(294 days)
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device intended for single use during dilatation of an obstructed nasolacrimal duct system to correct epiphora.
Indications for Use Statement:
The LacriCATH Lacrimal Duct Balloon Catheter is a sterile, prescription device intended for single use during dilatation of an obstructed nasolacrimal duct system to correct epiphora as a result of the following.
5 mm - LacriCATH Adult Catheter: Functional or complete nasolacrimal duct obstruction Dacryocystitis Failed DCR (Dacryocystorhinostomy)
2mm/3mm LacriCATH Pediatric catheter (intended for patients 12 months of age and older):
Congenital nasolacrimal duct obstruction Dacryocystocele
The Quest Medical, Inc. current legally marketed LacriCATH lacrimal duct catheters are sterile, hand held, ophthalmic surgical devices. The LacriCATH devices are designed to facilitate nasolacrimal duct surgeries by using balloon dilation to open occluded lacrimal passages. Each LacriCATH catheter has a stainless steel tube with positioning markers and an inflatable balloon. A luer connector on the proximal end of the catheter is attached to a separate inflation device or a syringe for inflation and deflation of the balloon. The balloon is designed to inflate to a known diameter and length at the specified pressure. The LacriCATH lacrimal duct catheters are sterile, single-use, biocompatible medical devices that are sterilized by ethylene oxide and labeled with a 3 year shelf life. The LacriCATH catheters are packaged with 1 device per pouch, and 2 pouches per carton. They are available by prescription only.
The provided 510(k) summary for the K113867 device (LacriCATH® Lacrimal Duct Balloon Catheter) indicates that no clinical studies were performed or required to prove the device met acceptance criteria.
Instead, the submission relied on non-clinical performance data (bench testing) to demonstrate substantial equivalence to a predicate device.
Therefore, many of the requested details concerning acceptance criteria for clinical performance and clinical study specifics are not applicable in this case.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document states that "Verification and Validation tests were performed to ensure the modified LacriCATH catheters continued to meet or exceed specification in accordance to the Design Requirements. Those specifications are the same as for the predicate device." While specific numerical acceptance criteria are not listed, the overarching criterion was to perform "as well or better than the predicate device" in non-clinical testing.
Reported Device Performance: The bench testing "concluded that the new modified LacriCATH catheters performed as well or better than the predicate device."
| Criterion | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical/Functional Performance | Meet or exceed predicate device specifications | Performed as well or better than predicate device |
| Biocompatibility | Meet requirements | Achieved requirements |
| Physicochemical Testing | Meet requirements | Achieved requirements |
| Shelf Life | Maintain integrity and function for 3 years | Demonstrated 3-year shelf life |
| Sterilization Residuals | Meet safety limits | Achieved safety limits |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set was used.
- Data Provenance: Not applicable. Data is from non-clinical (bench) testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. Ground truth for clinical performance was not established as no clinical studies were performed. Ground truth for bench testing would typically be established by engineering specifications and standards.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set was adjudicated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is not an AI-assisted diagnostic tool, and no MRMC study was performed.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Not applicable. This device is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
- For Non-Clinical Performance: Engineering specifications, industry standards, and internal design requirements. The "ground truth" for the device's technical performance was its ability to meet these established specifications, which were equivalent to or better than the predicate device.
8. Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device's non-clinical evaluation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
In summary, the K113867 submission relied solely on non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device. The acceptance criteria were based on meeting or exceeding the performance specifications of the predicate device. No clinical studies, human readers, or AI algorithms were part of this submission.
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