RADIONICS SINGLE USE GROUND PAD (DGP-HP) by RADIONICS, INC.

The Radionics Disposable Grounding Pad, DGP-HP, is a dispersive electrode that self adheres to the patients skin. The pad consists of an electrode element made up of a rubberized foam backing, a conducting plate, and a conductive gel. The electrode element is joined to a cable and standard connector that interfaces with an RF generator.

AI/ML Overview

This document describes the Radionics Single Use Grounding Pad (DGP-HP). The submission is a 510(k) summary, which indicates that the manufacturer is demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical trial data for new device approval. As such, the information typically requested in your prompt (e.g., detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is generally not included in a 510(k) summary for this type of device.

510(k) submissions for accessories like grounding pads primarily focus on demonstrating that the new device performs as intended and is as safe and effective as a legally marketed predicate device. This is often achieved through engineering testing, biocompatibility testing, electrical safety testing, and performance testing against recognized standards rather than extensive clinical efficacy studies with human subjects.

Here's a breakdown of the available information in relation to your request, with an emphasis on what is not present as per the nature of the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states that the grounding pad is designed to conform to "applicable sections of ANSI/AAMI HF18-1993, IEC 60601-2-2, 1998, and ISO 10993-1." However, the specific acceptance criteria (e.g., maximum impedance allowed, specific temperature rise limits, adhesion strength, biocompatibility results) from these standards, and the reported device performance against them, are not detailed in this 510(k) summary. These details would typically be in a more comprehensive technical report submitted to the FDA, but not in the public 510(k) summary.
Reported Device Performance: No specific quantitative performance metrics are provided in this summary. The summary only generally states that the device is a "dispersive electrode that self adheres to the patient's skin" and "interfaces with an RF generator."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided in this summary. For this type of device (electrosurgical grounding pad), a "test set" in the context of clinical performance data is not typically relevant in a 510(k) submission. Testing usually involves laboratory-based engineering and performance testing on physical units of the device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided in this summary. "Ground truth" established by human experts is relevant for diagnostic or AI-driven devices assessing images or patient data. This device is an accessory that performs a physical function.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided in this summary. Adjudication methods are used to resolve disagreements among experts interpreting data, which is not relevant for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, this was not done. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of data, often with AI assistance. This device is a medical accessory, not a diagnostic tool with AI.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, this was not done. Standalone algorithm performance is relevant for AI/software devices. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in this summary. The "truth" for this device would be its adherence to engineering and safety standards, and its physical performance (e.g., maintaining safe temperature, proper electrical dispersion), rather than a clinical ground truth.

8. The sample size for the training set

Not applicable/Not provided in this summary. Training sets are for AI/machine learning models.

9. How the ground truth for the training set was established

Not applicable/Not provided in this summary.

Summary of Device Acceptance and Study as described in the provided text (within the context of a 510(k) for an accessory):

The acceptance criteria for the Radionics Single Use Grounding Pad (DGP-HP) are based on the device conforming to applicable sections of recognized international and national standards:

ANSI/AAMI HF18-1993
IEC 60601-2-2, 1998
ISO 10993-1

The "study" demonstrating the device meets these criteria is an internal performance and safety evaluation, the details of which are not public in this summary. Instead, the 510(k) process relies on the assertion of substantial equivalence to predicate devices (Radionics RFG-DGP Disposable Grounding Pad K923647 and Nikopad Electrosurgical Grounding Pad Model 4777M K000079) which presumably met similar standards and demonstrated safe and effective use. The FDA's clearance (K030697) indicates that they reviewed the manufacturer's submission (which would contain detailed test reports) and agreed that the new device is substantially equivalent to the predicates.

Summary

{0}------------------------------------------------

Section 6: 510(k) Summary

Radionics Single Use Grounding Pad (DGP-HP) 510(k) Summary KO 30697

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Senior Regulatory Associate Radionics, a division of Tyco Healthcare Group LP 22 Terry Avenue Burlington, MA 01803 Tel .: (781) 272-1233 Fax: (781) 272-2428

This summary was prepared on March 4, 2003.

2.0 The name of the device is the Radionics Single Use Grounding Pad. The common name is Electrosurgical Grounding Pad, and its classification name is Electrosurgical Coagulation Device Accessory.
3.0 The above device is substantial equivalent to the Radionics RFG-DGP Disposable Grounding Pad that was cleared via 510(k), K923647, on November 9, and the Nikopad Electrosurgical Grounding Pad Model 4777M that was cleared via 510(k), K000079, on February 4, 2000.
4.0 The Radionics Disposable Grounding Pad, DGP-HP, is a dispersive electrode that self adheres to the patients skin. The pad consists of an electrode element made up of a rubberized foam backing, a conducting plate, and a conductive gel. The electrode element is joined to a cable and standard connector that interfaces with an RF generator.
5.0 The device like its predicates is intended for use as the dispersive electrode during radiofrequency lesioning procedures. The DGP-HP is specifically indicated for use with the Radionics Cool-tip™ RF System.
6.0 The grounding pad is designed to conform to the applicable sections of ANSI/AAMI HF18-1993, IEC 60601-2-2, 1998, and ISO 10993-1.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, arranged in a row. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps.

APR o 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, A Division of Tyco Healthcare Group LP 22 Terry Avenue Burlington, Massachusetts 01803

Re: K030697

Trade/Device Name: Radionics Single Use Ground Pad (DGP-HP) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 4, 2003 Received: March 6, 2003

Dear Mr. O'Connell:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

ODE Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Radionics Single Use Ground Pad (DGP-HP)

Indications for Use:

The Radionics DGP-HP Single Use Ground Pad is to be used with the Radionics Cooltip™ RF System.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR § 801.109)

OR
Over-the-Counter UseMiriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.