Intracept Intraosseous Nerve Ablation System
Device Facts
| Record ID | K213836 |
|---|---|
| Device Name | Intracept Intraosseous Nerve Ablation System |
| Applicant | Relievant Medsystems, Inc. |
| Product Code | GXI · Neurology |
| Decision Date | Mar 11, 2022 |
| 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).
Device Story
Intracept Intraosseous Nerve Ablation System uses radiofrequency (RF) energy to ablate basivertebral nerves (BVN) for chronic low back pain relief. System comprises sterile, single-use access instruments (introducers, cannulas, stylets) and an RF probe. Procedure involves minimally invasive transpedicular or extrapedicular placement of cannula/stylets into vertebral body to create channel to basivertebral foramen; RF probe inserted into channel; controlled RF energy delivered to ablate BVN. Used in clinical settings by physicians. Output is thermal ablation (cellular necrosis) of target nerve. Benefits include relief of chronic low back pain. Subject device adds a secondary set of ablation parameters (75°C, 0.5°C/s ramp, 7-minute duration) to existing 85°C protocol; removes SensTx chip functionality.
Clinical Evidence
Bench testing only. Risk analysis performed on additional ablation parameters (lower temperature, ramp, and time) demonstrated no increase in risk profile compared to the predicate device.
Technological Characteristics
Bipolar RF ablation system. Components: sterile, single-use access instruments and RF probe. Energy source: external RF generator. Ablation parameters: 85°C (1°C/s ramp, 15 min) and 75°C (0.5°C/s ramp, 7 min). Materials: no changes from predicate. Connectivity: standalone (requires external RF generator).
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 (K190504)
Reference Devices
Submission Summary (Full Text)
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March 11, 2022
Relievant Medsystems, Inc. Thomas Slater VP, Quality and Regulatory Affairs 1230 Midas Way, Suite 200 Sunnyvale, California 94085
Re: K213836
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: January 6, 2022 Received: January 23, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (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 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
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#### Indications for Use
510(k) Number (if known) K213836
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)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(k) SUMMARY 5.
## Applicant's Name and Address:
Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085
| Contact Person:<br>Telephone:<br>Facsimile: | Thomas A. Slater<br>650/368-1000 x135<br>650/298-9205 |
|---------------------------------------------|----------------------------------------------------------------|
| Date Prepared: | January 6, 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 (K190504)
### Reference Devices:
Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System:
- Intracept RF Probe (K180369) -
- -Access Instruments (K170827)
### Device Description:
The Intracept Intraosseous Nerve Ablation System) is comprised of sterile, singleuse 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 Radiofrequency Generator (RFG).
The Intracept System 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 (BVN). This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.
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#### 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
Compared to the Predicate Device, there have been no changes to the patient population or the Indications for Use for the Intracept System. The Subject and Predicate Devices have a functionally equivalent design, with the difference being the introduction of an additional set of ablation parameters for ablation of the basivertebral nerve. The data provided herein demonstrates substantial equivalence to the Predicate Device.
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| | 510(k) Notification: Relievant Intracept® Intraosseous Nerve Ablation System (K213836) | | | | | | | | |
|--|----------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
|--|----------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Characteristic<br>Device Component | Relievant Medsystems<br>Subject:<br>Intracept System | Relievant Medsystems<br>Predicate:<br>Intracept System (K190504)<br>Reference Devices:<br>RF Probe (K180369)<br>Access Instruments (K170827) | Comparison |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | To ablate the basivertebral nerves of the L3 to S1 vertebrae. | | Equivalent |
| Intracept System<br>Indication | The Intracept Intraosseous Nerve Ablation System is intended to<br>be used in conjunction with radiofrequency (RF) generators for the<br>ablation of basivertebral nerves of the L3 through S1 vertebrae for<br>the relief of chronic low back pain of at least six months duration<br>that has not responded to at least six months of conservative care,<br>and is also accompanied by features consistent with Type 1 or<br>Type 2 Modic changes on an MRI such as inflammation, edema,<br>vertebral endplate changes, disruption and fissuring of the<br>endplate, vascularized fibrous tissues within the adjacent marrow,<br>hypointensive signals (Type 1 Modic change), and changes to the<br>vertebral body marrow including replacement of normal bone<br>marrow by fat, and hyperintensive signals (Type 2 Modic change). | | Equivalent |
| Principle | Provide bipolar RF energy to the tissue between and around the<br>electrodes to achieve tissue ablation (i.e., cellular necrosis<br>through thermal ablation) | | Equivalent |
| Ablation Parameters:<br>Temperature | 85° C | 85° C | Equivalent |
| Ramp | 1°C/second<br>15 minutes (900 seconds) | 1°C/second<br>15 minutes (900 seconds) | Equivalent |
| Time | 75° C<br>0.5°C/second<br>7 minutes (420 seconds) | -- | Different |
| Access Instruments:<br>Design | No changes | | Equivalent |
| Materials | No changes | | Equivalent |
| Use | Single | | Equivalent |
| RF Probe:<br>Design | Removal of SensTx Chip | Optional SensTx Functionality | Different |
| Materials | No changes | No changes | Equivalent |
| Use | Single | Single | Equivalent |
# Non-Clinical Performance Testing
Risk analysis of an additional set of ablation parameters at lower temperature, ramp, and time showed no increase in risk profile.
### Conclusions
Based upon non-clinical performance testing, the Subject Device (Intracept System) with additional ablation parameters performs as intended and does not raise any new safety and/or efficacy concerns when compared to the legally marketed Predicate Device (Intracept System); therefore, these results support the substantial equivalence of the Subject and Predicate Device.
