Who is the manufacturer of Intracept Intraosseous Nerve Ablation System?

Relievant Medsystems, Inc. filed the 510(k) submission for Intracept Intraosseous Nerve Ablation System (K222281).

What is the FDA product code for Intracept Intraosseous Nerve Ablation System?

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

What is the regulatory pathway for Intracept Intraosseous Nerve Ablation System?

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

Who can help prepare an FDA 510(k) submission like Intracept Intraosseous Nerve Ablation System?

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.

Intracept Intraosseous Nerve Ablation System

Q: What are the predicate devices for Intracept Intraosseous Nerve Ablation System?

Intracept Intraosseous Nerve Ablation System (K213836).

K222281 · Relievant Medsystems, Inc. · GXI · Oct 26, 2022 · Neurology

Device Facts

Record ID	K222281
Device Name	Intracept Intraosseous Nerve Ablation System
Applicant	Relievant Medsystems, Inc.
Product Code	GXI · Neurology
Decision Date	Oct 26, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4725
Device Class	Class 2
Attributes	Therapeutic

Intended 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).

Device Story

System uses radiofrequency (RF) energy to ablate basivertebral nerves for chronic low back pain relief. Procedure: physician uses access instruments (cannulas, stylets) via transpedicular or extrapedicular approach to create path into vertebral body; RF probe inserted into channel; RF generator delivers controlled energy to nerve terminus. Generator monitors power, temperature, and impedance at treatment site to ensure safe operation. Used in surgical settings. Benefits patients by providing minimally invasive nerve ablation to address pain associated with Modic changes.

Clinical Evidence

No clinical data; substantial equivalence supported by non-clinical bench testing only.

Technological Characteristics

System components: access instruments (cannulas, stylets) and RF probe. Materials: 304 stainless steel, PEEK, Nitinol, 17-4PH stainless steel, polycarbonate, glass-filled nylon. Energy: bipolar RF. Sterilization: Gamma irradiation (SAL 10-6). Compliance: ISO 10993 (biocompatibility), ISO 10555-1 (corrosion), ASTM D4169 (transit), ASTM F2096/F88 (packaging), IEC 62366-1 (usability).

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, 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 (K213836)

Reference Devices

Intracept RF Probe (K180369)
Intracept Access Instruments (K170827)
Relievant Radiofrequency Generator (K171143)

Related Devices

K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator · Relievant Medsystems · May 3, 2019
K170827 — INTRACEPT Intraosseous Nerve Ablation System · Relievant Medsystems · Aug 9, 2017
K213836 — Intracept Intraosseous Nerve Ablation System · Relievant Medsystems, Inc. · Mar 11, 2022
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) · Stryker Instruments · May 15, 2025
K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) · Relievant Medsystems · Sep 14, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 26, 2022 Relievant Medsystems, Inc. Thomas Slater VP, Quality and Regulatory Affairs 1230 Midas Way, Suite 200 Sunnyvale, California 94085 Re: K222281 Trade/Device Name: Intracept Intraosseous Nerve Ablation System Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: July 28, 2022 Received: July 29, 2022 Dear Thomas Slater: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: 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) K222281 Device Name Intracept Intraosseous Nerve Ablation System #### 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). | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) 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 ### Applicant's Name and Address: Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085 | Contact Person: Telephone: Cell Phone: Facsimile: | Thomas A. Slater 650/368-1000 x135 408/835-8139 650/298-9205 | |------------------------------------------------------------|-----------------------------------------------------------------------| | Date Prepared: | October 26, 2022 | | Device Name: | | | Device Generic Name: | RF Ablation Catheter and Accessories | | Device Trade Name: | Intracept Intraosseous Nerve Ablation System | | Device Classification: | II | | Classification Name: | Radiofrequency lesion probe, 21 CFR 882.4725, Product Code GXI | ### Predicate Device: Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System (K213836) ### Reference Devices: Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System: - Intracept RF Probe (K180369) - - Intracept Access Instruments (K170827) - Relievant Medsystems, Inc .: Relievant Radiofrequency Generator (K171143) # Device Description: The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, singleuse components: - . The Intracept Access Instruments include 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 Radiofrequency Generator (RFG). The Relievant RFG is a universal AC powered, microcontroller controlled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. Currently, the Relievant RF Generator (reference device (K171143)) is the only compatible RF generator for use with the Intracept System. The Intracept System uses RF energy to ablate 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 {4}------------------------------------------------ body to create a path or channel to the terminus of the basivertebral foramen. The RF Probe is then placed into this channel 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. # 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). ## Substantial Equivalence The Subject Device (Intracept Access Instruments, a component of the Intracept System) has the same intended use, patient population, Indications for Use, principles of operation, and sterilization method as the Predicate Device (Intracept System). Changes were made to facilitate usability and performance. Based on the device comparison and non-clinical performance testing, the modifications do not raise any new questions of safety or effectiveness and support the substantial equivalence of the Subject and Predicate Devices. No modifications were made to the Intracept System's RF Probe. | Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | Device | Subject: Intracept System | Predicate: Intracept System | | | 510(k) | -- | (K213836) | | | FDA Classification/ Product Code | II GXI | II GXI | Same | | Intended Use | To ablate the basivertebral nerves of the L3 to S1 vertebrae. | | Same | | 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). | | Same | | Target Population | Chronic low back pain | | Same | | Anatomical Site | Basivertebral nerves L3-S1 vertebrae | | Same | | Where Used | Surgical setting | | Same | | Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison | | Device | Subject: Intracept System | Predicate: Intracept System | | | Device Component | Intracept Access Instruments | Intracept Access Instruments Reference Device (K170827) | -- | | TECHNICAL | | | | | Principle | Minimally invasive percutaneous transpedicular or extrapedicular access through the vertebral body to allow passage of the RF Probe. | | Same | | Components | Introducer Stylets: • Diamond Stylet • Bevel Stylet | Introducer Stylets: • Trocar Stylet • Bevel Stylet | Equivalent (performance & usability improvements) | | | Cannulas: • Introducer Cannula • Curved Cannula | Cannulas: • Introducer Cannula • Curved Cannula | Equivalent (performance & usability improvements) | | | Stylets: • J-Stylet • Straight Stylet | Stylets: • J-Stylet • Straight Stylet | Equivalent (performance & usability improvements) | | | Drill | | Additional Subcomponent | | Materials: Tissue/Bone Contact | • 304 stainless steel • PEEK • Nitinol • Silicone fluid • 17-4PH stainless steel | • 304 stainless steel • PEEK • Nitinol • -- • -- | Same Same Same Different Different | | Materials: Handles - Intact Skin Contact | • Polycarbonate with colorant • Ink • -- • Glass-filled nylon with colorant, 303 / 304 stainless steel | • Polycarbonate with colorant • Ink • 316 / 17-7PH stainless steel, silicone fluid • -- | Different Different Different Different | | Materials: Non Contact (contained within handles) | • -- • 303 / 316 stainless steel | • 304 stainless steel, platinum/iridium • -- | Different Different | | Indicators/ Markings | • Numeric indicators on handles to signify procedural step • Directionality indicated with arrows • Reference depth markers • -- | • Numeric indicators on handles to signify procedural step • Directionality indicated with arrows • Reference depth markers • Gap Indicator: Indicates when Wing Nut is making contact with the Introducer Cannula | Equivalent Equivalent Equivalent Different | | | • Visible red indicator to notify that Bail tab is open | • -- | Different | | Packaging | Double barrier thermoformed tray with a retainer lid and Tyvek over lids | Double barrier thermoformed tray with a retainer lid and Tyvek over lids | Same (packaging concept) | | Sterilization | Gamma irradiation SAL 10-6 | Gamma irradiation SAL 10-6 | Same | | Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison | | Device | Subject: Intracept System | Predicate: Intracept System | | | Shelf life | 6-month: Pass 2-year: In-Process | 6-month: Pass 2-year: Pass | Same Different | | Device Component | Intracept RF Probe | Intracept RF Probe Reference Device (K180369) | Same | {5}------------------------------------------------ {6}------------------------------------------------ # Non-Clinical Bench Testing The Intracept System with modified Access Instruments met specifications and performance requirements and is equivalent to the Predicate Intracept System. Non-clinical bench testing included mechanical durability with simulated use and usability. Biocompatibility, packaging, sterilization and shelf-life validation testing of the Subject Device were performed and met all applicable requirements of the relevant standards. {7}------------------------------------------------ | Test | Test Method Summary | Results | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Biocompatibility Testing | | | | Patient contact materials are classified as tissue/bone/dentin <24 hours and tested for compliance to applicable ISO 10993 standards. The Subject Device is the same classification as the Predicate and the materials used in construction are equivalent. | | | | Cytotoxicity | ISO 10993-5 - Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity (MEM Elusion) | PASS | | Sensitization | ISO 10993-10 – Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization (Guinea Pig Maximization Sensitization) | PASS | | Acute Systemic Toxicity | ISO 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests for systemic toxicity (Acute Systemic Injection Test in Mice) | PASS | | Intracutaneous Reactivity | ISO 10993-10- Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization (Intracutaneous Reactivity Irritation Test in Rabbits) | PASS | | Dimensional and Functional Testing | | | | The Subject and Predicate Devices are equivalent in size, materials, and construction. | | | | Corrosion | Corrosion testing per ISO 10555-1 Intravascular catheters - Sterile and single- use catheters - Part 1: General requirements (Annex A: No visible signs of corrosion) | PASS | | Transit | ASTM D4169 - Standard Practice for Performance Testing of Shipping Containers and Systems (DC 13, assurance level II) | PASS | | Gross Leaks | ASTM F2096 - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | PASS | | Seal Strength | ASTM F88/F88M - Standard Test Method for Seal Strength of Flexible Barrier Materials (Seal peel ≥1.0 lbs/in) | PASS | | Mechanical | Met all performance testing per Product Specifications | PASS | | Sterilization | ANSI/AAMI/ISO 11137-1: Sterilization of health care products - Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ANSI/AAMI/ISO 11137-2: Part 2: Establishing the sterilization dose (Sterility assurance of 10-6) | PASS | | Interface and Primary Operating Function Testing | | | | The Subject and Predicate Devices have equivalent performance. | | | | Simulated Use | Following exposure to 6 full deployments, devices remained functional without damage and met interface requirements. | PASS | | Usability | IEC 62366-1: Application of Usability Engineering to Medical Devices Usability testing simulated in sawbones with 15 users of the Intracept Intraosseous Nerve Ablation System (Access Instruments and RF Probe) were | PASS | No modifications were made to the RF Probe, therefore, previous testing remains applicable. ### Clinical Performance Testing Substantial equivalence is not dependent upon clinical data and no clinical testing was performed. ### Conclusions Based upon non-clinical performance testing, the Subject Device (Intracept System with modified Access Instruments) performs as intended and does not raise any new questions of safety or effectiveness when compared to the legally marketed Predicate Device (Intracept System); therefore, these results support the substantial equivalence of the Subject and Predicate Device.