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K Number
K092413
Device Name
INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
Manufacturer
INVIRO MEDICAL DEVICES, INC.
Date Cleared
2009-09-04

(28 days)

Product Code
MEG,REG
Regulation Number
880.5860
Type
Special
Panel
HO
Reference & Predicate Devices
K040036
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. In addition, the InviroSnap Safety Syringe is designed to aid in the prevention of needle stick injuries.

Device Description

The Inviro Medical InviroSnap 50 and 100 unit Insulin Safety Syringe is used to inject insulin into the body. The InviroSnap Insulin 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:

  • Barrel
  • Plunger
  • O-Ring
  • Stopper
  • Hub Assembly
  • Cannula
  • Locking Ring
  • Cap

After use, the health care professional fully depresses the plunger to engage the Luer Assembly. Once the Luer Assembly is engaged, pulling back the plunger causes the Adapter and the attached needle to be withdrawn into the safety of the barrel.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 insulin Safety Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack.

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text, structured according to your request:

Acceptance Criteria and Device Performance

Acceptance Criteria (Standard Reference)Reported Device Performance (Summary)
ISO 8537:1991 - Sterile single-use syringes, with or without needle, for insulinCompliance demonstrated through performance testing.
ISO 7886-4:2006 - Sterile hypodermic syringes for single use, Syringes with re-use prevention featureCompliance demonstrated through performance testing.
ISO 11135:2007 - Medical Devices - Validation and Routine Control of EO SterilizationCompliance demonstrated through performance testing.

Study that Proves the Device Meets the Acceptance Criteria:

A "Special 510(k)" submission was made, indicating that the device is substantially equivalent to a previously cleared predicate device. Performance testing was conducted to demonstrate compliance with the applicable sections of the three voluntary international standards listed above. The document concludes that "The InviroSnap 50 and 100 unit Insulin Safety Syringes are substantially equivalent to the InviroSnap 100 unit Insulin Safety Syringe in indications for use and technological characteristics."

Additional Study Information:

  1. Sample size used for the test set and the data provenance:

    • The document mentions "Performance testing" but does not specify the sample size used for these tests.
    • No information about data provenance (e.g., country of origin) is provided.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The device is a physical medical device (syringe), and ground truth is established through engineering and performance testing against international standards, not through expert human interpretation of data.

  3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, not for performance testing of a syringe against engineering standards.

  4. 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 device is not an AI algorithm for diagnostic imaging but a physical safety syringe.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical safety syringe, not an algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is defined by its ability to meet the specifications and performance requirements outlined in the international standards (ISO 8537:1991, ISO 7886-4:2006, ISO 11135:2007). This is a form of engineering and performance standard compliance.

  7. The sample size for the training set: Not applicable. There is no mention of a "training set" as this is a physical device, not a machine learning model.

  8. How the ground truth for the training set was established: Not applicable, for the same reason as above.

§ 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).