(71 days)
The Gettig Disposable Syringe, with or without a hypodermic single lumen needle, is intended to inject fluids into, or withdraw fluids from, the body. The syringe is designed for manual use.
The Gettig Disposable Syringe is a standard piston syringe. It consists of a calibrated hollow barrel and a moveable plunger. At one end of the barrel there is a male connector (nozzle) for the female connector (hub) of a hypodermic single lumen needle.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gettig Disposable Syringe:
Note: The provided document is a 510(k) summary for a medical device (syringe). For this type of device, the "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to predicate devices through compliance with established industry standards, rather than clinical efficacy studies often seen for diagnostic or therapeutic AI/ML devices. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, standalone performance with AI, etc.) is not applicable or not present in this type of submission.
Acceptance Criteria and Device Performance Study for Gettig Disposable Syringe (K022495)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 7886-1:1993 (Sterile Hypodermic Syringes for Single Use) | Device found compliant through testing |
| ISO 594-1:1986 (Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment, Part 1 General Requirements) | Device found compliant through testing |
| ISO 594-2:1991 (Conical Fitting With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment, Part 2 Lock Fittings) | Device found compliant through testing |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size (number of syringes) used for "standards testing." However, such testing typically involves a statistically relevant number of units to ensure product consistency and compliance.
- Data Provenance: The testing was conducted "on the Gettig Disposable Syringe and the predicate devices." This implies internal (manufacturer-sponsored) testing. The country of origin for the data is not explicitly stated, but since the submission is to the US FDA, the testing would generally adhere to international standards recognized by the FDA. The testing is prospective in the sense that it was performed on new devices manufactured for the purpose of demonstrating conformity to standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device submission. The "ground truth" for a mechanical device like a syringe is its physical and functional compliance with established international standards (ISO standards). The "experts" involved would be the engineers and technicians performing the tests and comparing results against the standard's specifications.
4. Adjudication Method for the Test Set:
This information is not applicable. The "adjudication method" as described typically refers to a process of resolving discrepancies in expert interpretations, which is relevant for subjective assessments (e.g., medical image interpretation). For compliance testing against objective engineering standards, the results are typically pass/fail based on objective measurements against defined thresholds.
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:
This is not applicable. This submission is for a medical device (a syringe), not an AI/ML-driven diagnostic or therapeutic system. Therefore, no MRMC study or AI-related comparative effectiveness was performed or presented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This submission is for a medical device (a syringe), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is compliance with established international engineering standards (ISO 7886-1, ISO 594-1, ISO 594-2). These standards define objective criteria for syringe performance, such as leakage, force to operate plunger, Luer taper dimensions, etc.
8. The Sample Size for the Training Set:
This is not applicable. This device is a traditional mechanical medical device, not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
This is not applicable. As stated above, there is no "training set" for this type of 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).