(214 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 either Type 1 or Type 2 Modic changes on an MRI.
The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of two 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 RF Generator (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.
This document is a 510(k) summary for the Intracept Intraosseous Nerve Ablation System (specifically the Intracept RF Probe component), submitted to the FDA by Relievant Medsystems, Inc. It describes the device's technical characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.
The provided text does not contain information about a study that assesses the device's performance against clinical acceptance criteria or involves human readers (MRMC study or standalone study). The device described is a medical instrument used in a surgical procedure, not an AI or imaging diagnostic device that would typically have acceptance criteria based on accuracy, sensitivity, or specificity of interpretation. Instead, the focus of this 510(k) submission is on demonstrating the device's safety and technical performance through non-clinical testing to establish substantial equivalence to a previously cleared predicate device.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set sample size, and ground truth for training set) are not applicable to the information presented in this 510(k) summary.
Here's a breakdown of the relevant information from the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on its compliance with various international standards and internal performance specifications for safety, biocompatibility, and functional integrity. The "reported device performance" indicates that the device met these specifications.
| Test Category | Acceptance Criteria/Test Method Summary | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Patient contact materials classified as tissue/bone/dentin <24 hours and tested for compliance to applicable ISO 10993 standards. Similar classification and materials to predicate device. - Cytotoxicity (RF Probe Tip & Handle): ISO 10993-5 (MEM Elusion) | PASS |
| - Sensitization (RF Probe Tip & Handle): ISO 10993-10 (Guinea Pig Maximization Sensitization) | PASS | |
| - Acute Systemic Toxicity (RF Probe Tip): ISO 10993-11 (Acute Systemic Injection Test in Mice) | PASS | |
| - Intracutaneous Reactivity (RF Probe Tip & Handle): ISO 10993-10 (Intracutaneous Reactivity Irritation Test in Rabbits) | PASS | |
| Functional Testing | Subject and predicate devices are equivalent in size, materials, and construction. - Corrosion: ISO 10555-1, Annex A (No visible signs of corrosion) | PASS |
| - Transit: ASTM D4169 (DC 13, assurance level II) | PASS | |
| - Gross Leaks: ASTM F 2096 (Bubble Test) | PASS | |
| - Seal Strength: ASTM F88/F88M (Seal peel ≥1.0 lbs/in) | PASS | |
| - Sterilization: ISO-11135 (Requirements for EO sterilization process) | PASS | |
| Electrical Safety | Compliance with electrical safety standards. - Electrical: IEC 60601-1 and IEC 60601-2-2 (Basic safety and essential performance of high frequency surgical equipment) | PASS |
| Electromagnetic Compatibility | - EMC: IEC 60601-1-2 (Electromagnetic compatibility, Requirements and Tests) | PASS |
| Interface & Primary Function | Evaluation of use with same Relievant RF Generator; equivalent performance demonstrated. - SensTx® Chip: Assessed software recognition and integration with Relievant RFG. | PASS |
| - Programmable Electrical Medical Systems (PEMS): IEC 60601-1 (Basic safety and essential performance) | PASS | |
| - Simulated Use with Mechanical Testing: Met performance specifications for mechanical durability and simulated use, and compatibility with Access Instruments. | PASS | |
| - Usability: IEC 62366-1 and IEC 60601-1-6 (Application of Usability Engineering to Medical Devices; basic safety and essential performance - usability) | PASS |
Study Details (as far as applicable)
- Sample size used for the test set and the data provenance: Not applicable. The testing described is non-clinical, involving material property tests, durability tests, electrical safety tests, and functional evaluations, rather than a "test set" of clinical data or patient samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant here. The ground truth for engineering and biocompatibility tests is established by adhering to recognized international standards and specifications.
- Adjudication method for the test set: Not applicable. This concept is for clinical studies with expert reviewers.
- 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, an MRMC study was not done. This device is a surgical instrument, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone performance study in the context of an algorithm or AI was not done. The non-clinical performance testing evaluates the device's technical specifications and safety.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical testing consists of established international standards (e.g., ISO, ASTM, IEC) and internal engineering specifications for device performance, safety, and biocompatibility. The tests aim to verify that the device's physical and functional properties meet these predefined criteria.
- The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Clinical Performance Testing:
The document explicitly states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."
Conclusion:
The 510(k) submission relies on non-clinical performance testing and a comparison of the device's technical characteristics to a predicate device to demonstrate substantial equivalence, rather than clinical efficacy or diagnostic accuracy.
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September 14, 2018
Relievant Medsystems Alex DiNello Chief Operating Officer 385 Moffett Park Drive, Suite 105 Sunnyvale, California 94089
Re: K180369
Trade/Device Name: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: Class II Product Code: GXI Dated: August 13, 2018 Received: August 15, 2018
Dear Alex DiNello:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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. Matthew C. Krueger -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180369
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 either Type 1 or Type 2 Modic changes on an MRI.
| 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
Applicant's Name and Address:
Relievant Medsystems, Inc. 385 Moffett Park Drive, Suite 105 Sunnyvale, CA 94089-1218
| Contact Person: | Laurie Hook |
|---|---|
| Telephone: | 650/368-1000 |
| Facsimile: | 650/298-9205 |
| Date Prepared: | August 13, 2018 |
| 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 probe21 CFR 882.4725, Product Code GXI |
Predicate Device:
Relievant Medsystems, Inc .: Intracept Intraosseous Nerve Ablation System (K153272)
Device Description:
The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of two 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 RF Generator (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.
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 either Type 1 or Type 2 Modic changes on an MRI.
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Substantial Equivalence
The subject device (Intracept RF Probe -- a component of the Intracept System) has the same intended use, has a similar overall design, and has the same operational characteristics as the predicate device (Flexible Bi-Polar RF Probe). Differences between the RF Probe devices do not raise different questions of safety and effectiveness for the subject device. In this submission, no modifications were made to the Intracept System's Access Instruments.
| Characteristic | Relievant MedsystemsSubject: | Relievant MedsystemsPredicate: | Comparison |
|---|---|---|---|
| Device Component | Intracept RF Probe | Intracept Flexible Bi-Polar RF Probe (K153272) | |
| Intended Use | To ablate the basivertebral nerves of the L3 to S1 vertebrae | Same | |
| Indication | 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. | Same | |
| Principle | Provide bipolar RF energy to the tissue between and around the electrodes to achieve tissue ablation (i.e., cellular necrosis through thermal ablation) | Same | |
| Probe Shaft Length/Diameter | 335mm/1.98mm | 335mm/1.98mm | Same |
| Distal Tip Length | 4mm | 4mm | Same |
| Electrodes | Two | Two | Same |
| Safety cable | Tether welded to distal electrode ensures the electrode tip is retained for device removal | -- | Different |
| Tip temperature monitor/control | Thermocouple at distal tip | Thermocouple at distal tip | Same |
| SensTx Chip | Treatment parameters stored on microchip in RF Probe Handle | -- | Different |
| Treatment ParametersTemperatureRampTime | 85° C1°C/second15 minutes (900 seconds) | 85° C1°C/second15 minutes (900 seconds) | SameSameSame |
| Indicators | Circumferential markings (exit of Curved Cannula and clearance for electrode)Light Ring | Circumferential markings (exit of Curved Cannula and clearance for electrode) | Different |
| Materials: Patient Contact | Stainless steel and Polyether Block Amide | Stainless steel and Polyether Block Amide | Same |
| Connect to RFG | Cable integrated with RF Probe | Separate cable | Different |
| Sterilization | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Use | Single | Single | Same |
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Non-Clinical Performance Testing
Testing of the Intracept RF Probe demonstrated that the device met specifications and performane requirements, and supports demonstration of equivalence to the predicate device. Performance testing of the subject device was completed as follows:
| 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 | RF Probe Tip: ≤ 24 hour contact with Tissue/Bone/DentinISO 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 |
| Cytotoxicity | RF Probe Handle: ≤ 24 hour contact with Intact SkinISO 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 |
| 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 |
| 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 forPerformance Testing of Shipping Containers and Systems (DC13, assurance level II) | PASS |
| Gross Leaks | ASTM F 2096 - Standard Test Method for Detecting GrossLeaks in Packaging by Internal Pressurization (Bubble Test) | PASS |
| Seal Strength | ASTM F88/F88M - Standard Test Method for Seal Strength ofFlexible Barrier Materials (Seal peel ≥1.0 lbs/in) | PASS |
| Sterilization | ISO-11135 – Sterilization of Health Care Products - EthyleneOxide - Requirements for the Development, Validation, andRoutine Control of a Sterilization Process for Medical Devices | PASS |
| Test | Test Method Summary | Results |
| compliance with the electrical safety standard; results demonstrated equivalence. | ||
| Electrical | IEC 60601-1 Medical electrical equipment Part 1: Generalrequirements for basic safety and essential performance and IEC60601-2-2 Medical electrical equipment-Part 2-2: Particularrequirements for the basic safety and essential performance ofhigh frequency surgical equipment and high frequency surgicalaccessories | PASS |
| ElectromagneticCompatibility (EMC) | IEC 60601-1-2 Medical electric equipment-Part 1-2: Generalrequirements of safety-Collateral Standard: Electromagneticcompatibility-Requirements and Tests | PASS |
| Interface and Primary Operating Function Testing | ||
| The subject and predicate devices have equivalent performance. | ||
| SensTx® Chip | Assessed use with Relievant RFG software recognition andintegration of SensTx Chip | PASS |
| Programmable ElectricalMedical Systems (PEMS) | IEC 60601-1 Medical electrical equipment Part 1: Generalrequirements for basic safety and essential performance | PASS |
| Simulated Use withMechanical Testing | Met performance specifications for mechanical durability andsimulated use, as well as compatibility with AccessInstruments. | PASS |
| Usability | IEC 62366-1: Application of Usability Engineering to MedicalDevices and IEC 60601-1-6 Medical Electrical Equipment – Part1-6: General Requirements for basic safety and essentialperformance - Collateral Standard: Usability | PASS |
| The subject and predicate devices are used with the same Relievant RF Generator and were evaluated for
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No modifications were made to the Intracept Access Instruments; 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 device comparison and non-clinical performance testing, the Intracept System with the RF Probe and Access Instruments is substantially equivalent to the legally marketed predicate device (Intracept System with the Flexible Bi-Polar RF Probe and Access Instruments) and any differences in design or technologic characteristics do not raise different questions of safety or effectiveness. All test requirements were met and results support the substantial equivalence of the subject and predicate devices.
§ 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).