(63 days)
Not Found
No
The document describes a system for radiofrequency ablation of nerves and does not mention any AI or ML components in its 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, which directly treats a medical condition.
No
The device is an "Intracept Intraosseous Nerve Ablation System" intended for the ablation of basivertebral nerves to relieve chronic low back pain, which is a therapeutic rather than diagnostic function.
No
The device description explicitly lists sterile, single-use components including access instruments and an RF probe, which are physical hardware components. It also mentions the use of an RF generator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The Intracept Intraosseous Nerve Ablation System is a surgical device used to ablate nerves within the vertebral body. It is used in vivo (within the living body) to treat chronic low back pain.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. Its function is to deliver energy to tissue.
The device uses MRI for patient selection (identifying Modic changes), but the device itself does not perform the diagnostic analysis of the MRI. The MRI is a separate diagnostic tool used in conjunction with the device's intended use.
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 six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
Product codes
GXI
Device Description
The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
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)
Substantial equivalence is not dependent upon non-clinical clinical performance testing.
Substantial equivalence is not dependent upon clinical data and no clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Relievant Medsystems Ms. Laurie Hook Clinical/Regulatory Consultant 358 Moffett Park Drive, Suite 105 Sunnyvale, California 94089
Re: K190504
Trade/Device Name: Intracept Intraosseous Nerve Ablation System (RF Probe). Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI
Dated: February 28, 2019 Received: March 1, 2019
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. 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.
1
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 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 (QS) 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,
Carlos L. Peña, PhD, MS Director Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190504
Device Name
Intracept Intraosseous Nerve Ablation System Relievant Medsystems RF Generator (RFG)
Indications for Use (Describe)
The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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3
510(k) SUMMARY -K190504
Applicant's Name and Address:
Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085-4068
| Contact Person: | Laurie Hook |
|---|---|
| Telephone: | 650/368-1000 |
| Facsimile: | 650/298-9205 |
| Date Prepared: | April 29, 2019 |
| Device Name: | |
| Device Generic Name: | RF Ablation Catheter and Accessories; |
| RF Generator | |
| Device Trade Name: | Intracept Intraosseous Nerve Ablation System; |
| Relievant Medsystems RF Generator (Relievant RFG) | |
| Device Classification: | II |
| Classification Name: | Radiofrequency lesion probe, 21 CFR 882.4725, Product Code GXI |
| Radiofrequency lesion generator, 21 CFR 882.4400, Product Code GXD | |
| Predicate Device: |
Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System (K180369, K170827) and Relievant RFG (K171143)
Device Description:
The Intracept Intraosseous Nerve Ablation System (Intracept System) is comprised of 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 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.
4
Indications for Use
The Intracept Intraosseous Nerve Ablation System is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant Intracept Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).
Substantial Equivalence
Compared to the Predicate Devices (Intracept System and Relievant RFG), there have been no design changes to the Intracept System or the Relievant RFG. The only difference between the Subject and Predicate Devices is the Indications for Use Statement. The Indications for Use Statements for the Subject Devices have been modified based on historical and current use of the Modic classification to include characteristics of each Modic Type following the references to Modic Type 1 and Type 2 based on MRI. The modification does not describe a new disease condition or patient population that the Subject Devices are intended to treat. The modification is intended to aid clinicians in their interpretation of MRI findings.
5
| Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison |
|---|---|---|---|
| Device Component | Subject: | Predicate: | -- |
| Intracept System: | |||
| RF Probe | |||
| Access Instruments |
RF Generator | Intracept System:
RF Probe (K180369)
Access Instruments
(K170827)
RF Generator (K171143) | -- |
| Intended Use | To ablate the basivertebral nerves of the L3 to S1 vertebrae | | Equivalent |
| Intracept System
Indication | The Intracept Intraosseous
Nerve Ablation System is
intended to be used in
conjunction with
radiofrequency (RF) generators
for the ablation of basivertebral
nerves of the L3 through S1
vertebrae for the relief of
chronic low back pain of at
least six months duration that
has not responded to at least six
months of conservative care,
and is also accompanied by
features consistent with Type 1
or Type 2 Modic changes on an
MRI such as inflammation,
edema, vertebral endplate
changes, disruption and
fissuring of the endplate,
vascularized fibrous tissues
within the adjacent marrow,
hypointensive signals (Type 1
Modic change), and changes to
the vertebral body marrow
including replacement of
normal bone marrow by fat,
and hyperintensive signals
(Type 2 Modic change) | The Intracept Intraosseous
Nerve Ablation System 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. | Different |
| Characteristic | Relievant Medsystems | Relievant Medsystems | Comparison |
| Relievant RFG
Indication | The Relievant RFG is intended
to be used with RF probes FDA
cleared as part of the Relievant
Intracept Intraosseous Nerve
Ablation System for the
ablation of basivertebral nerves
of the L3 through S1 vertebrae
for the relief of chronic low
back pain of at least six months
duration that has not responded
to at least six months of
conservative care, and is also
accompanied by features
consistent with Type 1 or Type
2 Modic changes on an MRI
such as inflammation, edema,
vertebral endplate changes,
disruption and fissuring of the
endplate, vascularized fibrous
tissues within the adjacent
marrow, hypointensive signals
(Type 1 Modic change), and
changes to the vertebral body
marrow including replacement
of normal bone marrow by fat,
and hyperintensive signals
(Type 2 Modic change). | The Relievant RFG is
intended to be used with RF
probes FDA cleared as part
of the Relievant Intracept
Intraosseous Nerve Ablation
System 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. | Equivalent
Different |
| Principle | Provide bipolar RF energy to the tissue between and around the
electrodes to achieve tissue ablation (i.e., cellular necrosis
through thermal ablation) | | Equivalent |
| Treatment Parameters:
Temperature | 85° C | | Equivalent |
| Ramp | 1°C/second | | Equivalent |
| Time | 15 minutes (900 seconds) | | Equivalent |
| Access Instruments and
RF Probe:
Design | No changes | | Equivalent |
| Materials | No changes | | Equivalent |
| Use | Single | | Equivalent |
| Connect to RF
Generator | Cable integrated with RF Probe | | Equivalent |
| RF Generator:
Operating Mode | Bipolar energy | | Equivalent |
| Output:
Power | 20W | | Equivalent |
| Frequency | 475 KHz | | Equivalent |
| Feedback mechanism | Temperature controlled | | Equivalent |
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7
Non-Clinical Performance Testing
No design changes were made to the Subject Devices. Substantial equivalence is not dependent upon non-clinical clinical performance testing.
Clinical Performance Testing
Substantial equivalence is not dependent upon clinical data and no clinical testing was performed.
Conclusions
The Indications for Use Statements of the Subject Devices have been modified to include characteristics of each Modic Type following references to Modic Type 1 and Type 2 based on MRI. The modification does not raise different questions of safety or effectiveness. There were no design changes to the Subject Devices. These results support the substantial equivalence of the Subject and Predicate Devices.