(51 days)
The reusable guide is intended to provide physicians a tool for performing needle/instrument guided procedures with the use of the ultrasound endocavity transducer. The guide is attached over the endocavity transducer/probe/scanhead instruments. This device provides a fixed path for the needle or the instrument that when coupled by the ultrasound system software corresponds to on-screen imaging guidelines for visualizing guided instrument placement procedures. KOELIS endorectal ultrasound guides are supplied cleaned and are reusable.
The reusable guide is dedicated for transrectal diagnosis ultrasound needle /instrument guided procedure.
The reusable guide is designed to be clipped onto an ultrasonic endocavity probe, to guide a needle along the said probe, and to be cleaned and re-sterilized after use.
The provided text describes a 510(k) summary for a "Reusable Guide" manufactured by KOELIS. This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical study data or acceptance criteria related to device performance in a clinical setting.
Therefore, many of the requested sections about acceptance criteria, detailed study designs, and performance metrics are not present in the provided text. The submission focuses on device characteristics, intended use, and materials to establish equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided as a formal table with acceptance criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (CIVCO Transrectal Needle biopsy Guide, K875128/A) by comparing technological characteristics, intended use, and materials.
The 'Effectiveness' section states:
- "Both the subject and predicate devices are designed for secure and aligned fit to the transducer, while not altering the transducer design integrity or function."
- "Positive registration features of the design ensures accurate needle / instrument path and placement in relation with the transducer."
- "Exterior shapes of the guide are contoured for patient comfort with no sharp edges."
These statements describe design goals and anticipated performance, but not quantifiable acceptance criteria or reported device performance metrics from a formal study.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission does not describe a clinical study with a test set of data. It is a 510(k) summary focused on device design and comparison to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical study or ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical study or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. No MRMC study or comparative effectiveness study involving human readers is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical guide, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. No ground truth for device performance is described. The submission relies on design specifications and material safety evaluations.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm is relevant to this mechanical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No ground truth for a training set is relevant to this mechanical device.
Summary of available information related to performance and safety:
The submission focuses on inherent device characteristics and comparison to the predicate device to establish safety and effectiveness, rather than a quantifiable performance study against specific acceptance criteria.
- Intended Use & Indications for Use: The device is intended for "transrectal diagnosis ultrasound needle/instrument guided procedures."
- Design & Effectiveness (as stated):
- Secure and aligned fit to the transducer without altering its function.
- Positive registration features ensure accurate needle/instrument path and placement.
- Contoured exterior shapes for patient comfort with no sharp edges.
- Material Safety: The device uses Stainless steel (304, 316L, 17/4 PH). KOELIS conducted a biological safety evaluation based on risk analysis, literature data, and manufacturing process according to ISO10993-1. The report concluded adequate data to demonstrate biological safety. This is a critical aspect for a reusable device with limited body contact (intact skin/mucosal membranes,
§ 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.