NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE

K121773 · Biomerics · GXI · Sep 21, 2012 · Neurology

Device Facts

• Record ID: K121773
• Device Name: NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE
• Applicant: Biomerics
• Product Code: GXI · Neurology
• Decision Date: Sep 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

The Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode is an accessory device used in RF heat lesion procedures for pain relief. It consists of an insulated cannula with an active tip and deployable tines that expand the ablation volume. The device is used in conjunction with a compatible RF generator and probe. It is operated by a clinician to direct RF energy into target tissues to create thermal lesions. The device benefits patients by providing a mechanism for targeted tissue ablation to alleviate pain. Performance is verified through bench testing of thermal properties, lesion formation, and electrical safety.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including thermal properties, lesion formation volume/shape, high-frequency dielectric strength, high-frequency leakage current, mains frequency dielectric strength, cord bend testing, dimensional conformance, luer/injection performance, needle durability, tine integrity/deployment, biocompatibility, and shelf-life testing.

Technological Characteristics

Insulated cannula with active tip and deployable tines. Features female luer fitting. Operates via RF energy delivered by a compatible generator (rated voltage ≤ 850V).

Indications for Use

Indicated for patients requiring radiofrequency (RF) heat lesion procedures for pain relief. Used in combination with a compatible RF generator (rated voltage ≤ 850V).

Regulatory Classification

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.

Predicate Devices

• BMC RF Cannula (K972846)

Submission Summary (Full Text)

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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 [phone]
FAX [phone]

#### 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 [phone] 2700 South 900 West Salt Lake City UT 84119 USA

Preference for Confidentiality: Continued Classification Regulation: 882.4725

ll

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

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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.

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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.

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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.

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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 [phone] or [phone] 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

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### Indications for Use

510(k) Number (if known):

Device Name:

Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode

Indications For Use:

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.

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

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