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510(k) Data Aggregation
(106 days)
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.
The PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing Luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.
The manufacturer, Portex, Inc., submitted a 510(k) premarket notification (K031057) for their PER-FIT™ Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner Cannula. The submission includes a summary of nonclinical and clinical tests that support the device's substantial equivalence to predicate devices and its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: No trauma associated with tube insertion. | The clinical user evaluation found "no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator." |
| Effectiveness (Occlusion): Reduction in the incidence of tracheostomy tube occlusion. | The clinical user evaluation concluded that "the reduction in the incidence of occlusion of the tracheostomy tube with the proposed device was statistically highly significant." It was also concluded that the proposed device is "at least equivalent to the current device in these respects." |
| Equivalence (Insertion Technique): No difficulty associated with tube insertion using the modified bevel and angled obturator. | The clinical user evaluation found "no trauma or difficulty associated with insertion of the tube featuring the modified bevel and using the angled obturator." This supported the conclusion that the proposed device is equivalent to the predicate device(s). |
| Substantial Equivalence (General): Device is substantially equivalent to predicate devices with respect to intended use, materials, and design characteristics. | A side-by-side comparison of the proposed device to three legally marketed devices (predicates) was conducted. This comparison "concluded that the proposed device is substantially equivalent to the predicate devices cited." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical user evaluation involved 28 subjects in the control group and 26 subjects in the two study groups. This totals 54 subjects for the clinical test set.
- Data Provenance: The study was a prospective clinical user evaluation conducted at St. John's Mercy Medical Center. The country of origin is not explicitly stated but can be inferred as the United States (given the submission to the FDA and the U.S. location of the manufacturer and study site).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It refers to a "clinical user evaluation," which implies participation from medical professionals. The study was conducted at "St. John's Mercy Medical Center," suggesting that the evaluation was carried out by healthcare professionals at that institution who are experienced in performing tracheostomies and managing tracheostomy patients.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical user evaluation. It presents the findings as conclusions from the evaluation without detailing the consensus or disagreement resolution process.
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
No, an MRMC comparative effectiveness study was not conducted, nor is this device an AI-assisted device. The study was a clinical user evaluation comparing a new medical device to existing (predicate) devices, focusing on clinical outcomes directly related to the device itself, not AI interpretation or human reader performance with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device (tracheostomy kit), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used in this study would be based on clinical observation and assessment of patient outcomes. This would include:
- Clinical Assessment: Direct observation by healthcare professionals during tube insertion for "trauma or difficulty."
- Patient Outcomes/Monitoring: Data collected on the "incidence of occlusion of the tracheostomy tube" over time for the study subjects.
- Expert Clinical Judgement: The expertise of the clinicians performing the procedures and evaluating the patients would form the basis of the "ground truth" for success or failure regarding safety and effectiveness.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of this device. As a physical medical device, there isn't a "training set" in the sense of data used to train a machine learning model. Instead, the design and development of the device would have involved internal testing and refinement (e.g., engineering tests, bench testing, animal studies, or earlier human factors analysis) which are not detailed as a "training set" in this summary.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of an algorithm or machine learning for this device, the concept of establishing ground truth for a training set does not apply. The development process for the physical device would have involved standard medical device design control procedures, where design inputs are translated into design outputs, and verification/validation activities ensure the device meets its requirements. Any "ground truth" during development would stem from engineering specifications, material testing standards, and preclinical (e.g., animal, bench) study results.
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(150 days)
Model 301: device is intended for providing tracheal access for airway management including artificial ventilation.
Model 302: device is intended for providing tracheal access for airway management, in which a fenestration is needed in order to sately wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with "speaking valve".
Model 303: device is intended for providing tracheal access for airway management.
Model 304: device is intended for providing tracheal access for airway management where a fenestration is needed in order to safely wean a patient from mechanical ventilation. It can also be used for phonation, if a patient with the larynx intact uses a fenestrated inner cannula with a "speaking valve".
Model 305: device is intended for providing tracheal access for airway management in patients after laryngectomy.
Model 401: device is intended for use in patients with the larynx intact in combination with TRACOES-FLEX model 302 and 304.
The TRACOE -FLEX tracheostomy tubes, the accessories as well as the replacement parts (inner cannulas and plugs) are sterile products for single patient use only. They essentially consist of a neck plate, an outer and an inner cannula. Outer and inner cannulas consists of thin walled relatively soft plastic material, which gets even softer at body temperature. The special feature of the TRACOE -FLEX tracheostomy tubes is, that the neck flange is movable in a horizontal as well as in a vertical axis, so that the cannula inside the trachea does not move, when the patient either bends or turns his head. The outer cannula can carry an inflatable low pressure high volume cuff (models 301 and 302) and/or can be perforated (models 302 and 304). Inner cannulas with a twist-lock 15 mm adapter are non fenestrated (models 301, 302, 303 and 304); additional inner cannulas with a short blue twist-lock adapter (models 302 and 304) are fenestrated. Fenestrated inner cannulas with an integrated "speaking valve" for models 302 and 304 are available as accessories (model 401) for all sizes.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of typical AI/ML medical device submissions. Instead, it describes a traditional medical device (tracheostomy tubes) and its comparison to predicate devices for 510(K) clearance.
Therefore, I cannot fulfill your request for the following sections:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
However, I can provide information based on the "Assessment of Substantial Equivalence based on non-clinical Performance Data" section:
Summary of Device Performance and Equivalence
The TRACOE®-FLEX tracheostomy tubes, including the "speaking valves," were tested in comparison to Shiley/Mallinckrodt tubes. The assessment aimed to demonstrate substantial equivalence, focusing on physical characteristics and performance rather than a clinical study with patients or AI-driven analysis.
Non-Clinical Performance Data Overview:
- Tests Conducted: Measurements of dimensions, resistance to airflow, kink resistance, and connection between cannula and neck plate.
- Results: All tested parameters were "at least as good as those of the predicate devices." Some features showed improvement, specifically:
- Resistance to airflow
- Softness of the wall
- Flexibility between cannula and neck plate
Key Technological Characteristics and Improvements (compared to predicate devices):
- Neck Plate Flexibility: TRACOE®-FLEX tubes have a neck plate that allows movement in both horizontal and vertical axes, enhancing cannula stability during patient head movements, unlike Shiley/Mallinckrodt tubes which only move horizontally, and other tubes with fixed neck plates.
- Thinner Cannulas: TRACOE®-FLEX tubes have thinner cannulas, which at a given tracheostoma size, provide comparatively higher airflow.
- Softer Material: Made from a softer plastic (polyurethane) than Shiley products, resulting in greater softness and flexibility.
- Integrated Speaking Valve: The Tracoe "speaking valves" are constructed as an integral part of the inner cannulas, making them less bulky than predicate devices from Shiley/Mallinckrodt and Passy-Muir.
Biocompatibility Assessment:
- All materials are medical grade with certificates of compliance.
- Elution tests according to USP23 on final sterilized products were negative.
This information describes the evidence provided for a traditional medical device's 510(k) submission, confirming its equivalence to existing devices based on non-clinical performance and material biocompatibility. It does not fit the structure of an AI/ML device study.
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