(89 days)
No
The description focuses on the mechanical and electrical components of the device and the RF energy delivery process, with no mention of AI or ML for data analysis, decision-making, or control beyond standard microcontroller functions.
Yes
The device is described as an "ablation system" intended to be used for the "relief of chronic low back pain," which directly implies its use for treatment and therapy.
No
The device is an ablation system designed to deliver radiofrequency energy to ablate basivertebral nerves for pain relief, which is a treatment, not a diagnostic, function.
No
The device description explicitly states that the system is comprised of sterile, single-use components including cannulas, stylets, and an RF probe, which are hardware components. It also requires the use of a compatible RF generator, another hardware component.
Based on the provided information, the Intracept Intraosseous Nerve Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Intracept System's Function: The Intracept System is a surgical device used to directly ablate nerves within the vertebral body. It is used in vivo (within the living body) to treat a condition, not to analyze samples in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for the "ablation of basivertebral nerves... for the relief of chronic low back pain." This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details instruments for accessing the vertebral body and a probe for delivering RF energy to ablate tissue. This aligns with a surgical/therapeutic device, not an IVD.
Therefore, the Intracept Intraosseous Nerve Ablation System falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
GXI
Device Description
The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of sterile, single-use 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
basivertebral nerves of the L3 through S1 vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Performance Testing: Substantial equivalence is not dependent upon clinical data and no clinical testing was performed.
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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)
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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:
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 |