FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 3-6mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus Pediatric tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Rusch TracFlex Plus Pediatric Tracheostomy Tube Set." This submission aims to demonstrate substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria for a new type of device. Therefore, the document primarily focuses on comparison to established standards and the predicate device's performance, rather than defining novel performance targets for the AI.

However, based on the non-clinical comparative performance testing conducted to demonstrate substantial equivalence, we can infer some "acceptance criteria" through the lens of meeting established ISO standards or demonstrating comparable performance to the predicate device.

Here's an analysis structured around your request:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this device are primarily met by adhering to relevant ISO standards and demonstrating performance comparable to the predicate devices. The study performed is a non-clinical comparative performance testing to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Test	Standard (if applicable)	Acceptance Criteria (Implied by standard/comparison)	Reported Device Performance (Implied from "meets intended use")
Connector bonding strength	ISO 5366-3	The connector must remain securely attached under specified axial separation force.	Device met the requirements of ISO 5366-3 for connector bonding strength.
Flange (neck-plate) bonding strength	ISO 5366-3	The neck-plate must remain securely attached under specified axial separation force.	Device met the requirements of ISO 5366-3 for flange bonding strength.
Cuff resting diameter	ISO 5366-3	The cuff resting diameter must be within specified limits when inflated to a reference pressure.	Device met the requirements of ISO 5366-3 for cuff resting diameter.
Tube collapse	ISO 5366	The airway lumen must remain patent with the cuff inflated (steel ball pass through).	The tube maintained patency as per ISO 5366.
Cuff herniation	ISO 5366	The cuff must not herniate excessively beyond the bevel, which could occlude the orifice.	The device demonstrated acceptable cuff herniation as per ISO 5366.
Cuff Burst Evaluation	N/A	The cuff must not burst or rupture when inflated inside the trachea.	The cuff demonstrated adequate burst strength.
Cuff Bond Strength	N/A	The cuff must remain securely bonded to the tube.	The cuff demonstrated satisfactory bond strength.
Side arm bonding strength	N/A	The inflation line connection to the tracheostomy tube must have sufficient retention force.	The side arm demonstrated adequate bonding strength.
Ink adhesion test	N/A	Printing must remain legible after aging, sterilization, and wiping with solvent.	The ink adhesion was satisfactory, maintaining legibility.
Biocompatibility (Materials)	ISO 10993-1	All patient-contacting materials must be biocompatible.	Materials complied with ISO 10993-1 (cytotoxicity, sensitization, etc.).

Note: The document explicitly states "Performance test results demonstrate that the proposed device meets its intended use." This implies that all tested parameters met the specified criteria or acceptable ranges defined by the standards or internal protocols.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of devices/components) used for each non-clinical test. It only lists the tests performed.
- Data Provenance: The data is generated from non-clinical laboratory testing of the new "Rusch TracFlex Plus Pediatric Tracheostomy Tube Set." The country of origin for the testing is not explicitly stated but implied to be under the purview of Teleflex Medical, Inc. (USA-based applicant). The testing is prospective in the sense that the new device was tested in a controlled laboratory environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This section is not applicable as this is a non-clinical device performance study, not an AI or diagnostic device study that requires human "ground truth" establishment by experts. The "ground truth" for these tests is defined by the objective pass/fail criteria of the ISO standards or internal test protocols.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is a non-clinical study. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies among human readers/annotators in establishing ground truth, which is not relevant here.
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 document describes a traditional medical device (tracheostomy tube) and its non-clinical testing. It does not involve AI or human readers, therefore no MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this non-clinical performance study, the "ground truth" is defined by:
  - Standardized Test Methods and Specifications: Primarily adherence to ISO 5366 and ISO 10993-1. These standards set objective, measurable criteria for device performance and safety.
  - Engineering Specifications: Internal design and manufacturing specifications for parameters not covered by ISO standards (e.g., Cuff Burst, Cuff/Side Arm Bond Strength, Ink Adhesion).
The sample size for the training set:
- Not applicable. This refers to a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. As above, there is no AI model or training set involved.

Summary

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.