(154 days)
The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
The Wiggins Medical Surgical Instruments are manufactured from 420 and 304 stainless-steel conforming to ASTM F899. Instruments are available in both Stainless Steel and Titanium Aluminum Nitride (AITiN) coated Stainless Steel configurations. They are packaged non-sterile and can be reprocessed per the instructions for use. Surgical instruments consist of Kerrison and Pituitary Rongeurs, and are available in numerous sizes and configurations including:
- Different handles (Large, Standard, for use with Rotating Shafts)
- Different shaft lengths (6-14 inches)
- Different Bite Sizes (0.5-6 mm)
- Different Angles (40° and 90°, up and down)
- Different Footplates (Standard, Thin and Ultra-Thin)
- With or without ejector
- Different shaft styles (Standard, Bayonet, Rotating, Endoscopic, Detachable, Curved)
The provided text is an FDA 510(k) summary for Wiggins Medical Surgical Instruments. It details a submission for manual surgical instruments (rongeurs) used for cutting or biting bone during skull or spinal column surgery.
Here's an analysis of the acceptance criteria and study data based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (Result) |
|---|---|
| Mechanical Strength | The predicate device (Fehling Punches) was subjected to static and dynamic mechanical testing to demonstrate fatigue resistance and cutting displacement in relation to force applied. Result: The subject device (Wiggins Medical Surgical Instruments) is stated to be identical to the predicate in materials, manufacture, design, and function. No further mechanical testing was conducted on the subject device. |
| Cleaning | A cleaning validation was performed on the worst-case instrument per the process provided in the Instructions for Use (IFU). Result: Instruments were free of visible soil and met acceptance criteria for protein and hemoglobin content per AAMI TIR 30:2011. |
| Sterilization | A steam sterilization validation was performed using the half-cycle approach. Result: Sterilization parameters will provide a sterility assurance level of 10^-6. |
| Biocompatibility | The predicate device was deemed biocompatible. Result: The subject device is stated to be identical to the predicate in materials, manufacturing processes, manufacturer, sterilization, and technical specifications. No further biocompatibility testing was required for the subject device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" for the Wiggins Medical Surgical Instruments in the context of typical AI/software device evaluation. Instead, the testing relies heavily on the predicate device (Fehling Punches) for mechanical strength and biocompatibility.
- Mechanical Strength: The predicate device was tested. The sample size for this testing is not specified. Data provenance is implied to be from the manufacturer of the predicate device (Gebruder Zepf Medizentechnik GmbH & Co. KG), which is also the manufacturer of the subject device. The nature of these tests (e.g., specific number of cycles for fatigue) is not detailed.
- Cleaning: "Worst case instrument" was tested. The specific number of instruments or samples is not specified. The test was performed by the manufacturer of the subject device.
- Sterilization: Performed using the "half-cycle approach." The number of samples or cycles is not specified.
- Biocompatibility: Relied on the biocompatibility of the predicate device. The underlying data provenance for the predicate's biocompatibility is not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The device is a manual surgical instrument, not an AI/software device that requires expert-established ground truth for its performance evaluation (e.g., diagnostic accuracy). The evaluations are based on physical and biological performance characteristics.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of a "test set" that requires expert adjudication for diagnostic or interpretive outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. The device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies are typically conducted.
6. Standalone Performance Study (Algorithm Only)
This is not applicable as the device is a manual surgical instrument, not an algorithm or software.
7. Type of Ground Truth Used
The "ground truth" for this type of device is established through:
- Objective physical testing: Mechanical strength (fatigue resistance, cutting displacement).
- Chemical/Biological testing: Cleaning validation (absence of soil, protein, hemoglobin), sterilization (sterility assurance level), and biocompatibility (lack of adverse biological response).
- Comparison to a legally marketed predicate device: Substantial equivalence claimed based on identical materials, manufacturing, design, function, and intended use as the predicate device.
8. Sample Size for the Training Set
This is not applicable as the device is a manual surgical instrument and does not involve AI or machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
§ 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).