(127 days)
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).
The provided document describes the Instylla Delivery Kit (K202544), which is a medical device intended for the administration of radiographic contrast media, saline, and other aqueous solutions. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device (K191659). This particular submission focuses on a modified version of the Instylla Delivery Kit with 3mL syringes, whereas the predicate device used 1mL syringes.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of specific, quantitative acceptance criteria. Instead, it states that "The Instylla Delivery Kit with 3mL syringes met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device."
Here's a summary of the performance tests conducted and the general outcome:
| Performance Test | Reported Device Performance |
|---|---|
| Visual Inspection | Met predetermined acceptance criteria |
| Dimensional Verification | Met predetermined acceptance criteria |
| Functional Testing: Syringe Holder and Plunger Clip Disconnection Force | Met predetermined acceptance criteria |
| Functional Testing: Syringe Compatibility | Met predetermined acceptance criteria |
| Functional Testing: Syringe Glide Force and Break Force | Met predetermined acceptance criteria |
| Functional Testing: Fluids Compatibility | Met predetermined acceptance criteria |
| Functional Testing: Delivery Integrity | Met predetermined acceptance criteria |
| Particulate Matter Testing per USP <788> | Met predetermined acceptance criteria |
| Biocompatibility | Deemed acceptable by referencing predicate device results due to identical materials and contact duration. |
| Sterilization (Ethylene Oxide) | Validated to a Sterility Assurance Level (SAL) of 10^-6, with acceptable EO and ECH levels. |
| Bacterial Endotoxin Test (BET) / LAL test | Validated to establish endotoxin level <20 EU/device. |
| Shelf Life | Demonstrated device performance and sterile barrier maintenance for 6 months. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the bench and functional testing. It mentions "Performance testing of the final, sterilized Instylla Delivery Kit with 3mL syringes included bench testing and functional testing." Without specific numbers, the sample size remains unknown.
Data provenance: All testing appears to be retrospective bench and functional testing conducted by the manufacturer, Instylla, Inc. There is no information provided regarding the country of origin of the data beyond the company's location (Bedford, Massachusetts).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes a 510(k) submission for a piston syringe device, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation. The "ground truth" here is defined by engineering specifications, material properties, and regulatory standards.
4. Adjudication method for the test set
This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert interpretations, which is not relevant for the type of testing described here.
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
There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone (algorithm-only) performance study conducted. This device is a physical medical device (syringe kit), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance specifications (e.g., disconnection force, glide force, particulate matter), the "ground truth" is based on predetermined engineering specifications, validated test methods, and compliance with recognized industry standards like ISO 7886-1, ISO 594-2, USP , ISO 11135, and ISO 10993-7. For biocompatibility, the ground truth was established by prior testing of the predicate device against ISO 10993-1.
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).