(344 days)
The UniVit™ HE and UniVit™ UHS are single use (disposable) products intended for use in both anterior and posterior segment (vitrectomy) ophthalmic surgeries when used with a pneumatically-driven vitrectomy system or phacoemulsification system that has a pneumatically-driven vitrectomy module.
The operation of a vitreous cutter is simple. An air pulse pushes down the diaphragm located inside the vitrectomy probe, leading the port to a closed position (the guillotine movement); at the same time, a spring is compressed and forces the diaphragm back to the open port position. In this submission VisionCare Devices is submitting two new models of vitreous cutter. The first model is the UniVit™ HE, which stands for Universal Vitcutter High Efficiency. The UniVit HE is offered in gauge sizes of 20, 23, 25, and 27). The UniVit™ HE™ operates up to 11,000 CPM depending upon vitrectorny system selection. The second model offered, in this submission, is the UniVit™ UHS™, which stands for Universal Vitcutter Ultra High Speed. The UniVit UHS is offered gauge sizes of 23, 25, and 27. The UniVit operates up to 11,000 CPM depending upon vitrectory system selection. The inner cutter has a port cut into it which allows for cutting forward and backwards; this in effect doubles the cut rate to 22,000 CPM.
The provided text describes the UniVit™ HE and UniVit™ UHS devices, which are vitreous aspiration and cutting instruments. The document is a 510(k) summary, indicating that the submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel technology requiring extensive clinical trials.
The acceptance criteria and device performance are primarily detailed through a series of "Non-Clinical Bench Test Summary Reports" and compliance with harmonized standards. No clinical studies involving human patients were conducted for this submission, nor were there any studies mentioned that involved human readers or AI assistance in interpretation. Therefore, much of the requested information regarding human expert involvement, MRMC studies, or AI specific performance will not be applicable.
Here's the breakdown of the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Test Name) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Harmonized Standards Compliance | ||
| ISO 10993-1 (Biological evaluation) | Compliance with risk management process for biological evaluation of medical devices. | Pass |
| ISO 10993-5 (In vitro cytotoxicity) | Device materials are not cytotoxic. | Pass |
| ISO 10993-10 (Irritation & skin sensitization) | Device materials do not cause irritation or skin sensitization. | Pass |
| ISO 11137-1 (Radiation sterilization, Part 1) | Requirements for development, validation, and routine control of sterilization process met. | Pass |
| ISO 11137-2 (Radiation sterilization, Part 2) | Requirements for establishing sterilization dose met. | Pass |
| ISO 11137-3 (Radiation sterilization, Part 3) | Guidance on dosimetric aspects of development, validation, and routine control met. | Pass |
| Non-Clinical Bench Tests | ||
| UniVit Needle Deformation | Outer needle should not fracture or break under normal operational circumstances. | The UniVit vitrector and outer cutter did not fracture or break in normal operational circumstances. All gauge sizes (20, 23, 25, 27) passed without deviation. |
| UniVit Diaphragm Burst | No pressure escape from the needle port during operation, even in extreme conditions (compromised diaphragm, overpressure). | Handpieces performed as designed; no pressure exited the port area during a diaphragm breach or fail event. All tests passed without deviation. |
| UniVit Fluidics | No spikes or pulling forces on the retina, no metal flaking, no tissue damage from heat. | Examination of rabbit retinas during vitreous evacuation showed no spikes or pulling forces. No evidence of tissue damage from heat or metal flaking in collected samples. All tests passed without deviation. |
| UniVit Metal Flaking | No metal flaking generated during operation, especially at high speeds. | The vitrector functioned as designed regarding metal flaking during vitreous removal. No shedding or flaking of metal occurred, preventing adverse effects on the patient. All tests passed without deviation. |
| UniVit Tip Temperature | Tip temperature not to exceed 104°F (40°C) during operation. | The vitrector outer cutter needle did not reach an excessive or unsafe temperature (below 104°F) when run in a worst-case condition (11,000 cpm, in air, without lubrication). All tests passed without deviation. |
| UniVit Vibrational Testing | Vibration not to exceed 2.5 m/S² during operation. | The UniVit vitrector exhibited very low vibration (below 2.5 m/S²) from 500 to 11,000 cuts per minute, even when run at the highest possible CPM without lubrication. It was also lower in vibration frequency than a competitor model (DORC EVA, K190875). All tests passed without deviation. |
| Increased Cutting Speed (UniVit HE) | Capable of increased cutting speed up to 8,000 CPM. | Implicitly met as the device description states it operates up to 11,000 CPM, and other tests were conducted at high speeds, including 11,000 CPM to ensure safety and functionality. The text specifically states UniVit HE's cutting speed is "Increased cutting speed to 8K for UniVit HE". |
| Increased Cutting Speed (UniVit UHS) | Capable of increased cutting speed up to 11,000 CPM (effectively 22,000 CPM). | Implicitly met as the device description states it operates up to 11,000 CPM (doubled to 22,000 CPM due to inner cutter design), and tests like tip temperature and vibration were conducted at 11,000 CPM. The text specifically states UniVit UHS's cutting speed is "Increased cutting speed to 11K for UniVit UHS". |
2. Sample Size Used for the Test Set and Data Provenance
- UniVit Needle Deformation: All available gauge sizes (20, 23, 25, 27) were tested. The exact number of devices or iterations per gauge is not specified, but it implies a comprehensive test of each type. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Diaphragm Burst: "Only one gauge of handpiece was required for testing due to the UniVit vitrector family internal operation." This suggests at least one finished device was tested for this specific criterion. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Fluidics: "(2) rabbit eyes" were used. Data provenance is from studies conducted on rabbit eyes, likely internal lab testing by VisionCare Devices, LLC.
- UniVit Metal Flaking: "The testing was done on a finished device." The number of finished devices tested is not specified beyond this. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Tip Temperature: "The vitrector was ran in a worse case condition..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.
- UniVit Vibrational Testing: "VCD ran the vitrector up to the highest CPM possible..." The number of devices or runs is not specified. Data provenance is internal lab testing by VisionCare Devices, LLC.
All tests appear to be retrospective internal bench tests conducted by VisionCare Devices, LLC. There is no indication of external data sources or geographic origin beyond the company's location in California.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no human experts used to establish a "ground truth" in the context of interpretation or diagnosis as this device is a surgical instrument, not an interpretative AI/image analysis device. The ground truth for the bench tests was based on measurable physical properties (e.g., fracture, pressure escape, temperature, vibration) and visual inspection (e.g., metal flaking, retinal damage in fluidics test) following defined protocols.
4. Adjudication Method for the Test Set
Not applicable. This device is a surgical tool, and the tests conducted were objective bench tests measuring physical performance, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study was not done. The device is a surgical instrument, not an AI or image-analysis tool that affects human reader performance. No human readers or AI assistance are involved in the specified testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way, all the bench tests performed are "standalone" in the sense that they evaluate the device's physical performance independent of human-in-the-loop operation, other than setting up and initiating the tests. However, this is not in the context of an "algorithm only" performance as would be applied to AI/software.
7. The Type of Ground Truth Used
The ground truth for the non-clinical bench tests was based on:
- Pre-defined pass/fail criteria for physical properties (e.g., temperature limits, vibration limits, absence of physical damage or leakage).
- Observational criteria, such as the absence of metal flaking or retinal damage in the fluidics test (using rabbit eyes).
- Compliance with recognized harmonized standards (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.