(179 days)
The UVE and the MID Labs Bi-Blade™ Vitrectomy Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Bi-Blade™ Vitrectomy Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).
The Vitrectomy Cutter, one of the accessories for the Ultimate Vit Enhancer and the subject of this 510(k), is a pneumatically actuated device, which supports aspiration and guillotine-style cutting functions for the purpose of removing vitreous and/or other tissues from the eye during surgery. This 510(k) describes dimensional changes to the cutter. Specifically, a second port opening was added, and this created a second cutting edge. As the cutter moves from its retracted position to its extended position, any material in the port is cut by the first cutting edge in cooperation with the distal side of the needle port, just as in the conventional vitrectomy cutter. Unlike the conventional vitrectomy cutter, aspiration is able to continue through the opening in the side of the cutter while the cutter is in the extended position, drawing more material into the port. As the cutter moves from the extended position to the retracted position, this material is cut by the second cutting edge in cooperation with the proximal side of the needle port. Thus, there are two cuts made during a single operating cycle, as opposed to one cut for the conventional vitrectomy cutter.
The provided text describes the 510(k) premarket notification for the Bi-Blade Vitrectomy Cutter. The device is a medical instrument used to remove vitreous and intraocular tissue. The document focuses on demonstrating substantial equivalence to a predicate device (K102222 – Ultimate Vit Enhancer and Accessories) rather than presenting a comparative effectiveness study with human readers or a standalone algorithm-only performance study.
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
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Heat Generation | Maximum temperature increase at the probe tip should not be greater than 10°C (based on literature review: Wu, J., Seregard, S., & Algvere, P.V. (2006). Photochemical damage of the retina. Survey of Ophthalmology, 51(5), 461–481). | Maximum temperature increase was 3°C, which is well below the maximum limit. |
| Metal Flaking | No stainless steel particle originating from the probe's cutter or needle, larger than 0.45 microns, should be present on the filter after 20 minutes of continuous use. | No stainless steel metal flakes were produced during 20 minutes of operation for all gauges tested throughout all cut rates (1500 to 8000 cpm). |
| Fluid Dynamics | Characteristics should not adversely affect nearby sensitive ocular structures; should be similar to the FDA cleared 23 gauge predicate cutter. (Implicit criteria based on the described testing and conclusion). | Fluid dynamics of the Bi-Blade™ vitrectomy cutter for all gauges (20G, 23G, 25G, and 27G) is similar to the FDA cleared 23 gauge predicate cutter. (Evaluated by measuring displacement of a marker in porcine vitreous and reviewing video footage). |
| Aspiration Flow Rates | Equal to or improved aspiration flow rate compared to the MID Labs previous FDA cleared predicate vitreous cutters. | The Bi-Blade Vitrectomy Cutter, with its second open port, has less flow resistance per duty cycle and thus decreased flow interruption. The flow rate in saline fluid of the Bi-Blade cutter is relatively independent of the cutting rate. The Bi-Blade cutter is able to provide continuous aspiration even when the cutter is fully closed. (Overall "improved" is implied by these findings). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a dataset of patient images or clinical cases for evaluation of an AI/ML algorithm. Instead, the testing described is focused on the device's physical and functional performance.
- For Heat Generation, Metal Flaking, Fluid Dynamics, and Aspiration Flow Rates, the tests were conducted across all four gauges of the Bi-Blade Vitrectomy Cutter (20G, 23G, 25G, and 27G) and a range of cut rates (e.g., 1500 to 8000 cpm, 1000 to 8000 cpm).
- The data provenance is from laboratory testing of the physical device, not patient data. "Porcine vitreous" was used for fluid dynamics testing, indicating an in vitro or ex vivo experimental setup rather than human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this device submission. The submission pertains to a physical medical device, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation of medical images or data for ground truth establishment. The "ground truth" for the performance tests (e.g., maximum temperature, presence of metal flakes) was established through objective measurement and observation during laboratory testing against pre-defined engineering and safety specifications, and comparison to existing scientific literature (for heat generation).
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation did not involve human expert adjudication of medical cases, but rather objective laboratory measurements and observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical surgical instrument and does not involve AI assistance for human readers in interpreting medical data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for these performance studies was based on:
- Objective physical measurements and observations: e.g., temperature readings, microscopic examination for metal flakes, video analysis of marker displacement for fluid dynamics, and flow rate measurements.
- Scientific literature/established safety thresholds: For example, the 10°C temperature increase limit was derived from a literature review on photochemical damage of the retina.
- Comparison to predicate device characteristics: Fluid dynamics were assessed against the performance of the predicate cutter.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical instrument and does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.