(133 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 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 Probe Accessory is comprised of a telescoping proximal handle, cannula, and deployable catheter used to access the decompression site and place the accessory iO-Flex® Wire. The Distal Handle Accessory is comprised of a handle to accommodate the iO-Flex Wire using a wire locking mechanism and wire capture receptacle and allows manual control of the MicroBlade Shaver and Neuro Check® devices.
This 510(k) pre-market notification describes a modification solely to the iO-Flex Wire. The modifications include an additional surface finish process that employs heat treatment and a subsequent chemical etching process applied to the proximal wire section intended to improve the fatigue stress resistance. There were no changes in the wire material and a small change to one nominal dimension.
The modified iO-Flex Wire is manufactured from nickel-titanium ("Nitinol") and is designed to connect to the distal end of the Neuro Check Device and MicroBlade® Shaver device for placement and allows manual control of the MicroBlade Shaver and Neuro Check devices in the neural foramen. The iO-Flex Wire is packaged with the Neuro Check Device and available as a separately packaged accessory device.
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 MicroBlade Shaver is designed to be flexible, with a low profile to allow access to compromised neural areas in the spinal column. The accessories include a Probe, Distal Handle and the iO-Flex Wire. The fundamental scientific technology and operating controls remain unchanged from the predicate iO-Flex Wire design.
Acceptance Criteria and Study for MicroBlade Shaver Device and Accessories
This document describes the acceptance criteria and a summary of the study used to demonstrate that the modified iO-Flex Wire, part of the MicroBlade Shaver Device and Accessories, meets these criteria.
This submission focuses on a modification to the iO-Flex Wire, specifically an additional surface finish process (heat treatment and chemical etching) to improve fatigue stress resistance, and a small change to one nominal dimension. The fundamental scientific technology and operating controls of the MicroBlade Shaver and its accessories remain unchanged from the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the modified iO-Flex wire are based on demonstrating equivalence to the predicate device's performance characteristics.
| Acceptance Criterion (Predicate Specification) | Reported Device Performance (Modified iO-Flex Wire) |
|---|---|
| Dimensional | |
| Overall iO-Flex Wire Length: 26.0" | Same as Predicate |
| Barrel Length: 0.030" | Same as Predicate |
| Proximal Barrel: Ø 0.0350" | Ø 0.0345" (Manufacturing Tolerance) |
| Distal Tip Angulation: 11 Degree | Same as Predicate |
| Tapered Section: Ø 0.023" | Same as Predicate |
| Surface Treatment | |
| Finish to be within 8 microns or better | Heat Treatment and Chemical Etching (This is the modification to increase fatigue cycling resistance) |
| Tensile Strength and Fatigue Cycling | |
| Tensile Strength: ≥ 38 lbs. | Same as Predicate |
| Fatigue Cycling: 12 cycles @ 38 lbs. of tensile load without gross failures | Same as Predicate |
| Fatigue Cycling: 180 cycles @ 6 lbs. of axial load of simulated decompression | Same as Predicate |
| Repeated Connectivity | |
| 12 attach/detach cycles without failure | Same as Predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Mechanical bench top comparison testing was conducted on the modified and non-modified iO-Flex Wire designs". However, the specific sample sizes used for this testing are not provided in the submitted summary.
The data provenance is implied to be from benchtop laboratory testing, which is prospective in nature, demonstrating performance of newly manufactured modified devices against existing predicate devices. No information on country of origin for the data is provided, but it is typically generated by the manufacturer, Baxano, Inc., located in San Jose, CA, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The study described is a mechanical benchtop comparison testing of a medical device component. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense (e.g., for diagnostic imaging or clinical outcomes). The "ground truth" for this testing is based on objective, quantifiable physical and mechanical properties measured against engineering specifications.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As the study involves objective mechanical testing rather than subjective assessments, there is no need for an adjudication method. The results are compared directly against predefined numerical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The current submission relates to a physical modification of a surgical device component and involves mechanical benchtop testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This question is not applicable. The device is a surgical instrument and accessories; it is not an algorithm or an AI-powered system that would have a "standalone" or "human-in-the-loop" performance. The testing described is for the physical and mechanical properties of a device component.
7. The Type of Ground Truth Used
The "ground truth" used for this study is based on engineering specifications and the established performance characteristics of the predicate device. The modified iO-Flex Wire was tested to verify that it meets these current design specifications and performance characteristics, thus demonstrating equivalence to the predicate. The criteria are quantitative measurements of physical properties (e.g., dimensions, tensile strength, fatigue cycling durability, connectivity).
8. The Sample Size for the Training Set
Not Applicable. This submission describes a modification to an existing medical device component and involves mechanical benchtop testing. There is no machine learning component, and therefore no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. Refer to point 8. No training set was used.
§ 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).