(98 days)
The InviroStripe Standard Luer Lock Syringes are used to inject medicines and vaccines into, or withdraw fluids from, the body.
The InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock 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 Cap - Covers the cannula/needle until the syringe is to be used. The InviroStripe Luer Lock Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in a Blister Pack. One Hundred syringes without needles are packaged in a Dispenser Box. Each Blister Pack, Dispenser Box and Case are labeled with the contents and the appropriate information per the FDA's Quality System Regulation and Labeling requirements.
The Inviro Medical Luer Lock Syringe (InviroStripe 1, 3, 5, 10, 20, 30 and 60 ml Standard Luer Lock syringes) is a Piston Syringe used to inject medicines and vaccines into, or withdraw fluids from, the body.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission indicates compliance with several international and national standards. The acceptance criteria essentially are successful adherence to the requirements outlined in these standards. The device's reported performance is its claim of successful compliance.
| Acceptance Criteria (Applicable Sections of Standards) | Reported Device Performance |
|---|---|
| ISO 594-1:1986: Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part One: General Requirement | The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the general requirements for luer taper connectors as specified in this ISO standard. |
| ISO 594-2:1986: Syringe, Syringe Needle and Other Medical Apparatus 6% (Lu-Er) Taper Connector - Part Two: Locked Connector | The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for locked luer taper connectors as specified in this ISO standard. |
| ISO 7886-1:1993: Single Use Sterile Syringe | The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for single-use sterile hypodermic syringes as specified in this ISO standard. |
| ANSI/AAMI/ISO 11135:2007: Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization | The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the validation and routine control of ethylene oxide sterilization as specified in this standard. The device is explicitly stated to be "sterilized by Ethylene Oxide Gas." |
| ISO 11607:2003: Packaging for terminally sterilized medical devices | The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for packaging of terminally sterilized medical devices as specified in this ISO standard. The device is supplied in a blister pack and dispenser box, with labeling complying with FDA's Quality System Regulation and Labeling requirements. |
| ISO 10993-4:2006: Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood | The submission states "Performance testing consisted of compliance to the applicable sections of the following voluntary standards," implying successful adherence to the requirements for biological evaluation, specifically concerning interactions with blood, as specified in this ISO standard. |
| Substantial Equivalence to Predicate Device (K081436) | The conclusion states: "The InviroStripe 1, 3, 5, 10, 20, 30 and 10 ml Standard Luer Lock Syringes are substantially equivalent to the InviroStripe 3, 5 and 10 ml Standard Luer Lock Syringes in indications for use and technological characteristics." This implies that the new devices perform similar to the previously cleared predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the exact sample sizes used for the performance tests conducted under the listed ISO/ANSI standards. It simply states that "Performance testing consisted of compliance to the applicable sections of the following voluntary standards." These standards themselves often outline appropriate sample sizes for various tests.
- Data Provenance: The document does not explicitly state the country of origin of the data. Given the "Submitter Information" indicates Inviro Medical, Inc. is located in Lawrenceville, GA, USA, it is highly probable that the testing, and thus the data, originated in the United States or was conducted on devices manufactured for the U.S. market. The study appears to be retrospective in the sense that the results of the performance testing are being presented to demonstrate compliance for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For this type of device (piston syringes), "ground truth" is not established by human experts in the sense of clinical diagnoses or image interpretations. Instead, the "ground truth" is determined by the objective and quantifiable pass/fail criteria defined within the specified international and national standards (ISO, ANSI/AAMI).
- Number of Experts: Not applicable in the context of human interpretation.
- Qualifications of Experts: Not applicable. The "experts" are the standards themselves and the engineers/technicians who perform the tests according to those standards.
4. Adjudication Method for the Test Set
Not applicable. The performance tests against established standards have objective pass/fail criteria, meaning there is no need for subjective adjudication by multiple experts. The outcome is determined by whether the device's measured properties fall within the specified limits of the standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the goal is to assess the impact of an AI algorithm on human performance. The Inviro Medical Luer Lock Syringe is a physical medical device, not a diagnostic AI system, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in essence. The compliance testing against ISO and ANSI/AAMI standards represents a "standalone" evaluation of the device's physical properties and performance characteristics. This evaluation does not involve a human-in-the-loop scenario, as the device itself is being tested to ensure it meets predefined technical specifications. There is no "algorithm" in the typical AI sense to be evaluated.
7. Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on objective, quantifiable specifications and pass/fail criteria defined in recognized international and national standards (e.g., ISO 594-1, ISO 7886-1). This is a form of engineering/performance standard compliance.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical product, not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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).