(65 days)
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Not Found
No
The device description and performance studies focus on the physical properties and sterility of a standard syringe, with no mention of AI or ML.
No
The intended use of the Shifa Syringes is for "injection of" and the device description details a standard piston syringe. There is no information suggesting it delivers therapy or has a therapeutic effect.
No
The device is a syringe, which is used for injection, not for diagnosing conditions. The 'Summary of Performance Studies' section describes tests for the syringe's physical properties and sterility, not for diagnostic capabilities.
No
The device description clearly states it is a physical syringe made of materials like polypropylene, natural rubber, and stainless steel, and the performance studies focus on physical characteristics and testing of the syringe itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "injection of". This describes a direct interaction with the patient's body for delivering substances, not for examining specimens in vitro (outside the body).
- Device Description: The description details a syringe, which is a tool for administering fluids or drawing samples from the body, not for performing tests on those samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any components typically associated with in vitro diagnostic testing. The testing described focuses on the physical and biological properties of the syringe itself, not its performance in a diagnostic assay.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. Syringes are used on the body for therapeutic or sample collection purposes.
N/A
Intended Use / Indications for Use
Shifa Syringes are intended for injection of
Product codes
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Device Description
Shifa Syringes are sterile disposable medical piston syringes consisting of barrel with luer-lock or slip-lock nozzle, gasket, and a needle. They are sold with or without needles. The barrel, and plunger are polypropylene, the gasket is natural rubber, and the needle is stainless steel.
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Shifa Sterile Disposable Syringes were tested for the following characteristics:
- Water Extract Appearance: Transparent, colorless, and no foreign matter
- Transmittance: Above 93%
- Difference in level of pH: Lower than 2.0
- Heavy metals: Less than 2 PPM
- Incompatibility between syringe and injection fluid: No change in appearance, opacity, or color of syringe or fluid
- Quantity of silicone lubricant: 3cc-Below 8 mg/pc; 5cc-Below 8 mg/pc; 10cc-Below 15 mg/pc
- Intravenous injection test: Complies with USP XXII
- Intracutaneous: Complies with USP XXII
- Pyrogen Test: Complies with USP XXII
- Sterility Test: No microbial growth in fluid thioglycolate medium after 7 days @ 22-25°C and soybean casein digest medium after 7 days @ 30-32°C.
- Air leakage during aspiration: No leakage past piston or seal , no fall in manometer reading. Piston not detached from plunger.
- Air leakage under compression: No leakage past piston or seal.
- Dead space of syringe: Less than 0.075 ml. in 3cc & 5 cc. Less than 0.1 ml. in 10cc.
- Air leak test of package Wrapper: No bubbles within 10 seconds after pressurized @ 0.07 KGF/CM2.
- Blister Package: No air bubbles within 10 seconds after pressurized @ 0.07 KGF/CM2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Mediplas Marketing SDN BHD MDP Disposable Syringes, Becton Dickinson Brand Disposable Syringes
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
XIII. SUMMARY OF SAFETY AND EFFECTIVENESS
ﭘ
SHIFA SYRINGES-STERILE DISPOSABLE
| Manufacturer: | Alshifa Medical Supplies Industry
P.O. Box 23032
DUBAI- United Arab Emirates |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| United States Contact: | William H. Damaska, RAC
International Regulatory Consultants, L.C.
2 Bayswater Court
Gaithersburg, Maryland 20878 |
| Telephone:
Fax: | (301) 208-9033
(301) 208-9037 |
| Date Summary Prepared: | June, 1995 |
| Product Trade Name: | Shifa Sterile Disposable Syringes |
| Common Name: | Sterile Disposable Syringes |
| Classification: | Piston Syringe |
| Predicate Devices: | Mediplas Marketing SDN BHD MDP Disposable
Syringes
Becton Dickinson Brand Disposable Syringes |
| Description: | Shifa Syringes are sterile disposable medical
piston syringes consisting of barrel with luer-
lock or slip-lock nozzle, gasket, and a needle.
They are sold with or without needles. The barrel,
and plunger are polypropylene, the gasket is natural
rubber, and the needle is stainless steel. |
| Intended Use: | Shifa Syringes are intended for injection of |
1
Summary of Safety and Effectiveness (Cont'd).
Substantial Equivalence:
The Shifa Sterile Disposable Syringes are substantially equivalent to Mediplas Marketing SDN BHD MDP Disposable Syringes and to Becton Dickinson Brand Disposable Syringes in that they provide the following characteristics:
-Similar design -Physical characteristics are essentially the same -Material composition essentially the same -Same intended use
Summary of Testing:
| Test | Result |
|---|---|
| Water Extract Appearance | Transparent, colorless, and no |
| foreign matter | |
| Transmittance | Above 93% |
| Difference in level of pH | Lower than 2.0 |
| Heavy metals | Less than 2 PPM |
| Incompatibility between | |
| syringe and injection fluid | No change in appearance, |
| opacity, or color of syringe | |
| or fluid | |
| Quantity of silicone | |
| lubricant | 3cc-Below 8 mg/pc |
| 5cc-Below 8 mg/pc | |
| 10cc-Below 15 mg/pc | |
| Intravenous injection test | Complies with USP XXII |
| Intracutaneous | Complies with USP XXII |
| Pyrogen Test | Complies with USP XXII |
2
Summary of Safety and Effectiveness (Cont'd).
(
| Sterility Test | No microbial growth in fluid
thioglycolate medium after 7
days @ 22-25°C and soybean
casein digest medium after 7
days @ 30-32°C. |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Air leakage during
aspiration | No leakage past piston or
seal , no fall in manometer
reading. Piston not detached
from plunger. |
| Air leakage under
compression | No leakage past piston or
seal. |
| Dead space of syringe | Less than 0.075 ml. in 3cc &
5 cc. Less than 0.1 ml. in
10cc. |
| Air leak test of package
Wrapper | No bubbles within 10
seconds after pressurized @
0.07 KGF/CM2. |
| Blister Package | No air bubbles within 10
seconds after pressurized @
0.07 KGF/CM2. |
.