(128 days)
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No
The description details a standard syringe and needle, with no mention of AI or ML capabilities. The performance studies focus on mechanical and material properties.
No
The device is described as a hypodermic needle and syringe, used for injecting or withdrawing fluids. This function is for delivery or removal of substances and not inherently for treating a condition, even though the injected substance might be therapeutic.
No
Explanation: The device is described as a hypodermic needle intended for injecting or withdrawing fluids, which are procedural actions, not diagnostic ones. The performance studies also focus on physical properties and safety for fluid transfer, not on diagnostic accuracy.
No
The device description clearly outlines physical components (metal tube, hub, syringe, plunger) and performance testing related to these physical attributes (sealing, volume, strength, etc.), indicating it is a hardware device. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." This describes a procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a hypodermic needle and syringe, which are tools for administering or collecting substances from the body, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The performance studies focus on the physical properties and safety of the syringe and needle themselves, not on the accuracy of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
FMF, FMI
Device Description
The International Medsurg Connections piston syringe and hypodermic needle. Description: The covers are offered sterile, single use.
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
parts of the body below the surface of the skin
Indicated Patient Age Range
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Intended User / Care Setting
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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
Summary of Testing: All materials used in the fabrication of the International Medsurg Connections O.R. piston syringe and hypodermic needles were evaluated for: Syringe Column Sealing, Volume, Tip Sealing Property, Indicating Ruler - 0 level line, Tip size, Draw Strength, Residue Contents, Sliding Property, Appearance, Non-Bacteria, Pyrogen, Toxicity.
Key results:
- Syringe Column Sealing: 300 Kpa Positive Pressure - No leakage, 88 Kpa Negative Pressure - No leakage
- Volume: +/- 4%
- Tip Sealing Property: No Leakage
- Indicating Ruler - 0 level line: Within 1/4 range
- Tip size, Draw Strength: No separation at 25N
- Residue Contents:
§ 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
Attachment 3
9.0 SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 7 2002 INTERNATIONAL MEDSURG CONNECTIONS SYRINGE AND NEEDLES
| Manufacturer: | International Medsurg Connections, Inc.
935 N. Plum Grove Road, Suite F
Schaumburg, Illinois 60173-4770 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Michele Vovolka
P.O. Box 848
Grayslake, Illinois 60030 |
| Telephone: | (847) 856-0355 |
| Date Summary Prepared: | October 11, 2002 |
| Product Trade Name: | International Medsurg Connections Equipment Covers |
| Common Name: | Piston Syringe and Needles |
| Classification: | Class II |
| Predicate Devices: | |
The International Medsurg Connections piston syringe and hypodermic needle. Description: The covers are offered sterile, single use.
This device is intended for inject fluids into, or withdraw fluids from, parts of the Intended Use: 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
Substantial Equivalence:
The International Medsurg Connections piston syringe and hypodermic needles are substantially equivalent to the Becton Dickinson Piston Syringes and the Nipro needles in that they provide the following characteristics:
- Intended use is the same
- Size, configuration, color are similar
- Materials
- Physical properties are similar
1
Attachment 3
Summary of Testing: All materials used in the fabrication of the International Medsurg Connections O.R. piston syringe and hypodermic needles were evaluated for:
| Testing Items | Code Requirement |
|---|---|
| Syringe Column | |
| Sealing | 300 Kpa Positive Pressure - No |
| leakage | |
| 88 Kpa Negative Pressure - No | |
| leakage | |
| Volume | $\pm 4%$ |
| Tip Sealing Property | No Leakage |
| Indicating Ruler - 0 | |
| level line | Within ¼ range |
| Tip size, Draw | |
| Strength | No separation at 25N |
| Residue Contents |