(119 days)
The Lenstec Fluid Isolation Device is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells
The Fluid Isolation Device (FID) is a medical device which is intended to hold and seal the lens capsule, to allow irrigation of the capsular bag in an aphakic patient, in order to remove residual cortex and/or epithelial cells. The system consists of the following components: Vacuum ring suction cup connected to lure lock with silicone tubing, 20 mL Vaclok Syringe. Following cataract extraction, the device's vacuum ring suction cup is placed onto the posterior surface of the anterior capsule, and a seal is created by the user drawing back the handle of the Vaclok Syringe. Once the seal is created, the user irrigates the capsule of residual cortex and/or epithelial cells. The device is provided sterile (ethylene oxide).
Here's an analysis of the provided text regarding the Lenstec Fluid Isolation Device (FID) and its acceptance criteria, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | All contact materials tested; all results satisfactory and considered equivalent to the predicate device. |
| Functional Suction Power over Time | Performance equivalence established using a side-by-side comparison; all results satisfactory and considered equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" sample size in the context of clinical or in-vivo testing. The performance data presented are from non-clinical bench testing for functional suction power and biocompatibility.
Data Provenance: The studies were non-clinical (bench tests) and were performed by Lenstec Inc. No country of origin for a clinical test set is relevant here, nor is it retrospective or prospective in the clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The performance testing was non-clinical (biocompatibility and functional suction power). "Ground truth" in the sense of expert clinical diagnosis or interpretation is not relevant for these types of tests.
4. Adjudication Method for the Test Set
Not applicable, as the tests were non-clinical bench tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Clinical tests: Not required." Therefore, no MRMC study comparing human readers with or without AI assistance was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The Fluid Isolation Device (FID) is a medical device, not an AI algorithm. Its performance is directly dependent on user interaction (ophthalmic surgeon drawing back the syringe plunger to create suction).
7. The Type of Ground Truth Used
For the non-clinical tests:
- Biocompatibility: Likely based on standardized assays and comparison to established biological safety limits for medical device materials.
- Functional Suction Power over Time: Likely based on objective measurements of pressure/vacuum and seal integrity, with "ground truth" being the measurements themselves and the comparison to the predicate device's measured performance.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device is not an AI algorithm.
Summary of the Study Proving Device Meets Acceptance Criteria:
The Lenstec Fluid Isolation Device (FID) was determined to be substantially equivalent to its predicate device, the Milvella Perfect Capsule (K030957), based on non-clinical performance data.
The studies conducted were:
- Biocompatibility Testing: All contact materials were tested, and the results were deemed "satisfactory" and "equivalent to the predicate device" (Section 16 of the submission). This addresses the biological safety of the materials used in the device.
- Functional Suction Power over Time Testing (Bench Test): A "side-by-side comparison" of the FID's functional suction power over time was performed against the predicate device. All results were found to be "satisfactory" and "equivalent to the predicate device" (Section 19 of the submission). This test aimed to demonstrate that the FID could achieve and maintain the necessary seal and suction performance comparable to the legally marketed predicate.
No clinical studies were required or performed for this 510(k) submission, as the device's technological characteristics and intended use were considered substantially equivalent to a predicate device already on the market. The equivalence was established through material testing and bench performance comparisons.
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.