(90 days)
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.
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.
The provided text describes the Baxano Neural Localization Probe, but it does not contain specific numerical acceptance criteria for its performance or a detailed study report that would typically be associated with AI/ML device evaluations. This document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical trial report with predetermined acceptance criteria for AI performance.
Therefore, I cannot populate all the requested information as it is not present in the given text.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical targets; instead, the implied criterion is accurate and reproducible real-time feedback about nerve function, especially when visualization is impaired. | "The nerve root could be identified 100% of the time relative to the Probe positioning." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number. The text mentions "animal studies including blinded studies."
- Data Provenance: Animal studies. No country of origin is specified. The studies were retrospective or prospective is not mentioned, though "blinded studies" suggests a structured, prospective approach.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The statement implies the ground truth was established by direct observation or histological examination in the animal model, but it doesn't detail the involvement of human experts in establishing truth for a test set as would be typical for an AI/ML device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This refers to consensus methods for human readers, which is not described for this device evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is not an AI-assisted diagnostic tool for human readers but a surgical instrument that provides direct feedback.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The device itself (the probe) is the "standalone" component in the animal studies, where it demonstrated its ability to identify nerve roots without reference to human interpretation of images or data. The "100% identification" was attributed to the probe's function.
7. The type of ground truth used:
- Direct observation/identification of nerve root position in animal models, likely confirmed by anatomical dissection or other physiological markers in the animal studies.
8. The sample size for the training set:
- Not applicable/Not specified. This device is not described as an AI/ML system that undergoes a "training set" phase in the typical sense. It's a hardware device evaluated through mechanical tests and animal studies.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
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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 BMountain View, CA 94043Tel: 650-937-1400Fax: 650-937-1410 |
|---|---|
| Contact Person: | Trena DepelTel: 650-937-1400E-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) andNuVasive 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 MicrobladeShaver) with the modification of circumferential bipolar electrodes. TheNeural Localization Probe provides the surgeon additional feedback forlocalizing the nerve root instead of removing additional bone to improvevisualization 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
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| SubstantialEquivalence: | Substantial equivalence of the Neural Localization Probe has been shownto both the existing Baxano Standard Probe, product code HEA, and tosurgical nerve stimulators and locators with product code ETN. TheNeural Localization Probe has the same indications for use as the BaxanoStandard Probe (K080494); it is designed for use with the Baxano UltraLow Profile Rongeur and the Baxano Microblade Shaver for accessing,cutting, and biting soft tissue and bone during surgery involving thespinal column. In addition, it is indicated for use in identification ofmotor nerves during surgery including spinal nerve roots, the same assurgical nerve stimulators and locators with product code ETN. Anydifferences between the Neural Localization Probe and Switch Box andthe predicates are specific in design and do not raise new questions ofsafety or effectiveness. |
|---|---|
| TechnologicalCharacteristics: | The Neural Localization Probe is made of stainless steel shaped to enablethe surgeon to utilize both direct visualization and tactile feedback inorder to evaluate foraminal bone and soft tissue landmarks duringplacement of Baxano cutting devices. The Switch Box allows energy tobe directed from a commercial EMG system to one of four pair ofbipolar electrodes so that the surgeon gets feedback as to the relativelocation of the nerve root to the probe placement. |
| Non-ClinicalPerformance Data: | Mechanical performance tests were conducted to verify that the devicemeets design specifications and intended performance characteristics,based on the application for localization of nerve roots. |
| The Neural Localization Probe was used in animal studies includingblinded studies which established that the nerve root could be identified100% of the time relative to the Probe positioning. The NeuralLocalization Probe provided accurate and reproducible real-timefeedback about nerve function, even when visualization was impaired. | |
| Conclusions: | Baxano has determined, based on the performance testing and animalstudies, that the Neural Localization Probe conforms to the designspecifications and is substantially equivalent to the predicate devices forneural stimulation and for use with Baxano devices for accessing andremoving soft tissue and bone in the spinal column. |
| Any statement regarding "substantial equivalence" made in this 510(k) submission andsummary only relates to whether the product addressed in this submission may belawfully marketed without premarket approval or reclassification, and is not intended tobe interpreted as an admission or any other type of evidence in any patent proceeding,including patent infringement, litigation or proceeding before any Patent Office. Thepresent submission and statements therein therefore should not be construed as affectingor relating to the scope of any patent or patent application, or to whether the productaddressed in this submission, or its use, may be considered indistinct, from apatentability 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.
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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
§ 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.