Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

Q: Who is the manufacturer of Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

Relievant Medsystems filed the 510(k) submission for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator (K190504).

Q: What is the FDA product code for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

GXI. It is classified under 21 CFR 882.4725 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K190504 · Relievant Medsystems · GXI · May 3, 2019 · Neurology

Device Facts

Record ID	K190504
Device Name	Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
Applicant	Relievant Medsystems
Product Code	GXI · Neurology
Decision Date	May 3, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4725
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

Device Story

System uses radiofrequency (RF) energy to ablate basivertebral nerves for chronic low back pain relief. Procedure involves two steps: 1) Access instruments (introducers, cannulas, stylets) create a path to the basivertebral foramen via transpedicular or extrapedicular approach; 2) RF probe delivers controlled thermal energy (85°C, 15 minutes) to the nerve terminus. Used in clinical settings by physicians. Output is thermal ablation (cellular necrosis). Benefits include pain relief for patients with specific MRI-confirmed Modic changes. Device consists of sterile, single-use access components and an RF probe connected to a dedicated RF generator.

Clinical Evidence

No clinical data was performed; substantial equivalence is based on design identity and labeling clarification.

Technological Characteristics

Bipolar RF ablation system. Operating frequency: 475 KHz. Power output: 20W. Treatment parameters: 85°C, 1°C/second ramp, 15-minute duration. Feedback mechanism: temperature-controlled. Components: sterile, single-use RF probe and access instruments (introducers, cannulas, stylets).

Indications for Use

Indicated for patients with chronic low back pain (≥6 months) unresponsive to ≥6 months of conservative care, with MRI evidence of Type 1 or Type 2 Modic changes (inflammation, edema, endplate disruption/fissuring, vascularized fibrous tissue, or marrow fat replacement) at L3-S1 vertebrae.

Regulatory Classification

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.

Predicate Devices

Intracept Intraosseous Nerve Ablation System (K180369, K170827)
Relievant RFG (K171143)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Relievant Medsystems Ms. Laurie Hook Clinical/Regulatory Consultant 358 Moffett Park Drive, Suite 105 Sunnyvale, California 94089 Re: K190504 Trade/Device Name: Intracept Intraosseous Nerve Ablation System (RF Probe). Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: February 28, 2019 Received: March 1, 2019 Dear Ms. Hook: 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. {1}------------------------------------------------ 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); 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.htm); 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, Carlos L. Peña, PhD, MS Director Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K190504 #### Device Name Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG) #### Indications for Use (Describe) The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| |----------------------------------------------------------------------------------|----------------------------------------------------------------------| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) SUMMARY -K190504 ## Applicant's Name and Address: Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085-4068 | Contact Person: | Laurie Hook | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Telephone: | 650/368-1000 | | Facsimile: | 650/298-9205 | | Date Prepared: | April 29, 2019 | | Device Name: | | | Device Generic Name: | RF Ablation Catheter and Accessories; RF Generator | | Device Trade Name: | Intracept Intraosseous Nerve Ablation System; Relievant Medsystems RF Generator (Relievant RFG) | | Device Classification: | II | | Classification Name: | Radiofrequency lesion probe, 21 CFR 882.4725, Product Code GXI Radiofrequency lesion generator, 21 CFR 882.4400, Product Code GXD | | Predicate Device: | | Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System (K180369, K170827) and Relievant RFG (K171143) #### Device Description: The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, single-use components: - . The Intracept Access Instruments include introducers, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. - The Intracept RF Probe conducts RF energy to the target location. To obtain the energy needed for tissue ablation, the Intracept RF Probe is used with the Relievant RFG. The Intracept System technique uses RF ablation of the basivertebral nerve for relief of chronic low back pain and involves a two-step process. First, utilizing the Access Instruments, based on a minimally invasive, transpedicular or extrapedicular approach, a cannula and stylets are placed into the vertebral body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel at the terminus of the basivertebral foramen and controlled RF energy is delivered to ablate the basivertebral nerve. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates. {4}------------------------------------------------ #### Indications for Use The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). ### Substantial Equivalence Compared to the Predicate Devices (Intracept System and Relievant RFG), there have been no design changes to the Intracept System or the Relievant RFG. The only difference between the Subject and Predicate Devices is the Indications for Use Statement. The Indications for Use Statements for the Subject Devices have been modified based on historical and current use of the Modic classification to include characteristics of each Modic Type following the references to Modic Type 1 and Type 2 based on MRI. The modification does not describe a new disease condition or patient population that the Subject Devices are intended to treat. The modification is intended to aid clinicians in their interpretation of MRI findings. {5}------------------------------------------------ | Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Device Component | Subject: | Predicate: | -- | | | Intracept System: RF Probe Access Instruments RF Generator | Intracept System: RF Probe (K180369) Access Instruments (K170827) RF Generator (K171143) | -- | | Intended Use | To ablate the basivertebral nerves of the L3 to S1 vertebrae | | Equivalent | | Intracept System Indication | The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change) | The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with RF generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI. | Different | | Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison | | Relievant RFG Indication | The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change). | The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI. | Equivalent Different | | Principle | Provide bipolar RF energy to the tissue between and around the electrodes to achieve tissue ablation (i.e., cellular necrosis through thermal ablation) | | Equivalent | | Treatment Parameters: Temperature | 85° C | | Equivalent | | Ramp | 1°C/second | | Equivalent | | Time | 15 minutes (900 seconds) | | Equivalent | | Access Instruments and RF Probe: Design | No changes | | Equivalent | | Materials | No changes | | Equivalent | | Use | Single | | Equivalent | | Connect to RF Generator | Cable integrated with RF Probe | | Equivalent | | RF Generator: Operating Mode | Bipolar energy | | Equivalent | | Output: Power | 20W | | Equivalent | | Frequency | 475 KHz | | Equivalent | | Feedback mechanism | Temperature controlled | | Equivalent | {6}------------------------------------------------ {7}------------------------------------------------ #### Non-Clinical Performance Testing No design changes were made to the Subject Devices. Substantial equivalence is not dependent upon non-clinical clinical performance testing. #### Clinical Performance Testing Substantial equivalence is not dependent upon clinical data and no clinical testing was performed. #### Conclusions The Indications for Use Statements of the Subject Devices have been modified to include characteristics of each Modic Type following references to Modic Type 1 and Type 2 based on MRI. The modification does not raise different questions of safety or effectiveness. There were no design changes to the Subject Devices. These results support the substantial equivalence of the Subject and Predicate Devices.

Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

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Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator

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Indications for Use

Device Story

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Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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