(156 days)
The Trachealator is indicated for use in dilatation techniques to open or expand stenosis in the airway.
The D35 Airway Dilation Catheter (marketing name: Trachealator) is a sterile single-use device used during airway dilatation procedures. The proposed device consists of a series of parallel balloons on a catheter which, when deployed, provides an outward radial force while also creating an inter balloon space or passage for airflow. Thus, airway occlusion is avoided. The D35 Airway Dilation Catheter is also packaged with a double-ended PTFE-coated stainlesssteel guidewire. The guidewire consists of a two-tip configuration with a length of 1500 mm. One end has a straight tip configuration, while the other end consists of a J-tip with a 6 mm diameter. The catheter is also used with an inflation device that is not provided with the catheter. The D35 Airway Dilation Catheter is provided in nine models. The only differences between the models are the balloon length and diameter.
The provided text describes the 510(k) summary for the Trachealator (D35 Airway Dilation Catheter). It details the device, its intended use, comparison to predicate devices, and performance data. However, it explicitly states that clinical data and animal testing are "Not applicable" and "Clinical studies are not necessary to establish the substantial equivalence of this device."
Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of clinical performance or human expert evaluation. The performance data provided consists solely of bench testing and biocompatibility testing to demonstrate substantial equivalence to predicate devices, rather than establishing clinical efficacy against specific acceptance criteria.
Below is a summary of the requested information based on the provided text, primarily focusing on the engineering and safety aspects for which data exists:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical acceptance criteria or corresponding clinical performance data are presented, this table will focus on the bench testing that was conducted to demonstrate device specifications and substantial equivalence. The document describes several tests performed but does not explicitly list "acceptance criteria" values for each, rather it states that "the D35 Airway Dilation Catheters performs as intended and that the catheter's meets their device specifications."
| Performance Test Category | Specific Test | Reported Device Performance / Outcome | Comments on Acceptance Criteria (as implied) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Passed | Met ISO 10993-5 standards |
| Sensitization | Passed | Met ISO 10993-10 standards | |
| Irritation/Intracutaneous Reactivity | Passed | Met ISO 10993-10 standards | |
| Acute Systemic Toxicity | Passed | Met ISO 10993-11 standards | |
| Pyrogenicity | Passed | Met relevant standards | |
| Sterilization | EO Sterilization Validation (Half cycle / over-kill) | Validated | Sterility Assurance Level (SAL) 10⁻⁶ (ISO 11135:2014) |
| Ethylene Oxide Sterilization Residuals | Verified | Met ISO 10993-7:2008 | |
| Shelf Life | Shelf-life testing | Supports a 3-year shelf life | N/A (Supports claimed shelf life) |
| Packaging Seal Strength | Tested | N/A | |
| Packaging Dye Leak | Tested | N/A | |
| Bench Testing | Visual inspection and dimensional verification | Performed | Met device specifications |
| Force to remove balloon protector | Performed | Met device specifications | |
| Crossing diameter | Performed | Met device specifications | |
| Simulated use | Performed | Performed as intended | |
| Friction on the guide wire | Performed | Met device specifications | |
| Visibility/radiopacity | Performed | Met device specifications | |
| Compliance and nominal length | Performed | Met device specifications | |
| Inflation/deflation times | Performed (2-17 seconds) | Within acceptable range, improved vs predicate | |
| Rated fatigue pressure | Performed | Met device specifications | |
| Rated burst pressure | Performed (12 atm) | Within acceptable range (within predicate/reference range) | |
| Bond strength | Performed | Met device specifications | |
| Catheter flexibility | Performed | Met device specifications | |
| Catheter kink | Performed | Met device specifications | |
| Torque strength | Performed | Met device specifications | |
| Air leak | Performed | Met device specifications | |
| Liquid leak | Performed | Met device specifications | |
| Cluster crushing | Performed | Met device specifications | |
| Radial strength | Performed | Met device specifications | |
| Dilation force | Performed | Met device specifications | |
| Tip perforation | Performed | Met device specifications | |
| High tensile load balloon deflation | Performed | Met device specifications | |
| Inter balloon area verification | Performed | Met device specifications |
(Note: "Met device specifications" is inferred as the acceptance criteria for each bench test, as specific numerical criteria are not detailed in the provided text.)
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any of the bench tests.
- Data Provenance: Not explicitly stated, but the submission is from DISA Medinotec, located in Johannesburg, South Africa. The testing was presumably conducted by or for the manufacturer. The data is retrospective in the context of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The document explicitly states that "Clinical Data" is "Not applicable." The ground truth for bench and biocompatibility tests is established by laboratory measurements against defined standards and internal device specifications, not by human experts adjudicating clinical cases.
4. Adjudication method for the test set
- Not applicable. No expert adjudication of clinical outcomes or diagnostic interpretations was performed as no clinical studies were deemed necessary.
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 device is a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance evaluations (biocompatibility, sterilization, bench testing), the "ground truth" implicitly refers to adherence to established international standards (e.g., ISO) and the manufacturer's internal device specifications.
8. The sample size for the training set
- Not applicable. This device is a physical medical device; there is no "training set" in the context of an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.