(29 days)
No
The summary describes a physical device for delivering RF energy or anesthetic, with localization performed by electrostimulation or radiography. There is no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is described as creating radiofrequency (RF) lesions on nerves and delivering anesthetic to the site to treat pain, which are therapeutic interventions.
No
The device is primarily intended for therapeutic purposes (lesioning nerves and delivering anesthetic for nerve blocks) rather than diagnosing conditions. The methods mentioned (electrostimulation or contrast injection with radiography) are used to localize the target nerve before treatment, not to diagnose a disease or condition.
No
The device description explicitly states it is a single-use, surgically invasive device constructed with a steel cannula and various polymers, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Rulo™ Radiofrequency Lesion Probe is a surgical device used directly on the patient's body to perform nerve blocks or create radiofrequency lesions on nerves. It is an invasive procedure.
- Intended Use: The intended use is for percutaneous nerve blocks or radiofrequency lesioning, which are therapeutic procedures performed in vivo.
- Device Description: The description clearly states it's a "surgically invasive device" inserted to contact a nerve.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
The device uses radiography and potentially electrostimulation for localization of the nerve, but the primary function is a therapeutic intervention performed directly on the patient's tissue, not an analysis of a sample outside the body.
N/A
Intended Use / Indications for Use
The RuloTM Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
Product codes
GXI
Device Description
The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency (RF) lesions on nerves and can also create percutaneous nerve blocks by delivering anesthetic to the site. It is a single-use, surgically invasive device. It is inserted with the use of a flexible introducer accessory to contact a nerve in an area of the spine for less than 15 minutes to treat pain. The RF energy creates a lesion on nerve tissue that conducts pain signals. The tissue's ability to conduct electrical signals is disrupted by the lesion. The targeted nerve can be localized either by using RF electrostimulation through the cannula or by injecting contrast medium through the cannula with the use of the fluid injection port and using radiography concomitantly. The nerve may be blocked by injecting local anesthetic solution or making an RF lesion. The device is used by a trained physician in a clinical setting.
The device is constructed with a steel cannula and uses a variety of polymers for the insulation, hub, cable, connector, cap and fluid injection port
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiography
Anatomical Site
nerve in an area of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician in a clinical setting
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
Nonclinical Testing: The results of the performance testing, demonstrate that the Epimed Rulo™ Radiofrequency Lesion Probe performs comparably to and is substantially equivalent to the predicate device (K141586).
There is not a harmonized standard or quidance document that directly applies to radiofrequency lesion devices. Applicable tests and requirements have been adopted from the following standards to compile the suite of performance testing:
- ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
- ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: Lock Fittings
- BS 6196 British Standard Specification for Sterile Epidural Catheters and Introducer Needles for Single Use
- ANSI/AAMI/ EN 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
- ISO 7864 Sterile Hypodermic Needles for Single Use
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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March 8, 2019
Epimed International, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K190256
Trade/Device Name: Rulo Radiofrequency Lesion Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: Class II Product Code: GXI Dated: February 5, 2019 Received: February 7, 2019
Dear Mark Job:
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
1
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); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew C. Krueger -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190256
Device Name RuloTM Radiofrequency Lesion Probe
Indications for Use (Describe)
The RuloTM Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: K190256
Submitter Information:
| Name:
Address: | Epimed International, Inc.
13958 Diplomat Drive
Farmers Branch, Texas 75234 |
|--------------------------------------|-----------------------------------------------------------------------------------|
| Telephone Number: | (518) 725-0209 |
| Fax Number: | (518) 725-0207 |
| Contact Person:
Telephone Number: | Preston H. Frasier
Manager – QA/RA
(518) 725-0209 Ext. 1300 |
| Email Address: | prestonf@epimed.com |
| Date Prepared: | January 23, 2019 |
Device Name & Classification:
| Device Trade Name: | Rulo™ Radiofrequency Lesion Probe |
|---|---|
| Common Name: | Radiofrequency Lesion Probe |
| Classification Names: | Radiofrequency Lesion Probe, GXI (21 CFR 882.4725) |
| Models/Sizes: | 300-1615 (16 gauge); 300-1815 (18 gauge) |
Predicate Device(s) Information:
Predicate Device: Diros OWL Sterile Single Use R.F. Insulated Cannulae Models 466 and DHC (K141586)
Device Description:
The Rulo™ Radiofrequency Lesion Probe (Rulo Probe) creates radiofrequency
(RF) lesions on nerves and can also create percutaneous nerve blocks by
delivering anesthetic to the site. It is a single-use, surgically invasive device. It is
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Image /page/4/Picture/0 description: The image is a logo for a company called "Epimed". The logo consists of a red triangle on the left side and the company name in black letters on the right side. Below the company name is the text "Designed by Experts for Experts" in a smaller font.
inserted with the use of a flexible introducer accessory to contact a nerve in an area of the spine for less than 15 minutes to treat pain. The RF energy creates a lesion on nerve tissue that conducts pain signals. The tissue's ability to conduct electrical signals is disrupted by the lesion. The targeted nerve can be localized either by using RF electrostimulation through the cannula or by injecting contrast medium through the cannula with the use of the fluid injection port and using radiography concomitantly. The nerve may be blocked by injecting local anesthetic solution or making an RF lesion. The device is used by a trained physician in a clinical setting.
The device is constructed with a steel cannula and uses a variety of polymers for the insulation, hub, cable, connector, cap and fluid injection port
The flexible introducer accessory was cleared in K051860. The fluid injection port was cleared as an extension set in K020926.
Statement of Intended Use:
The Rulo™ Radiofrequency Lesion Probe is an injection probe which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
The Rulo Radiofrequency Lesion Probe Intended Use/Indications for Use statement is essentially identical to that of the predicate device, Diros OWL Sterile Single Use R.F. Insulated Cannulae Models 466 and DHC (K141586).
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Technological Characteristics and Substantial Equivalence:
The Rulo Probe is similar in design and material composition to the predicate device, Diros OWL Sterile Single Use R.F. Insulated Cannulae Models 466 and DHC (K141586). Both have an insulated steel needle (cannula) where the opening in the insulation at the tip of the device delivers radiofrequency energy and fluid to the tissue it contacts. Both devices connect to radiofrequency generators and have a fluid port. The uninsulated delivery site on the cannula of the Rulo Probe is directional and can focus the energy and fluid to the desired tissue target while the Diros predicate device does not have the directional feature. The Diros device has a sharp tip for direct insertion into the tissue while the Rulo Probe is inserted with a flexible introducer accessory.
Nonclinical Testing:
The results of the performance testing, demonstrate that the Epimed Rulo™ Radiofrequency Lesion Probe performs comparably to and is substantially equivalent to the predicate device (K141586).
There is not a harmonized standard or quidance document that directly applies to radiofrequency lesion devices. Applicable tests and requirements have been adopted from the following standards to compile the suite of performance testing:
ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 594-2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: Lock Fittings
BS 6196 British Standard Specification for Sterile Epidural Catheters and Introducer Needles for Single Use
ANSI/AAMI/ EN 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
ISO 7864 Sterile Hypodermic Needles for Single Use
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In accordance with the applicable sections recommended per ISO 10993-1, the relevant patient contacting components have been shown to meet the necessary biocompatibility requirements. The biocompatibility of the materials used to manufacture the Rulo Probe have been tested and analyzed with discussion in the Biocompatibility Assessment. The biocompatibility testing which has been performed includes the following:
- . Cytotoxicity (per ISO 10993-5)
- Sensitization (per ISO 10993-10) .
- . Irritation or Intracutaneous Reactivity (per ISO 10993-10)
- Systemic Toxicity (per ISO 10993-11) .
The flexible introducer accessory is made of stainless steel and was cleared in K051860. The fluid port is made of PVC and was cleared as an extension set in K020926.
Conclusions:
Epimed's Rulo Radiofrequency Lesion Probe and the predicate device, Diros OWL Sterile Single Use R.F. Insulated Cannulae Models 466 and DHC (K141586), have the same intended use/indications for use and the probes are very similar in technological characteristics, including the overall design, dimensions, delivery of RF energy and fluids, and choice of materials.
There are some minor differences in technological characteristics that do not raise new questions of safety or efficacy. The predicate device has an active tip that does not direct the energy or fluids in a specific direction. The Rulo Probe has a focused active tip for directionality in delivery of RF energy, and this direction is indicated by the handle. The predicate device has a sharper tip and can be inserted directly into the tissues, the while Rulo Probe has a blunt tip, and is inserted into the tissue with the use of a flexible introducer accessory. This accessory has been cleared in in the marketplace for several years, and does not present any new questions of safety or efficacy.
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In additional to the same intended use, the technological characteristics are the same or similar, and where there are minor differences, there are not new or different questions of safety or efficacy, as demonstrated by bench and laboratory testing. Epimed's Rulo Radiofrequency Lesion Probe is substantially equivalent to the predicate device.