(177 days)
Not Found
Not Found
No
The description focuses on mechanical function and surgical technique, with no mention of AI/ML terms or capabilities.
No
The device is a surgical instrument used to cut and bite tissue and bone during spinal surgery for decompression. It is not designed to treat, cure, or prevent disease, which are characteristics of a therapeutic device.
No
This device is a surgical instrument designed for accessing, cutting, and biting soft tissue and bone, primarily for decompression during spinal surgery. It treats an existing condition rather than diagnosing one.
No
The device description clearly describes a physical surgical instrument (Rongeur and Access Tools) used for cutting and biting tissue and bone, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Baxano, Inc. Ultra Low Profile Rongeur is a surgical instrument designed for accessing, cutting, and biting soft tissue and bone during surgery on the spinal column. This is an invasive procedure performed inside the body.
- Intended Use: The intended use is for surgical procedures to decompress the neural foramen and lateral recess. This is a direct surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical tool used for treatment, not for diagnosing a condition by analyzing samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HAE
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.
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 ULP Rongeur was 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Codman Laminectomy Shaver, Integra Ruggles Instrument, Surgical Kerrison Spinal Rongeur, Zeppelin Laminectomy Rongeur Ellman Disc FX System (access tools)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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: 650-937-1400 Fax: 650-937-1410
- Contact Person: Jefferey Bleam Tel: 650-937-1400 ext. 408 E-mail: jbleam@baxano.com
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.
1
| 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.
2
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
3
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-free 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 Pedro Ruiz
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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.