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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Abbott Medical Grounding Pad:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device's performance against specific acceptance criteria in a clinical study. Therefore, some of the requested information (like effect size in MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format typically associated with AI/software performance. Instead, it describes various non-clinical tests designed to show the device meets its performance requirements and specifications, thereby demonstrating substantial equivalence to the predicate.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	hydrogel material with PET liner meets ISO 10993-1 requirements for cytotoxicity, sensitization, and irritation	PASS: The hydrogel material with PET liner passed all testing for cytotoxicity, sensitization, and irritation. Differences in adhesive liner material do not raise new questions of safety and effectiveness.
EMC and Electrical Product Safety Testing	Device meets relevant requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2	PASS: The devices met all relevant requirements, confirming compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
Grounding Pad Cable Tensile Strength	Tensile strength of cable attachment to grounding pad $\ge$ 20N	PASS: The devices met the tensile strength requirements of $\ge$ 20N.
Shelf Life and Operating Environment Testing	Device meets performance specifications within the range of operating environment and at end of 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	Device is usable when operated as intended	PASS: The devices met all relevant requirements and confirm that the device is usable when operated as intended.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test, but implied to be sufficient for each specific test as per standards like ISO 10993-1 or IEC 60601 series. The testing involved physical devices (Abbott Medical Grounding Pad and some leveraging the predicate device).
Data Provenance: The tests were non-clinical, involving laboratory testing of the physical device components and assembled device. There is no mention of country of origin for data as it's not a clinical data study. The nature of the studies is prospective in the sense that controlled tests were performed on the device to assess its compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as this is a non-clinical device submission. The "ground truth" for the non-clinical tests is established by industry standards (e.g., ISO 10993-1, IEC 60601 series) or the device's own internal specifications. Expert consensus or clinical diagnosis is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or decision-making being assessed, only objective physical, electrical, and biological performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the cognitive performance of human readers, sometimes with AI assistance, which is outside the scope of this medical device (a grounding pad).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a passive electrosurgical component (grounding pad), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests refers to the established requirements and standards:

Industry Standards: ISO 10993-1 for biocompatibility, IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 for electrical safety and electromagnetic compatibility.
Device Specifications: Specific values like the $\ge$ 20N for cable tensile strength, and parameters for shelf life and operating environment.
Predicate Device Equivalence: The primary "ground truth" for the overall submission is demonstrating that the subject device is substantially equivalent to the predicate device and that its differences do not raise new questions of safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable as there is no AI algorithm being developed or "trained."

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no AI algorithm or training set.

Summary

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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 (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

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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)
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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 &Address:	Abbott Medical5050 Nathan Lane NorthPlymouth, Minnesota, 55442USA
Contact Person:	Jordan HansonProject Manager, Regulatory Affairs(972) 309-2113jordan.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 foruse in monopolar electrosurgical procedures in adult patients. It is a single-use,non-sterile and disposable device. The Abbott Medical Grounding Pad iscompatible 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 (alsocalled a neutral electrode, dispersive electrode or return electrode) and anattached cable. The grounding pad component includes a conductive aluminumfoil 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 iscovered with a protective liner while it is packaged.
Indications for Use:	This disposable electrosurgical return electrode with conductive adhesive gel isused 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 DeviceAbbott MedicalGrounding Pad (model:RF-DGP-IS)510(k): K203293	Predicate DeviceCathay Disposable NeutralElectrode510(k): K130027	Discussion
General Characteristics
Common Name	Grounding Pad	Grounding Pad	Same as predicate
Class	II	II	Same as predicate
ClassificationName	21 CFR 882.4400:Radiofrequency LesionGenerator	21 CFR 878.4400:Electrosurgical cutting andcoagulation devices andaccessories	The Abbott Medical GroundingPad is compatible only with theIonicRF Generator, therefore itis using the same product code
Product Code	GXD	GEI	to align with the system it isintended to be used with.
Indications forUse	This disposableelectrosurgical returnelectrode withconductive adhesive gelis used in monopolarelectrosurgicalprocedures for adultpatients	This disposable neutralelectrode for adult patientswith conductive adhesivegel is used as neutralreference duringelectrosurgical procedures	The wording of the indicationshas updated slightly to alignwith verbiage across Abbott'sRF system instructions for use.The Abbott Medical GroundingPad is indicated for monopolarelectrosurgical procedures,which is a subset of theindications for the predicatedevice.
Prescription orOTC	Prescription	Prescription	Same as predicate
Technical Specifications/Characteristics
Type ofConductor	Conductive	Conductive	Same as predicate
ConductiveMaterial	Same	Same
Sterile	No	No
Single Use	Yes	Yes

Substantial Equivalence Table

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Description	Subject DeviceAbbott MedicalGrounding Pad (model:RF-DGP-IS)510(k): K203293	Predicate DeviceCathay Disposable NeutralElectrode510(k): K130027	Discussion
ElectrodeConductiveSurface Area	127.8 cm²	Configuration 1:121 cm²Configuration 2:127.8 cm²	Same as predicateconfiguration 2
OverallDimensions	203 (±2mm) x 105(±2mm)	202mm x 107mm	Similar to predicate
ConductiveAdhesiveMaterial	Conductive adhesive:Hydrogel	Conductive adhesive:Hydrogel	Similar to predicate
Adhesive Liner	Single-sided siliconecoated PET(thermoplasticpolyester), clear	Double-sided siliconecoated 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 NewTesting	Test Summary	Results
Biocompatibility	NewThe patient skin contactinghydrogel material with PETliner was evaluated toevaluate thebiocompatibility impact ofthe change in adhesiveliner material.	The hydrogel materialwith PET liner wasevaluated per ISO10993-1. Testingincluded cytotoxicity,sensitization andirritation testing.	PASSThe hydrogel materialwith PET liner passedall testing forcytotoxicity,sensitization andirritation. Therefore, thedifference in theadhesive liner materialdoes not raise newquestions of safety andeffectiveness.
EMC and ElectricalProduct SafetyTesting	LeveragedThe design of the subjectand predicate devices isidentical for all electrical	The Cathay DisposableNeutral Electrodes(predicate device) weretested in accordancewith IEC 60601-1.	PASSThe devices met allrelevant requirementsconfirming compliance
Test	Leveraged or NewTesting	Test Summary	Results
	aspects, therefore testingon the predicate deviceapplies to the AbbottMedical Grounding Pad.	60601-1-2 and IEC60601-2-2.	with IEC 60601-1, IEC60601-1-2 and IEC60601-2-2.
Grounding PadCable TensileStrength	NewThe tensile strength of thecable attachment to thegrounding pad wasevaluated after aging toensure it meets theproduct requirements( $\ge$ 20N).	Tensile strength of thecable attachment to thegrounding pad wasevaluated to ensure itmeets the productrequirements ( $\ge$ 20N).	PASSThe devices met thetensile strengthrequirements of $\ge$ 20N.
Shelf Life andOperatingEnvironmentTesting	NewAging testing wasperformed to confirm thatthe device meets itsrequirements at the end ofshelf-life. Additionally,operating environmenttesting was performed withthe generator system toconfirm functionality in theoperating conditions. Theshelf life and operatingenvironment of the AbbottMedical Grounding Padare within the ranges forthe predicate device.	Testing was performedto confirm that thedevices met theperformancespecifications whilewithin the range of theoperating environmentand at the end of the 2-year shelf life.	PASSThe devices met allrequirements whilewithin the range of theoperating environmentand at the end of the 2-year shelf life.
Usability	New and LeveragedThe use of the AbbottMedical Grounding Padfalls within the range ofuse for the predicatedevice and the change tothe adhesive liner does notimpact usability.	Testing was performedto confirm the usabilityof the grounding pad asa standalone device andas part of a RFgenerator system.	PASSThe devices met allrelevant requirementsand confirm that thedevice is usable whenoperated 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.

Regulation Number and Section

§ 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).