(116 days)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are indicated for diagnosis and treatment for ultrasound-guided interventions.
-
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range)
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) are indicated for guiding needles during ultrasound-guided interventions for diagnosis and treatment. -
a. CON-LEAD range and LIN-LEAD range
The guides from CON-LEAD range and LIN-LEAD range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment. -
b. PERINE range
The guides from the PERINE range are indicated for guiding needles during percutaneous ultrasound-guided interventions for diagnosis and treatment on adult males. -
Steady Pro range
The Steady Pro range provides physician a tool for performing ultrasound-guided interventions with the use of an endocavity ultrasound transducer for adult males requiring prostate biopsy mapping and cancer treatment.
The reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range are intended to provide a fixed path for needle insertion during ultrasound-guided interventions. The path is aligned with the ultrasound scan plane for needle imaging during the procedure. The ultrasound system can visualize the prospective path (as an on-screen guideline) in the ultrasound image to help needle positioning.
CON-LEAD range and LIN-LEAD range: The guides have an attachment system in which a perforated part is attached in order to place a needle. It is a system with removable parts (nails) to adapt to the different diameters of needles. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile.
PERINE range: The guides have an attachment system in which a perforated part is attached in order to place a needle. For some applications, there is a system with removable parts (nails) to adapt to the different diameters of needles. There is a possibility to have a fix or a movable system depending on the guide chosen. The guides shall guide and align needles of 14 gauge to 20 gauge with the (central) imaging plane of an ultrasound transducer such that needle is visible in the ultrasound plane at all relevant depth. The guides are reusable medical devices. It is delivered cleaned but not sterile.
Steady Pro range: The Steady Pro range is a system which holds a 2D/3D lateral-fire endocavitary or 2D/3D endfire endocavitary ultrasound probe. It is an accessory of KOELIS systems. The main functions are to move the probe freely inside the working space of the probe holder in unlocked state, to maintain the probe in a specific position for an extended time when locked, to provide 6 degrees of freedom (rotation + translation) for arm and probe positioning, easy to use, sterilizable and cleanable, easy to cover and protect.
The provided text is a 510(k) summary for Koelis' reusable guides, specifically the PERINE range, NAIL range, CON-LEAD range, LIN-LEAD range, and the STEADY PRO range. This document focuses on demonstrating substantial equivalence to predicate devices and does not describe acceptance criteria, test reports, or specific study designs with detailed performance metrics.
Therefore, many of the requested items cannot be extracted directly from this document. However, I can still provide information based on what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "Verification and validation were performed to ensure that devices meet requirements" for the CON-LEAD, LIN-LEAD, and PERINE ranges, and "The design ensures accurate holding of the transducer. Verification and validation were performed to ensure that devices meet requirements" for the Steady Pro range. However, it does not specify what these requirements or acceptance criteria were, nor does it provide quantitative performance data. The device's primary function is guiding needles or holding an ultrasound probe, implying accuracy and stability as key performance indicators, but no specific metrics are given.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Verification and validation were performed to ensure that devices meet requirements." (for all ranges) |
| Not specified | "The design ensures accurate needle path and placement in relation with the transducer." (for CON-LEAD, LIN-LEAD, PERINE ranges) |
| Not specified | "The design ensures accurate holding of the transducer." (for STEADY PRO range) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence." This means there was no "test set" in the context of clinical performance evaluation with human data. The "tests" performed were non-clinical (biocompatibility, cleaning, disinfection effectiveness, and compliance with safety standards). No sample sizes or data provenance for these non-clinical tests are provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no clinical studies were performed and thus no "test set" with ground truth from human data was established, this information is not applicable and not available in the provided document.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No MRMC study was mentioned. The submission states that no clinical studies were required.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Not applicable as this is not an AI/algorithm-based device. It is a physical guide and holder for medical procedures.
7. The Type of Ground Truth Used:
For the non-clinical tests (biocompatibility, cleaning, disinfection effectiveness, and safety standards compliance), the "ground truth" would be established by the specifications defined in relevant international and national standards and regulations. The document states that the devices were "found to be compliant with applicable medical device safety standards" and "comply with voluntary standards," implying that these standards served as the basis for evaluation.
8. The Sample Size for the Training Set:
Not applicable, as this is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.