(28 days)
No
The summary describes a device that uses electrical stimulation for nerve localization, with no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on mechanical and electrical characteristics, not algorithmic performance.
No
The device is used to localize motor nerves and nerve roots during surgery, assisting in the surgical procedure rather than directly treating a disease or condition.
No
The device is described as assisting in the localization of motor nerves during surgery, which is an intraoperative tool for guidance rather than a pre-operative diagnostic assessment of a medical condition.
No
The device description explicitly mentions a "switch" and "stimulus signal," indicating hardware components are involved in its function. The performance studies also mention "mechanical and electrical performance tests," further confirming the presence of hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Baxano Neuro Check Device is used during surgery to locate nerves in situ (within the body) using electrical stimulation. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "localization of motor nerves in settings where visualization is compromised" during spinal column surgery. This is a surgical aid, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the Baxano Neuro Check Device is a surgical instrument used for nerve localization during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
Product codes
ETN
Device Description
A switch directs the stimulus signal so that the nerve can be located relative to the Neuro Check Device. The Neuro Check Device assists in the localization of nerve roots during spinal column surgery where visualization is limited as an alternative to removing additional bone for direct visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerve roots, neural foramen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, spinal column surgery
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
Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use.
Baxano has determined, based on the performance testing and animal studies that the Neuro Check Device conforms to the design specifications and is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
BAXAN
OCT - 2 2009
510(K) SUMMARY (21 CFR 807.92)
NEURO CHECK DEVICE
510(k) Owner:
ﻘ
Baxano, Inc. 2660 Marine Way, Suite B Mountain View, CA 94043 Tel: 650-937-1400 Fax: 650-937-1410
September 3, 2009
(21 CFR 874.1820)
etn, hae
Baxano Neuro Check Device
Surgical nerve stimulator/locator
Class II, Surgical nerve stimulator/locator
Contact Person:
Cindy Domecus Tel: (650) 343-4813 E-mail: domecusconsulting@comcast.net
Date Prepared:
Trade Name:
Common Name:
Classification:
Product Code:
Predicate Device Information:
The modified Baxano Neural Localization Probe (now referred to as the Baxano Neuro Check Device) is substantially equivalent to the Baxano Neural Localization Probe, which was determined substantially equivalent on Sept 17, 2008 (K081742).
The modified device allows for addition of monopolar stimulation. Device Description: A switch directs the stimulus signal so that the nerve can be located relative to the Neuro Check Device. The Neuro Check Device assists in the localization of nerve roots during spinal column surgery where visualization is limited as an alternative to removing additional bone for direct visualization.
Page 1 of 2
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Intended Use:
Technological
Characteristics:
The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
The Neuro Check Device is designed to be placed in the neural foramen to enable the surgeon to direct energy from a commercial EMG system to electrodes on the device enabling feedback regarding relative location of a nerve root to the device. The modification allows for the use of both bipolar and monopolar stimulation. The fundamental scientific technology is unchanged from the predicate.
Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use. The modified Neuro Check Device is equivalent to the predicate Neural Localization Probe.
The Neuro Check Device is substantially equivalent to the Neural Localization Probe, which was determined substantially equivalent on Sept 17, 2008 (K081742). The Neuro Check Device has the same indications for use and fundamental scientific technology as its predicate. Based upon the indications for use, technological characteristics and performance test results, changes to the Neuro Check Device do not raise new questions of safety or effectiveness.
Baxano has determined, based on the performance testing and animal studies that the Neuro Check Device conforms to the design specifications and is substantially equivalent to the predicate device.
Any statement regarding "substantial equivalence" made in this 510(k) submission and summary only relates to whether the product addressed in this submission may be lawfully morketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including potent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting to the scope of any patent or patent or patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.
Performance Data:
Non-Clinical
Substantial Equivalence:
Conclusions:
$
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVIC" in all capital letters. The text is black and appears to be printed on a white background. The text is horizontally oriented and evenly spaced.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Baxano, Inc. c/o Ms. Patty Hevey Director of Clinical and Regulatory Affairs 2660 Marine Way Suite B Mountain View, CA 94043
OCT - 2 2009
Re: K092729
Trade/Device Name: Baxano Neuro Check Device Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: September 3, 2009 Received: September 4, 2009
Dear Ms. Hevey:
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.
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.
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 (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.
3
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/CDRH0ffices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Robe. Thm. m k
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
4
INDICATIONS FOR USE STATEMENT
K092729 510(k) Number (if known):
Device Name: Neuro Check Device
Indications for Use: The Baxano, Inc. Neuro Check Device is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
Over-The-Counter Use Prescription Use _ × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kristen Bowsher
(Division Sign-Off)
Page of
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_Kog_23229