(11 days)
The Baxano, Inc. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.
The ULP Rongeur and accessory devices are used to access the neural foramen and decompress targeted areas. The Rongeur attaches to a needle wire and is pulled into the foramen with the distal handle also attached to the needle wire. Tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The accessories include a probe, guide and needle wire, which are used to explore the foramen, and position the needle wire through soft tissue and the skin.
The provided text describes a 510(k) submission for a medical device (Baxano Ultra Low Profile Rongeur) and does not contain the typical structure of a study report with defined acceptance criteria and detailed quantitative performance results. The focus is on demonstrating "substantial equivalence" to a predicate device.
Therefore, many of the requested fields cannot be directly extracted or are not applicable in the context of this document. I will fill in what can be inferred and explicitly state what information is missing.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Device meets original design specifications and intended performance characteristics for removing bone in compromised neural areas. | Mechanical performance tests were conducted to verify that the modified device meets original design specifications and intended performance characteristics, based on the application for removing bone in compromised neural areas. (No specific quantitative metrics or thresholds are provided for "meets original design specifications" or "intended performance characteristics"). |
| Device provides comparable decompression to the predicate device. | 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 in combination with the integrated Probe and Guide, provided comparable decompression to the predicate device. (No specific quantitative measure of "comparable decompression" is provided, nor the predicate device's performance for comparison). |
| Device is at least as safe and effective as the predicate device. | Baxano has determined, based on the performance testing and cadaver studies, that the ULP Rongeur and accessories conform to the design specifications and are at least as safe and effective as the predicate device for accessing and decompressing bone in the spinal column. (This is a conclusion based on the other tests, not a separate measurable performance outcome). |
| Modified Probe and Guide maintain intended functionality and ease of manipulation. | The Probe and Guide have been integrated into one tool, which contains a stiffer Guide for easier manipulation. (Implied, but no direct performance measure of "easier manipulation" compared to the predicate). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated. The text mentions "multiple cadaver studies," but the number of cadavers or specific cases is not provided.
- Data Provenance: Cadaver studies. The country of origin is not specified but is presumably the US given the context of a US-based company submitting to the FDA. The studies were likely "prospective" in the sense that they were designed to test the modified device, but performed on "retrospective" biological material (cadavers).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not explicitly stated. The text mentions "physicians skilled in procedures for decompressing neural foramen and lateral recess."
- Qualifications of Experts: "Physicians skilled in procedures for decompressing neural foramen and lateral recess." No specific number of years of experience or board certifications are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned. It's unclear how "comparable decompression" was assessed or whether multiple physicians independently assessed and then adjudicated findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this was not an MRMC study and does not involve AI assistance. The study described is a mechanical performance and cadaver study on a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" was likely assessed by expert physicians through observation and potentially measurements during cadaver studies, focusing on the ability to achieve "comparable decompression." This falls under expert assessment/observation in a cadaveric setting.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This refers to performance testing and cadaver studies involving a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical surgical rongeur.
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Image /page/0/Picture/1 description: The image shows the word "BAXANO" in a bold, sans-serif font. The word is enclosed in a rectangular box. A curved line cuts through the letter "X", adding a unique design element to the logo. The overall design is simple, yet eye-catching, with a focus on the brand name.
MAR - 4 2008
SPECIAL 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
- Michael Wallace Contact Person: Tel: 650-937-1400 ext. 408 E-mail: mwallace@baxano.com
- February, 2008 Date Prepared:
Ultra Low Profile (ULP) Rongeur (modified) Trade Name:
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Common Name: Manual rongeur for cutting or biting bone in the skull or spinal column
Classification: Manual rongeur (per 21 CFR section 882.4840) -
Predicate Devices: Baxano Ultra Low Profile (ULP) Rongeur
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The ULP Rongeur and accessory devices are used to access the Device Description: neural foramen and decompress targeted areas. The Rongeur attaches to a needle wire and is pulled into the foramen with the distal handle also attached to the needle wire. Tissue is removed by pulling up on the distal handle to decompress the impinged nerve root. The accessories include a probe, guide and needle wire, which are used to explore the foramen, and position the needle wire through soft tissue and the skin.
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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 predicate; to access, cut, and bite soft tissue and bone involving the spinal column. The Probe and Guide have been modified to an integrated tool, eliminating the need for the physician to load the Guide for positioning the Needle Wire. Any differences between the modified ULP Rongeur and the predicate do not raise new questions of safety or effectiveness. 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. The Probe and Guide have been integrated into one tool, which contains a stiffer Guide for easier manipulation. Two sizes are available to accommodate ipsilateral and contralateral access. Non-Clinical Performance Data: Mechanical performance tests were conducted to verify that the modified device meets original 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 in combination with the integrated Probe and Guide, provided comparable decompression to the predicate device. Conclusions: Baxano has determined, based on the performance testing and cadaver studies, that the ULP Rongeur and accessories conform to the design specifications and are at least as safe and effective as the predicate device 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 subnission may be lawfully marketed without premarket approval or reclassification, and is not interpreted as an admission or any other twoe 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 consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Baxano, Inc. % Ms. Sharon Rockwell Director, Regulatory Affairs 5582 Chalon Road Yorba Linda, California 92886
MAR - 4 2008
Re: K080494
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 20, 2008 Received: February 25, 2008
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 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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Page 2 - Ms. Sharon Rockwell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
Mark N. Millman
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
6080494 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)
Neil R. Ryder for mxm
(Division Sign-Of Division of General, Restorative, and Neurological Devices
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510(k) Number K080494
§ 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).