The Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.

Device Description

The NIMBUS Electrosurgical Radiofrequency Mutitined Expandable Electrode consists of an insulated cannula with an active tip that directs RF energy into target tissues, and a pair of deployable tines which expand the volume of the ablation. It is intended, in combination with an RF generator and probe, for use in radiofrequency (RF) heat lesion procedures for relief of pain.

AI/ML Overview

The provided 510(k) summary for the NIMBUS Electrosurgical Radiofrequency Multitined Expandable Electrode describes a regulatory submission establishing substantial equivalence to a predicate device, rather than a clinical study with detailed acceptance criteria and performance metrics for an AI device. Therefore, a direct response to your request, which presumes a study showing an AI device meeting specific acceptance criteria, cannot be fully provided from the given document.

However, I can extract the information that is present and indicate what is not available based on the nature of this submission.

The document discusses performance tests conducted to demonstrate substantial equivalence to a predicate device (BMC RF Cannula, K972846). The objective of these tests was to show that the Nimbus device performs similarly and is as safe and effective as the predicate, not to meet pre-defined acceptance criteria in the context of an AI device's performance.

Here's the information synthesized from the document, acknowledging its limitations regarding typical AI device study data:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a medical device and not an AI algorithm, there are no specific "acceptance criteria" presented in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI device. Instead, the document lists performance tests (implicitly with internal pass/fail criteria) performed to demonstrate substantial equivalence.

Acceptance Criteria Type (Implied for Device Performance)	Reported Device Performance (Summary)
Comparative Performance vs. Predicate	Passed all comparative tests; found substantially equivalent to the predicate device.
Thermal Properties	Not explicitly stated, but implies performance met expectations for substantial equivalence.
Lesion Formation Volume and Shape	Not explicitly stated, but implies performance met expectations for substantial equivalence.
High frequency dielectric strength	Passed (implied as "passed all tests").
High frequency leakage current	Passed (implied as "passed all tests").
Mains frequency dielectric strength	Passed (implied as "passed all tests").
Connection cord bend test	Passed (implied as "passed all tests").
Conformance to Specification	Passed all tests.
Dimensional conformance to specification	Passed.
Active tip characterization	Passed.
Luer/injection performance	Passed.
Needle durability and Tine Integrity	Passed.
Tine deployment	Passed.
Biocompatibility and Durability	Passed.
Label verification; packaging	Passed.
Sterilization Validation	Passed.
Shelf-life Testing	Passed.

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

Sample Size: Not specified for any of the performance tests. The testing appears to be bench testing and not a clinical study involving human subjects or data sets in the way an AI study would.
Data Provenance: Not applicable in the context of an AI study. The tests were likely conducted in a controlled laboratory environment by the manufacturer (Biomerics, LLC) in Salt Lake City, Utah, USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is not an AI device, and the ground truth for its performance tests (e.g., electrical measurements, physical dimensions, lesion formation) is based on engineering specifications and measurement standards, not expert interpretations of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not Applicable. As there are no expert interpretations or consensus required for typical engineering and performance bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is specifically for evaluating the effectiveness of a diagnostic aid (like AI) on human reader performance. This device is a surgical tool, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance

Not Applicable. The device itself is the "algorithm" in a sense (its design and function), and its performance is evaluated directly through physical and electrical tests, not as a standalone software algorithm separate from human interaction for diagnostic purposes.

7. Type of Ground Truth Used

Engineering Specifications and Standardized Test Methods: The "ground truth" for the performance tests would be established by validated measurement equipment and adherence to relevant industry standards (e.g., for electrical safety, material properties, biocompatibility) and the device's own design specifications. For example, a dielectric strength test has a pass/fail threshold defined by an electrical standard. Lesion formation is likely compared to a predefined expectation or to the predicate device's measured lesion formation under identical conditions.

8. Sample Size for the Training Set

Not Applicable. This is not an AI device trained on data. There is no concept of a "training set" for the NIMBUS Electrosurgical Radiofrequency Multitined Expandable Electrode.

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

Not Applicable. (See point 8).

Summary Regarding AI-Specific Information:

The provided document is a 510(k) summary for a physical medical device (an electrosurgical electrode), not an Artificial Intelligence (AI) enabled device. Therefore, the questions related to AI acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance are not applicable to the content of this document. The document describes traditional device verification and validation activities aimed at demonstrating substantial equivalence to a predicate device.

Summary

{0}------------------------------------------------

K,21773

Image /page/0/Picture/1 description: The image shows the word "BIOMERICS" in a bold, sans-serif font. To the left of the word is a logo consisting of a cluster of interconnected circles. The circles are arranged in a way that resembles a molecular structure or a network.

Salt Lake City, Utah
84119

TEL 801.355.2705
FAX 801.355.3045

510(k) Summary

Submission by:

R r l

Date Prepared:

Official Contact:

Type of 510(k) submission:

Common Name:

510(k) Submitter;

Contact Person:

NIMBUS Electrosurgical Cutting and Coagulation

Biomerics, LLC

Emily Madsen Quality Manager

Traditional

-Accessory .

September 19, 2012

Biomerics, LLC 2700 South 900 West Salt Lake City UT 84119 USA .

Emily Madsen Quality Manager (801) 355-2705 2700 South 900 West Salt Lake City UT 84119 USA

Preference for Confidentiality: Continued Classification Regulation: 882.4725

GXI

N/A

Neurology

Class: Panel:

Product Code:

Basis for submission:

FDA Document Numbers:

Traditional Submission New device

Name of Device: Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode

{1}------------------------------------------------

Predicate Device:

510(k) No.	Trade Name	Manufacturer
KK972846	BMC RF Cannula	Baylis Medical Company Inc.

Device Description: The NIMBUS Electrosurgical Radiofrequency Mutitined Expandable Electrode consists of an insulated cannula with an active tip that directs RF energy into target tissues, and a pair of deployable tines which expand the volume of the ablation. It is intended, in combination with an RF generator and probe, for use in radiofrequency (RF) heat lesion procedures for relief of pain.

Indications for Use

The NIMBUS Electrosurgical Radiofrequency Multitined Expandable Electrode is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain using a compatible RF Generator with rated voltage less than or equal to 850V.

Technological Characteristics Comparison

The NIMBUS Electrosurgical Radiofrequency Multitined Expandable Electrode device is substantially equivalent to the indication for use predicate device. The NIMBUS Electrosurgical Radiofrequency Mutitined Expandable Electrode and the Baylis predicate consist of an insulated cannula with an active tip that directs RF energy into target tissues. Both are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. Both devices are of similar gauge, cannula length, useable active tip length, and female luer fitting interface. The NIMBUS and Baylis devices both demonstrate substantial equivalent lesion formation under identical RF frequency and power conditions.

Brief Summary of Performance Test Results

Comparative testing versus the predicate device included:

Thermal Properties .
Lesion Formation Volume and Shape
Electrical Testing of .
- 0 High frequency dielectric strength
- High frequency leakage current 0
- Mains frequency dielectric strength o'
- Connection cord bend test o

The technological characteristics of the Nimbus device are substantially equivalent to those of the predicate device.

{2}------------------------------------------------

Additional testing involved the following:

Dimensional conformance to specification and active tip characterization .
Luer/injection performance .
. Needle durability and Tine Integrity
. Tine deployment
Biocompatibility and Durability .
Label verification; packaging .
Sterilization Validation ●
Shelf-life Testing ◆

The Nimbus device passed all tests and was found equivalent to the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biomerics
c/o Mark Job
Third Party Reviewer
Regulatory Technology Services, LLC
1394 25th Street, NW
Buffalo, Minnesota 55313

SEP 21 2012

Re: K121773

Trade/Device Name: Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode, Model NIM17-100-10BB Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: August 31, 2012 Received: September 4, 2012

Dear Mr. Job:

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.

{4}------------------------------------------------

Page 2 – Mr. Mark Job

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name:

Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode

Indications For Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

SZel

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121773

1 Page 1 of

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).