(240 days)
No
The summary describes a system for radiofrequency ablation of nerves using instruments and an RF generator. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes.
The device is intended for the ablation of basivertebral nerves for the relief of chronic low back pain, directly treating a medical condition.
No
The device is an interventional device designed to ablate basivertebral nerves for pain relief. While patient selection is based on pain duration and MRI findings (Type 1 or Type 2 Modic changes), the device itself is not used to diagnose these conditions.
No
The device description explicitly states it is comprised of two basic, sterile, single use components: an Instrument Set (containing trocars, cannulas, and guides) and an RF Probe. It also mentions the use of a commercially available RF Generator and an Interconnect Cable. These are all hardware components.
Based on the provided information, the Intracept Intraosseous Nerve Ablation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Intracept System Function: The Intracept System is a surgical device used to directly treat chronic low back pain by ablating (destroying) the basivertebral nerves within the vertebrae. It is an interventional procedure performed in vivo (within the living body), not in vitro (in a test tube or lab setting).
- Device Components: The components described (instrument set, RF probe, RF generator) are all used for performing a surgical procedure, not for analyzing biological samples.
- Intended Use: The intended use is for the relief of chronic low back pain through a direct intervention, not for diagnosing the cause of the pain by analyzing samples.
Therefore, the Intracept Intraosseous Nerve Ablation System is a therapeutic device used for a surgical procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 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.
Product codes (comma separated list FDA assigned to the subject device)
GXI
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
basivertebral nerves of the L3 through S1 vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LS Mean ODI Change from Baseline for Intracept System: -20.5 (95% Confidence Interval: [-23.2, -17.8])
LS Mean ODI Change from Baseline for Sham System: -15.2 (95% Confidence Interval: [-18.7, -11.7])
Difference from Sham System in LS Mean: -5.3 (p=0.019) (95% Confidence Interval: [-9.8, -0.9])
ODI 3-Month Responder Rates (10 point MCID):
ITT Population: Intracept System 70.1% (101/144), Sham System 54.5% (42/77)
PP Population: Intracept System 75.6% (96/127), Sham System 55.3% (42/76)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
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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).
4
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
| Company
and 510(k)
Number | Relievant Medsystems
Proposed Device | Relievant Medsystems
K100641 | Stryker Instruments
K043442 |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Intracept Intraosseous Nerve
Ablation System (RF Probe and
Instrument Set) | INTRACEPT Flexible Bipolar RF
Probe and Easy Access
Instrument Set | STRYKER RF COAXIAL BIPOLAR
ELECTRODES & CANNULAE |
| Classification | GXI
882.4725 Radiofrequency lesion
probe) Class II | GEI
878.4400 Electrosurgical
cutting and coagulation
device and accessories Class
II | GXI
882.4725 Radiofrequency
lesion probe) Class II |
| Technological
Characteristics | The Relievant Intracept RF
probe is intended to be used
with the Stockert Neuro N50 RF
Generator. The Stockert N50 is
510(k) cleared as a
Neurosurgical generator under
GXD for "Lesioning nerve tissue
for functional neurosurgical
procedures; or Radiofrequency
heat lesion procedures for the
relief of pain..." (K070336)
The Flexible RF Probe is a hand
held, bipolar single use sterile
device that connects to an RF
Generator and conducts
energy in a controlled manner
to the tissue between and
around the electrodes. The RF
Probe also employs a
thermocouple for monitoring
and controlling tip
temperature. The RF Probe is
used with the Easy Access
Instrument Set, which allows
for the placement of the RF
probe into the intended
anatomical treatment area. | Identical to the proposed
device | The Stryker RF Electrodes and Cannulae,
in combination with the Stryker RF
Generator (N50), are intended for
coagulation of soft tissues in orthopedic,
spinal, and neurosurgical applications.
They are also used for selective
denervation and tissue destruction
procedures which may be performed on
the lumbar, thoracic, and cervical regions
of the spinal cord, peripheral nerves, and
nerve roots for the relief of pain.
Examples include, but are not limited to,
Facet Denervation, Percutaneous
Chordotomy/Dorsal Root Entry Zone
(DREZ) Lesion, Trigeminus Neuralgia,
Peripheral Neuralgia and Rhizotomy. |
| Method of Use | Placement of the RF probe at
the target; delivery of RF
energy into the tissue to
achieve tissue ablation (i.e.,
Cellular necrosis through
thermal coagulation) | Identical to the proposed
device | Identical to the proposed device |
| Intended Use | Delivery of RF energy into
tissue to
ablate tissue and relieve pain | Delivery of RF energy into
tissue to
coagulate soft tissue | Delivery of RF energy into tissue to
ablate tissue and relieve pain |
| Indication 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. | The INTRACEPT Flexible Bipolar
RF Probe and Easy Access
Instrument Set is intended to
be used in conjunction with
radiofrequency (RF) generators
for the thermal coagulation of
soft tissues. | The Stryker RF Electrodes and Cannulae,
in combination with the Stryker RF
generator, are intended for coagulation of
soft tissues in orthopedic, spinal, and
neurosurgical applications.
They are also used for selective
denervation and tissue destruction
procedures which may be performed
on the lumbar, thoracic, and cervical
regions of the spinal cord, peripheral
nerves, and nerve roots for the relief of
pain.
Examples include, but are not limited to,
Facette Denervation, Percutaneous
Chordotomy/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 1.0 lbs) | PASS |
| Mechanical Testing | Meets all performance specs per Product
Specifications; testing includes:
- Bend/Buckling (Flexure/Compression)
- Handle: Tensile
- Distal tip: Tensile | PASS |
| Sterilization Validation | ISO-11135-2014 - Sterilization of Health Care
Products – Ethylene Oxide – Requirements for
the Development, Validation and Routine
Control of a Sterilization Process for Medical
Devices (Sterility assurance of 10-6) | PASS |
| Intracept Easy Access
Instrument Set - Tests | | |
| Dimensional | Meet dimensional specs per Product
Specifications | PASS |
| 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 D4169-09 - Standard Practice for
Performance Testing of Shipping Containers
and Systems (DC 13, assurance level II) | PASS |
| Bubble Test | ASTM F 2096-11 - Standard Test Method for
Detecting Gross Leaks in Packaging by Internal
Pressurization (Bubble Test) | PASS |
| | | |
| Seal Peel Test | ASTM F88/F88M-09 - Standard Test Method for
Seal Strength of Flexible Barrier Materials (Seal
peel >1.0 lbs) | PASS |
| Mechanical Testing | Meets all performance specs per Product
Specifications; 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 Care
Products – Ethylene Oxide – Requirements for
the Development, Validation and Routine
Control of a Sterilization Process for Medical
Devices (Sterility assurance of 10-6) | PASS |
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10
| Interface and Primary Operating Function Testing
| The 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 Set | |
| compatibility specs met per Product | ||
| Specifications; testing includes: |
- Dimensional measurements
- Performance testing
- Simulated use testing
Probe and Cable/RFG compatibility specs were
met per Product Specifications; testing
includes: - Performance testing
- Simulated use testing | PASS |
| Temperature Accuracy | Accuracy verified by measurements and
performance testing covering full functional use
range | 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
11
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)
12
| | 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.