(28 days)
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.
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.
The provided document is a 510(k) summary for the Baxano Neuro Check Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical study with acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) submission.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment methods, and multi-reader multi-case studies are not available in this document.
Here's a breakdown of what can be extracted and what is explicitly not available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, accuracy, etc. for the device. Instead, it states that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets design specifications | Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use. |
| Conforms to design specifications | 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. |
| Substantially equivalent to predicate | The modified Neuro Check Device is equivalent to the predicate Neural Localization Probe. The Neuro Check Device has the same indications for use and fundamental scientific technology as its predicate. |
| Does not raise new questions of safety or effectiveness | 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. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention human patient test sets, sample sizes, or data provenance (country of origin, retrospective/prospective). The performance evaluation was based on "mechanical and electrical performance tests" and "animal studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as no human-read test set is described. Performance was evaluated through engineering tests and animal studies.
4. Adjudication Method
Not applicable, as no human-read test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done or reported in this 510(k) submission. There is no mention of human readers improving with or without AI assistance, as this is a medical device for nerve localization, not an AI-assisted diagnostic imaging tool.
6. Standalone Performance Study
The document states that "Mechanical and electrical performance tests were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use." This indicates some form of standalone testing was performed to ensure the device itself functions as intended. The "animal studies" also demonstrate standalone device performance in a biological setting. However, specific metrics (e.g., probability of correctly locating a nerve) are not provided.
7. Type of Ground Truth Used
For the "mechanical and electrical performance tests," the ground truth would be the expected output or behavior according to engineering specifications and design. For the "animal studies," the ground truth would be the actual anatomical location of nerves as confirmed through direct observation or other validated methods in the animal models.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the typical sense. Its function is based on principles of electrical stimulation and feedback.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
Summary of Device and Study Focus:
The Baxano Neuro Check Device is a surgical nerve stimulator/locator. The 510(k) submission (K092729) is for a modification of an existing predicate device (Baxano Neural Localization Probe, K081742) to include monopolar stimulation. The study presented here is a demonstration of substantial equivalence to the predicate device, emphasizing that the fundamental scientific technology remains unchanged, the indications for use are the same, and the modifications do not raise new questions of safety or effectiveness. The performance data relied upon are "mechanical and electrical performance tests" and "animal studies." This type of submission does not typically involve extensive clinical trials with human subjects and corresponding statistical analyses of performance metrics and ground truth as would be seen in a PMA.
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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:
$
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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.
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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
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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
§ 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.