(371 days)
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.
K2 Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs (Intervertebral Disk Rongeurs) are reusable manual stainless steel instruments. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.
The devices are available with the following features:
Kerrison style Rongeur with a fixed and a sliding shaft and an angled footplate
- with different handles (Micro Handle, Spurling Handle, Ferris-Smith handle, Tarpon handle)
- with different surface treatments (mirror finish, satin finish, matt/dull finish, brush-finished and different coatings (ceramic, black, gold)
- different shaft overall length (6 " inch to 15 " inch) -
- different sizes (1mm to 6 mm)
- different angles (up 40°, up 90°, down 90° -
- without ejector or with different types of ejectors
- with straight shaft, curved (Foraminotomy style) or with Bayonet Shaft,
- traditional style or with special cleaning channel
- traditional style or with opening mechanism (convertible, take-apart)
- with rotating shaft angled 90° and 40°
IVD Rongeurs (Intervertebral disk Rongeurs) with one fixed shaft, one sliding shaft and a hinged mouthpart
- in different styles: Decker Forceps, MIS* Rongeurs/Micro-Pituitary, MIS* Cushing Rongeurs, -Spence iVD Rongeurs, Poppen IVD Rongeurs, Peapod IVD Rongeurs, Love-Gruenwald, Selverstone Rongeurs, Williams Dissecting Forceps, Spurling IVD Rongeurs, Sypert Rongeur, Wilde IVD Rongeurs, Hoen IVD Rongeurs, Oldberg Disc Rongeur, Jackson IVD Rongeurs, Schlesinger IVD Rongeurs, Caspar type Rongeur, Schlesinger Rongeur (MIS* Minimally Invasive Surgery)
- with different length and jaw sizes
- angled and straight
- with closed jaw and with fenestrated jaws
- with smooth jaw and with teeth
Laminectomy Rongeurs with double action joints and strong handle
- Fulton Laminectomy Rongeurs -
This document describes the regulatory clearance (K150468) for K2 Medical GmbH & Co. KG's Laminectomy Rongeurs, Kerrison Rongeurs, and IVD Rongeurs. These devices are manual surgical instruments intended for cutting or biting bone during skull or spinal column surgeries in patients aged two years or older.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Test Method Summary | Reported Device Performance |
|---|---|---|
| Automatic Reprocessing Validation ("Panther Kerrison Rongeur") | Assure devices can be cleaned with provided cleaning steps in the Instructions for Use (IFU). Involves contamination of accessible, interior, and exterior surfaces, especially least accessible sites (worst case). Evaluates effectiveness by comparing visible contamination (red blood cells), residual protein, number of organisms, and TOC levels recovered from control and test instruments, according to AAMI TIR 30. | This validation provides evidence that viable microbiological contamination as well as soil contamination of the "Panther Kerrison Rongeur" are removed by the given cleaning and disinfection instructions. |
| Sterilization Testing | Verify devices can be sterilized with the provided sterilization procedure in the IFU. Test specimens contaminated with bioindicators or challenge suspension, then tested for sterility after sterilization. A part cycle of the recommended sterilization process was performed to assure a Sterility Assurance Level (SAL) of $10^{-6}$. | A reduction of test bacteria was observed and assured, showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization. |
| Boiling Test (Corrosion Resistance) | Verify corrosion resistance of instruments according to ASTM F1089-10 section 6.1. Devices boiled in distilled water for 30 minutes, cooled in water for 3 hours, and air-dried for 2 hours. Requirement: Devices not allowed to show signs of corrosion. | The tested instruments did not show any signs of corrosion. |
| Cytotoxic Testing | Demonstrate no toxic residuals from manufacturing remained on the device. Performed with finished devices from all different materials and coatings according to ISO 10993-5. Requirement: Devices must be considered non-cytotoxic. | All the tested samples were considered to be NON CYTOTOXIC. |
| Irritation Testing | Determine if device extracts produced an irritation reaction when injected intracutaneously in rabbits. Performed according to ISO 10993-10 with finished devices in all material-coating configurations. Devices extracted in 0.9% saline and cottonseed oil for 72 hours. Extracts injected intracutaneously, and sites graded for tissue reaction at 24, 48, and 72 hours after dose administration. Skin irritation evaluated according to ISO 10993-10. | Test data indicated that the device extracts did not cause a skin irritation reaction. |
| Mechanical Testing (Handle force, Bite force, Extended use) | Compare functional requirements of K2 Rongeurs with predicate devices. Measured handle force for actuating the device and force to cut artificial bone material. Also, cutting force and cutting size of new and worn instruments were measured with artificial bone material. Requirement: Devices must perform similar or better than predicate devices. | Test showed that the measured functional specifications of the K2 Rongeurs were equivalent or better than the comparable specifications of the predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the exact sample sizes (number of devices) used for each specific test. For the "Automatic Reprocessing Validation", "Sterilization testing", "Boiling Test", "Cytotoxic testing", and "Irritation testing", the tests were performed on "the devices" or "test specimens" or "finished devices from all the different materials and coatings configurations," implying representative samples of the product line were tested. For "Mechanical testing", "new instruments" and "worn out instruments" were tested.
The data provenance is not explicitly stated in terms of country of origin for the data collection, nor whether it was retrospective or prospective. However, the submitter is K2 Medical GmbH & Co. KG, located in Germany, suggesting the testing was likely conducted in Germany or a location aligned with their quality management system. Given the nature of these engineering and biocompatibility tests, they are inherently prospective, conducted specifically to demonstrate device performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This type of information is not applicable to the tests described in this document. The ground truth for these performance, reprocessing, and biocompatibility tests is established through objective, quantitative measurements against predefined standards (e.g., AAMI TIR 30, ASTM F1089-10, ISO 10993-5, ISO 10993-10) and performance comparisons with predicate devices, not through expert consensus or clinical interpretation.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the ground truth is established through objective measurements against standards, not through human interpretation requiring adjudication.
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:
Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool that would involve human readers or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a manual surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for these tests is based on:
- A-priori defined objective criteria derived from recognized standards: e.g., AAMI TIR 30 for reprocessing, ASTM F1089-10 for corrosion resistance, ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation.
- Quantitative measurements and observations: e.g., reduction in bacteria for sterilization, absence of corrosion, non-cytotoxicity, lack of irritation reaction, and comparison of mechanical forces (handle and bite force) against predicate devices.
- Material specifications: for biocompatibility and mechanical properties.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, there is no training set for this type of device.
§ 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).