INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 by RELIEVANT MEDSYSTEMS, INC.

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set 1s ıntended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

Device Description

The Relievant INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Sets are used in comunction with the Stockert NEURO N50 RF Generator and Interconnect Cable to create radiofrequency lessons 11 soft tissue The device is a modification to the Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set to incorporate a curved instrument set and a more flexible tip of the radiofrequency probe The system delivers temperature-controlled, radiofrequency (RF) energy into targeted tissue via the probe to create lessons in soft tissue The Instrument Sets are used to provide access to the target tissue

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set:

Summary of Acceptance Criteria and Device Performance

Acceptance Criterion	Reported Device Performance
Creation of Clinically Relevant Lesions	Demonstrated that the device "creates clinically relevant lesions"
Equivalence in Lesion Size to Predicate Device	Lesions are "equivalent in size to the predicate device"
No New Safety Issues Raised	"No new safety or effectiveness issues have been raised"
Substantial Equivalence to Predicate Device	"Demonstrate that this device is substantially equivalent to the predicate device"

Study Details

1. A table of acceptance criteria and the reported device performance: (Provided above)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "In vivo data," implying animal or human subject testing, but does not provide specific numbers of subjects or cases.
- Data Provenance: "In vivo data" is mentioned, suggesting prospective experimental data collected for the purpose of this submission. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. Establishing ground truth typically involves expert assessment, but the summary focuses on direct comparison of lesion characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the given text.
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:
- No MRMC study was done. This device is a medical instrument (RF probe), not an AI diagnostic or assistance tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a software algorithm. The "performance" refers to its ability to create lesions, not a diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly refers to the characteristics of the lesions created. This would likely be determined through direct measurement and observation of the lesions, possibly via histological analysis (pathology) or imaging, to compare their size and other clinically relevant features to those created by the predicate device. The document states "In vivo data demonstrated that... creates clinically relevant lesions that are equivalent in size," suggesting direct measurement was the basis.
8. The sample size for the training set:
- Not applicable. This device is hardware; there is no "training set" in the context of machine learning. The device itself is "trained" through its design and manufacturing process, and tested directly.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no training set for a hardware device.

Summary

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K083856

Page 1 of 2

510(k) Summary of Safety and Effectiveness

I Submitter's Name Relievant MedSystems, Inc 713 Sandoval Way Hayward, CA 94544
JAN 2 2 2009
2 Company Contact Mark Smutka Regulatory, Clinical, and Quality Consultant Telephone - 510-489-1080 Fax - 510-489-1082
3 Device Name INTRACEPT Flexible B1-Polar RF Probe and Trade Name Curved Instrument Set Common Name Radiofrequency Probe Electrosurgical, cutting & coagulation & Classification Name accessories
Date Summary Prepared 4 December 19, 2008
5 Predicate Device Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set (K070443)
Description of Device 6

7 Intended Use The INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set 1s intended to be used with radiofrequency (RF) generators for the thermal coagulation of soft tissues
Comparison of Technological Characteristics 8

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K083856

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrament Set are substantially equivalent in design, materials, function and intended use to the following device cleared for commercial distribution Relievant MedSystems INTRACEPT B1-Polar RF Probe and Instrument Set (K070443)

9 Summary of Performance Data

The INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set was tested and compared to the predicate device In vivo data demonstrated that the INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set creates clinically relevant lessons that are equivalent in size to the predicate device The test data gathered demonstrate that this device is substantially equivalent to the predicate device No new safety or effectiveness issues have been ra1sed

\\PH 075527/000630 31758 v1

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Admınıstratıon 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2009

Relievant MedSystems, Inc % Mr Mark Smutka Regulatory, Clinical and Quality Consultant 713 Sandoval Way Hayward, California 94544

Re K083856

Trade/Device Name INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set Regulation Number 21 CFR 878 4400 Regulation Name Electrosurgical cutting and coagulation device and accessories Regulatory Class II Product Code GEI Dated December 23, 2008 Received December 24, 2008

Dear Mr Smutka

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. Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Reguster

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), good manufacturing practice requirements as set

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Page 2 - Mr Mark Smutka

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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Brometric's (OSB's) Drvision of Postmarket Surveillance at (240) 276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Mark N. Wilkerson

Mark N Melkerson Director DIVISIOn of General, Restorative and Neurological Devices Office of Device Evaluation ، Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known) K083856

Device Name INTRACEPT Flexible Bi-Polar RF Probe and Curved Instrument Set

Indications for Use

The INTRACEPT Flexible B1-Polar RF Probe and Curved Instrument Set 1s ıntended to be used in conjunction with radiofrequency (RF) generators for the thermal coagulation of soft tissues

Prescription Use X (Per 21 C F R 801 109) AND/OR

Over-The-Counter Use (Per 21 C F R 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kramer for MyM 1/22/2009

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083856

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.