(242 days)
No
The device description and performance studies focus on electrical and material properties, with no mention of AI or ML.
No.
The device is a patient return electrode, which is an accessory used in monopolar electrosurgery to safely conduct electrosurgical energy back to the generator, rather than directly providing a therapeutic effect itself.
No
The device is a patient return electrode used in electrosurgery to conduct energy back to a generator, not to diagnose medical conditions.
No
The device description clearly details physical components including conductive material, polymer gel, plastic film, and cables, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device's intended use is to "conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators." This is a function performed on the patient during a surgical procedure, not a test performed on a sample from the patient.
- No Mention of Samples or Testing: The text does not mention any analysis of biological samples, diagnostic testing, or the detection of diseases or conditions.
The device is a patient return electrode used in electrosurgery, which is a therapeutic procedure, not a diagnostic one.
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 device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators.
The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure.
A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.
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
12 years and older
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)
Bench performance testing was conducted to demonstrate equivalency of the subject devices to the predicate devices. The following parameters were evaluated:
- Electrical resistance
- Wear and use
- Cleaning and handling
- Compliance with IEC 60601-1, IEC 60601-1-2
- Compliance with IEC 60601-2-2
Acute animal studies were conducted that evaluated the performance of the Mega Soft Universal Patient Return Electrode in simulated surgical procedures.
- Compliance with IEC 60601-2-2 5th Ed
- Pad orientation
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 12, 2024
Megadyne Medical Products, Inc. Brian Godwin Associate Director, Regulatory Affairs 4545 Creek Road Cincinnati, Ohio 45242
Re: K23364
Trade/Device Name: Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 5, 2024 Received: June 5, 2024
Dear Brian Godwin:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Long H. Chen
Long H. Chen -S-s
Date: 2024.07.12 07:15:22 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
evice Name
| Device Name |
|---|
| Megadyne Patient Return Electrode Pad (Universal Dual (model 0846)); |
| Megadyne Patient Return Electrode Pad (Universal Plus (model 0847)); |
| Megadyne Patient Return Electrode Pad (Universal Plus Dual (model 0848)); |
| Megadyne Patient Return Electrode Pad (Universal (model 0845)) |
| Indications for Use (Describe) |
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.
Type of Use (Select one or both, as applicable)
escription Use (Part 21 CFR 801 Subpart D)
er-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
I. SUBMITTER
Company: Megadyne Medical Products, Inc 4545 Creek Rd Cincinnati, OH 45242
Establishment Registration: 1721194
| Contact: | Brian Godwin
Associate Director, Regulatory Affairs |
|----------|--------------------------------------------------------|
| Phone: | 513-337-3623 |
| Email: | bgodwin@its.jnj.com |
Date Prepared: 13 Nov 2023
II. SUBJECT DEVICES
Trade Name:
- Megadyne Mega Soft Patient Return Electrode Universal (model 0845) ●
- Megadyne Mega Soft Patient Return Electrode Universal Dual (model 0846)
- Megadyne Mega Soft Patient Return Electrode Universal Plus (model 0847) ●
- Megadyne Mega Soft Patient Return Electrode Universal Plus Dual (model 0848) ●
| Common or Usual Name: | Device, electrosurgical & coagulation and accessories | |
|---|---|---|
| Classification Name: | Electrosurgical cutting & coagulation device & accessories | |
| Classification Number: | 21 CFR 878.4400 | |
| Regulatory Class: | II | |
| Product Code: | GEI |
III. PREDICATE DEVICES
| Predicate Device
510(k) Number
| (Clearance Date) | Predicate Device Name | Model |
|---|---|---|
| K133726 | ||
| (24 Jan 2014) | Mega Soft Universal Patient | |
| Return Electrode | 0845 |
This predicate has not been subjected to a recall related to these design modifications.
5
K233644
IV. REFERENCE DEVICES
| Reference Device
510(k) Number
| (Clearance Date) | Reference Device Name | Model |
|---|---|---|
| K031285 | ||
| (19 May 2003) | Mega Soft Dual Cord Patient Return Electrode | 0835 |
| K080741 | ||
| (16 Dec 2008) | Mega Soft Universal Patient Return Electrode | 0840 |
| K183148 | ||
| (05 Feb 2020) | OKLand Patient Return Electrode Pad | AHD-001, AHD-003 |
| AHD-004, AHD-005 | ||
| AHD-006 |
There is no change in the base materials or technological characteristics between the subject Megadyne Mega Soft Patient Return Electrode (models 0845, 0846, 0847, 0848) and the predicate devices Mega Soft Universal Patient Return Electrode model 0845 which was cleared under K133726 on 24 Jan 2014.
V. DEVICE DESCRIPTION
The device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators.
The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure.
A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.
VI. 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.
6
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Technological Characteristics
The Megadyne Mega Soft Patient Return Electrodes (subject devices) have the identical technological characteristics as the predicate device Mega Soft Universal Patient Return Electrode. Both the subject and predicate devices are intended to pass current from the active electrode through the patient's body to the patient return electrode and back to the generator to complete the circuit.
Similarities with the subject devices compared to the predicate devices cleared under K133726 are listed below.
- Indications ●
- Materials ●
- Operational principles
- Packaging ●
- Shelf-Life
The following differences exist between the subject and predicate device, (dependent upon model):
- Intended population ●
- Pad thickness
- Dual cord (model 0846 and 0848) ●
- Model number/tradename
VIII. PERFORMANCE DATA
Bench Performance
Bench performance testing was conducted to demonstrate equivalency of the subject devices to the predicate devices. The following parameters were evaluated:
- Electrical resistance
- Wear and use
- Cleaning and handling ●
- Compliance with IEC 60601-1, IEC 60601-1-2
- Compliance with IEC 60601-2-2
Animal Testing
Acute animal studies were conducted that evaluated the performance of the Mega Soft Universal Patient Return Electrode in simulated surgical procedures.
- Compliance with IEC 60601-2-2 5th Ed
- Pad orientation
7
IX. CONCLUSION
The testing criteria demonstrates that the following subject devices perform and are substantially equivalent to the predicate device, Mega Soft Universal Patient Return Electrode (K133726, model 0845).
- Megadyne Mega Soft Patient Return Electrode Universal (model 0845) ●
- . Megadyne Mega Soft Patient Return Electrode Universal Dual (model 0846)
- Megadyne Mega Soft Patient Return Electrode Universal Plus (model 0847) .
- . Megadyne Mega Soft Patient Return Electrode Universal Plus Dual (model 0848)
The design requirements raise no new questions of safety and effectiveness.