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).

Device Description

The Intracept Intraosseous Nerve Ablation System is comprised of sterile, singleuse 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 Radiofrequency Generator (RFG).
The Intracept System 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 (BVN). This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Intracept Intraosseous Nerve Ablation System. It focuses on demonstrating substantial equivalence to a predicate device, specifically regarding the introduction of an additional set of ablation parameters.

Based on the provided information, the device in question is a medical device for radiofrequency ablation, not an AI/ML powered device. Therefore, many of the requested elements for describing an AI/ML powered medical device, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth for training was established, are not applicable and not present in this document.

The document primarily focuses on demonstrating that the new version of the device, with additional ablation parameters, is substantially equivalent to a previously cleared version. The "acceptance criteria" here are effectively the criteria for establishing substantial equivalence, which is shown through non-clinical performance testing.

Here's an interpretation based on the provided text, recognizing its focus on a hardware device rather than an AI/ML algorithm:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a hardware device (RF ablation system) rather than an AI/ML diagnostic device, the "acceptance criteria" are not reported in terms of standard diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are framed around demonstrating safety and efficacy comparable to a predicate device, particularly with the introduction of new ablation parameters.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Device performs as intended.	"Subject Device (Intracept System) with additional ablation parameters performs as intended."
No new safety and/or efficacy concerns raised by changes.	"does not raise any new safety and/or efficacy concerns when compared to the legally marketed Predicate Device (Intracept System)."
Risk profile of additional ablation parameters is acceptable.	"Risk analysis of an additional set of ablation parameters at lower temperature, ramp, and time showed no increase in risk profile."
Functional equivalence to predicate device.	"The Subject and Predicate Devices have a functionally equivalent design, with the difference being the introduction of an additional set of ablation parameters."

The key difference for the new device is the addition of ablation parameters:

New Ablation Parameters: 75° C, 0.5°C/second ramp, 7 minutes (420 seconds) time. The predicate had only 85° C, 1°C/second ramp, 15 minutes (900 seconds).

2. Sample Size Used for the Test Set and Data Provenance:

This document does not describe a clinical study with a "test set" of patient data for evaluating an AI/ML algorithm. The "testing" mentioned is "Non-Clinical Performance Testing." This likely refers to in-vitro or bench testing, and potentially animal studies, to validate the device's physical performance, safety, and the effects of the new ablation parameters on tissue.

Sample Size: Not explicitly stated, as it's non-clinical performance testing, not a clinical trial with a patient test set.
Data Provenance: Not applicable as it refers to non-clinical testing, not patient data (e.g., retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for a hardware device's performance is typically established through engineering specifications, physical measurements, and biological response studies, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of expert review of data for AI/ML performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

Not applicable. This is a hardware device submission, not an AI/ML algorithm where MRMC studies are relevant for assessing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This is a standalone device in the sense that it performs a physical action (ablation), but not a standalone AI algorithm generating an output without human intervention for diagnostic or clinical decision-making purposes.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on non-clinical performance testing. This would involve:

Engineering specifications and measurements: Ensuring the device delivers RF energy as expected.
Pre-clinical (in-vitro/ex-vivo/animal) studies: Demonstrating the desired biological effect (ablation leading to cellular necrosis) and safety profile in relevant tissues using the specified parameters.
Risk analysis: Evaluating potential increases in risk profile with the new ablation parameters.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML model that undergoes a "training set" process.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as it's not an AI/ML model with a training set.

Summary

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March 11, 2022

Relievant Medsystems, Inc. Thomas Slater VP, Quality and Regulatory Affairs 1230 Midas Way, Suite 200 Sunnyvale, California 94085

Re: K213836

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: January 6, 2022 Received: January 23, 2022

Dear Thomas Slater:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213836

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 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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510(k) SUMMARY 5.

Applicant's Name and Address:

Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale, CA 94085

Contact Person:Telephone:Facsimile:	Thomas A. Slater650/368-1000 x135650/298-9205
Date Prepared:	January 6, 2022
Device Name:
Device Generic Name:	RF Ablation Catheter and Accessories
Device Trade Name:	Intracept Intraosseous Nerve Ablation System
Device Classification:	II
Classification Name:	Radiofrequency lesion probe, 21 CFR 882.4725, Product Code GXI
Predicate Device:

Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System (K190504)

Reference Devices:

Relievant Medsystems, Inc.: Intracept Intraosseous Nerve Ablation System:

Intracept RF Probe (K180369) -
-Access Instruments (K170827)

Device Description:

The Intracept Intraosseous Nerve Ablation System) is comprised of sterile, singleuse 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 Radiofrequency Generator (RFG).

The Intracept System 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 (BVN). This nerve has been identified as a proprioceptive sensory nerve with enervation of the vertebral endplates.

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Indications for Use

Substantial Equivalence

Compared to the Predicate Device, there have been no changes to the patient population or the Indications for Use for the Intracept System. The Subject and Predicate Devices have a functionally equivalent design, with the difference being the introduction of an additional set of ablation parameters for ablation of the basivertebral nerve. The data provided herein demonstrates substantial equivalence to the Predicate Device.

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	510(k) Notification: Relievant Intracept® Intraosseous Nerve Ablation System (K213836)
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CharacteristicDevice Component	Relievant MedsystemsSubject:Intracept System	Relievant MedsystemsPredicate:Intracept System (K190504)Reference Devices:RF Probe (K180369)Access Instruments (K170827)	Comparison
Intended Use	To ablate the basivertebral nerves of the L3 to S1 vertebrae.		Equivalent
Intracept SystemIndication	The Intracept Intraosseous Nerve Ablation System is intended tobe used in conjunction with radiofrequency (RF) generators for theablation of basivertebral nerves of the L3 through S1 vertebrae forthe relief of chronic low back pain of at least six months durationthat has not responded to at least six months of conservative care,and is also accompanied by features consistent with Type 1 orType 2 Modic changes on an MRI such as inflammation, edema,vertebral endplate changes, disruption and fissuring of theendplate, vascularized fibrous tissues within the adjacent marrow,hypointensive signals (Type 1 Modic change), and changes to thevertebral body marrow including replacement of normal bonemarrow by fat, and hyperintensive signals (Type 2 Modic change).		Equivalent
Principle	Provide bipolar RF energy to the tissue between and around theelectrodes to achieve tissue ablation (i.e., cellular necrosisthrough thermal ablation)		Equivalent
Ablation Parameters:Temperature	85° C	85° C	Equivalent
Ramp	1°C/second15 minutes (900 seconds)	1°C/second15 minutes (900 seconds)	Equivalent
Time	75° C0.5°C/second7 minutes (420 seconds)	--	Different
Access Instruments:Design	No changes		Equivalent
Materials	No changes		Equivalent
Use	Single		Equivalent
RF Probe:Design	Removal of SensTx Chip	Optional SensTx Functionality	Different
Materials	No changes	No changes	Equivalent
Use	Single	Single	Equivalent

Non-Clinical Performance Testing

Risk analysis of an additional set of ablation parameters at lower temperature, ramp, and time showed no increase in risk profile.

Conclusions

Based upon non-clinical performance testing, the Subject Device (Intracept System) with additional ablation parameters performs as intended and does not raise any new safety and/or efficacy concerns when compared to the legally marketed Predicate Device (Intracept System); therefore, these results support the substantial equivalence of the Subject and Predicate Device.

Regulation Number and Section

§ 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).