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510(k) Data Aggregation
(191 days)
ICU MEDICAL SINGLE-USE SYRINGE
ICU Medical piston syringes are single use syringes that are intended for injecting fluids into or withdrawing fluids from the body.
The ICU Medical Single-use Syringes is a pre-sterilized, single-use disposable that is equivalent to the predicate device. It is made of a calibrated hollow barrel, a moveable piston or plunger. Only two of the components ever touch the fluids or blood: the barrel and piston tip. All components are made from existing biocompatible materials that are routinely used in the medical device industry. This device works with a small amount of lubricant for moving the piston shaft. The connection luer on the end is identical to the predicate device. Syringe sizes include: 1ml; 10ml; 20ml; and 30ml. The barrel is visually clear, and the plungers are available in multiple colors (for indication of contents per hospital protocol).
The provided text describes a 510(k) premarket notification for ICU Medical Syringes. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way clinical studies for AI/software devices do.
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth establishment, training set details) are not applicable to the information provided in this document as it's a submission for a physical medical device (syringes).
However, I can extract the relevant information from the document to answer the applicable sections.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (syringes), the "acceptance criteria" are typically conformity to recognized standards and demonstrating substantial equivalence in materials, performance, and operational features. The "performance" is implicitly deemed acceptable if these criteria are met.
| Acceptance Criteria / Standard | Reported Device Performance (ICU Medical Syringes) |
|---|---|
| Conformity to ISO 7886-1 (Sterile hypodermic syringes for single use) | "ICU Medical syringes will conform to the requirements of ISO 7886-1, an FDA recognized standard, prior to marketing the devices." |
| Sterility Assurance Level (SAL) | "ICU Medical's Sterility Assurance Level, (SAL) has an established history of meeting the 10⁻⁶ level." |
| Conformity to ISO 10993-1 (Biological evaluation of medical devices) for packaging and minimizing residual gases | "The single use syringes will be packaged in a way as to ensure conformity with ISO 10993-1, including minimizing residual gases." |
| Substantial Equivalence to Predicate Device (K024052 - Merit Medical Systems, Inc. syringe) | Materials (Polycarbonate barrel, Polyisoprene plunger tip), Calibrated Barrel Volume (YES), Sterilization method (EtO), Operational characteristics are identical. "The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use." |
| Biocompatibility | "All components are made from existing biocompatible materials that are routinely used in the medical device industry." |
| Latex-free | "Both the submitted device and the predicate are latex-free." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a physical device (syringes), not a clinical study involving a test set of data. The "testing" refers to meeting engineering and manufacturing standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically understood in AI/software device studies is not relevant here. Ground truth for the syringe device would be based on validated engineering specifications and performance benchmarks from recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is a physical medical device, not an AI/software device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by conformance to recognized international standards (ISO 7886-1, ISO 10993-1), validated material specifications (biocompatibility), and demonstration of operational equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/software device that is "trained."
9. How the ground truth for the training set was established
Not applicable.
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