(59 days)
The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:
- · Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
- · During dacryocystorhinostomy
- · Congenital lacrimal duct obstruction
The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olivetipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation.
This document describes the Oasis Lacrimal Intubation Set with Retrieval Device and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or device performance metrics in a pass/fail format. Instead, it focuses on demonstrating equivalence to a predicate device across several characteristics. The "performance" is implicitly deemed acceptable if it's equivalent to the legally marketed predicate.
However, we can infer the areas of assessment and the reported findings for each:
| Acceptance Criteria Area | Reported Device Performance (Comparison to Predicate Device) |
|---|---|
| Indications for Use | Equivalent: Intended for nasolacrimal intubation in patients 12 months+ for canalicular pathologies (congenital/acquired stenosis, lacerations), during dacryocystorhinostomy, and congenital lacrimal duct obstruction. |
| Technological Characteristics | Design: Oasis Lacrimal Intubation Design (probes and silicone) is equivalent. Retrieval Device Design differs (single-use plastic handled vs. reusable stainless steel handled predicate, slightly angled/ergonomic hook on Oasis). |
| Mode of Action: Equivalent (intubation of lacrimal ducts enabling drainage of tears by capillarity). | |
| Instructions for Use: Equivalent (insertion and removal). | |
| Materials: Equivalent (Stainless steel and silicone). | |
| Sterility | Retrieval Device Sterility differs: Oasis device is provided sterile; predicate hook is not provided sterile. Mode of Sterilization for Oasis Lacrimal Intubation differs: Oasis is gamma sterilized (VDmax method-25kGy); predicate is EtO sterilized. |
| Biocompatibility | Tested for Cytotoxicity, Sensitization, and Irritation. Concluded no adverse reaction. Silicone tubing (tissue contacting portion) considered to exceed USP Class VI due to manufacturing process not introducing novel impurities. |
| Durability/Strength | Performed equivalently to predicate device in bench tests assessing dimensional attributes and device durability via strength testing (known pull force on junctions). Concluded similar safety, effectiveness, and performance due to equivalent overall design and strength. |
| Overall Safety & Effectiveness | Concluded to be as safe and effective as the predicate device, based on independent laboratory and internal comparative bench testing, despite stated differences. Differences "do not affect the Oasis Medical Lacrimal Intubation Set with Retrieval Device in terms of relevant functionality and safety." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing. It does not specify a numerical "sample size" in terms of patients or independent test articles for each specific test performed. However, it indicates:
- Bench tests: A "series of bench tests" was conducted.
- Biocompatibility tests: These were conducted for Cytotoxicity, Sensitization, and Irritation.
- Provenance: The tests were conducted by "independent laboratories and internal comparative bench testing." No country of origin for the data is specified, nor is whether the testing was retrospective or prospective (it would inherently be prospective for product development).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes a medical device (intubation set), not a diagnostic AI device requiring expert ground truth for interpretation. Therefore, these categories are not applicable. The "truth" here is established by engineering specifications, material properties, and functionality comparison against a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as this is bench testing of a physical device, not a diagnostic assessment requiring expert adjudication of findings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This is a 510(k) submission for a physical medical device, not a diagnostic AI system requiring MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Engineering specifications and standards: For dimensional attributes, material properties (e.g., USP Class VI for silicone).
- Functional comparison to a predicate device: For durability and overall performance (e.g., "performed equivalently to the predicate device").
- Standardized biocompatibility test protocols: For cytotoxicity, sensitization, and irritation.
8. The Sample Size for the Training Set
No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.
9. How the Ground Truth for the Training Set was Established
No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.
N/A