(142 days)
Not Found
No
The document describes a medical device system for radiofrequency ablation of nerves and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the ablation of basivertebral nerves for the relief of chronic low back pain, which is a therapeutic purpose.
No
The device is used for the ablation of basivertebral nerves for pain relief, which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is comprised of two sterile, single-use components: Access Instruments (trocars, cannulas, stylets) and a Flexible Bi-Polar RF Probe. These are physical hardware components, not software.
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 Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- INTRACEPT's Function: The INTRACEPT system is a surgical device used to treat chronic low back pain by ablating (destroying) the basivertebral nerves within the vertebrae. It is used in vivo (within the living body) to perform a therapeutic procedure.
- No Specimen Analysis: The description does not mention the device being used to analyze any specimens from the human body. Its function is to deliver energy directly to a target tissue within the body.
Therefore, the INTRACEPT Intraosseous Nerve Ablation System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
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® 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.
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)
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.
- Biocompatibility Testing: Patient contact materials are classified as tissue/bone/dentin
§ 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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Public Health Service
Image /page/0/Picture/2 description: The image is a black and white 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 connected and flow into each other, creating a sense of unity and movement. 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 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
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
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
2
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 System |
| II | |
| Classification Name: | Radiofrequency lesion probe |
| 21 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.
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 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 |
|---|---|---|---|
| Device | |||
| Component | Subject: INTRACEPT | ||
| Access Instruments | Predicate: INTRACEPT Easy | ||
| Access Instrument Set | |||
| (K153272) | |||
| Intended Use | To create a path or channel to the terminus of the basivertebral | ||
| foramen. | Same | ||
| Indication | 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. | Same | ||
| Principle | Minimally invasive percutaneous transpedicular or | ||
| extrapedicular access through the vertebral body to allow | |||
| passage of the RF probe | Same | ||
| Instruments | Introducers: | ||
| • Trocar Introducer | |||
| • Bevel Introducer | |||
| Cannulas: | |||
| • Introducer Cannula | |||
| • Curved Cannula | |||
| Stylets: | |||
| • J-Stylet | |||
| • Straight Stylet | Introducers: | ||
| • Trocar Introducer | |||
| Cannulas: | |||
| • Introducer Cannula | |||
| • Curved Cannula | |||
| Stylets: | |||
| • J-Stylet | |||
| • Straight Stylet | Same and added | ||
| Bevel Introducer | |||
| as an additional | |||
| tip style | |||
| Indicators | Added Gap Indicator to the | ||
| Introducer Cannula; | |||
| removed circumferential | |||
| depth marker on the | |||
| Straight Stylet | Visual estimation of depth | ||
| performed by operator using | |||
| depth marker | Different | ||
| Materials: | |||
| Patient Contact | Stainless steel, PEEK, | ||
| Nitinol | Stainless steel, PEEK with | ||
| BaSO4, Nitinol | Same and PEEK | ||
| without BaSO4 | |||
| Sterilization | Gamma irradiation | Ethylene Oxide | Different |
| Device | |||
| Component | Subject: INTRACEPT | ||
| Flexible Bi-Polar RF Probe | Predicate: INTRACEPT | ||
| Flexible 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 1.0 lbs) | PASS |
| Mechanical | Met all performance testing per Product | |
| Specifications: |
- 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: 2006
Sterilization of health care products –
Radiation - Part 1: Requirements for
development, validation and routine control
of a sterilization process for medical
devices ANSI/AAMI/ISO 11137-2: Part 2:
Establishing the sterilization dose (Sterility
assurance of 10-6) | PASS |
| Interface and Primary Operating Function Testing | | |
| Simulated Use | Following exposure to 6 full deployments,
devices remained functional without
damage and met interface requirements. | PASS |
| Usability | IEC 62366-1: 2015: Application of
Usability Engineering to Medical Devices.
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. | 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.