(95 days)
Not Found
No
The summary describes a physical medical device (electrode) and its performance in creating heat lesions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as "intended for use in radiofrequency (RF) heat lesion procedures for relief of pain," which indicates a therapeutic purpose.
No
The device is intended for therapeutic electrosurgical radiofrequency heat lesion procedures to relieve pain, not for diagnosing conditions.
No
The device description and performance studies clearly indicate a physical electrode with tines, requiring electrical and mechanical testing, not just software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiofrequency (RF) heat lesion procedures for relief of pain." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that delivers RF energy to target tissues within the body. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to create therapeutic lesions within the body.
N/A
Intended Use / 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.
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.
Product codes
GXI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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
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
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:
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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