(277 days)
The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct.
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
- a. The 2mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
- b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
- c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and polyethylene terephthalate balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.
The provided text describes the DacryoCath Lacrimal Duct Balloon Catheter and its non-clinical performance testing for substantial equivalence to a predicate device. There is no clinical study or clinical performance data described in the provided document that would establish acceptance criteria or demonstrate the device meets such criteria in a clinical setting.
The document focuses on non-clinical performance tests to show similar technological characteristics and safety.
Here's a breakdown of the information requested, based only on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Test Category | Acceptance Criteria/Methodology | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO10993 (Cytotoxicity, Sensitization, Irritation) | PASS |
| ISO Guinea Pig Maximization Sensitization Test | Did not elicit a sensitization response. | PASS |
| ISO Intracutaneous Reactivity Test | Met the requirements of ISO Intracutaneous Reactivity. | PASS |
| Rabbit Pyrogen Test (Material Mediated) - ISO | Non-pyrogenic and meets ISO10993-11 guidelines. | PASS |
| ISO Acute Systemic Injection Test | Met the requirements of the ISO Acute Systemic Injection Test. | PASS |
| MEM Elution GLP Report (Cytotoxicity) | Determines cytotoxicity of extractable substances; cell monolayers examined and scored. All acceptance criteria met. | PASS |
| Functional Performance | ||
| Inflation/Deflation Time | Inflation and deflation of balloons using conventional techniques within a specified time. | PASS |
| Fatigue Testing | Repeatability of balloon inflation without failure using recommended inflation pressure. | PASS |
| Rupture Testing | Balloons will not burst at or below the maximum recommended burst pressure. | PASS |
| Tensile Testing | Bond strength at joining locations can withstand tensile forces greater than clinical use. | PASS |
| ISO 594-1 Testing (Luer Taper) | Gauging, Liquid Leakage, Air Leakage, Separation Force. (Tests conducted within ISO 594-1 guidance) | PASS |
| Sterilization & Packaging | ||
| Packaging Validation | Transportation (ASTM D169), Seal Peel Test, Dye Migration Test (ASTM F1929), Aerosol Challenge Test, Accelerated Aging Test (3.3 weeks @ 55± 4°C simulating 0.5 year shelf life). | PASS |
| EO Sterilization Validation | Microbiological challenge utilizing half-cycle (overkill) method per ISO11135. | PASS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact sample sizes for each individual test. It mentions "balloons of each diameter and length" for rupture testing, and "test article" for others. No specific numbers are provided for these non-clinical tests.
- Data Provenance: Not applicable for non-clinical lab tests. The tests refer to ISO and ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. These were non-clinical, laboratory-based engineering and biological safety tests. Ground truth in this context refers to the defined parameters and expected outcomes of the standardized tests, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used for clinical result interpretation, particularly when expert consensus or review is needed. These are objective engineering and biological tests with pass/fail criteria.
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. This document does not describe an MRMC study or any clinical comparative effectiveness study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical device (balloon catheter) intended for manual use by a clinician, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" is defined by the specific requirements and methodologies of the international and national standards (ISO, ASTM, USP) referenced for each test. For example, for biocompatibility, the ground truth is the absence of cytotoxicity, sensitization, irritation, etc., as determined by the specified assays. For functional tests, it's meeting predefined performance specifications (e.g., burst pressure, inflation time).
8. The sample size for the training set
- Not applicable. This document describes the testing of a physical medical device. There is no mention of a "training set" as would be relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set described.
N/A