(29 days)
Not Found
No
The device description and intended use describe a passive grounding pad, and there are no mentions of AI, ML, or related concepts in the summary.
No
The device is described as a "dispersive electrode" and "Disposable Grounding Pad" used with an RF system. Its function is to ground the patient, not to treat a specific medical condition or disease.
No
Explanation: The device is a single-use grounding pad used with an RF system, designed to disperse electrical current from a patient's skin, not to diagnose a condition or disease.
No
The device description clearly states it is a physical grounding pad with hardware components (electrode element, cable, connector) that interfaces with an RF generator. It is not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used with an RF system as a grounding pad, which is a component used during a medical procedure performed on a patient.
- Device Description: The description details a physical electrode that adheres to the skin to provide a return path for radiofrequency energy.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health status. This device is a component used during a medical procedure on a patient's body.
N/A
Intended Use / Indications for Use
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.
The Radionics DGP-HP Single Use Ground Pad is to be used with the Radionics Cooltip™ RF System.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
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
Not Found
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)
Not Found
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.
Not Found
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
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_________________________________________________________________________________________________________________________________________________________________