(240 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 6 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 System is comprised of two basic, sterile, single use components, both of which are currently cleared for marketing via 510(k).
- The Intracept Easy Access Instrument Set (Instrument Set) is an instrument kit containing trocars, cannulas and guides that provide access to the intended site of radiofrequency (RF) ablation.
- The Intracept Flexible Bi-Polar RF Probe (RF Probe) conducts RF energy to the target location.
Additionally, a commercially available, legally marketed RF Generator provides RF energy to the RF Probe. An Interconnect Cable is provided to connect the RF Generator. The only RF Generator currently recommended for use with the Intracept System is the Stockert Neuro N50 (K070336).
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 Instrument Set, a minimally invasive, "transpedicular approach" is used to allow the placement of a cannula into the vertebral body, and a path or channel is created to the terminus of the basivertebral foramen. An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy the basivertebral nerve where it enters the vertebral body. This nerve has been identified as a proprioceptive sensory nerve with innervation of the vertebral endplates.
This document describes the Intracept Intraosseous Nerve Ablation System, which is used for the relief of chronic low back pain. The acceptance criteria and supporting studies are presented, though not in the format of a typical AI device study.
Here's an analysis of the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format alongside specific numerical performance targets for an AI device. Instead, it describes performance in terms of "PASS" for various tests and clinical efficacy for the medical device itself.
Since this is not an AI device, but a physical medical device, the acceptance criteria are related to safety, biocompatibility, electrical safety, mechanical integrity, sterilization, and clinical effectiveness. The performance is reported as meeting these criteria.
Table of Acceptance Criteria and Reported Device Performance (Non-AI Device)
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | PASS (Same materials, same testing as for predicate device.) |
| Sensitization (ISO 10993-10) | PASS (Same materials, same testing as for predicate device.) | |
| Acute Systemic toxicity (ISO 10993-11) | PASS (Same materials, same testing as for predicate device.) | |
| Intracutaneous Reactivity (ISO 10993-10) | PASS (Same materials, same testing as for predicate device.) | |
| Ethylene Oxide (EtO) residuals (ISO 10993-7) | PASS (Same materials, same testing as for predicate device.) | |
| Electrical Safety | IEC 60601-1 (General requirements for basic safety and essential performance) | In compliance (Same as for predicate device) |
| IEC 60601-1-2 (Electromagnetic compatibility) | In compliance (Same as for predicate device) | |
| IEC 60601-2-2 (Particular requirements for basic safety and essential performance of high frequency surgical equipment and accessories, including external surface temperature, dielectric, and leakage current) | PASS (Same as for predicate device) | |
| Physical/Mechanical | Intracept RF Probe: Dimensional specifications, Corrosion (ISO 10555-1), Transit (ASTM D4169-09), Bubble Test (ASTM F 2096-04), Seal Peel Test (ASTM F88/F88M-09), Mechanical Testing (Bend/Buckling, Handle Tensile, Distal tip Tensile) | All PASS |
| Intracept Easy Access Instrument Set: Dimensional specifications, Corrosion (ISO 10555-1), Transit (ASTM D4169-09), Bubble Test (ASTM F 2096-11), Seal Peel Test (ASTM F88/F88M-09), Mechanical Testing (Introducer Cannula Tensile & Torque, Trocar Tensile & Torque, Curved Cannula Tensile & Torque, J-Stylet Tensile & Torque, Straight Stylet Tensile, Stopper Ring Torque) | All PASS | |
| Sterilization | Sterilization Validation (ISO-11135-2014) | PASS (Sterility assurance of 10^-6) |
| System Performance | Device Compatibility (Probe and Instrument Set compatibility, Probe and Cable/RFG compatibility) | PASS (Specs met per Product Specifications; includes dimensional measurements, performance, and simulated use testing) |
| Temperature Accuracy | PASS (Accuracy verified by measurements and performance testing) | |
| Lesion (Measured RF Lesion Size in Tissue Model, Bovine In Vivo, Thermal distribution, Lesion size based on Thermal Dosimetry and histology) | PASS | |
| Clinical Efficacy | Primary Endpoint: Change from Baseline in Oswestry Disability Index (ODI) at Month 3 (Per-Protocol Population) - LS Mean Improvement | Intracept Arm: -20.5 points; Sham Arm: -15.2 points. Difference from Sham System in LS Mean: -5.3 (p=0.019), showing statistical superiority for Intracept. |
| ODI Responder Rates (percentage of patients with >10-point MCID improvement) at 3 months (Per-Protocol Population) | Intracept Arm: 75.6% (96/127); Sham Arm: 55.3% (42/76). This difference indicates a higher clinically meaningful improvement rate with Intracept. |
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 (Clinical Study - Test Set):
- Pilot Study: Seventeen patients.
- Pivotal Randomized, Double-Blind, Sham Controlled Clinical Study: 225 patients.
- Intention-To-Treat (ITT) population: 144 in Intracept arm, 77 in Sham arm.
- Per Protocol (PP) population: 128 in Intracept arm, 77 in Sham arm.
- Data Provenance: The document does not specify the country of origin of the data. The clinical studies were prospective, as indicated by the description of a randomized, double-blind, sham-controlled clinical study with follow-up.
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)
This section is not applicable as the document describes a physical medical device (Intracept Intraosseous Nerve Ablation System) and its clinical efficacy, not an AI device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" here is the patient's self-reported pain and disability scores (ODI), which are clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a clinical trial evaluating the efficacy of a medical device based on patient-reported outcomes (ODI scores) and not an AI device that requires adjudication of algorithmic outputs against expert opinions. The clinical trial was randomized and double-blind, with data analysis determining the efficacy.
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
This is not applicable as the document describes a physical medical device and its direct clinical effectiveness study, not an AI device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document describes a physical medical device and its clinical effectiveness, not a standalone AI algorithm. The Intracept System is a medical procedure performed by a clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical performance testing, the "ground truth" or primary measure of effectiveness was the patient's self-reported outcomes data, specifically the Oswestry Disability Index (ODI) Total Score. This index measures disability due to low back pain. The improvement in this score over time, compared to a sham control, served as the primary clinical ground truth.
8. The sample size for the training set
This is not applicable as the document describes a physical medical device and its clinical efficacy, not an AI device that requires a training set. The device itself (RF Probe, Instrument Set) undergoes engineering and performance testing, but there's no "training set" in the machine learning sense.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are designed with flowing lines, giving the impression of movement or wind. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2016
Relievant Medsystems, Inc. Mr. Adam Savakus Executive Vice President 2688 Middlefield Road, Suite A Redwood City, California 94063
Re: K153272
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: June 8, 2016 Received: June 9, 2016
Dear Mr. Savakus:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -SFD/△
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) K153272
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 6 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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Premarket Notification 510(k) Summary
Applicant's Name and Address:
Relievant Medsystems, Inc. 2688 Middlefield Road, Suite A Redwood City, CA 94063
| Contact Person: | Adam Savakus |
|---|---|
| Executive Vice President | |
| Telephone: | 650-368-1000 |
| Facsimile: | 650-298-9205 |
Date Prepared: July 8, 2016
Device Name:
| Device Generic Name: | RF Ablation Catheter and Accessories |
|---|---|
| Device Trade Name: | Intracept Intraosseous Nerve Ablation System |
| Classification Name: | Radiofrequency lesion probe, (21 CFR 882.4725, Product Code GXI |
Predicate Devices:
The Intracept Intraosseous Nerve Ablation System is substantially equivalent to the following legally marketed devices:
Intracept Easy Access Instrument Set and Flexible Bi-Polar RF Probe (K100641) Stryker RF Coaxial Bipolar Electrodes and Cannulae (K043442)
Device Description:
The Intracept System is comprised of two basic, sterile, single use components, both of which are currently cleared for marketing via 510(k).
- The Intracept Easy Access Instrument Set (Instrument Set) is an instrument kit containing trocars, cannulas and guides that provide access to the intended site of radiofrequency (RF) ablation.
- The Intracept Flexible Bi-Polar RF Probe (RF Probe) conducts RF energy to the target location.
Additionally, a commercially available, legally marketed RF Generator provides RF energy to the RF Probe. An Interconnect Cable is provided to connect the RF Generator. The only RF Generator currently recommended for use with the Intracept System is the Stockert Neuro N50 (K070336).
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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 Instrument Set, a minimally invasive, "transpedicular approach" is used to allow the placement of a cannula into the vertebral body, and a path or channel is created to the terminus of the basivertebral foramen. An RF Probe is then placed into this channel at the terminus of the basivertebral foramen, and controlled RF energy is delivered to destroy the basivertebral nerve where it enters the vertebral body. This nerve has been identified as a proprioceptive sensory nerve with innervation 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 6 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.
Substantial Equivalence
Comparison with Predicate Devices
| Companyand 510(k)Number | Relievant MedsystemsProposed Device | Relievant MedsystemsK100641 | Stryker InstrumentsK043442 |
|---|---|---|---|
| Description | Intracept Intraosseous NerveAblation System (RF Probe andInstrument Set) | INTRACEPT Flexible Bipolar RFProbe and Easy AccessInstrument Set | STRYKER RF COAXIAL BIPOLARELECTRODES & CANNULAE |
| Classification | GXI882.4725 Radiofrequency lesionprobe) Class II | GEI878.4400 Electrosurgicalcutting and coagulationdevice and accessories ClassII | GXI882.4725 Radiofrequencylesion probe) Class II |
| TechnologicalCharacteristics | The Relievant Intracept RFprobe is intended to be usedwith the Stockert Neuro N50 RFGenerator. The Stockert N50 is510(k) cleared as aNeurosurgical generator underGXD for "Lesioning nerve tissuefor functional neurosurgicalprocedures; or Radiofrequencyheat lesion procedures for therelief of pain..." (K070336)The Flexible RF Probe is a handheld, bipolar single use steriledevice that connects to an RFGenerator and conductsenergy in a controlled mannerto the tissue between andaround the electrodes. The RFProbe also employs athermocouple for monitoringand controlling tiptemperature. The RF Probe isused with the Easy AccessInstrument Set, which allowsfor the placement of the RFprobe into the intendedanatomical treatment area. | Identical to the proposeddevice | The Stryker RF Electrodes and Cannulae,in combination with the Stryker RFGenerator (N50), are intended forcoagulation of soft tissues in orthopedic,spinal, and neurosurgical applications.They are also used for selectivedenervation and tissue destructionprocedures which may be performed onthe lumbar, thoracic, and cervical regionsof the spinal cord, peripheral nerves, andnerve roots for the relief of pain.Examples include, but are not limited to,Facet Denervation, PercutaneousChordotomy/Dorsal Root Entry Zone(DREZ) Lesion, Trigeminus Neuralgia,Peripheral Neuralgia and Rhizotomy. |
| Method of Use | Placement of the RF probe atthe target; delivery of RFenergy into the tissue toachieve tissue ablation (i.e.,Cellular necrosis throughthermal coagulation) | Identical to the proposeddevice | Identical to the proposed device |
| Intended Use | Delivery of RF energy intotissue toablate tissue and relieve pain | Delivery of RF energy intotissue tocoagulate soft tissue | Delivery of RF energy into tissue toablate tissue and relieve pain |
| Indication for Use | The Intracept IntraosseousNerve Ablation System isintended to be used inconjunction with radiofrequency(RF) generators for the ablationof basivertebral nerves of the L3through S1 vertebrae for therelief of chronic low back pain ofat least 6 months duration thathas not responded to at least sixmonths of conservative care,and is also accompanied byeither Type 1 or Type 2 Modicchanges on an MRI. | The INTRACEPT Flexible BipolarRF Probe and Easy AccessInstrument Set is intended tobe used in conjunction withradiofrequency (RF) generatorsfor the thermal coagulation ofsoft tissues. | The Stryker RF Electrodes and Cannulae,in combination with the Stryker RFgenerator, are intended for coagulation ofsoft tissues in orthopedic, spinal, andneurosurgical applications.They are also used for selectivedenervation and tissue destructionprocedures which may be performedon the lumbar, thoracic, and cervicalregions of the spinal cord, peripheralnerves, and nerve roots for the relief ofpain.Examples include, but are not limited to,Facette Denervation, PercutaneousChordotomy/Dorsal Root Entry Zone(DREZ) Lesion, Trigeminus Neuralgia,Peripheral Neuralgia and Rhizotomy. |
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Non-Clinical Testing (Performance Data)
The Intracept device is identical to the predicate Intracept device. Tests setup and execution were performed in accordance with applicable standards.
Results of the testing demonstrate compliance to the standards, and/or matching the performance of new devices to the predicate device.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
Patient contact materials are classified as tissue/bone/dentin < 24hours and tested for compliance to applicable ISO 10993 standards.
The new device is similar in classification, and the materials used in construction are identical to those used in the Intracept predicate device. This table summarizes the biocompatibility testing done and the results.
| Intracept RF Probe-Tests | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5:1999 - BiologicalEvaluation of Medical Devices –Part 5: Tests for in vitrocytotoxicity (MEM Elusion) | PASS(Same materials, same testing as for predicatedevice.) |
| Sensitization | ISO 10993-10:2002 – BiologicalEvaluation of Medical Devices -Part 10: Tests for irritation and skinsensitization (Guinea PigMaximization Sensitization) | PASS(Same materials, same testing as for predicatedevice.) |
| Acute Systemic toxicity | ISO 10993-11:2006 — BiologicalEvaluation of Medical Devices –Part 11: Tests for systemic toxicity(Acute Systemic Injection Test inMice: Saline and Cottonseed OilExtracts) | PASS(Same materials, same testing as for predicatedevice.) |
| Intracutaneous Reactivity | ISO 10993-10:2002 — BiologicalEvaluation of Medical Devices – Part10: Tests for irritation and skinsensitization (IntracutaneousReactivity Test: Saline andCottonseed Oil Extracts) | PASS(Same materials, same testing as for predicatedevice.) |
| EtO residuals | ISO 10993-7:2008 - BiologicalEvaluation of Medical Devices -Part 7: Ethylene oxide sterilizationresiduals | PASS(Same materials, same testing as for predicatedevice.) |
| Intracept Easy AccessInstrument Set- Tests | Test Method Summary | Results |
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| Cytotoxicity | ISO 10993-5:2009 - BiologicalEvaluation of Medical Devices –Part 5: Tests for in vitrocytotoxicity (MEM Elusion) | PASS(Same materials, same testing as for predicatedevice.) |
|---|---|---|
| Sensitization | ISO 10993-10:2010 – BiologicalEvaluation of Medical Devices –Part 10: Tests for irritation and skinsensitization (Guinea PigMaximization Sensitization) | PASS(Same materials, same testing as for predicatedevice.) |
| Acute Systemic toxicity | ISO 10993-11:2006 – BiologicalEvaluation of Medical Devices –Part 11: Tests for systemic toxicity(Acute Systemic Injection Test inMice: Saline and Cottonseed OilExtracts) | PASS(Same materials, same testing as for predicatedevice.) |
| Intracutaneous Reactivity | ISO 10993-10:2010 – BiologicalEvaluation of Medical Devices –Part 10: Tests for irritation and skinsensitization (IntracutaneousReactivity Test: Saline andCottonseed Oil Extracts) | PASS(Same materials, same testing as for predicatedevice.) |
| EtO residuals | ISO 10993-7:2008 – BiologicalEvaluation of Medical Devices –Part 7: Ethylene oxide sterilizationresiduals | PASS(Same materials, same testing as for predicatedevice.) |
Electrical safety testing
The Intracept device is identical in size, materials, construction and used with the same equipment as the Intracept predicate device, therefore the same-IEC 60601-1-2, and IEC 60601-2-2 test reports are applicable to the subject device. The Intracept RF Probe was evaluated for compliance with the following standards and was found to be in compliance:
IEC 60601-1; Medical electrical equipment; Part 1: General requirements for basic safety and essential performance IEC 60601-1-2; Medical electrical equipment; Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility
Additional testing also performed as a part of IEC 60601-2-2 for high frequency surgical accessories.
| Tests | Test Method Summary | Results |
|---|---|---|
| High frequency surgicalaccessories | IEC 60601-2-2 Medical electrical equipmentPart 2-2: Particular requirements for basicsafety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories:- External Surface Temperature per IEC 60601-1: Third Edition 2012 & IEC 60601-2-2:2009- Dielectric and Leakage Current per EN 60601-1:2012 & IEC 60601-2-2:2009 | PASS(same as for predicate device) |
| Intracept RF Probe -Tests | Test Method Summary | Results |
| Dimensional | Meet dimensional specs per ProductSpecifications | PASS |
| Corrosion | Corrosion testing per ISO 10555-1:1995 -Intravascular catheters - Sterile and single-usecatheters - Part 1: General requirements(Annex A: No visible signs of corrosion) | PASS |
| Transit | ASTM D4169-09 - Standard Practice forPerformance Testing of Shipping Containersand Systems (DC 13, assurance level II) | PASS |
| Bubble Test | ASTM F 2096-04 - Standard Test Method forDetecting Gross Leaks in Packaging by InternalPressurization (Bubble Test) | PASS |
| Seal Peel Test | ASTM F88/F88M-09 - Standard Test Method forSeal Strength of Flexible Barrier Materials (Sealpeel >1.0 lbs) | PASS |
| Mechanical Testing | Meets all performance specs per ProductSpecifications; testing includes:- Bend/Buckling (Flexure/Compression)- Handle: Tensile- Distal tip: Tensile | PASS |
| Sterilization Validation | ISO-11135-2014 - Sterilization of Health CareProducts – Ethylene Oxide – Requirements forthe Development, Validation and RoutineControl of a Sterilization Process for MedicalDevices (Sterility assurance of 10-6) | PASS |
| Intracept Easy AccessInstrument Set - Tests | ||
| Dimensional | Meet dimensional specs per ProductSpecifications | PASS |
| Corrosion | Corrosion testing per ISO 10555-1:2013 -Intravascular catheters – Sterile and single-usecatheters - Part 1: General requirements(Annex A: No visible signs of corrosion) | PASS |
| Transit | ASTM D4169-09 - Standard Practice forPerformance Testing of Shipping Containersand Systems (DC 13, assurance level II) | PASS |
| Bubble Test | ASTM F 2096-11 - Standard Test Method forDetecting Gross Leaks in Packaging by InternalPressurization (Bubble Test) | PASS |
| Seal Peel Test | ASTM F88/F88M-09 - Standard Test Method forSeal Strength of Flexible Barrier Materials (Sealpeel >1.0 lbs) | PASS |
| Mechanical Testing | Meets all performance specs per ProductSpecifications; testing includes:- Introducer Cannula: Tensile & Torque- Trocar: Tensile & Torque- Curved Cannula: Tensile & Torque- J-Stylet: Tensile & Torque- Straight Stylet: Tensile- Stopper Ring: Torque | PASS |
| Sterilization Validation | ISO-11135-2014 - Sterilization of Health CareProducts – Ethylene Oxide – Requirements forthe Development, Validation and RoutineControl of a Sterilization Process for MedicalDevices (Sterility assurance of 10-6) | PASS |
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| Interface and Primary Operating Function TestingThe new and the Intracept predicate device are identical. Results of performance testing are summarized below. | ||
|---|---|---|
| Intracept System Tests | Test Method Summary | Results |
| Device Compatibility | Probe and Easy Access Instrument Setcompatibility specs met per ProductSpecifications; testing includes:- Dimensional measurements- Performance testing- Simulated use testingProbe and Cable/RFG compatibility specs weremet per Product Specifications; testingincludes:- Performance testing- Simulated use testing | PASS |
| Temperature Accuracy | Accuracy verified by measurements andperformance testing covering full functional userange | PASS |
| Lesion | Measured RF Lesion Size in Tissue Model,Bovine In Vivo:- Thermal distribution within vertebral bodies- Lesion size, based on Thermal Dosimetry- Lesion size, based on histological analysis | PASS |
Clinical Performance Testing
A Pilot study was performed in seventeen patients, which demonstrated that the Intracept System was effective and safe for treatment of chronic low back pain of at least 6 months duration that had not responded to at least three months of conservative care, and was also accompanied by
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either Type 1 or Type 2 Modic changes on an Magnetic Resonance Imaging (MRI) or positive provocative discography.
Based on the results of the pilot study, a pivotal randomized, double-blind, sham controlled clinical study was performed in 225 patients. The results of this study showed that the Intracept System is safe, well-tolerated, and effective for the relief of chronic low back pain of at least 6 months duration that had not responded to at least six months of conservative care, and was also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
Results of the primary end point analysis for the Intent-To-Treat (ITT) population did not show a statistically significant difference between the study arms. While this analysis showed a 19.0 point Least Squares (LS) mean Oswestry Disability Index (ODI) improvement in the Intracept arm, there was a greater than expected response in the Sham arm (Sham ODI LS mean improvement was 15.4 points).
Results of the primary end point analysis for the Per Protocol (PP) population showed that the LS mean improvement in ODI observed in the Intracept arm was statistically superior to the Sham arm (p=0.019). This analysis is a direct comparison of ODI outcomes between the treatment arms in the study population that successfully received the intended therapy per randomization assignment (appropriate ablation of the Basivertebral Nerve (BVN) in the Intracept arm) and completed follow-up per the study protocol (i.e., visit compliant, with no confounding medications or interventions). The results of a 3 Group Model ITT analysis also allowed for a direct comparison of efficacy between patients who received correctly targeted Intracept System treatment (i.e., only patients who received the treatment at the intended location) and patients who received the Sham treatment and demonstrated that the efficacy of the Intracept System is superior to the Sham (p=0.045).
The mean improvement in ODI in the Intracept patients (PP population) at 3 months was 20.5 points; twice the 10-point Minimally Important Clinical Difference (MCID) for ODI as recognized in the published literature. The corresponding mean improvement in ODI in the Sham arm at 3 months was 15.2. See Table 1 below:
| Sham System(N=77) | Intracept System(N=128) | P-Value | |
|---|---|---|---|
| Baseline | |||
| ODI Total Score | |||
| N | 77 | 128 | |
| Mean | 41.2 | 42.4 | |
| SD | 10.38 | 10.92 | |
| Median | 38.0 | 39.0 | |
| Min. to Max. | 26 to 78 | 30 to 76 | |
| Month 3 | |||
| ODI Total Score | |||
| N | 77 | 128 | |
| Mean | 25.8 | 22.1 |
Table 1: Primary Analysis: Change from Baseline in Oswestry Disability Index (ODI) at Month 3 (Per-Protocol Population)
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| Sham System(N=77) | Intracept System(N=128) | P-Value | |
|---|---|---|---|
| SD | 17.44 | 15.39 | |
| Median | 26.0 | 22.0 | |
| Min. to Max. | 0 to 74 | 0 to 60 | |
| ODI Change from Baseline | |||
| Mean | -15.5 | -20.3 | |
| SD | 17.87 | 15.56 | |
| Median | -12.0 | -18.0 | |
| Min. to Max. | -62 to 20 | -70 to 20 | |
| LS Mean ODI Change from Baselinea | -15.2 | -20.5 | |
| 95% Confidence Interval for LS Meana | [-18.7, -11.7] | [-23.2, -17.8] | |
| Difference from Sham System in LS Meansa | -5.3 | 0.019 | |
| 95% Confidence Interval for Differencea | [-9.8, -0.9] |
Table 1: Primary Analysis: Change from Baseline in Oswestry Disability Index (ODI) at Month 3 (Per-Protocol Population)
a Estimates and p-value from ANCOVA (Analysis of Covariance) with factors of treatment group, analysis center and treatment group by analysis center interaction, and a covariate of baseline ODI score.
Note: Last observation carried forward used to impute missing values.
The result for the PP population was sustained through two years of follow-up. Additionally, an analysis of ODI responder rates found that 75.6% of patients treated with the Intracept System demonstrated a greater than 10-point, clinically meaningful improvement in their low back pain and associated disability at 3 months compared to 55.3% in the Sham arm. See Table 2 below:
| Table 2: ODI 3-Month Responder Rates (Intent-to-Treat and Per Protocol Populations) | |||||||
|---|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| Intracept System% Responders | Sham System% Responders | ||
|---|---|---|---|
| ITT Population* | 10 point MCID | 70.1% (101/144) | 54.5% (42/77) |
| PP Population** | 10 point MCID | 75.6% (96/127) | 55.3% (42/76) |
No imputations for missing data were made.
- 4 patients in the ITT population (3 in the Intracept System arm and 1 in the Sham System arm) had missing ODI scores at the 3-month time point.
**2 patients in the PP population (1 in each arm) had missing ODI scores at the 3-month time point.
Conclusions
Based upon the testing, the Intracept System performs as intended and does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Intracept System is substantially equivalent to these existing 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).