(91 days)
The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
The Inviro Medical InviroSnap Safety Syringe is used to inject medicines and vaccines into, or withdraw fluids from, the body. The InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.
The retractable type piston syringe is a plastic disposable antineedlestick syringe made of the following components:
- l 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 - After using the syringe, the plunger is retracted and snapped off leaving the needle in the barrel of the syringe.
- 3 O-Ring - The O-ring minimizes the risk of leakage around the Adapter.
- Stopper The Stopper maintains the fluid in the barrel 4 between the Adapter and Plunger.
- Adapter The Adapter facilitates passage of the fluid 5 between the cannula and the barrel. In addition, the cannula/needle is bonded to the Adapter.
- 6 Cannula - The cannula/needle penetrates the patient's skin to inject/withdraw fluid from the body.
- 7 Cap - Covers the cannula/needle until the syringe is to be used.
After use, the health care professional fully depresses the plunger to engage the Adapter Needle assembly. Once the Adapter Needle Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and plunger are discarded in a Sharps container.
The InviroSnap Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack. One hundred blister packs are packaged in a chipboard box. Each Blister pack and chipboard box is labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
This 510(k) summary describes a special 510(k) submission for the InviroSnap Safety Syringe, which is an updated version of a previously cleared device. The submission primarily focuses on demonstrating substantial equivalence to the existing predicate device through compliance with recognized standards rather than extensive clinical studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Voluntary Standards) | Reported Device Performance |
|---|---|
| ISO 594-1:1986 "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part One: General Requirement" | Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance". |
| ISO 594-2:1986 "Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part Two: Locked Connector" | Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance". |
| ISO 7886-1:1993 "Single Use Sterile Syringe" | Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance". |
| ISO 7886-3:2005 "Auto-disable syringes for fixed-4 - dose immunization" | Compliance with applicable sections stated. No specific numeric performance values are reported, rather a statement of "compliance". |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing. The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond the general statement that "performance testing consisted of compliance to the applicable sections of the following voluntary standards." This suggests that the testing was likely conducted in a controlled lab environment and is not based on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on engineering and device performance standards, not expert-adjudicated clinical data to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. No adjudication method is mentioned as the testing is based on engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical and functional equivalence of the device to standards, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical medical device (syringe), not an algorithm or AI-driven system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the specified voluntary international standards (ISO 594-1, ISO 594-2, ISO 7886-1, ISO 7886-3). These standards define the expected physical and functional characteristics for syringes.
8. The Sample Size for the Training Set
Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The design and manufacturing process would adhere to an established quality system and engineering specifications, which are based on the requirements of the referenced ISO standards.
§ 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).