(64 days)
For pneumatic infusion of silcone oil into the posterior segment.
The Peregrine V.F.I. Tubing Set is 8' in length and designed to infuse silicone oil into the posterior segment of the eye. It consists of the following: A connector at the proximal end to fit into a pneumatic injection system, 8' PVC tubing running from the connector and attaching to a Delrin Syringe Head which incorporates a .2um filter, and a syringe assembly (Terumo) which is attaches to the syringe head.
The provided document is a 510(k) Premarket Notification for a medical device called the "V.F.I. (Viscous Fluid Injection) Tubing Set." It seeks to establish substantial equivalence to a predicate device, rather than demonstrate performance against specific acceptance criteria through a study.
Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) are not applicable to this type of regulatory submission.
The document primarily focuses on:
- Device Description: What the Peregrine V.F.I. Tubing Set is and what it's used for.
- Substantial Equivalence Comparison: Directly comparing its features to a legally marketed predicate device (Grieshaber & Co. V.I.S. Pack Tubing Set).
- Sterility: Mentioning that the device will be ETO sterilized and the validation method (AAMI Overkill Method).
- Intended Use: For pneumatic infusion of silicone oil into the posterior segment.
Key points from the document regarding the "study" for regulatory approval:
- Acceptance Criteria: The primary "acceptance criterion" for this 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device. This is determined by comparing its design, materials, indications for use, and technological characteristics.
- Study Proving Equivalence: The "study" is a comparative textual analysis presented in Section {1} "Substantial Equivalence Comparison." It lists features of the Peregrine V.F.I. Tubing Set alongside the predicate Grieshaber & Co. V.I.S. Pack Tubing Set.
- Reported Device Performance: The document states: "The Peregrine V.F.I. Tubing Set, product #PD300.01, is identical to the Grieshaber V.I.S. Pack with the exception of the labeling specifications." This implies that its performance is expected to be identical to the predicate.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for 510(k) Equivalence) | Reported Device Performance/Comparison |
|---|---|
| Substantial Equivalence to Predicate Device | Peregrine V.F.I. Tubing Set is "identical" to the Grieshaber V.I.S. Pack (predicate device) with the exception of labeling specifications. |
| Intended Use | For pneumatic infusion of silicone oil into the posterior segment. (Matches predicate) |
| Design/Materials | Nylon connectors, PVC Tubing 8', Delrin Syringe Head, Terumo Syringe 35cc, Gelman .2um filter. (Matches predicate) |
| Sterility | ETO Sterilized, validated by AAMI Overkill Method. (Implied to be equivalent/acceptable for this type of device) |
| Single Use | Single Use (Matches predicate) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This was a comparative analysis of device specifications, not a clinical trial or performance study requiring a "test set" of patient data or device units to be run.
- Data Provenance: Not applicable in the context of a clinical or performance study. The data provenance is the design specifications of the Peregrine device and the known specifications of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" requiring expert ground truth establishment in this type of submission. The "ground truth" for substantial equivalence is the set of specifications of the predicate device and the new device.
4. Adjudication method for the test set
- Not applicable. No "test set" or adjudication process for performance data was described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a medical tubing set, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical tubing set, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this 510(k) submission is the documented specifications and indications for use of the predicate device (Grieshaber V.I.S. Pack Tubing Set). The new device is then compared against this "truth" to establish equivalence.
8. The sample size for the training set
- Not applicable. There is no "training set" for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this type of device submission.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).