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).

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.

AI/ML Overview

This document is a 510(k) premarket notification for the Intracept Intraosseous Nerve Ablation System and its associated RF Generator. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily by clarifying the Indications for Use related to Modic changes on MRI.

Based on the provided text, the device itself is an RF ablation system used to treat chronic low back pain. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission are not about the performance of a new or modified device against specific performance metrics for clinical efficacy or diagnostic accuracy. Instead, the focus is on demonstrating that the clarified indications for use do not alter the substantial equivalence to the previously cleared devices, meaning it does not introduce new questions of safety or effectiveness.

Therefore, the typical structure for describing an AI/ML device's acceptance criteria and proven performance doesn't directly apply here. The device itself is not an AI/ML system, nor is the 510(k) submission primarily presenting a study to prove its performance in a diagnostic or predictive sense. The "proof" in this context is the argument for substantial equivalence without new clinical or non-clinical testing.

Here's an attempt to answer your questions based on what is relevant and stated in the document, acknowledging that many of your specific questions about AI/ML acceptance criteria and testing are not addressed because this is a different type of medical device submission:

Summary of Acceptance Criteria and Device Performance (in the context of a 510(k) for modified Indications for Use):

The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating Substantial Equivalence to the predicate devices (Intracept Intraosseous Nerve Ablation System K180369, K170827 and Relievant RFG K171143), specifically concerning the modification of the Indications for Use statement. The key "performance" here is that the modified Indications for Use do not raise different questions of safety or effectiveness and do not describe a new disease condition or patient population.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion (Implicit for 510(k))	Reported Device Performance (as argued in 510(k))
No change in device design/technology.	"No design changes were made to the Subject Devices." (Page 7) "Compared to the Predicate Devices (Intracept System and Relievant RFG), there have been no design changes to the Intracept System or the Relievant RFG." (Page 5)
Modified Indications for Use (IFU) do not alter fundamental intended use.	The Intended Use remains: "To ablate the basivertebral nerves of the L3 to S1 vertebrae." (Page 5)
Modified IFU do not describe a new disease condition or patient population.	"The modification does not describe a new disease condition or patient population that the Subject Devices are intended to treat." (Page 5) "The modification does not raise different questions of safety or effectiveness." (Page 7) The modifications clarify features consistent with Type 1 or Type 2 Modic changes (e.g., inflammation, edema, vertebral endplate changes, etc.), aiding clinicians' interpretation of MRI findings, rather than defining new conditions. (Page 5)
Non-clinical performance maintained (due to no design changes).	"No design changes were made to the Subject Devices. Substantial equivalence is not dependent upon non-clinical clinical performance testing." (Page 7) – Implicitly, previous non-clinical data remains valid.
Clinical performance maintained (due to no design changes).	"Substantial equivalence is not dependent upon clinical data and no clinical testing was performed." (Page 7) – Implicitly, previous clinical data (if any was required for the predicates) remains valid, and no new clinical questions are raised.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission is not based on a new test set of data for performance evaluation in the way an AI/ML device would be. It relies on the substantial equivalence argument, stating no new clinical or non-clinical testing was performed because the device design remained unchanged and the IFU modification did not raise new questions of safety or effectiveness.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set data or formal independent ground truth establishment processes (as would be typical for diagnostic performance studies) are described in this 510(k) submission. The clarification of Modic changes in the IFU is based on existing medical understanding and classification, not a novel ground truth process for a test set.

4. Adjudication method for the test set:

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-enabled device, and no MRMC study was conducted or presented in this 510(k) for the purpose of demonstrating comparative effectiveness with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML algorithm or software device that performs a diagnostic function. It is a physical medical device (RF ablation system).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No new ground truth derivation was required for this 510(k) submission. The modifications to the Indications for Use reflect an elaboration of existing, clinically recognized characteristics of Modic changes on MRI, which are established medical knowledge.

8. The sample size for the training set:

Not applicable. There is no AI/ML model described in this submission that would require a training set.

9. How the ground truth for the training set was established:

Not applicable. There is no AI/ML model described in this submission.

Summary

{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)

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)
----------------------------------------------------------------------------------	----------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 GXIRadiofrequency 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 ProbeAccess InstrumentsRF 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 SystemIndication	The Intracept IntraosseousNerve Ablation System isintended to be used inconjunction withradiofrequency (RF) generatorsfor the ablation of basivertebralnerves of the L3 through S1vertebrae for the relief ofchronic low back pain of atleast six months duration thathas not responded to at least sixmonths of conservative care,and is also accompanied byfeatures consistent with Type 1or Type 2 Modic changes on anMRI such as inflammation,edema, vertebral endplatechanges, disruption andfissuring of the endplate,vascularized fibrous tissueswithin the adjacent marrow,hypointensive signals (Type 1Modic change), and changes tothe vertebral body marrowincluding replacement ofnormal bone marrow by fat,and hyperintensive signals(Type 2 Modic change)	The Intracept IntraosseousNerve Ablation System isintended to be used inconjunction with RFgenerators for the ablationof basivertebral nerves ofthe L3 through S1 vertebraefor the relief of chronic lowback pain of at least sixmonths duration that has notresponded to at least sixmonths of conservativecare, and is alsoaccompanied by either Type1 or Type 2 Modic changeson an MRI.	Different
Characteristic	Relievant Medsystems	Relievant Medsystems	Comparison
Relievant RFGIndication	The Relievant RFG is intendedto be used with RF probes FDAcleared as part of the RelievantIntracept Intraosseous NerveAblation System for theablation of basivertebral nervesof the L3 through S1 vertebraefor the relief of chronic lowback pain of at least six monthsduration that has not respondedto at least six months ofconservative care, and is alsoaccompanied by featuresconsistent with Type 1 or Type2 Modic changes on an MRIsuch as inflammation, edema,vertebral endplate changes,disruption and fissuring of theendplate, vascularized fibroustissues within the adjacentmarrow, hypointensive signals(Type 1 Modic change), andchanges to the vertebral bodymarrow including replacementof normal bone marrow by fat,and hyperintensive signals(Type 2 Modic change).	The Relievant RFG isintended to be used with RFprobes FDA cleared as partof the Relievant IntraceptIntraosseous Nerve AblationSystem for the ablation ofbasivertebral nerves of theL3 through S1 vertebrae forthe relief of chronic lowback pain of at least 6months duration that has notresponded to at least sixmonths of conservativecare, and is alsoaccompanied by either Type1 or Type 2 Modic changeson an MRI.	EquivalentDifferent
Principle	Provide bipolar RF energy to the tissue between and around theelectrodes to achieve tissue ablation (i.e., cellular necrosisthrough thermal ablation)		Equivalent
Treatment Parameters:Temperature	85° C		Equivalent
Ramp	1°C/second		Equivalent
Time	15 minutes (900 seconds)		Equivalent
Access Instruments andRF Probe:Design	No changes		Equivalent
Materials	No changes		Equivalent
Use	Single		Equivalent
Connect to RFGenerator	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

{6}------------------------------------------------

{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.

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).