(122 days)
No
The description focuses on a microcontrolled RF generator that monitors and controls power based on temperature and impedance, which are standard feedback mechanisms in medical devices, not indicative of AI/ML. There is no mention of AI, ML, or related concepts in the document.
Yes.
The device is intended to ablate nerves for the relief of chronic low back pain, which is a therapeutic purpose.
No
The device is an RF generator intended to deliver RF energy for the ablation of basivertebral nerves, which is a treatment, not a diagnostic procedure.
No
The device description explicitly states it is a "universal AC powered, microcontrolled, bipolar RF generator" and mentions hardware components like temperature and impedance measurements, indicating it is a physical device, not software-only.
Based on the provided information, the Relievant RFG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "ablation of basivertebral nerves... for the relief of chronic low back pain." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a "bipolar RF generator intended to deliver RF energy to a targeted site." This is consistent with a device used for energy delivery for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Relievant RFG is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GXD
Device Description
The Relievant RFG is a universal AC powered, microcontrolled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone and soft tissue
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)
Non-Clinical Performance Testing: Testing of the Relievant RFG demonstrated that the device met specifications and performance requirements, and supports demonstration of equivalence to the predicate device.
- Electrical (IEC 60601-1-1 and IEC 60601-2-2): Pass. Complies with the standards.
- Electromagnetic Compatibility (EMC) (IEC 60601-1-2): Pass. Complies with the standard.
- Temperature Accuracy (Verify output temperature 25°C-100°C+1.9°C): Pass.
- RF Output Power (IEC 60601-1-2): Pass. Complies with the standard.
- Mechanical Testing (IEC 60601-1-1, IEC 60601-2-2, and Relievant specified requirements): Pass. Complies with the standards and Relievant requirements.
- Software (FDA's May 2005 “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"): Pass. Met FDA's Guidance requirements for software development documentation and testing.
- Other (Programmable Electrical Medical System (PEMS) IEC 62304 Medical Device Software – Software Life-Cycle Processes): Pass. Complies with the standard.
- Interface: Usability (FDA Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices, IEC 60601-6, and IEC 62366): Pass. Complies with the standards.
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): 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
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a way that they resemble a bird in flight. The profiles are black, and they are set against a white background. 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
August 18, 2017
Relievant Medsystems Laurie Hook Clinical/Regulatory Consultant 2688 Middlefield Road. Suite A Redwood City, California 94063
Re: K171143
Trade/Device Name: Relievant Medsystems RF Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: Class II Product Code: GXD Dated: July 18, 2017 Received: July 20, 2017
Dear Laurie 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
1
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
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171143
Device Name Relievant Medsystems RF Generator (RFG)
Indications for Use (Describe)
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.
| 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
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 18, 2017 |
| Device Name: | |
| Device Generic Name: | RF Generator |
| Device Trade Name: | Relievant Medsystems RF Generator™ (Relievant RFG) |
| Device Classification: | II |
| Classification Name: | Radiofrequency lesion generator |
| 21 CFR 882.4400, Product Code GXD | |
| Predicate Devices: |
Stockert NEURO N50 Generator: K070336 (primary) Relievant INTRACEPT Intraosseous Nerve Ablation System: K153272 (reference)
Device Description:
The Relievant RFG is a universal AC powered, microcontrolled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.
Indications for Use
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.
Substantial Equivalence
The Relievant RFG and the Stockert NEURO N50 RFG are microcontrolled, bipolar RF energy generators intended to delivery RF energy to a targeted site for thermal coagulation. The RFGs include the same indication, have the same intended use, have a similar overall design, and similar operational characteristics. The ablation settings for the Relievant RFG are embedded within the RFG. These embedded settings are a subset of the manually set ablation settings for the primary
4
predicate device and are the same as the manually set ablation settings for the reference predicate. Differences between the devices do not raise different questions of safety and effectiveness for the subject device. A comparison of the subject to the predicate devices is provided in the table below.
| | PREDICATE | PREDICATE:
Reference | SUBJECT | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Category | Stockert NEURO N50
Radiofrequency
Lesion Generator | Relievant
INTRACEPT
Intraosseous Nerve
Ablation System | Relievant RF
Generator | COMPARISON |
| 510(k) | K070336 | K153272 | K171143 | -- |
| Class | II | II | II | Equivalent |
| Product
Code/Classification | GXD, 882.4400 | GXI, 882.4725 | GXD, 882.4400 | Equivalent |
| Characteristics: | | | | |
| Indications For Use | The Stockert NEURO
N50 RFG is for general
high frequency
applications:
-
Radiofrequency heat
lesion procedures for
the relief of pain, or -
Lesioning nerve
tissue for functional
neurosurgical
procedures; or | The Relievant
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 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 |
| | PREDICATE | PREDICATE:
Reference | SUBJECT | |
| Category | Stockert NEURO N50
Radiofrequency
Lesion Generator | Relievant
INTRACEPT
Intraosseous Nerve
Ablation System | Relievant RF
Generator | COMPARISON |
| | 3. Stimulation
procedures like
provoking stimulation,
localized stimulation,
blocking stimulation or
intraoperative test
stimulation. | -- | -- | -- |
| Anatomical Site | Bone and soft tissue | Bone and soft tissue | Bone and soft
tissue | Equivalent |
| Energy type | Radiofrequency energy | Radiofrequency
energy | Radiofrequency
energy | Equivalent |
| Mechanism of
action | Cellular necrosis
through thermal
coagulation | Cellular necrosis
through thermal
coagulation | Cellular necrosis
through thermal
coagulation | Equivalent |
| Operating Mode | Monopolar
Bipolar RF energy
Neuro-stimulation | Bipolar RF energy | Bipolar RF energy | Equivalent |
| Output Power | 50 W | Not applicable* | 20 W | Different |
| Output Frequency | 475kHz | Not applicable* | 475kHz | Equivalent |
| Feedback
Mechanism | Power Controlled
Temperature
Controlled | Not applicable* | Temperature
Controlled | Equivalent |
| Ablation Settings: | User Set, manual | User Set, manual | Embedded | Equivalent |
| Temperature | 42°C - 100.0°C | 85° C | 85° C | Equivalent |
| Temperature Ramp | 0 - 50°C /seconds | 1°/seconds | 1°/seconds | Equivalent |
| RF Duration |