(104 days)
The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.
The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
Here's an analysis of the provided text regarding the Welmed Hypodermic Syringe, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary for a medical device (hypodermic syringe), not an AI/software as a medical device (SaMD). Therefore, many of the requested categories related to AI development (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, ground truth establishment) are not applicable to this type of submission. The device is a physical product, and its performance is evaluated against established physical standards.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The Welmed Hypodermic Syringe demonstrates conformance to the FDA-recognized consensus standard ISO 7886-1:1993, "Sterile hypodermic syringes for single use - Part 1: Syringes for manual use." This standard sets forth the acceptance criteria for various performance characteristics of manually operated hypodermic syringes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 7886-1:1993, implied) | Reported Device Performance |
|---|---|
| Various physical and functional requirements for sterile hypodermic syringes for single use. This standard covers aspects such as: | Welmed Inc. has established that its family of syringes conform to ISO 7886-1:1993. Data supporting conformance is available from Welmed. |
| * Freedom from defects (e.g., burrs, foreign matter) | Conforms |
| * Dimensional accuracy (e.g., barrel diameter, plunger fit) | Conforms |
| * Performance characteristics (e.g., ease of gliding of plunger, liquid leakage, freedom of air and liquid from the plunger, plunger retention, scale legibility) | Conforms |
| * Sterility | Conforms |
| * Biocompatibility of materials | Conforms |
| * Packaging and labeling requirements | Conforms |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a compliance study against the ISO 7886-1:1993 standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the 510(k) summary. For physical device testing against an ISO standard, samples of each syringe size (1, 3, 5, 10, 20, 30, and 60 ml) would have been taken to perform the various tests outlined in the standard. The sample size would be determined by the specific requirements of ISO 7886-1:1993 for each test.
- Data Provenance: Not explicitly stated. For a 510(k) submission, the testing would typically be performed by the manufacturer, or a qualified third-party laboratory, in line with Good Manufacturing Practices (GMP) and relevant quality systems. Given the US submission, the testing would likely have been conducted in the US or a facility adhering to similar international standards. The data would be prospective as it's specifically generated for the purpose of demonstrating compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This question is relevant to AI/SaMD devices where expert consensus is used to label data. For a physical device conforming to an ISO standard, "ground truth" is typically defined by the objective measurement and testing methods specified within the standard itself, performed by trained technicians or engineers, not by medical experts establishing diagnostic ground truth.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (like 2+1, 3+1) are used in AI/SaMD studies to resolve disagreements among human reviewers when establishing ground truth for diagnostic tasks. This is not applicable to the physical testing of a syringe against an ISO standard, where results are typically objective measurements.
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
- N/A. This is a question specifically for AI/SaMD comparative effectiveness studies and is not relevant to a physical medical device like a syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- N/A. This is a question about AI algorithm performance. No algorithm is involved in the function of a manual hypodermic syringe.
7. The Type of Ground Truth Used
- The "ground truth" for the Welmed Hypodermic Syringe's performance is defined by the objective specifications and performance criteria laid out in the ISO 7886-1:1993 standard. This includes specific physical and functional tests, measurement tolerances, and material requirements. The results of these tests (e.g., leakage rate, gliding force, dimensional accuracy) directly constitute the "ground truth" for compliance.
8. The Sample Size for the Training Set
- N/A. There is no "training set" for a physical device like a syringe in the context of AI/machine learning. The device's design, manufacturing processes, and quality control are developed over time using engineering principles, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no training set in the AI/ML sense, this question is not applicable. The design principles and manufacturing specifications for the syringe are based on established engineering practices and the requirements of relevant standards like ISO 7886-1:1993.
§ 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).