(149 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic function of a cannula, with no mention of AI or ML.
Yes
The device is described as being used in "radiofrequency (RF) heat lesion procedures for the relief of pain," which is a therapeutic application.
No
The device is described as an "RF Introduction Cannula" intended for use in "radiofrequency (RF) heat lesion procedures for the relief of pain." This indicates a therapeutic or procedural function, rather than a diagnostic one.
No
The device description explicitly states it consists of physical components like a coated stainless steel cannula, a stainless steel stylet, and a molded plastic hub, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiofrequency (RF) heat lesion procedures for the relief of pain." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "cannula," which is a tube inserted into the body. This is consistent with a surgical or interventional device, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Product codes
GXI, GXD
Device Description
The Epimed RF Introduction Cannula consists of a coated stainless steel cannula with a stainless steel stylet and molded plastic hub. The cannula will be available in various lengths, gauges and tip configurations.
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)
Bench Testing performed on the Epimed RF Introduction cannula to compare performance characteristics to the predicate device(s) confirmed that the performance of the RF Introduction Cannula is similar to the predicate device(s).
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.
Radionics Disposable RF Cannulae (K980430), Cotop International RF Cannula (K# unknown)
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
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
SEP 1 6 2004
Page 1 of 2
Section II
510(K) Summary
Company Information:
K 0 4 10 21
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of RA/QA
Trade Name:
Epimed RF Introduction Cannula
Common Name:
Disposable Cannula for Radiofrequency Electrode
Product Class/Classification:
Class II
Predicate Device(s):
Radionics Disposable RF Cannulae (K980430) Cotop International RF Cannula (K# unknown)
Description:
The Epimed RF Introduction Cannula consists of a coated stainless steel cannula with a stainless steel stylet and molded plastic hub. The cannula will be available in various lengths, gauges and tip configurations.
Intended Use:
The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
1
Page 2 of 2
Comparison to Predicate:
The Epimed RF Introduction cannula has similar physical and technical characteristics to the predicate device(s) and a similar intended use to the predicate device(s).
Non-Clinical Data:
Bench Testing performed on the Epimed RF Introduction cannula to compare performance characteristics to the predicate device(s) confirmed that the performance of the RF Introduction Cannula is similar to the predicate device(s).
Conclusion:
The testing performed and comparison to the predicate device(s) demonstrates that the Epimed RF Introduction cannula is safe and effective and is substantially equivalent to the predicate device(s).
Very truly yours,
Epimed International, Inc.
Chall
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
SEP 1 6 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance Epimed International, Inc. 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095
Re: K041021
Trade/Device Name: Epimed RF Cannula Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI, GXD Dated: September 1, 2004 Received: September 7, 2004
Dear Mr. Lake:
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. Christopher B. Lake
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. 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 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
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
4
Indications for Use
K04:021
510(k) Number (if known): unk
Device Name: Epimed RF Cannula
Indications for Use:
The Epimed RF Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain
| Prescription Use | >
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| (Part 21 CFR 801 Subpart D) | | |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number_Ko4102/