(89 days)
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 (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 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.
The Relievant Medsystems, Inc. Intracept Intraosseous Nerve Ablation System (K222281) did not undergo a clinical study as substantial equivalence was determined based on non-clinical performance testing. The device is a modification of a previously cleared device (K213836). Modifications were made to the Access Instruments component of the system to improve usability and performance, but the RF Probe remained unchanged.
Here's a summary of the non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance to applicable ISO 10993 standards for tissue/bone/dentin contact <24 hours. Materials used in construction are equivalent to the Predicate Device. | All tests passed. |
| Cytotoxicity | ISO 10993-5 (MEM Elusion) | PASS |
| Sensitization | ISO 10993-10 (Guinea Pig Maximization Sensitization) | PASS |
| Acute Systemic Toxicity | ISO 10993-11 (Acute Systemic Injection Test in Mice) | PASS |
| Intracutaneous Reactivity | ISO 10993-10 (Intracutaneous Reactivity Irritation Test in Rabbits) | PASS |
| Dimensional and Functional Testing | Devices are equivalent in size, materials, and construction to the Predicate Device. | All tests passed. |
| Corrosion | ISO 10555-1, 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 and 11137-2: Sterility assurance of 10-6. | PASS |
| Interface and Primary Operating Function Testing | Devices have equivalent performance to the Predicate Device. | All tests passed. |
| 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. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each bench test, but the usability testing involved "15 users."
- Data Provenance: Not applicable as these were non-clinical bench tests. The provenance is internal laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this was non-clinical bench testing. The evaluation was against established standards and product specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was non-clinical bench testing. Results were objectively measured against predefined criteria in relevant standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, as this was a non-clinical submission for device modification, not an AI/software device requiring comparative effectiveness studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device (nerve ablation system), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For non-clinical bench testing, the "ground truth" is defined by the technical specifications and international standards (e.g., ISO, ASTM, AAMI, IEC) to which the device must conform.
8. The sample size for the training set
Not applicable, as this was not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this was not an AI/ML device requiring a training set.
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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
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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
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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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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. Slater650/368-1000 x135408/835-8139650/298-9205 |
|---|---|
| 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
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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 | IIGXI | IIGXI | Same |
| Intended Use | To ablate the basivertebral nerves of the L3 to S1 vertebrae. | Same | |
| Indications for Use | The Intracept Intraosseous Nerve Ablation System isintended to be used in conjunction with radiofrequency (RF)generators for the ablation of basivertebral nerves of the L3through S1 vertebrae for the relief of chronic low back painof at least six months duration that has not responded to atleast six months of conservative care, and is alsoaccompanied by features consistent with Type 1 or Type 2Modic changes on an MRI such as inflammation, edema,vertebral endplate changes, disruption and fissuring of theendplate, vascularized fibrous tissues within the adjacentmarrow, hypointensive signals (Type 1 Modic change), andchanges to the vertebral body marrow including replacementof 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 | |
| DeviceComponent | Intracept AccessInstruments | Intracept AccessInstrumentsReference Device(K170827) | -- |
| TECHNICAL | |||
| Principle | Minimally invasive percutaneous transpedicular orextrapedicular access through the vertebral body to allowpassage of the RF Probe. | Same | |
| Components | Introducer Stylets:• Diamond Stylet• Bevel Stylet | Introducer Stylets:• Trocar Stylet• Bevel Stylet | Equivalent(performance &usabilityimprovements) |
| Cannulas:• Introducer Cannula• Curved Cannula | Cannulas:• Introducer Cannula• Curved Cannula | Equivalent(performance &usabilityimprovements) | |
| Stylets:• J-Stylet• Straight Stylet | Stylets:• J-Stylet• Straight Stylet | Equivalent(performance &usabilityimprovements) | |
| Drill | AdditionalSubcomponent | ||
| Materials:Tissue/BoneContact | • 304 stainless steel• PEEK• Nitinol• Silicone fluid• 17-4PH stainless steel | • 304 stainless steel• PEEK• Nitinol• --• -- | SameSameSameDifferentDifferent |
| Materials:Handles - IntactSkin Contact | • Polycarbonate withcolorant• Ink• --• Glass-filled nylon withcolorant, 303 / 304stainless steel | • Polycarbonate withcolorant• Ink• 316 / 17-7PH stainlesssteel, silicone fluid• -- | DifferentDifferentDifferentDifferent |
| Materials:Non Contact(contained withinhandles) | • --• 303 / 316 stainless steel | • 304 stainless steel,platinum/iridium• -- | DifferentDifferent |
| Indicators/Markings | • Numeric indicators onhandles to signifyprocedural step• Directionality indicatedwith arrows• Reference depth markers• -- | • Numeric indicators onhandles to signifyprocedural step• Directionality indicatedwith arrows• Reference depth markers• Gap Indicator: Indicateswhen Wing Nut ismaking contact with theIntroducer Cannula | EquivalentEquivalentEquivalentDifferent |
| • Visible red indicator tonotify that Bail tab isopen | • -- | Different | |
| Packaging | Double barrier thermoformedtray with a retainer lid andTyvek over lids | Double barrier thermoformedtray with a retainer lid andTyvek over lids | Same(packagingconcept) |
| 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: Pass2-year: In-Process | 6-month: Pass2-year: Pass | SameDifferent |
| DeviceComponent | Intracept RF Probe | Intracept RF ProbeReference Device(K180369) | Same |
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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.
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| Test | Test Method Summary | Results |
|---|---|---|
| Biocompatibility Testing | ||
| Patient contact materials are classified as tissue/bone/dentin <24 hours and tested for compliance to applicableISO 10993 standards. The Subject Device is the same classification as the Predicate and the materials used inconstruction are equivalent. | ||
| Cytotoxicity | ISO 10993-5 - Biological Evaluation of Medical Devices - Part 5: Tests for invitro cytotoxicity (MEM Elusion) | PASS |
| Sensitization | ISO 10993-10 – Biological Evaluation of Medical Devices - Part 10: Tests forirritation and skin sensitization (Guinea Pig Maximization Sensitization) | PASS |
| Acute SystemicToxicity | ISO 10993-11 - Biological Evaluation of Medical Devices - Part 11: Tests forsystemic toxicity (Acute Systemic Injection Test in Mice) | PASS |
| IntracutaneousReactivity | ISO 10993-10- Biological Evaluation of Medical Devices - Part 10: Tests forirritation and skin sensitization (Intracutaneous Reactivity Irritation Test inRabbits) | 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 ofcorrosion) | PASS |
| Transit | ASTM D4169 - Standard Practice forPerformance Testing of Shipping Containers and Systems (DC 13, assurancelevel II) | PASS |
| Gross Leaks | ASTM F2096 - Standard Test Method for Detecting Gross Leaks in Packagingby Internal Pressurization (Bubble Test) | PASS |
| Seal Strength | ASTM F88/F88M - Standard Test Method for Seal Strength of Flexible BarrierMaterials (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 asterilization process for medical devicesANSI/AAMI/ISO 11137-2: Part 2: Establishing the sterilization dose (Sterilityassurance 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 functionalwithout damage and met interface requirements. | PASS |
| Usability | IEC 62366-1: Application of Usability Engineering to Medical DevicesUsability testing simulated in sawbones with 15 users of the IntraceptIntraosseous 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.
§ 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).