ULTRA LOW PROFILE RONGEUR

K062711 · Baxano, Inc. · HAE · Mar 7, 2007 · Neurology

Device Facts

• Record ID: K062711
• Device Name: ULTRA LOW PROFILE RONGEUR
• Applicant: Baxano, Inc.
• Product Code: HAE · Neurology
• Decision Date: Mar 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

Device Story

Manual surgical instrument for spinal decompression; includes rongeur, probe, guide, and needle wire. Device provides access to neural foramen; surgeon pulls distal handle to cut/remove bone and soft tissue. Used in open decompression procedures by surgeons. Benefits include improved access to compromised neural areas where exposure is difficult. Output is physical removal of tissue/bone; aids clinical decision-making by enabling targeted decompression of impinged nerve roots.

Clinical Evidence

No clinical trials; evidence based on mechanical bench testing and cadaver studies. Cadaver studies performed by skilled physicians demonstrated comparable decompression performance to standard-of-care rongeurs with no visible damage to neural structures and equivalent ease of use.

Technological Characteristics

Stainless steel construction; curved, low-profile geometry for neural access. Manual operation. Includes probe and guide accessories. No energy source or software components.

Indications for Use

Indicated for patients undergoing spinal surgery requiring access, cutting, or biting of soft tissue and bone for decompression of the spinal column.

Regulatory Classification

Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Predicate Devices

• Codman Laminectomy Shaver
• Integra Ruggles Instrument
• Surgical Kerrison Spinal Rongeur
• Zeppelin Laminectomy Rongeur
• Ellman Disc FX System

Submission Summary (Full Text)

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K062711

MAR 0 7 2007

# 510(K) SUMMARY (21 CFR 807.92)

## ULTRA LOW PROFILE RONGEUR

- 510(k) Owner: Baxano, Inc. 2660 Marine Way, Suite B Mountain View, CA 94043 Tel: [phone] Fax: [phone]
- Contact Person: Jefferey Bleam Tel: [phone] ext. 408 E-mail: [e-mail]

Date Prepared: September, 2006

Trade Name: Ultra Low Profile (ULP) Rongeur and Access Tools

- Common Name: Manual rongeur for cutting or biting bone in the skull or spinal column
Classification: Manual rongeur (per 21 CFR section 882.4840)

Codman Laminectomy Shaver, Integra Ruggles Instrument, US Predicate Devices: Surgical Kerrison Spinal Rongeur, Zeppelin Laminectomy Rongeur Ellman Disc FX System (access tools)

- Device Description: The ULP Rongeur and Access Tools are used to access the neural foramen and decompress targeted areas. The Rongeur is pulled into the foramen with the distal handle and tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The Access accessories include a probe, guide and needle wire.
- Intended Use: The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

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| Substantial | |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalence: | The ULP Rongeur has the same indications for use as the predicates; to access, cut, and bite soft tissue and bone involving the spinal column. In addition, the Access Tools have the same intended uses; to access, guide, and probe in neurosurgical applications. Any differences between the ULP Rongeur 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 ULP Rongeur is made of stainless steel and is curved, 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 Access Tools include a probe and guide substantially equivalent to probes and guides 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 ULP Rongeur was used in multiple cadaver studies by physicians skilled in procedures for decompressing neural foramen and lateral recess. Results demonstrated that the ULP Rongeur provided comparable decompression with no visible damage to neural structures, and an ease of use comparable to the standard of care, when compared to commercially available ronguers. |
| Conclusions: | Baxano has determined, based on the performance testing and cadaver studies, that the ULP Rongeur and Access Tools conform to the design specifications and are at least as safe and effective as the predicate devices for accessing and decompressing 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 ary 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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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Baxano, Inc. % Rockwell & Associates Ms. Sharon Rockwell Vice-President, Regulatory and Clinical Affairs 2660 Marine Way, Suite B Mountain View, California 94043

MAR 0 7 2007

Re: K062711

Trade/Device Name: Baxano Ultra Low Profile Rongeur Regulation Number: 21 CFR 882.4840 Regulation Name: Manual rongeur Regulatory Class: II Product Code: HAE Dated: February 26, 2007 Received: February 27, 2006

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 [phone]. 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For Pedro Ruiz

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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Baxano, Inc. Ultra Low Profile Rongeur

## TAB 4

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ________________

Device Name: Baxano Ultra Low Profile Rongeur

Indications for Use:

The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

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)

Signature

(Division Sign-Off) Division of Ceneral. Restorative, and Neurological Devices

Page of

510(k) Number |\ b(27)1

4-1

Confidential: This document and the information contained herein may not be reproduced, used or disclosed without written permission from Baxano, Inc.