PISTON SYRINGE by UNIVEC, INC. | FDA 510(k) Summary

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.

Device Description

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.

AI/ML Overview

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.

Summary

{0}------------------------------------------------

K961877

1.0 510(k) SUMMARY

AUG - 7 1996

(1) Submitter's Information
UNIVEC Inc. 999 Franklin Avenue Garden City, New York 11530 (516) 294-1000 (tel) (516) 739-3343 (fax)
(2) Device Name

Proprietary Name:	UNIVEC Nonreusable Locking Syringe
Common or Usual Names:	Piston; Hypodermic Needle
Classifiation Names:	Piston Syringe21 C.F.R. 880.5680 Class II
Classifiation Names:	Hypodermic single lumen needle21 C.F.R. 880.5570 Class II

(3) Predicate Device:

K 943679. UNIVEC Nonreusable Locking Syringe with non-aspirating

plunger

(4) Description of Device:

(5) Statement of Intended Use

(6) Statement of Technological Characteristics

{1}------------------------------------------------

The UNIVEC Nonreusable Locking Syringe with Coupling Assembly has no significant change in design, except for the stainless steel locking clip of the predicate. Otherwise, it has the same material, chemical composition, energy source, or other technological characteristics compared to the predicate device listed in paragraph (3).

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to 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 or an intravascular administration set.(b)
Classification. Class II (performance standards).