(89 days)
K 943679
Not Found
No
The device description focuses on a mechanical mechanism for single-use functionality and does not mention any computational or data-driven components. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is a syringe used for injecting medications, which is a delivery mechanism, not a therapeutic agent itself. Its primary function is to administer a substance that may or may not be therapeutic.
No
The device is described as a syringe used for injecting medications, not for diagnosing conditions.
No
The device description clearly describes a physical syringe with a mechanical assembly for disabling it after single use. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of medications into a person. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The device is a syringe designed to deliver substances into the body and then be disabled. This aligns with drug delivery, not diagnostic testing of samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This syringe's function is solely for administering substances.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals, diabetics and other persons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 943679
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Syringe |
| 21 C.F.R. 880.5680 Class II | |
| Classifiation Names: | Hypodermic single lumen needle |
| 21 C.F.R. 880.5570 Class II |
(3) Predicate Device:
K 943679. UNIVEC Nonreusable Locking Syringe with non-aspirating
plunger
(4) Description of Device:
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.
(5) Statement of Intended Use
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.
(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).
4