(120 days)
The Chartis System is indicated for use by bronchoscopists during a bronchoscopy in adult patients with emphysema, a form of Chronic Obstructive Pulmonary Disease (COPD), in a bronchoscopy suite. The system, composed of the Chartis Catheter and Chartis Console, is designed to measure pressure and flow in order to calculate resistance to airflow and quantify collateral ventilation in isolated lung compartments. The Chartis Catheter is used through the working channel of a bronchoscope and connects to the Chartis Console is capital equipment that is reusable and displays the patient information.
The Chartis Precision Catheter is a single use, sterile, disposable device designed to be inserted into the working channel of a standard video or fiber bronchoscope during a diagnostic bronchoscopy procedure. After the target lung segment is accessed by the bronchoscope, the distal tip of the Chartis Precision Catheter can be introduced through the bronchoscope directly into the target airway. Inflation of the compliant balloon on the distal tip of the Chartis Precision Catheter causes the airway to become sealed and isolated. Air can then flow out of the isolated lung compartment into the environment only through the central lumen of the Chartis Precision Catheter. Assessment is accomplished by measuring air flows and pressures exiting the Chartis Precision Catheter lumen during spontaneous respiration or air flow during mechanical ventilation. The Chartis Precision Catheter is designed for use in conjunction with the Chartis Console. The Chartis Console is a previously cleared device (under K180011) and the subject 510(k) is solely for the Chartis Precision Catheter.
Here's a breakdown of the acceptance criteria and the study information for the Chartis Precision Catheter based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various non-clinical tests performed to demonstrate the safety and efficacy of the Chartis Precision Catheter. However, it does not explicitly list quantitative acceptance criteria or specific reported performance values in a single table as typically expected for device performance metrics like sensitivity, specificity, or accuracy.
Instead, the document states that "The Chartis Precision Catheter completed the following functional testing after being subjected to sterilization, conditioning and distribution" and that "The Chartis Precision Catheter successfully completed repeated functional testing..." and "Packaging validation testing..." and "Sterilization validation testing..." These statements imply that the device met predetermined, internally established acceptance criteria for each test. The "reported device performance" is essentially that the device passed these tests.
Below is a table summarizing the types of tests performed, which indirectly represent the areas where acceptance criteria were applied:
| Test Category | Description of Tests Performed (Implied Acceptance Criteria) |
|---|---|
| Functional Testing | - Balloon inflation, deflation and balloon burst testing: Implies the balloon inflates/deflates as intended and can withstand specified pressures without bursting prematurely. |
- Tensile testing of all fittings and joints of catheter, obturator, and connector set: Implies components can withstand specified tensile forces without failure.
- Airway resistance testing: Implies the catheter functions to allow measurement of airflow and pressure for resistance calculation as intended.
- Bronchoscope deflection angle testing: Implies the catheter does not impede bronchoscope movement beyond acceptable limits.
- Obturator removal force testing: Implies the obturator can be removed with an acceptable force.
- Torque transmission and kink testing: Implies the catheter can transmit torque effectively and resists kinking.
- Leak testing: Implies the system maintains integrity and prevents leaks during operation.
- Catheter insertion and withdrawal force testing: Implies the catheter can be inserted and withdrawn smoothly with acceptable force.
- Dimensional and visual inspection verifications: Implies the catheter meets specified dimensions and visual quality standards.
- Simulated use testing: Implies the device performs as intended in a simulated clinical environment. |
| Shelf-life Testing | - Repeated functional testing: Implies the device maintains functional performance after accelerated aging. - Pouch seal tensile strength testing: Implies the packaging maintains integrity over the specified shelf-life. |
| Packaging Validation Testing | - Visual inspection, bubble leak testing, pouch seal tensile strength testing: Implies packaging integrity and sterile barrier are maintained after sterilization, conditioning, and distribution. |
| Biocompatibility Testing | - Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity: Implies no unacceptable biological response to device components. - Gas Pathway Testing (Particulate Matter, Volatile Organic Components, Toxicological Risk Assessment): Implies gas pathway is safe and free from harmful contaminants. |
| Sterilization Validation | - Electron beam irradiation process at a sterility assurance level (SAL) of 10^-6: Implies the device achieves the required sterility level after sterilization. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the individual non-clinical tests (e.g., how many catheters were used for tensile testing, or how many packages for shelf-life). It indicates that the tests conform to design controls (21 CFR §820.30) and relevant ASTM and ISO standards, which would dictate appropriate sample sizes for each test.
The data provenance is non-clinical bench and lab testing conducted by the manufacturer, Pulmonx Corporation, in Redwood City, California. It does not involve patient data (retrospective or prospective) in the way a clinical study would.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the provided information. The tests described are non-clinical, mechanical, and material-based. They do not involve expert interpretation or subjective evaluation that would require establishing "ground truth" by experts in a clinical sense. The ground truth for these tests is based on objective measurements against established engineering specifications and industry standards.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple experts evaluate ambiguous cases to reach a consensus. The tests performed here are objective performance tests with pass/fail criteria based on measured values.
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
This question is not applicable. The Chartis Precision Catheter is a medical device for measuring pressure and flow to quantify collateral ventilation, not an AI-powered diagnostic tool that assists human readers in interpreting images or data. Therefore, an MRMC study related to AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Chartis Precision Catheter is a physical medical device. While it works in conjunction with the Chartis Console (which processes data), the submission does not describe an "algorithm only" or "AI" component in the context of its performance evaluation. The device's performance is intrinsically linked to its physical interaction and measurements.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" is based on established engineering specifications, industry standards (ASTM, ISO), and predefined performance metrics. For example:
- Functional Testing: Ground truth is defined by specified force limits, pressure ranges, dimensional tolerances, and successful operation during simulated use.
- Shelf-life Testing: Ground truth is the maintenance of functional performance and sterile barrier integrity over the specified shelf-life.
- Biocompatibility Testing: Ground truth is the absence of adverse biological reactions as per ISO 10993.
- Sterilization Validation: Ground truth is achieving a Sterility Assurance Level (SAL) of 10^-6.
8. The Sample Size for the Training Set
This question is not applicable. This device does not use machine learning or AI models that require a "training set" of data. The evaluation is based on traditional engineering and medical device testing principles.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).