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K Number
K180970
Device Name
Disposable guides KDNG00
Manufacturer
Koelis
Date Cleared
2018-07-10

(88 days)

Product Code
ITX
Regulation Number
892.1570
Type
Traditional
Panel
RA
Reference & Predicate Devices
K170521,K141334
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The disposable guide KDNG00 is dedicated for endocavity diagnosis ultrasound needle guided procedure. It is intended for clinicians and assistant clinic and hospital, to guide linear instrument with a transrectal approach.

Device Description

The products concerned are plastic guides designed to be clipped on an endocavity ultrasound probe (KOELIS probes K3DEC00/K3DEC00-2 cleared under K170521), to guide a linear instrument through transrectal access. The disposable guides KDNG00 are packaged individually in pouches and delivered sterile. Pouches are then gathered in dispenser boxes (24 guides/dispenser box).

AI/ML Overview

This is a 510(k) premarket notification for a medical device called "Disposable Guide KDNG00". The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria and a study proving the device meets them, especially in the context of an AI/human-in-the-loop system, is not available in the provided text. The document explicitly states: "The subject of this premarket submission did not require clinical studies to support substantial equivalence."

This device, a disposable guide for ultrasound-guided needle procedures, is a hardware accessory and not an AI or software-driven diagnostic tool. The "performance" discussed is primarily related to its physical characteristics, biocompatibility, and sterilization, which are evaluated through non-clinical testing and comparison to existing predicate devices.

Here's a breakdown of why each requested point cannot be answered from the provided text:

  1. A table of acceptance criteria and the reported device performance: Not available. The document demonstrates substantial equivalence through a comparison of technological characteristics, materials, and safety/effectiveness principles, not against a predefined set of performance metrics of an AI system.
  2. Sample size used for the test set and the data provenance: Not applicable. No test set for an AI model or clinical study is mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI model is established.
  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or ground truth adjudication process is mentioned.
  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 is not an AI-assisted diagnostic device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth generation for an AI model is mentioned. The "effectiveness" mentioned refers to its mechanical function and secure fit, analogous to hardware performance, not diagnostic accuracy.
  8. The sample size for the training set: Not applicable. This is not an AI device requiring a training set.
  9. How the ground truth for the training set was established: Not applicable. No ground truth for a training set is established.

The provided document details a 510(k) submission for a physical medical device. The "performance" is assessed through comparison to predicate devices, focusing on:

  • Intended Use and Indications for Use: Both the subject device and predicates provide a fixed path for the needle for transrectal ultrasound-guided procedures (Pages 4, 5).
  • Design: Plastic vs. Inox (stainless steel) with similar clipping mechanisms for stability (Page 6).
  • Materials: Polycarbonate (medical grade) for the subject device compared to stainless steel and thermoplastics for predicates (Page 6).
  • Safety (Biocompatibility): Tested for cytotoxicity, irritation, and sensitization in accordance with ISO 10993-1 and FDA Good Laboratory Practices (GLP). Sterilization effectiveness (EtO) tested per ISO 11135-1. These tests concluded the device is biologically safe (Pages 6-7).
  • Effectiveness (Mechanical): Designed for secure and aligned fit, accurate needle path, and contoured for patient comfort (Page 7).

The conclusion explicitly states: "KOELIS considers the subject device to be as safe, as effective and with performance substantially equivalent to the predicate devices." (Page 7)

§ 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.