Abbott Medical Grounding Pad, model RF-DGP-IS

K203293 · ABBOTT MEDICAL · GXD · Jan 21, 2022 · Neurology

Device Facts

• Record ID: K203293
• Device Name: Abbott Medical Grounding Pad, model RF-DGP-IS
• Applicant: ABBOTT MEDICAL
• Product Code: GXD · Neurology
• Decision Date: Jan 21, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2

Intended Use

This disposable electrosurgical return electrode with conductive adhesive gel is used in monopolar electrosurgical procedures for adult patients.

Device Story

Abbott Medical Grounding Pad (RF-DGP-IS) is a single-use, non-sterile dispersive electrode; provides return path for RF energy from electrode to IonicRF Generator during monopolar electrosurgical procedures. Device consists of conductive aluminum foil layer, conductive hydrogel adhesive, and attached cable. Used in clinical settings by healthcare professionals. Before use, protective liner is removed; pad is applied to patient skin. Conductive hydrogel ensures electrical contact. Output is electrical return path; facilitates safe RF energy delivery, minimizing risk of thermal injury at return site. Benefits patient by enabling controlled tissue lesioning/coagulation.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including biocompatibility (cytotoxicity, sensitization, irritation), electrical safety (IEC 60601-1, 60601-1-2, 60601-2-2), cable tensile strength, and shelf-life/environmental performance testing.

Technological Characteristics

Conductive aluminum foil electrode; conductive hydrogel adhesive; single-use; non-sterile. Dimensions: 203mm x 105mm. Adhesive liner: silicone-coated PET. Compatible with IonicRF Generator. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Indications for Use

Indicated for adult patients undergoing monopolar electrosurgical procedures as a return electrode for RF energy.

Regulatory Classification

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.

Predicate Devices

• Cathay Disposable Neutral Electrode (K130027)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K203293

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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# 510(k) Summary

| 510(k) Number: | K203293 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Type: | Traditional 510(k) |
| Date Prepared: | 21 December 2021 |
| Manufacturer Name &<br>Address: | Abbott Medical<br>5050 Nathan Lane North<br>Plymouth, Minnesota, 55442<br>USA |
| Contact Person: | Jordan Hanson<br>Project Manager, Regulatory Affairs<br>[phone]<br>[e-mail] |
| 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<br>use in monopolar electrosurgical procedures in adult patients. It is a single-use,<br>non-sterile and disposable device. The Abbott Medical Grounding Pad is<br>compatible with the lonicRF™ Generator and provides a path for radiofrequency<br>(RF) energy produced at an RF electrode to return to the generator.<br>The Abbott Medical Grounding Pad consists of a grounding pad component (also<br>called a neutral electrode, dispersive electrode or return electrode) and an<br>attached cable. The grounding pad component includes a conductive aluminum<br>foil layer which acts as the neutral electrode that connects back to the generator.<br>The aluminum foil layer is covered with a conductive hydrogel adhesive which is<br>covered with a protective liner while it is packaged. |
| Indications for Use: | This disposable electrosurgical return electrode with conductive adhesive gel is<br>used in monopolar electrosurgical procedures for adult patients. |

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#### 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<br>Abbott Medical<br>Grounding Pad (model:<br>RF-DGP-IS)<br>510(k): K203293 | Predicate Device<br>Cathay Disposable Neutral<br>Electrode<br>510(k): K130027 | Discussion |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Common Name | Grounding Pad | Grounding Pad | Same as predicate |
| Class | II | II | Same as predicate |
| Classification<br>Name | 21 CFR 882.4400:<br>Radiofrequency Lesion<br>Generator | 21 CFR 878.4400:<br>Electrosurgical cutting and<br>coagulation devices and<br>accessories | The Abbott Medical Grounding<br>Pad is compatible only with the<br>IonicRF Generator, therefore it<br>is using the same product code |
| Product Code | GXD | GEI | to align with the system it is<br>intended to be used with. |
| Indications for<br>Use | This disposable<br>electrosurgical return<br>electrode with<br>conductive adhesive gel<br>is used in monopolar<br>electrosurgical<br>procedures for adult<br>patients | This disposable neutral<br>electrode for adult patients<br>with conductive adhesive<br>gel is used as neutral<br>reference during<br>electrosurgical procedures | The wording of the indications<br>has updated slightly to align<br>with verbiage across Abbott's<br>RF system instructions for use.<br>The Abbott Medical Grounding<br>Pad is indicated for monopolar<br>electrosurgical procedures,<br>which is a subset of the<br>indications for the predicate<br>device. |
| Prescription or<br>OTC | Prescription | Prescription | Same as predicate |
| Technical Specifications/Characteristics | | | |
| Type of<br>Conductor | Conductive | Conductive | Same as predicate |
| Conductive<br>Material | Same | Same | |
| Sterile | No | No | |
| Single Use | Yes | Yes | |

#### Substantial Equivalence Table

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| Description | Subject Device<br>Abbott Medical<br>Grounding Pad (model:<br>RF-DGP-IS)<br>510(k): K203293 | Predicate Device<br>Cathay Disposable Neutral<br>Electrode<br>510(k): K130027 | Discussion |
|-----------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------|
| Electrode<br>Conductive<br>Surface Area | 127.8 cm² | Configuration 1:<br>121 cm²<br>Configuration 2:<br>127.8 cm² | Same as predicate<br>configuration 2 |
| Overall<br>Dimensions | 203 (±2mm) x 105<br>(±2mm) | 202mm x 107mm | Similar to predicate |
| Conductive<br>Adhesive<br>Material | Conductive adhesive:<br>Hydrogel | Conductive adhesive:<br>Hydrogel | Similar to predicate |
| Adhesive Liner | Single-sided silicone<br>coated PET<br>(thermoplastic<br>polyester), clear | Double-sided silicone<br>coated release paper,<br>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<br>Testing | Test Summary | Results |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | New<br>The patient skin contacting<br>hydrogel material with PET<br>liner was evaluated to<br>evaluate the<br>biocompatibility impact of<br>the change in adhesive<br>liner material. | The hydrogel material<br>with PET liner was<br>evaluated per ISO<br>10993-1. Testing<br>included cytotoxicity,<br>sensitization and<br>irritation testing. | PASS<br>The hydrogel material<br>with PET liner passed<br>all testing for<br>cytotoxicity,<br>sensitization and<br>irritation. Therefore, the<br>difference in the<br>adhesive liner material<br>does not raise new<br>questions of safety and<br>effectiveness. |
| EMC and Electrical<br>Product Safety<br>Testing | Leveraged<br>The design of the subject<br>and predicate devices is<br>identical for all electrical | The Cathay Disposable<br>Neutral Electrodes<br>(predicate device) were<br>tested in accordance<br>with IEC 60601-1. | PASS<br>The devices met all<br>relevant requirements<br>confirming compliance |
| Test | Leveraged or New<br>Testing | Test Summary | Results |
| | aspects, therefore testing<br>on the predicate device<br>applies to the Abbott<br>Medical Grounding Pad. | 60601-1-2 and IEC<br>60601-2-2. | with IEC 60601-1, IEC<br>60601-1-2 and IEC<br>60601-2-2. |
| Grounding Pad<br>Cable Tensile<br>Strength | New<br>The tensile strength of the<br>cable attachment to the<br>grounding pad was<br>evaluated after aging to<br>ensure it meets the<br>product requirements<br>( $\ge$ 20N). | Tensile strength of the<br>cable attachment to the<br>grounding pad was<br>evaluated to ensure it<br>meets the product<br>requirements ( $\ge$ 20N). | PASS<br>The devices met the<br>tensile strength<br>requirements of $\ge$ 20N. |
| Shelf Life and<br>Operating<br>Environment<br>Testing | New<br>Aging testing was<br>performed to confirm that<br>the device meets its<br>requirements at the end of<br>shelf-life. Additionally,<br>operating environment<br>testing was performed with<br>the generator system to<br>confirm functionality in the<br>operating conditions. The<br>shelf life and operating<br>environment of the Abbott<br>Medical Grounding Pad<br>are within the ranges for<br>the predicate device. | Testing was performed<br>to confirm that the<br>devices met the<br>performance<br>specifications while<br>within the range of the<br>operating environment<br>and at the end of the 2-<br>year shelf life. | PASS<br>The devices met all<br>requirements while<br>within the range of the<br>operating environment<br>and at the end of the 2-<br>year shelf life. |
| Usability | New and Leveraged<br>The use of the Abbott<br>Medical Grounding Pad<br>falls within the range of<br>use for the predicate<br>device and the change to<br>the adhesive liner does not<br>impact usability. | Testing was performed<br>to confirm the usability<br>of the grounding pad as<br>a standalone device and<br>as part of a RF<br>generator system. | PASS<br>The devices met all<br>relevant requirements<br>and confirm that the<br>device is usable when<br>operated as intended. |

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## 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.