(1007 days)
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No
The device description details a mechanical syringe with a locking mechanism and makes no mention of AI or ML technology.
No.
The document describes a syringe used for injecting medications, which is a delivery device, not a therapeutic device designed to treat a condition itself.
No
Explanation: The device description states its purpose is for "injecting insulin, tuberculin or immunization serum and other injectible medications" and for "aspirating and mixing various serums... for subsequent injection." This indicates a therapeutic or drug delivery function, not a diagnostic one.
No
The device description clearly states it is a physical syringe made of polypropylene with a locking mechanism, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the syringe is for injecting medications (insulin, tuberculin, immunization serum, etc.) into the body. This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description details a syringe with a locking mechanism for preventing reuse. This is a device designed for administering substances, not for testing samples in vitro (outside of the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, such as blood glucose meters, pregnancy tests, or diagnostic kits for infectious diseases. This syringe is a tool for delivering substances into the body.
N/A
Intended Use / Indications for Use
This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.
Product codes
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Device Description
The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacitivs fabricated of polypropylene. It has a locking device made of the same polypropylene material. The "umbrella" describes the locking mechanism which emulates the shape and functioning of an umbrella.
Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the foward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
diabetics who inject insulin and healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
SUMMARY OF SAFETY AND EFFECTIVENESS OF UNIVEC NONREUSABLE LOCKING SYRINGE
(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:
Model 884 Umbrella Nonreusable Syringe Proprietary Name: Common or Usual Name: Piston, Hypodermic Needle Classification Names: Piston Syringe 21 C.F.R. 880.5860 Class II . Hypodermic Single Lumen Needle 21 C.F.R. 880.5570 Class II
(3) Predicate Devices:
UNIVEC Nonreusable Locking Syringe (K943679)
FLP Enterprises LOKSHOT Syringe (K891467)
(4) Description of Device:
The UNIVEC Model 884 Umbrella Nonreusable Syringe is a sterile piston syringe with 1 cc or 0.5 cc capacitivs fabricated of polypropylene. It has a locking device made of the same polypropylene material. The "umbrella" describes the locking mechanism which emulates the shape and functioning of an umbrella.
Functioning in the traditional manner, this syringe is capable of aspirating and mixing various serums in its barrel by health practitioners and individuals for subsequent injection. It can be locked or prevented from further use by depressing the plunger toward the foward end of the barrel (and past noticeable resistance) in order to activate the locking device. Further use of the syringe is thus prevented.
(5) Statement of Intended Use
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This syringe is intended for diabetics who inject insulin and healthcare professionals who inject insulin, tuberculin or immunization serum and other injectible medications.
- (6) Statement of Technological Characteristics
The UNIVEC Nonreusable Syringe has no significant change in design, material, chemical composition, energy source or other characteristics compared to the predicate devices listed. The locking device, fabricated of polypropylene, the same material as the rest of the syringe, is the only difference with one of the predicates, the UNIVEC Model 888 Nonreusable I .ocking Syringe (K943679), (its locking device is made from stainless steel 304). There are no differences with the FLP Enterprises LOKSHOT Syringe, # K891467