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories |
D. Predicate Device
Mega 2000® Soft Patient Return Electrode Pad manufactured by Megadyne (K021077).
Megadyne Medical Products, Inc. Page 30 of 35 510(k): Mega 2000® Soft Dual Cord Patient Return Electrode Pad
1
2 + 3 K031285
E. Applicant Device Description
The Mega 2000 Soft Dual Cord is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric layers of a viscoelastic polymer. (The top layer of polymer is thinner than the bottom layer.) The polymer is encapsulated by a layer of urethane film. Two cables connect the conductive layer of the device to two DetachaCables". The DetachaCable(s) are connected to a standard monopolar electrosurgical unit (ESU). The device cables are insulated and strain-relieved well inside the device to prevent patient or user burns.
The 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 ½".
In use, this device will lay on an operating room table with the patient lying on top, on the side labeled "patient side".
F. Applicant Device Intended Use
The Mega 2000 Soft Dual Cord Patient Return Electrode Pad is to be used as a general purpose return electrode for one or two electrosurgical generators and/or a pressure reduction pad in any surgical application. Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators.
G. Technological Characteristics
The technological characteristics of the proposed device are similar to the predicate device. The only difference is the addition of a second cord for connection to two different electrosurgical units at the same time during a procedure. Other technological characteristics (capacitive coupling and pressure reduction) are identical to the predicate device.
H. Safety Information
The only current flow from the patient to the Mega2000 Soft Dual Cord Patient Return Electrode Pad is via capacitive coupling. This device is designed to be current limiting (