(438 days)
No
The description focuses on the physical and electrical properties of a disposable electrosurgical return electrode and does not mention any AI or ML components.
No
The device, an electrosurgical return electrode, provides a path for radiofrequency energy, but it does not directly treat or diagnose a disease or condition. Its function is supportive to a therapeutic procedure (electrosurgery) rather than being therapeutic itself.
No
The device is described as an electrosurgical return electrode that provides a path for radiofrequency energy to return to a generator. Its purpose is to facilitate an electrosurgical procedure, not to diagnose a condition.
No
The device is a physical electrosurgical return electrode with a cable and conductive adhesive gel, clearly describing hardware components and their function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monopolar electrosurgical procedures for adult patients." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a "dispersive electrode" that provides a path for RF energy during surgery. This is a component used during a medical procedure, not for analyzing a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the realm of a surgical procedure.
N/A
Intended Use / Indications for Use
This disposable electrosurgical return electrode with conductive gel is used in monopolar electrosurgical procedures for adult patients.
This disposable electrosurgical return electrode with conductive adhesive gel is used in monopolar electrosurgical procedures for adult patients.
Product codes
GXD
Device Description
The Abbott Medical Grounding Pad is a dispersive electrode that is designed for use in monopolar electrosurgical procedures in adult patients. It is a single-use, non-sterile and disposable device. The Abbott Medical Grounding Pad is compatible with the IonicRF™ Generator and provides a path for radiofrequency (RF) energy produced at an RF electrode to return to the generator. The Abbott Medical Grounding Pad consists of a grounding pad component (also called a neutral electrode, dispersive electrode or return electrode) and an attached cable. The grounding pad component includes a conductive aluminum foil layer which acts as the neutral electrode that connects back to the generator. The aluminum foil layer is covered with a conductive hydrogel adhesive which is covered with a protective liner while it is packaged.
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 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
Non-clinical testing was performed to confirm that the physical, electrical and biological properties of the Abbott Medical Grounding Pad meet the performance requirements and specifications.
- Biocompatibility: New testing. The hydrogel material with PET liner was evaluated per ISO 10993-1. Testing included cytotoxicity, sensitization and irritation testing. Results: PASS. The hydrogel material with PET liner passed all testing for cytotoxicity, sensitization and irritation.
- EMC and Electrical Product Safety Testing: Leveraged testing based on predicate device. The Cathay Disposable Neutral Electrodes (predicate device) were tested in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2. Results: PASS. The devices met all relevant requirements confirming compliance.
- Grounding Pad Cable Tensile Strength: New testing. Tensile strength of the cable attachment to the grounding pad was evaluated to ensure it meets the product requirements ( $\ge$ 20N). Results: PASS. The devices met the tensile strength requirements of $\ge$ 20N.
- Shelf Life and Operating Environment Testing: New testing. Testing was performed to confirm that the devices met the performance specifications while within the range of the operating environment and at the end of the 2-year shelf life. Results: PASS. The devices met all requirements while within the range of the operating environment and at the end of the 2-year shelf life.
- Usability: New and Leveraged testing. Testing was performed to confirm the usability of the grounding pad as a standalone device and as part of a RF generator system. Results: PASS. The devices met all relevant requirements and confirm that the device is usable when operated as intended.
No clinical studies were required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Abbott Medical Jordan Hanson Project Manager, Regulatory Affairs 5050 Nathan Lane Plymouth, Minnesota 55442
Re: K203293
Trade/Device Name: Abbott Medical Grounding Pad, model RF-DGP-IS Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: December 21, 2021 Received: December 22, 2021
Dear Jordan Hanson:
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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
for Adam Pierce Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Abbott Medical Grounding Pad
Indications for Use (Describe)
This disposable electrosurgical return electrode with conductive gel is used in monopolar electrosurgical procedures for adult patients.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| 510(k) Number: | K203293 |
|---|---|
| 510(k) Type: | Traditional 510(k) |
| Date Prepared: | 21 December 2021 |
| Manufacturer Name & | |
| Address: | Abbott Medical |
| 5050 Nathan Lane North | |
| Plymouth, Minnesota, 55442 | |
| USA | |
| Contact Person: | Jordan Hanson |
| Project Manager, Regulatory Affairs | |
| (972) 309-2113 | |
| jordan.hanson@abbott.com | |
| Device Information | |
| Trade Name: | Abbott Medical Grounding Pad (Model: RF-DGP-IS) |
| Common Name: | Grounding Pad |
| Class: | II |
| Classification Name: | 882.4400 Radiofrequency Lesion Generator |
| Product Code: | GXD |
| Predicate Device: | Cathay Disposable Neutral Electrode (Model: GP202D-AC) |
| Predicate 510(k): | K130027 |
| Device Description: | The Abbott Medical Grounding Pad is a dispersive electrode that is designed for |
| use in monopolar electrosurgical procedures in adult patients. It is a single-use, | |
| non-sterile and disposable device. The Abbott Medical Grounding Pad is | |
| compatible with the lonicRF™ Generator and provides a path for radiofrequency | |
| (RF) energy produced at an RF electrode to return to the generator. | |
| The Abbott Medical Grounding Pad consists of a grounding pad component (also | |
| called a neutral electrode, dispersive electrode or return electrode) and an | |
| attached cable. The grounding pad component includes a conductive aluminum | |
| foil layer which acts as the neutral electrode that connects back to the generator. | |
| The aluminum foil layer is covered with a conductive hydrogel adhesive which is | |
| covered with a protective liner while it is packaged. | |
| Indications for Use: | This disposable electrosurgical return electrode with conductive adhesive gel is |
| used in monopolar electrosurgical procedures for adult patients. |
4
Comparison of Technological Characteristics with the Predicate Device
The predicate device is the Cathay Disposable Neutral Electrode (cleared in K130027). The intended use of the Abbott Medical Grounding Pad and predicate device are the same. Both are electrosurgical return electrodes used in electrosurgical procedures in adult patients.
Based on comparison of intended use and technical characteristics, the Abbott Medical Grounding Pad is similar to the legally marketed predicate device. The only design difference is the different adhesive liner that covers the adhesive while the grounding pad is packaged and is removed before use. A biocompatibility assessment and biocompatibility testing of the patient skin-contacting materials confirm the biological safety of the Abbott Medical Grounding Pad. Bench and electrical testing demonstrate that the grounding pad meets its performance specifications. Any differences between the Abbott Medical Grounding Pad and the predicate device do not raise new questions of the safety and efficacy. Therefore, the Abbott Medical Grounding Pad is substantially equivalent to the predicate device.
| Description | Subject Device
Abbott Medical
Grounding Pad (model:
RF-DGP-IS)
510(k): K203293 | Predicate Device
Cathay Disposable Neutral
Electrode
510(k): K130027 | Discussion |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Common Name | Grounding Pad | Grounding Pad | Same as predicate |
| Class | II | II | Same as predicate |
| Classification
Name | 21 CFR 882.4400:
Radiofrequency Lesion
Generator | 21 CFR 878.4400:
Electrosurgical cutting and
coagulation devices and
accessories | The Abbott Medical Grounding
Pad is compatible only with the
IonicRF Generator, therefore it
is using the same product code |
| Product Code | GXD | GEI | to align with the system it is
intended to be used with. |
| Indications for
Use | This disposable
electrosurgical return
electrode with
conductive adhesive gel
is used in monopolar
electrosurgical
procedures for adult
patients | This disposable neutral
electrode for adult patients
with conductive adhesive
gel is used as neutral
reference during
electrosurgical procedures | The wording of the indications
has updated slightly to align
with verbiage across Abbott's
RF system instructions for use.
The Abbott Medical Grounding
Pad is indicated for monopolar
electrosurgical procedures,
which is a subset of the
indications for the predicate
device. |
| Prescription or
OTC | Prescription | Prescription | Same as predicate |
| Technical Specifications/Characteristics | | | |
| Type of
Conductor | Conductive | Conductive | Same as predicate |
| Conductive
Material | Same | Same | |
| Sterile | No | No | |
| Single Use | Yes | Yes | |
Substantial Equivalence Table
5
| Description | Subject Device
Abbott Medical
Grounding Pad (model:
RF-DGP-IS)
510(k): K203293 | Predicate Device
Cathay Disposable Neutral
Electrode
510(k): K130027 | Discussion |
|-----------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------|
| Electrode
Conductive
Surface Area | 127.8 cm² | Configuration 1:
121 cm²
Configuration 2:
127.8 cm² | Same as predicate
configuration 2 |
| Overall
Dimensions | 203 (±2mm) x 105
(±2mm) | 202mm x 107mm | Similar to predicate |
| Conductive
Adhesive
Material | Conductive adhesive:
Hydrogel | Conductive adhesive:
Hydrogel | Similar to predicate |
| Adhesive Liner | Single-sided silicone
coated PET
(thermoplastic
polyester), clear | Double-sided silicone
coated release paper,
white | Similar to predicate |
Non-clinical Testing Summary
The Abbott Medical Grounding Pad design is identical to the predicate device with the exception of the adhesive liner material. Non-clinical testing was performed to confirm that the physical, electrical and biological properties of the Abbott Medical Grounding Pad meet the performance requirements and specifications. Due to the design similarities, testing using the predicate device is leveraged to support requirements related to identical aspects of the predicate and subject devices. The passing test results demonstrated that the Abbott Medical Grounding Pad meets its product requirements and that no new questions of safety and effectiveness are raised. Testing included the following:
| Test | Leveraged or New
Testing | Test Summary | Results |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | New
The patient skin contacting
hydrogel material with PET
liner was evaluated to
evaluate the
biocompatibility impact of
the change in adhesive
liner material. | The hydrogel material
with PET liner was
evaluated per ISO
10993-1. Testing
included cytotoxicity,
sensitization and
irritation testing. | PASS
The hydrogel material
with PET liner passed
all testing for
cytotoxicity,
sensitization and
irritation. Therefore, the
difference in the
adhesive liner material
does not raise new
questions of safety and
effectiveness. |
| EMC and Electrical
Product Safety
Testing | Leveraged
The design of the subject
and predicate devices is
identical for all electrical | The Cathay Disposable
Neutral Electrodes
(predicate device) were
tested in accordance
with IEC 60601-1. | PASS
The devices met all
relevant requirements
confirming compliance |
| Test | Leveraged or New
Testing | Test Summary | Results |
| | aspects, therefore testing
on the predicate device
applies to the Abbott
Medical Grounding Pad. | 60601-1-2 and IEC
60601-2-2. | with IEC 60601-1, IEC
60601-1-2 and IEC
60601-2-2. |
| Grounding Pad
Cable Tensile
Strength | New
The tensile strength of the
cable attachment to the
grounding pad was
evaluated after aging to
ensure it meets the
product requirements
( $\ge$ 20N). | Tensile strength of the
cable attachment to the
grounding pad was
evaluated to ensure it
meets the product
requirements ( $\ge$ 20N). | PASS
The devices met the
tensile strength
requirements of $\ge$ 20N. |
| Shelf Life and
Operating
Environment
Testing | New
Aging testing was
performed to confirm that
the device meets its
requirements at the end of
shelf-life. Additionally,
operating environment
testing was performed with
the generator system to
confirm functionality in the
operating conditions. The
shelf life and operating
environment of the Abbott
Medical Grounding Pad
are within the ranges for
the predicate device. | Testing was performed
to confirm that the
devices met the
performance
specifications while
within the range of the
operating environment
and at the end of the 2-
year shelf life. | PASS
The devices met all
requirements while
within the range of the
operating environment
and at the end of the 2-
year shelf life. |
| Usability | New and Leveraged
The use of the Abbott
Medical Grounding Pad
falls within the range of
use for the predicate
device and the change to
the adhesive liner does not
impact usability. | Testing was performed
to confirm the usability
of the grounding pad as
a standalone device and
as part of a RF
generator system. | PASS
The devices met all
relevant requirements
and confirm that the
device is usable when
operated as intended. |
6
Clinical Testing
Based on substantial equivalence to the predicate device, clinical studies were not required to establish the safety or effectiveness of the Abbott Medical Grounding Pad.
Statement of Equivalence
Based on comparison of intended use and technical characteristics, the Abbott Medical Grounding Pad is similar to the Cathay Disposable Neutral Electrode. The results of testing confirm that the subject device meet the prescribed product requirements and differences in the subject and predicate device do not raise new questions of safety and effectiveness. Therefore, the Abbott Medical Grounding Pad is substantially equivalent to the predicate device.