(142 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® Intraosseous Nerve Ablation System is comprised of two sterile, single use components:
- The INTRACEPT Access Instruments include trocars, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. This submission describes modifications to the Access Instruments to improve ease of use compared to the predicate. Easy Access Instrument Set.
- The INTRACEPT Flexible Bi-Polar RF Probe conducts RF energy to the target location. There have been no changes to this component; therefore, there is no impact on RF ablation.
Additionally, a commercially available, legally marketed, RF Generator that has been confirmed by Relievant to be compatible, provides RF energy to the RF Probe. An Interconnect Cable connects the RF Probe to the RF Generator.
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 is placed into the vertebral body to create a path or channel 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. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.
This document is a 510(k) Premarket Notification from the FDA regarding the INTRACEPT Intraosseous Nerve Ablation System. It describes the device, its intended use, and the rationale for its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: This 510(k) submission primarily focuses on the INTRACEPT Access Instruments and their modifications. The manufacturer claims substantial equivalence to a previously cleared device, asserting that the changes improve ease of use without impacting safety or effectiveness. No clinical performance testing was performed for this submission, as substantial equivalence was deemed achievable through non-clinical testing and device comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Test | Acceptance Criteria (What was measured against) | Reported Device Performance (Results) |
|---|---|---|
| Material Biocompatibility | Compliance to ISO 10993 standards for tissue/bone/dentin contact <24 hours. | PASS for all tests (Cytotoxicity, Sensitization, Acute Systemic Toxicity, Intracutaneous Reactivity). Stated that materials are equivalent to predicate device and same testing was performed. |
| Cytotoxicity | Measured using ISO 10993-5: 2009 (MEM Elution). | PASS |
| Sensitization | Measured using ISO 10993-10: 2010 (Guinea Pig Maximization Sensitization). | PASS |
| Acute Systemic Toxicity | Measured using ISO 10993-11: 2006 (Acute Systemic Injection Test in Mice: Saline and Cottonseed Oil Extracts). | PASS |
| Intracutaneous Reactivity | Measured using ISO 10993-10: 2010 (Intracutaneous Reactivity Irritation Test in Rabbits: Saline and Cottonseed Oil Extracts). | PASS |
| Dimensional and Functional Performance | Equivalent in size, materials, and construction to predicate. | The document states the subject and predicate devices are equivalent in size, materials, and construction. Specific dimensions are not provided, only the tests performed to verify function. |
| Corrosion | No visible signs of corrosion per ISO 10555-1:2013 (Annex A). | PASS |
| Transit | Compliance with ASTM D4169-14 (DC 13, assurance level II). | PASS |
| Gross Leaks (Packaging) | Compliance with ASTM F 2096-11 (Bubble Test). | PASS |
| Seal Strength (Packaging) | Seal peel >1.0 lbs per ASTM F88/F88M-15. | PASS |
| Mechanical (Introducer Cannula, Trocar/Bevel, Curved Cannula, J-Stylet, Straight Stylet) | Met all performance testing per Product Specifications (Tensile & Torque). Specific limits not detailed in the table provided. | PASS (Met all performance testing per Product Specifications) |
| Sterilization | Sterility assurance level of 10-6 per ANSI/AAMI/ISO 11137-1: 2006 and ANSI/AAMI/ISO 11137-2. | PASS |
| Interface and Primary Operating Function | Devices remained functional without damage and met interface requirements after 6 full deployments. | PASS (Following exposure to 6 full deployments, devices remained functional without damage and met interface requirements.) |
| Usability | Safe and effective for intended users, uses, and use environments, per IEC 62366-1: 2015. | PASS (Usability testing simulated in sawbones with 16 users of the INTRACEPT Intraosseous Nerve Ablation System (Access Instruments and RF Probe) were safe and effective for intended users, uses and use environments.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Usability Testing: 16 users were involved in the usability simulation in sawbones.
- For other non-clinical tests (biocompatibility, mechanical, corrosion, etc.), the exact sample sizes (e.g., number of units tested for mechanical strength) are not specified in this summary document, but standard testing practices for these ISO/ASTM standards would imply a statistically relevant number of samples.
- Data Provenance: The data is from non-clinical bench testing and simulated use/usability studies conducted by Relievant Medsystems. There is no information about the country of origin of the data beyond it being generated by the applicant company (Relievant Medsystems, Redwood City, CA, USA). All data is prospective as it was generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- No external human "experts" established ground truth for the technical performance of the device. The acceptance criteria for the non-clinical tests (material, mechanical, sterilization, etc.) are based on established international standards (ISO, ASTM) and the manufacturer's internal product specifications. The "ground truth" here is compliance with these predefined engineering and safety standards.
- For the usability study, "users" (16 of them) participated in a simulated environment. Their qualifications are not specified beyond being "users of the INTRACEPT Intraosseous Nerve Ablation System." It is implied they are medical professionals who would operate such a device. This is not a "ground truth" derived from expert consensus on medical image interpretation, for example.
4. Adjudication Method for the Test Set
- Not applicable in the conventional sense. For this type of 510(k) submission based on non-clinical testing for substantial equivalence, formal "adjudication" by multiple human reviewers as seen in AI/CAD studies is not performed. The "adjudication" is inherent in the objective measurements against established engineering and biological standards. If a test "passed," it met the objective criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."
- Therefore, there is no effect size given for human readers improving with AI vs. without AI assistance, as AI is not a component of this device, and no human readership study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical instrument (ablation system with access instruments), not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
- The "ground truth" for this submission is based on adherence to international consensus standards (ISO, ASTM) for biocompatibility, mechanical properties, sterilization, packaging integrity, and the manufacturer's own product specifications for mechanical performance and interface functionality validated through bench and simulated use testing.
- For usability, the ground truth was derived from the observation of simulated use and the assessment of "safe and effective for intended users, uses and use environments" by the manufacturer against IEC 62366-1.
- No expert consensus on medical findings, pathology, or clinical outcomes data was used because clinical data was not required for this specific 510(k) submission, which focused on modifications to access instruments for improved ease of use, asserting equivalence to a predicate device.
8. The Sample Size for the Training Set
- Not applicable. This submission is for a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2017
Relievant Medsystems Ms. Laurie Hook Clinical/Regulatory 2688 Middlefield Road. Suite A Redwood City, California 94063
Re: K170827
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 7, 2017 Received: July 10, 2017
Dear Ms. Hook:
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 device
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related 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.
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,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for 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) K170827
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) | |
|---|---|
| XPrescription 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. 2688 Middlefield Road, Suite A Redwood City, CA 94063
| Contact Person: | Laurie Hook |
|---|---|
| Telephone: | 650/368-1000 |
| Facsimile: | 650/298-9205 |
| Date Prepared: | July 7, 2017 |
Device Name:
| Device Generic Name: | RF Ablation Catheter and Accessories |
|---|---|
| Device Trade Name:Device Classification: | INTRACEPT® Intraosseous Nerve Ablation SystemII |
| Classification Name: | Radiofrequency lesion probe21 CFR 882.4725, Product Code GXI |
| Predicate Device: |
INTRACEPT® Intraosseous Nerve Ablation System (K153272)
Device Description:
The INTRACEPT® Intraosseous Nerve Ablation System is comprised of two sterile, single use components:
- The INTRACEPT Access Instruments include trocars, cannulas and stylets that provide access to the intended site of radiofrequency (RF) ablation. This submission describes modifications to the Access Instruments to improve ease of use compared to the predicate. Easy Access Instrument Set.
- The INTRACEPT Flexible Bi-Polar RF Probe conducts RF energy to the target location. There have been no changes to this component; therefore, there is no impact on RF ablation.
Additionally, a commercially available, legally marketed, RF Generator that has been confirmed by Relievant to be compatible, provides RF energy to the RF Probe. An Interconnect Cable connects the RF Probe to the RF Generator.
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 is placed into the vertebral body to create a path or channel 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. This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.
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Indications for Use
The INTRACEPT Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
Substantial Equivalence
Compared to the previously cleared INTRACEPT Easy Access Instrument Set, the INTRACEPT Access Instruments have the same indication, the same intended use, the same overall design and the same operational characteristics. Modifications to the Access Instruments were made to improve their ease of use. No modifications were made to the INTRACEPT Flexible Bi-Polar RF Probe.
| Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison |
|---|---|---|---|
| DeviceComponent | Subject: INTRACEPTAccess Instruments | Predicate: INTRACEPT EasyAccess Instrument Set(K153272) | |
| Intended Use | To create a path or channel to the terminus of the basivertebralforamen. | Same | |
| Indication | The INTRACEPT Intraosseous Nerve Ablation System isintended to be used in conjunction with RF generators for theablation of basivertebral nerves of the L3 through S1 vertebraefor the relief of chronic low back pain of at least six monthsduration that has not responded to at least six months ofconservative care, and is also accompanied by either Type 1 orType 2 Modic changes on an MRI. | Same | |
| Principle | Minimally invasive percutaneous transpedicular orextrapedicular access through the vertebral body to allowpassage of the RF probe | Same | |
| Instruments | Introducers:• Trocar Introducer• Bevel IntroducerCannulas:• Introducer Cannula• Curved CannulaStylets:• J-Stylet• Straight Stylet | Introducers:• Trocar IntroducerCannulas:• Introducer Cannula• Curved CannulaStylets:• J-Stylet• Straight Stylet | Same and addedBevel Introduceras an additionaltip style |
| Indicators | Added Gap Indicator to theIntroducer Cannula;removed circumferentialdepth marker on theStraight Stylet | Visual estimation of depthperformed by operator usingdepth marker | Different |
| Materials:Patient Contact | Stainless steel, PEEK,Nitinol | Stainless steel, PEEK withBaSO4, Nitinol | Same and PEEKwithout BaSO4 |
| Sterilization | Gamma irradiation | Ethylene Oxide | Different |
| DeviceComponent | Subject: INTRACEPTFlexible Bi-Polar RF Probe | Predicate: INTRACEPTFlexible Bi-Polar RF Probe(K153272) | Same |
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Non-Clinical Testing
The INTRACEPT Access Instruments met specifications and performance requirements, and are equivalent to the predicate INTRACEPT Easy Access Instrument Set. Performance testing of the INTRACEPT Access Instruments was provided in support of the substantial equivalence determination 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 | ISO 10993-5: 2009 – Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity (MEM Elusion) | PASS(Equivalent materials, same testing as for predicate device.) |
| Sensitization | ISO 10993-10: 2010 - Biological Evaluation of Medical Devices - Part 10:Tests for irritation and skin sensitization(Guinea Pig Maximization Sensitization) | PASS(Equivalent materials, same testing as for predicate device.) |
| Acute Systemic Toxicity | ISO 10993-11: 2006 – Biological Evaluation of Medical Devices - Part 11:Tests for systemic toxicity (Acute Systemic Injection Test in Mice: Saline andCottonseed Oil Extracts) | PASS(Equivalent materials, same testing as for predicate device.) |
| Intracutaneous Reactivity | ISO 10993-10: 2010 – Biological Evaluation of Medical Devices - Part 10:Tests for irritation and skin sensitization(Intracutaneous Reactivity Irritation Test in Rabbits: Saline and Cottonseed OilExtracts) | PASS(Equivalent materials, same testing as for predicate device.) |
| Dimensional and Functional Testing | The subject and predicate devices are equivalent in size, materials, and construction. | |
| Corrosion | Corrosion testing per ISO 10555-1:2013 -Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements(Annex A: No visible signs of corrosion) | PASS |
| Transit | ASTM D4169-14 - Standard Practice forPerformance Testing of Shipping Containersand Systems (DC 13, assurance level II) | PASS |
| Gross Leaks | ASTM F 2096-11 - Standard Test Methodfor Detecting Gross Leaks in Packaging byInternal Pressurization (Bubble Test) | PASS |
| Seal Strength | ASTM F88/F88M-15 - Standard TestMethod for Seal Strength of Flexible BarrierMaterials (Seal peel >1.0 lbs) | PASS |
| Mechanical | Met all performance testing per ProductSpecifications:- Introducer Cannula: Tensile & Torque- Trocar/Bevel Introducer: Tensile & Torque | PASS |
| Test | Test Method Summary | Results |
| - Curved Cannula: Tensile & Torque- J-Stylet: Tensile- Straight Stylet: Tensile | ||
| Sterilization | ANSI/AAMI/ISO 11137-1: 2006Sterilization of health care products –Radiation - Part 1: Requirements fordevelopment, validation and routine controlof a sterilization process for medicaldevices ANSI/AAMI/ISO 11137-2: Part 2:Establishing the sterilization dose (Sterilityassurance of 10-6) | PASS |
| Interface and Primary Operating Function Testing | ||
| Simulated Use | Following exposure to 6 full deployments,devices remained functional withoutdamage and met interface requirements. | PASS |
| Usability | IEC 62366-1: 2015: Application ofUsability Engineering to Medical Devices.Usability testing simulated in sawboneswith 16 users of the INTRACEPTIntraosseous Nerve Ablation System(Access Instruments and RF Probe) weresafe and effective for intended users, usesand use environments. | PASS |
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No modifications were made to the INTRACEPT Flexible Bi-Polar RF Probe; therefore, previous testing of the RF Probe (i.e., biocompatibility, electrical safety, dimensional and functional, temperature accuracy, and lesion) remains applicable for the INTRACEPT Intraosseous Nerve Ablation System (Flexible Bi-Polar RF Probe with the Access Instruments) and retesting was not needed.
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 bench testing, the INTRACEPT System with the Flexible Bi-Polar RF Probe and the Access Instruments is substantially equivalent to the legally marketed predicate device and does not raise any new safety or effectiveness concerns.
§ 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).