(173 days)
Codman Laminectomy Shaver, Integra Ruggles Instrument, Zeppelin Laminectomy Rongeur, Ellman Disc FX System
Codman Laminectomy Shaver, Integra Ruggles Instrument, Zeppelin Laminectomy Rongeur, Ellman Disc FX System
No
The summary describes a mechanical surgical instrument and its accessories, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is used to cut and remove tissue and bone during surgery, which is a surgical tool, not a therapeutic device designed to cure, treat, or prevent disease.
No
Explanation: The device is described as a surgical tool used for cutting, biting, and removing tissue and bone, specifically for decompression during spinal surgery. Its function is interventional, not diagnostic.
No
The device description clearly outlines physical components made of stainless steel (Microblade Shaver, Probe, Guide, Needle Wire, Distal Handle) used for cutting and removing tissue and bone during surgery. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column." This describes a surgical instrument used directly on a patient's body.
- Device Description: The description details a mechanical device used for tissue removal during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used in vitro (in glass, or outside the body) to analyze biological samples. This device is used in vivo (in the body) during a surgical procedure.
N/A
Intended Use / 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.
Product codes
HAE
Device Description
The Microblade Shaver and Accessories are used to access the neural foramen and decompress targeted areas. The Microblade Shaver is pulled into the foramen with the Distal Handle and tissue is removed by pulling up on the distal handle to cut the targeted soft tissue and bone. The Accessories include a Probe, Guide, Needle Wire and Distal Handle.
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
Not Found
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
The Microblade Shaver and Accessories were used in multiple cadaver studies by physicians skilled in procedures for decompressing neural foramen and lateral recess.
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 removing bone in compromised neural areas.
The Microblade Shaver and Accessories were used in multiple cadaver studies by physicians skilled in procedures for decompressing neural foramen and lateral recess. Results demonstrated that the Microblade Shaver and Accessories provided comparable tissue removal with no visible damage to neural structures, and an ease of use comparable to the standard of care, when compared to commercially available rongeurs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Codman Laminectomy Shaver, Integra Ruggles Instrument, Zeppelin Laminectomy Rongeur, Ellman Disc FX System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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APR 16 2007
Image /page/0/Picture/2 description: The image shows the word "BAXANO" in a bold, sans-serif font, enclosed in a rectangular box. A stylized, curved line bisects the "X" in "BAXANO", adding a unique visual element to the design. The overall design is simple, bold, and modern, with a focus on the word "BAXANO" as the central element.
510(K) SUMMARY (21 CFR 807.92)
MICROBLADE SHAVER AND ACCESSORIES
| 510(k) Owner: | Baxano, Inc.
2660 Marine Way, Suite B
Mountain View, CA 94043
Tel: 650-937-1400
Fax: 650-937-1410 |
| --------------- | --------------------------------------------------------------------------------------------------------------- |
|---|
- Contact Person: Jefferey Bleam Tel: 650-937-1400 ext. 408 E-mail: jbleam@baxano.com
- Date Prepared: October, 2006
Trade Name: Microblade Shaver and Accessories
- Manual rongeur for cutting or biting bone in the skull or spinal Common Name: column
Classification: Manual rongeur (per 21 CFR section 882.4840)
Predicate Devices: Codman Laminectomy Shaver, Integra Ruggles Instrument, Zeppelin Laminectomy Rongeur Ellman Disc FX System (accessories)
- Device Description: The Microblade Shaver and Accessories are used to access the neural foramen and decompress targeted areas. The Microblade Shaver is pulled into the foramen with the Distal Handle and tissue is removed by pulling up on the distal handle to cut the targeted soft tissue and bone. The Accessories include a Probe, Guide, Needle Wire and Distal Handle.
- 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.
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| Substantial | |
|---|---|
| Equivalence: | The Microblade Shaver and Accessories have the same indications |
| for use as the predicates; to access, cut, and bite soft tissue and | |
| bone involving the spinal column. In addition, the Accessories | |
| have the same intended uses; to access, guide, and probe in | |
| neurosurgical applications. Any differences between the | |
| Microblade Shaver and Accessories and the predicates are specific | |
| in design and do not raise new questions of safety or effectiveness. | |
| The device and the predicates are labeled for open decompression | |
| procedures. | |
| Technological | |
| Characteristics: | The Microblade Shaver is made of stainless steel and is flexible, |
| with a low profile, to allow access to compromised neural areas | |
| when exposure is otherwise difficult to obtain. These are the same | |
| materials and technological characteristics as the predicate devices. | |
| The Accessories include a probe, guide and wire substantially | |
| equivalent to probes, guides and wires commercially available for | |
| discectomy procedures in the lumbar spine. | |
| 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 removing bone in | |
| compromised neural areas. | |
| The Microblade Shaver and Accessories were used in multiple | |
| cadaver studies by physicians skilled in procedures for | |
| decompressing neural foramen and lateral recess. Results | |
| demonstrated that the Microblade Shaver and Accessories | |
| provided comparable tissue removal with no visible damage to | |
| neural structures, and an ease of use comparable to the standard of | |
| care, when compared to commercially available rongeurs. | |
| Conclusions: | Baxano has determined, based on the performance testing and |
| cadaver studies, that the Microblade Shaver and Accessories | |
| conform to the design specifications and are substantially | |
| equivalent to the predicate 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 interpreted as an admission or any other type of evidence in pay patent in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The procent ubbission and statements therein therefore should not be construed as affecting or relating to the scope of any patent of passent 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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Baxano, Inc. % Rockwell & Associates Ms. Sharon Rockwell VP, Regulatory & Clinical Affairs 5582 Chalon Road Yorba Linda, California 92886
APR 1 6 2007
Re: K063231
Trade/Device Name: Microblade Shaver and Accessories Regulation Number: 21 CFR 882.4840 Regulation Name: Manual rongeur Regulatory Class: II Product Codc: HAE Dated: March 15, 2007 Received: March 30, 2007
Dear Ms. Rockwell:
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'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); good manufacturing practice requirements as set
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Page 2 - Ms. Sharon Rockwell
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,
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
For
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Microblade Shaver 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.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices 11063231
Prescription Use
(Part 21 CFR 801 Subpart D)
X
AND/OR
510(k) Number_
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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