(197 days)
No
The description focuses on the physical characteristics and function of radiofrequency needles for tissue coagulation, with no mention of AI or ML.
Yes.
The device is used for radiofrequency lesioning to coagulate soft tissues and disrupt nerve bundles for pain treatment, which are therapeutic interventions.
No
The device is described as being used for treatment (lesioning, disruption of nerves with heat) rather than for diagnosing a condition.
No
The device description clearly describes a physical needle (RF-cannulas) used for surgical procedures, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pajunk RFTL Radiofrequency needles are used for percutaneous nerve blocks and radiofrequency lesioning. This involves inserting the needle directly into the body to deliver local anesthetic or to apply heat to soft tissues and nerves.
- Method of Use: The device is used in vivo (within the living body) for therapeutic purposes (pain treatment via neurosurgical lesioning). It does not analyze samples taken in vitro (outside the living body).
Therefore, the function and intended use of the Pajunk RFTL Radiofrequency needles clearly fall outside the scope of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures, as determined by professional neurosurgeon/ anesthetist and the instructions for use.
The Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.
Product codes (comma separated list FDA assigned to the subject device)
GXI, GXD
Device Description
Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures, as determined by professional neurosurgeon/ anesthetist and the instructions for use. These RF-cannulas are single use, sterile, non-pyrogenic and latex free medical devices. The RF-cannulas have bevel tips with an active area of 2 - 10 mm.
The needle puncture depth depends on the path chosen by the surgeon to reach and to eliminate the nerve bundle site. This required needle length is the patient contact part of the thermolesion needle. The nerve causing constant pain will be disrupted by utilizing the thermolesion heat radiating from the needle tip. Heat is generated by radio frequency and radiates only from the non-insulated needle tip. This limited heat radiation is used for focussed heat treatment depending on the surgeon's method of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, long term pain (via neurosurgical lesioning procedures), nerve bundle site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional neurosurgeon/ anesthetist
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.
K000722, K043130, K033018, K042979, K023218, K013041, K053283
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
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
0
Thermolesion Premarket Notification Submission
KO 60397
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: July 10th, 2006
Page 1 of 2
AUG 3 1 2006
MEDIZINTECHNOLOGIE
Submitter Information/ production site:
Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-00 Fax: +49(0)7704-9291-605
Sterilizer: SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Germany Tel +49 6105 23091 or +49 (0) 6105 93470 Fax +49 6105 24760
Contact:
Christian Quass, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com
Establishment Registration Number:
9611612
Device Information:
| Trade Names: | Pajunk RFTL Radiofrequency needle |
|---|---|
| Common Name: | Disposable cannula for RF Thermolesion |
| Classification Name: | Neurological Devices: Radiofrequency lesion probe |
| Classification Reference: | 21 CFR 882.4725, April 1. 2005 |
| Proposed Classification: | Regulatory Class II |
| Proposed Product Code: | GXI |
| Predicate Devices: | 1. Radionics thermo lesion needles K021942 |
- Stryker's RF cannulas K032406 |
2006-06-27 007
1
Device Description:
MEDIZINTECHNOLOGIE
Page 2 of 2
Pajunk RFTL Radiofrequency needles are intended for coagulation of soft tissues, such as in long term pain treatment via neurosurgical lesioning procedures, as determined by professional neurosurgeon/ anesthetist and the instructions for use. These RF-cannulas are single use, sterile, non-pyrogenic and latex free medical devices. The RF-cannulas have bevel tips with an active area of 2 - 10 mm.
The needle puncture depth depends on the path chosen by the surgeon to reach and to eliminate the nerve bundle site. This required needle length is the patient contact part of the thermolesion needle. The nerve causing constant pain will be disrupted by utilizing the thermolesion heat radiating from the needle tip. Heat is generated by radio frequency and radiates only from the non-insulated needle tip. This limited heat radiation is used for focussed heat treatment depending on the surgeon's method of operation.
Predicate Devices
Pajunk's single use anesthesia conduction needles for thermo lesion and neuro-stimulation are substantially equivalent in technique, specification, intended use, safety and effectiveness to the marketed predicate device listed above.
Sterilization
The contract sterilizer and the sterilizing process other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) is the same as that used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041.
Packaging
The packaging materials and procedures of Pajunk's RFTL cannulas are the same as those used for Unipolar cannulas cleared for market by FDA under 510(k) number K000722 and Kit Products Pajunks Stimulong Set K043130, K033018 and Pajunks Plexolong Set K042979, K023218, K013041.
Technology Characteristics
The indications for use as well as the basic technological characteristics of Pajunk's RFTL cannulas are identical to Radionics thermo lesion needles K021942 manufactured by TOP. Coating, overall cannula lenght of deinsulated tip are substantially equivalent and as safe and effective as the predicate device's.
Pajunk's RFTL cannulas have the same technological characteristics as the predicate device identified above.
The NanoLine coating technique Pajunks cannulas are coated with is cleared for market in Pajunks NanoLine PMN K053283.
Conclusion:
The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2006
Pajunk GmbH Medizintechnologie % Mr. Christian Quass Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany
Re: K060397
Trade/Device Name: Pajunk Thermolesion Cannula ,,RFTL Radiofrequency Needle" Regulatory Number: 21 CFR 882.4725 Regulatory Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: July 31, 2006 Received: August 3, 2006
Dear Mr. Quass:
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.
3
Page 2 - Mr. Christian Quass
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 (240) 276-0115. 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 from the Division of Small Marv Sacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely you
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: This document is a Thermolesion Premarket Notification Submission from Pajunk. The 510(k) Number is K060397, and the device name is Pajunk Thermolesion Cannula "RFTL Radiofrequency Needle". The indications for use are that the Pajunk RFTL Radiofrequency needles are electrically insulated and may be used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The document indicates prescription use and is page 1 of 1.