(90 days)
Not Found
No
The description focuses on electrical stimulation and feedback for nerve localization, not AI/ML algorithms.
No.
The device is used for localization of motor nerves to provide feedback to the surgeon during a procedure, not for treating a condition, disease, or injury.
Yes
The device assists in "localization of motor nerves," provides "additional feedback for localizing the nerve root," and gives "feedback as to the relative location of the nerve root to the probe placement." These functions are for identifying the position of an anatomical structure, which is a diagnostic purpose. The performance studies also state it provides "accurate and reproducible real-time feedback about nerve function," which implies assessing a physiological state.
No
The device description clearly details physical components (Neural Localization Probe made of stainless steel, Switch Box) and their interaction with a commercial EMG system, indicating it is a hardware-based medical device with potential software control or processing, but not software-only.
Based on the provided information, the Baxano, Inc. Neural Localization Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Neural Localization Probe is used directly on the patient during surgery to locate nerves within the spinal column. It uses electrical stimulation and feedback from an EMG system to guide the surgeon.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is an in vivo device used during a surgical procedure.
N/A
Intended Use / Indications for Use
The Baxano, Inc. Neural Localization Probe is designed for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised. The Baxano, Inc. Neural Localization Probe is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
Product codes (comma separated list FDA assigned to the subject device)
ETN, HAE
Device Description
The Neural Localization Probe is based on the Baxano Standard Probe (for use with the Ultra Low Profile Rongeur and the Baxano Microblade Shaver) with the modification of circumferential bipolar electrodes. The Neural Localization Probe provides the surgeon additional feedback for localizing the nerve root instead of removing additional bone to improve visualization within the spinal column. A Switch Box directs the stimulus signal so that the nerve can be located on the top, bottom, left or right of the Neural Localization Probe. The Neural Localization Probe is made of stainless steel shaped to enable the surgeon to utilize both direct visualization and tactile feedback in order to evaluate foraminal bone and soft tissue landmarks during placement of Baxano cutting devices. The Switch Box allows energy to be directed from a commercial EMG system to one of four pair of bipolar electrodes so that the surgeon gets feedback as to the relative location of the nerve root to the probe placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal column
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Mechanical performance tests were conducted to verify that the device meets design specifications and intended performance characteristics, based on the application for localization of nerve roots. The Neural Localization Probe was used in animal studies including blinded studies which established that the nerve root could be identified 100% of the time relative to the Probe positioning. The Neural Localization Probe provided accurate and reproducible real-time feedback about nerve function, even when visualization was impaired.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K080494, K031510, K063560, K051384
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the word "BAXANO" in bold, black letters. A stylized black shape bisects the "X" in the word. The word is contained within a black rectangle.
SEP 1 7 2008
510(K) SUMMARY (21 CFR 807.92)
NEURAL LOCALIZATION PROBE
| 510(k) Owner: | Baxano, Inc.
2660 Marine Way, Suite B
Mountain View, CA 94043
Tel: 650-937-1400
Fax: 650-937-1410 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Trena Depel
Tel: 650-937-1400
E-mail: tdepel@baxano.com |
| Date Prepared: | June 18, 2008 |
| Trade Name: | Baxano Neural Localization Probe |
| Common Name: | Surgical nerve stimulator/locator |
| Classification: | Nerve stimulation device (per 21 CFR section 874.1820)
Probe for skull or spinal column (per 21 CFR section 882.4840) |
| Predicate Devices: | Baxano Standard Probe (K080494), Medtronic Xomed NIM Spine
(K031510), WR Medical Dual Stim Nerve Stimulator (K063560) and
NuVasive NeuroVision JJB System (K051384) |
| Device Description: | The Neural Localization Probe is based on the Baxano Standard Probe
(for use with the Ultra Low Profile Rongeur and the Baxano Microblade
Shaver) with the modification of circumferential bipolar electrodes. The
Neural Localization Probe provides the surgeon additional feedback for
localizing the nerve root instead of removing additional bone to improve
visualization within the spinal column. A Switch Box directs the |
Intended Use: The Baxano, Inc. Neural Localization Probe is designed for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
right of the Neural Localization Probe.
stimulus signal so that the nerve can be located on the top, bottom, left or
1
| Substantial
Equivalence: | Substantial equivalence of the Neural Localization Probe has been shown
to both the existing Baxano Standard Probe, product code HEA, and to
surgical nerve stimulators and locators with product code ETN. The
Neural Localization Probe has the same indications for use as the Baxano
Standard Probe (K080494); it is designed for use with the Baxano Ultra
Low Profile Rongeur and the Baxano Microblade Shaver for accessing,
cutting, and biting soft tissue and bone during surgery involving the
spinal column. In addition, it is indicated for use in identification of
motor nerves during surgery including spinal nerve roots, the same as
surgical nerve stimulators and locators with product code ETN. Any
differences between the Neural Localization Probe and Switch Box and
the predicates are specific in design and do not raise new questions of
safety or effectiveness. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The Neural Localization Probe is made of stainless steel shaped to enable
the surgeon to utilize both direct visualization and tactile feedback in
order to evaluate foraminal bone and soft tissue landmarks during
placement of Baxano cutting devices. The Switch Box allows energy to
be directed from a commercial EMG system to one of four pair of
bipolar electrodes so that the surgeon gets feedback as to the relative
location of the nerve root to the probe placement. |
| Non-Clinical
Performance Data: | Mechanical performance tests were conducted to verify that the device
meets design specifications and intended performance characteristics,
based on the application for localization of nerve roots. |
| | The Neural Localization Probe was used in animal studies including
blinded studies which established that the nerve root could be identified
100% of the time relative to the Probe positioning. The Neural
Localization Probe provided accurate and reproducible real-time
feedback about nerve function, even when visualization was impaired. |
| Conclusions: | Baxano has determined, based on the performance testing and animal
studies, that the Neural Localization Probe conforms to the design
specifications and is substantially equivalent to the predicate devices for
neural stimulation and for use with Baxano devices for accessing and
removing soft tissue and bone in the spinal column. |
| | 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 marketed 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 patent infringement, litigation or proceeding before any Patent Office. The
present submission and statements therein therefore should not be construed as affecting
or relating to the scope of any 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. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with a bird-like figure with outstretched wings and a staff entwined with snakes. The logo is black and white.
SEP 1 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Baxano, Inc. % Ms. Trena Depel Vice President, Regulatory Affairs 2660 Marinc Way, Suite B Mountain View, California 94043
Re: K081742 Trade Name: Baxano Neural Localization Probe Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator. Regulatory Class: Class II Product Code: ETN, HAE Dated: June 18, 2008 Received: June 19, 2008
Dear Ms. Trepel:
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 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 Register.
Please be advised that FDA is 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 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
Page 2 - Ms. Trena Depel
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.
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 marketcd 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) 276-0120. 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 Biometric's (OSB's) Division 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincercly yours.
Mark W. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081742
Device Name: Neural Localization Probe
Indications for Use: The Baxano, Inc. Neural Localization Probe is for use with Baxano cutting and biting devices for localization of motor nerves in settings where visualization is compromised.
Prescription Use X (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)
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Sign-Off) (Division Division of General, Restorative, and Neurological Devices
510(k) Number | K041792