SHIFA STERILE DISPOSABLE SYRINGES

K962614 · International Regulatory Consultants · FMF · Sep 6, 1996 · General Hospital

Device Facts

• Record ID: K962614
• Device Name: SHIFA STERILE DISPOSABLE SYRINGES
• Applicant: International Regulatory Consultants
• Product Code: FMF · General Hospital
• Decision Date: Sep 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Shifa Syringes are intended for injection of hypodermic medication.

Device Story

Shifa Syringes are sterile, disposable piston syringes used for hypodermic medication injection. Device consists of polypropylene barrel and plunger, natural rubber gasket, and stainless steel needle (optional). Available with luer-lock or slip-lock nozzle. Operated by clinicians or patients to draw and deliver liquid medication. Provides standard manual fluid delivery mechanism.

Clinical Evidence

Bench testing only. Testing included water extract appearance, transmittance, pH levels, heavy metals, fluid incompatibility, silicone lubricant quantity, USP XXII intravenous injection, intracutaneous, and pyrogen tests. Additional performance testing included sterility, air leakage (aspiration and compression), dead space, and package integrity (air leak and blister package tests).

Technological Characteristics

Materials: Polypropylene (barrel/plunger), natural rubber (gasket), stainless steel (needle). Design: Piston syringe with luer-lock or slip-lock nozzle. Sterilization: Sterile disposable. No software or electronic components.

Indications for Use

Indicated for the injection of hypodermic medication in patients requiring parenteral administration.

Regulatory Classification

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.

Predicate Devices

• Mediplas Marketing SDN BHD MDP Disposable Syringes
• Becton Dickinson Brand Disposable Syringes

Submission Summary (Full Text)

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SEP - 6 1996
K962614

# XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

## 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: | [phone] |
| Fax: | [phone] |
| 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 hypodermic medication. |

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# 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 |

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# 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. |