(154 days)
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicine or vaccines into, or withdraw fluids from, the body.
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
The piston syringe is a plastic disposable htpodermic syringe made of the following components:
- 1 Barrel - The barrel has a scale showing the capacity of the syringe. In addition, the tip of the barrel has a luer lock fitting for the user to attach a needle.
- 2 Plunger - The plunger is used to aspirate and inject fluids into and out of the syringe.
- 3 Stopper - The Stopper maintains the fluid in the barrel between the syringe nozzle and the Plunger.
- 4 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
- 5 Cap - Covers the cannula/needle until the syringe is to be used.
The InviroStripe Standard 3, 5 and 10 ml hypodermic syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a tray pack. Twenty five syringes without needles are packaged in a tray and sealed with a tyvek Lid. Each tray pack and case is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
This is an analysis of a 510(k) premarket notification for a medical device, specifically hypodermic syringes. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a specific performance metric against acceptance criteria in the way a diagnostic AI device would.
Therefore, the requested information elements related to AI performance, ground truth, expert consensus, and sample sizes for training/test sets are not applicable to this document. This submission is for a physical medical device (syringes), not a diagnostic algorithm.
However, I can extract the acceptance criteria based on voluntary standards and the reported device performance as stated.
1. Table of Acceptance Criteria and Reported Device Performance
For this physical medical device, the "acceptance criteria" are compliance with established international and national standards for medical devices, and the "reported device performance" is the claim of compliance to these standards.
| Acceptance Criterion (Voluntary Standard) | Reported Device Performance |
|---|---|
| ISO 594-1:1986, "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector -Part One: General Requirement" | Compliance demonstrated |
| ISO 594-2:1986, "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector -Part Two: Locked Connector" | Compliance demonstrated |
| ISO 7886-1:1993, "Single Use Sterile Syringe" | Compliance demonstrated |
| ANSI/AAMI/ISO 11135, "Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization" | Compliance demonstrated |
| ISO 11607:2003, "Packaging for terminally sterilized medical devices" | Compliance demonstrated |
| ISO 10993-4:2006, "Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood" | Compliance demonstrated (Biocompatibility considered) |
The study proving the device meets these criteria is referred to as "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." The conclusion of the submission is that the device is "substantially equivalent" to its predicate based on these tests and technological characteristics.
Non-Applicable Information for this Device (Hypodermic Syringes)
The following points are not applicable to the provided 510(k) summary for the InviroStripe hypodermic syringes, as this is a physical medical device and not an AI/diagnostic algorithm:
- Sample size used for the test set and the data provenance: Not applicable. Performance testing for physical devices typically involves engineering tests, material testing, and sterilization validation, not data sets in the context of AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI is not relevant here. Device performance is assessed against technical specifications and standard requirements.
- Adjudication method for the test set: Not applicable. Adjudication relates to expert human review of data, which is not part of physical device testing.
- 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 for AI-assisted diagnostic devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical syringe. The "ground truth" for this device's performance would be its adherence to the physical and functional specifications defined by the voluntary standards.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: Not applicable. There is no AI model to train.
§ 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).