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510(k) Data Aggregation
(77 days)
The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.
The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy.
The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.
The provided text describes the acceptance criteria and the results of various bench tests for the aeris Balloon Dilation Catheter as part of a 510(k) submission for substantial equivalence. It does not include information about a study involving human readers, AI, or specific details on studies for ground truth establishment for a test set. This is a technical device submission, not an AI/algorithm-based diagnostic device.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides multiple tables summarizing the bench testing results for different sizes of the aeris Balloon Dilation Catheter and a comparison with predicate devices. For conciseness, a combined table of the types of tests and their general acceptance criteria and performance will be presented, referencing the detailed tables for specific values.
| Test Category | Study Endpoint | Requirement | Acceptance Requirement | Reported Device Performance (aeris Balloon Dilation Catheter) |
|---|---|---|---|---|
| Functional Performance | ||||
| Balloon Working Length | Balloon pressure at 1 ATM | Balloon working length within tolerance | 5x30mm: 30 ± 1 mm9x30mm: 30 ± 0.6 mm16x40mm: 40 ± 1 mm | Pass |
| Inflation Time | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Balloon able to inflate | < 10 seconds | Pass |
| Deflation Time | Balloon Pressure at 0 ATM | Balloon able to deflate | ≤ 15 seconds | Pass |
| Catheter Fatigue | Balloon inflated 10 times to recommended use pressure | 10 cycles to recommended use pressure | No evidence of balloon leakage | Pass |
| Maximum Inflation Pressure | Balloon ruptures | Balloon failure pressure > recommended use pressure | 5x30mm & 9x30mm: Balloon failure pressure > 17 ATM16x40mm: Balloon failure pressure > 10 ATM | Pass |
| Balloon Hub Measurement | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Measure diameter of hub and working length | 5x30mm & 9x30mm: Hub diameter minus working length diameter < 1 mm16x40mm: Hub diameter minus working length diameter < 2 mm | Pass |
| Balloon Diameter | Balloon pressure at recommended use pressure (17 ATM for 5/9mm, 10 ATM for 16mm) | Balloon diameter within tolerance | 5x30mm: 5 ± 0.4 mm9x30mm: 9 ± 0.4 mm16x40mm: 16 ± 0.6 mm | Pass |
| Insertability | Distal end inserted through a 10° bend in a tube with specific diameter | Distal end inserted through 10° bend in tube | No visual signs of kinking or damage done to catheter or stylet | Pass |
| Removability | Distal end withdrawn through a tube with specific diameter | Distal end withdrawn through tube | No visual signs of damage | Pass |
| Proximal Luer Fitting | Tested | Per ISO 594-1 & 594-2 | Meet acceptance criteria of ISO 594-1 & 594-2 | Pass |
| Torqueable | Catheter rotated 2 times | Catheter turned at least 2 times | No visual signs of damage | Pass |
| Luer/Catheter Shaft Connection | Connection failure | Bond tensile force per ISO 10555 | 5x30mm & 9x30mm: ≥ 10 N16x40mm: ≥ 15 N | Pass |
| Biocompatibility | ||||
| L929 MEM Elution Cytotoxicity | Test article must have a reactivity grade of mild or less (≤ 2) | There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. | Pass | |
| Guinea Pig Maximization Sensitization | Test article must have a reaction sensitivity grade of no visible change (Grade 0) | There was no sensitization response (Grade 0) in the test articles. | Pass | |
| Acute Systemic Toxicity | Animals treated with test article extract must not show signs indicative of toxicity. | None of the test article extract treated animals observed with clinical signs consistent with toxicity. | Pass | |
| Intracutaneous Irritation | Tissue reaction to the test article to control dermal observation score is ≤ 1. | Differences in mean test and control scores of extract dermal operations were less than 1. | Pass | |
| Comparison to Predicate Devices | ||||
| Radiopacity | X-ray performed | The balloon will have marker bands, one under each balloon neck, that are visible under fluoroscopy | Equivalent visibility of the aeris marker bands to the predicate devices (specifically CRE Pulmonary) | Equivalent |
2. Sample Size Used for the Test Set and the Data Provenance
The document details bench testing for various physical attributes of the device and biocompatibility testing. It does not describe a clinical "test set" in the context of diagnostic AI models (i.e., human patient data with ground truth labels).
- Bench Testing: The sample sizes for each specific bench test (e.g., number of catheters tested for inflation time, fatigue, etc.) are not explicitly stated in the provided summary tables. The results are presented as "Pass" for each test.
- Biocompatibility Testing: The number of biological samples or animals used for tests like L929 MEM Elution Cytotoxicity, Guinea Pig Maximization Sensitization, Acute Systemic Toxicity, and Intracutaneous Irritation are not specified.
- Data Provenance: Not applicable in the context of clinical patient data. The tests are laboratory-based bench tests and preclinical biocompatibility assessments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided document. The submission is for a medical device (balloon dilation catheter) and involves physical and biological performance testing, not a diagnostic AI device requiring expert-established ground truth from clinical images or data. Bench test acceptance criteria are based on engineering specifications and regulatory standards (e.g., ISO standards).
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" involving expert review or adjudication in the context of AI/diagnostic performance described in this document.
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 a medical device for dilating strictures of the airway, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document pertains to a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is established by:
- Engineering Specifications: Defined tolerances for physical dimensions (e.g., balloon working length, diameter), time limits (e.g., inflation/deflation time), force requirements (e.g., bond tensile force), and operational limits (e.g., maximum inflation pressure).
- Regulatory Standards: Adherence to ISO standards (e.g., ISO 594-1 & 594-2 for luer fittings, ISO 10555 for bond tensile force).
- Visual Inspection: "No visual signs of kinking or damage" for insertability/removability, "No evidence of balloon leakage" for fatigue, "No visual signs of damage" for torqueable.
- Biocompatibility Assessment: Biological responses meeting defined safety thresholds (e.g., reactivity grade of mild or less, no sensitization response, no signs of toxicity, differences in scores less than 1).
- Equivalence to Predicate Devices: For radiopacity, the visibility of the aeris marker bands needed to be "Equivalent" to that of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm-based device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for an AI/algorithm described in this document.
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