(107 days)
The Baxano, Inc. MicroBlade, Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.
The modified MicroBlade Shaver device is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting and biting soft tissue and bone. The modified Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the GuideWire. The Distal Handle Accessory is comprised of a handle to accommodate the GuideWire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check devices.
The provided document is a 510(k) premarket notification for a medical device, the MicroBlade Shaver Device and Accessories. It details the device's description, intended use, technological characteristics, and a claim of substantial equivalence to predicate devices based on non-clinical performance data.
However, the document does not contain information related to acceptance criteria, specific performance metrics, or a study design typical of AI/ML device evaluations. It describes bench performance, functional testing, and cadaveric analyses to verify that the device (a mechanical surgical tool) meets design specifications and performance characteristics.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of AI/ML performance metrics. The information requested (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) is not applicable to this type of device and the information provided in this 510(k) summary.
The 510(k) summary focuses on demonstrating that the modified device is substantially equivalent to previously cleared versions and does not raise new questions of safety or effectiveness, primarily through non-clinical bench and cadaveric testing.
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JUL 2 3 2010
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510(K) SUMMARY (21 CFR 807.92)
MICROBLADE SHAVER DEVICE AND ACCESSORIES
| 510(k) Owner: | Baxano, Inc. |
|---|---|
| 655 River Oaks Parkway | |
| San Jose, CA 95134 | |
| Tel: 408-514-2200 | |
| Fax: 408-514-2201 | |
| Contact Person: | Edward J. Sinclair |
| Tel: 408-514-2220 | |
| E-mail: esinclair@baxano.com | |
| Date Prepared: | April 5, 2010 |
| Trade Name: | MicroBlade Shaver and Accessories |
| Common Name: | Rongeur, Manual |
| Classification: | Class II (21 CFR 882.4840) |
| Product Code: | HAE |
| Predicate Device Information: | Baxano MicroBlade Shaver and Accessories (K063231) and modified Accessories (K080494). |
| Device Description: | The modified MicroBlade Shaver device is comprised of a proximal handle, rigid shaft, and flexible cutting platform used for cutting and biting soft tissue and bone. The modified Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the GuideWire. The Distal Handle Accessory is comprised of a handle to accommodate the GuideWire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check devices. |
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Intended Use: The Baxano, Inc. MicroBlade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column. Technological The MicroBlade Shaver is designed to be flexible, with a low profile Characteristics: to allow access to compromised neural areas in the spinal column. The accessories include a Probe, Distal Handle and a GuideWire. The fundamental scientific technology is unchanged from the predicate. Non-Clinical Bench performance, functional testing and cadaveric analyses Performance Data: were conducted to verify that the device meets design specifications and performance characteristics, based upon the intended use. Substantial The modified MicroBlade Shaver Device and Accessories are Equivalence: substantially equivalent to the MicroBlade Shaver and Accessories cleared on April 16, 2007 (K063231) and March 4, 2008 (K080494). The MicroBlade Shaver and Accessories have the same indications for use and fundamental scientific technology as their predicate. Based upon the indications for use, technological characteristics and performance test results, changes to the MicroBlade Shaver and Accessories do not raise new questions of safety or effectiveness. Conclusions: Baxano has determined, based on performance testing and cadaver studies that the MicroBlade Shaver device and Accessories conform to the design specifications and are 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 marketed without premarket approval or reclossification, 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 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 & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 2 3 2010
Baxano, Inc. c/o Mr. Edward J. Sinclair Vice President, Clinical, Regulatory and Quality Affairs 655 River Oaks Pkwy San Jose, CA 95134
Re: K100958
Trade/Device Name: MicroBlade Shaver Device and Accessories Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: June 18, 2010 Received: June 23, 2010
Dear Mr. Sinclair:
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.
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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.
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/CDRH/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ria Atkin M.D. fr.
Malvina B. Eydelman, I 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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K/00758
INDICATIONS FOR USE STATEMENT
KIDO958 510(k) Number (if known):
Device Name: MicroBlade Shaver Device and Accessories
Indications for Use: The Baxano, Inc. MicroBlade, Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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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Daniel Clupp
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_K/00958
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).