(14 days)
Not Found
No
The device description focuses on the physical construction and materials of a patient return electrode pad, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as a "general purpose return electrode" and "pressure reduction pad" for use in surgical applications, specifically with electrosurgical generators, rather than directly treating a disease or condition.
No
The device is described as a return electrode pad and pressure reduction pad for surgical applications, which are therapeutic or supportive functions, not diagnostic ones.
No
The device description clearly outlines physical components such as viscoelastic polymer, urethane material, conductive material, and a cable, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a patient return electrode and/or pressure reduction pad during surgery, specifically for use with electrosurgical generators. This is a therapeutic and surgical support function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of a pad designed to be placed on an operating table with a patient on it. It connects to an electrosurgical generator. This aligns with a surgical accessory, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device's function is to safely return electrical current from the patient during electrosurgery and potentially provide pressure reduction. This is a direct interaction with the patient during a medical procedure, not an in vitro analysis of a sample.
N/A
Intended Use / Indications for Use
The Mega 2000 Soft Patient Return Electrode Pad is to be used as a general purpose return electrode 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 Patient Return Electrode Pad is constructed of a layer of urethane material, and conductive material strain-reneved must a viscoelastic polymer called Akton®. sealed between two asymilieure layers of a +1.0000m layer.) (The top layer of polymer is thinner than the bottom layer, it as the company the (The top layer of polymer is thinner than the so conductor cable connects the least the learned encapsulated by a layer of are to a two conductor DetachaCable"". The conductive layer of the device to a the over on and institution the device to preven DetachaCable is comfected to a starratered 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 The device is harge enos 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
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)
Reference Device(s)
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
K 021077
510(k) Summary Section XIV
February 28, 2002
A. Submitter's Name / Address
Ronda K. Magneson Ronda II. 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: Trade Name: Classification (if known):
Electrode, Electrosurgical, Patient Return Mega 2000 Soft Patient Return Electrode Pad 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories
D. Predicate Devices
Mega2000® Reusable Patient Return Electrode manufactured by Megadyne (K982826) and the Action® Operating Table Pad (K801694).
Page 28 of 33 Megadyne Medical Products, Inc. 510(k): Mega 2000® Soft Patient Return Electrode Pad
1
E. Applicant Device Description
Applicant Device Deserprises
The Mega 2000 Soft Patient Return Electrode Pad is constructed of a layer of
the Mega 2000 Soft Patient Return Electrode Pad is constructed on a The Mega 2000 Soft Faticil Recurn Libers of urethane material, and conductive material strain-reneved must a viscoelastic polymer called Akton®. sealed between two asymilieure layers of a +1.0000m layer.) The Akton polymer is
(The top layer of polymer is thinner than the bottom layer, it as the company the (The top layer of polymer is thinner than the so conductor cable connects the least the learned encapsulated by a layer of are to a two conductor DetachaCable"". The conductive layer of the device to a the over on and institution the device to preven DetachaCable is comfected to a starratered 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 The device is harge enos 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 Patient Return Electrode Pad is to be used as a general The Mega 2000 Soft I atient Ar a pressure reduction pad in any surgical purpose return clectrosurgical use is restricted to use with isolated monopolar electrosurgical generators.
G. Technological Characteristics
The technological characteristics of the proposed device are identical to the predicate devices.
H. Safety information
Burent working of the patient to the Mega2000 Soft Patient Return a The only current now from the poupling. This device is designed to be current Electrode I ad 13 Via capacitire oo aprevent the patient from getting return electrode minting (