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This device is intended for inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

The covers are offered sterile, single use. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger.

The provided document describes the acceptance criteria and testing summary for the International Medsurg Connections Piston Syringe and Needles, submitted for 510(k) clearance (K022159).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provides the criteria and states that all materials used were "evaluated for" these criteria. For each criterion, the "Reported Device Performance" column implies that the device met these criteria, as the submission was granted 510(k) clearance, indicating substantial equivalence. Specific numerical results for each test (e.g., exact volume deviation, actual residue content) are not provided in this summary.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set for any of the individual tests. The data provenance is not explicitly stated in terms of country of origin, nor whether the data was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer as part of the submission for market clearance in the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission describes the testing of physical properties and biological compatibility of a medical device (syringes and needles). It does not involve medical image analysis or diagnostic tasks where human expert-established ground truth would be relevant. Therefore, this question is not applicable to the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device testing does not involve human adjudication of results in the typically understood context of diagnostic or interpretive tasks. The evaluation is based on objective measurements against predefined criteria.

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

Not applicable. This is a submission for a physical medical device (syringes and needles), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement effect size are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This involves a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is based on established industry standards and regulatory requirements for medical devices of this type. This includes objective physical measurements (e.g., pressure, volume, strength), chemical analyses (e.g., residue content), and biological tests (e.g., bacterial, pyrogen, toxicity). These "ground truths" are derived from recognized standards and scientific principles rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for this type of submission.

9. How the ground truth for the training set was established

Not applicable. See response to question 8.

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The UNIVEC Nonreusable Locking Syringe with Coupling Assembly can be used by health care professionals, diabetics and other persons for injection of insulin, tuberculin, immunization serum, and other injectible medications.

The UNIVEC Nonreusable Syringe with Coupling Assembly provides a single use function. This assembly, inserted between the syringe plunger and the syringe rubber stopper, will decouple the plunger from the stopper (and disable the syringe) after injecting one dosage of serum. The assembly materials will be fabricated from the same polypropylene as the syringe.

This 510(k) submission describes a physical medical device (a syringe), not an AI/ML powered software device. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, ground truth, and training sets is not applicable.

The submission focuses on comparing the new device to a predicate device based on its physical characteristics and intended use. The "acceptance criteria" for a device like this would typically involve meeting performance standards for syringes (e.g., proper delivery of medication, prevention of reuse, material biocompatibility, structural integrity, etc.) as defined by relevant standards and regulations, rather than metrics like AUC or sensitivity/specificity for an AI algorithm.

Here's a breakdown of why this information is inapplicable and what the existing submission does provide:

• 1. A table of acceptance criteria and the reported device performance: This request is for quantitative performance metrics typically associated with AI/ML or diagnostic devices. For a syringe, acceptance criteria would be based on mechanical and functional tests defined by international standards (e.g., ISO, ASTM) for syringes. The submission doesn't contain specific performance data tables because it's establishing substantial equivalence, not conducting a performance study against novel metrics.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical device like a syringe. Test sets and data provenance are concepts for evaluating data-driven models.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a physical device. Ground truth is a concept for evaluating the accuracy of a diagnostic or predictive system.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is used to resolve disagreements among human annotators or experts.
• 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: Not applicable. This is specific to AI-assisted diagnostic tools.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to the performance of an AI algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable. Training sets are for machine learning models.
• 9. How the ground truth for the training set was established: Not applicable.

What the provided text does tell us about the device:

• Device Name: UNIVEC Nonreusable Locking Syringe with Coupling Assembly
• Intended Use: For injection of insulin, tuberculin, immunization serum, and other injectable medications by health care professionals, diabetics, and others.
• Key Feature: Single-use function, disengaging the plunger from the stopper after one dose to prevent reuse.
• Technological Characteristics: Similar to the predicate device (K 943679) except for a stainless steel locking clip; otherwise, same material, chemical composition, energy source.
• Predicate Device: K 943679, UNIVEC Nonreusable Locking Syringe with non-aspirating plunger.

The submission aims to demonstrate "substantial equivalence" to the predicate device, meaning it's as safe and effective as the legally marketed predicate. This is typically achieved by showing similar technological characteristics and intended use, and if there are differences, demonstrating that those differences do not raise new questions of safety or effectiveness.

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