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The Sterile Hypodermic Syringe for Single Use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

1 ml Sterile Hypodermic Syringe is 3-piece design. These 3 pieces are piston, plunger and barrel. The piston is made from isoprene rubber. Barrel is made from polypropylene. Plunger is made from polypropylene and polyethylene combination. Needle is made from stainless steel 304 grade and hub of needle is made from polypropylene. There are with or without needle configurations within this Special 510k submission. There are luer and luer-lock configurations within this special 510k submission. This special 510k submission only covers the 1ml syringe but several needle dimensions including 21Gx5/8", 23Gx1", and 25Gx1". The barrel marking scale interval is 0.1 ml and legible for all configurations covered by this Special 510k submission. Luer and Luer-lock have a 6% conical design. The barrel is transparent. The length (without needle), outside diameter are 99.30/100.2mm, 6.9/6.75 and 4.70/4.70, respectively for luer and luer-lock configurations. Intended users are medical professionals and trained caregivers. It is prescription use only.

It is EtO sterile and a single use device. Packaging combination is maintained from a transparent sterilization film and Tyvek paper appropriate to EtO sterilization.

The plunger of syringe can be pulled and pushed along inside the barrel, allowing the syringe to take in and expel the fluids through the connector to the patient.

The products covered in this special 510k are in compliance with ISO 10993-1 and ISO 7886-1.

This is a 510(k) premarket notification for a medical device (Sterile Hypodermic Syringe for Single Use) and not a study on an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML, expert adjudication, MRMC studies, standalone performance, ground truth establishment, and training set details are not applicable as they relate to AI/ML device evaluations.

The document indicates that the device's performance was evaluated against recognized international standards. It states that the device complies with:

• ISO 7886-1: Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
• ISO 7864: Sterile hypodermic needles for single use — Requirements and test methods
• ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
• ISO 10993-4: Biological Evaluation of Medical Devices — Part 4: Selection of Tests for Interactions with Blood
• ISO 10993-5: Biological Evaluation of Medical Devices — Part 5: Tests for In Vitro Cytotoxicity
• ISO 10993-10: Biological Evaluation of Medical Devices — Part 10: Tests for Irritation and Skin Sensitization
• ISO 10993-11: Biological Evaluation of Medical Devices — Part 11: Tests for Systemic Toxicity

The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K201284) by adding a new size (1ml syringe). The conclusion states that the differences do not raise new questions of safety or effectiveness because the modified devices were tested in accordance with ISO 7886-1.

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