To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
Device Story
TSK STERUEKT is a sterile, single-use hypodermic needle; consists of stainless steel beveled cannula bonded to plastic hub; compatible with standard luer lock or luer slip syringe tips. Used by clinicians for fluid injection or withdrawal from body tissues. Device provides physical conduit for fluid transfer; ensures patient safety through sterile, disposable design; prevents cross-contamination.
Clinical Evidence
Bench testing only. Results: Protector removal and needle bond strength met specifications. Biocompatibility testing passed for sensitization, intracutaneous reactivity, hemolysis, systemic toxicity, and cytotoxicity. LAL pyrogen test passed.
Indicated for patients requiring fluid injection or withdrawal via hypodermic needle; applicable for all ages and genders requiring subcutaneous, intramuscular, or intravenous access.
Regulatory Classification
Identification
A hypodermic single lumen needle is a device intended to 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 or an intravascular administration set.
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Attachment VII
510 (k) SUMMARY
K970370
TSK STERUEKT Premium Disposable Hypodermic Needle
APR 10 1997
Manufacturer: Tochigi Seiko KK
2-1-5 Hirayanagi-cho
Tochigi-shi, Tochigi Ken 328
Japan
Telephone: +81 282 27 8426
Fax: +81 282 27 1943
510 (k) submitted by: Norman Shane Johnson
Distribution Manager
TSK Laboratory, Japan
2-1-5 Hirayanagi-cho
Tochigi-shi, Tochigi Ken 328
Japan
Telephone: +81 282 27 8426
Fax: +81 282 27 1943
Date Summary Prepared: January 10, 1997
Device Trade Name: TSK STERUEKT Premium Disposable Hypodermic Needle
Common Name: Hypodermic Needle
Classification Name: Hypodermic Single Lumen Needle (per 21CFR 880.5570)
Predicate Device: Becton Dickinson & Company, 'B-D PrecisionGlide' needles
Description of Device: TSK STERUEKT is a sterile Hypodermic Single Lumen Needle, packaged individually for single patient use. It consists of a stainless steel beveled cannula bonded to a plastic hub. Sizes include 14G-31G and various lengths. The needle is intended to fit any luer lock or luer slip syringe tip.
Intended Use: To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
Safety and Efficacy: The following tests were performed to show the safety and efficacy of the device.
| TEST | RESULT |
| --- | --- |
| Protector Removal | Meets Specification |
| Needle Bond Strength | Meets Specification |
| Sensitization | Pass |
| Intracutaneous | Pass |
| Hemolysis | Pass |
| Systemic Toxicity | Pass |
| LAL Pyrogen Test | Pass |
| Cytotoxicity | Pass |
Substantial Equivalence: The TSK Premium Disposable Hypodermic Needle and the predicate device, the B-D PrecisionGlide Needle, have been shown to be substantially equivalent based on the following:
- identical intended use - disposable sterile hypodermic needle, individually packaged.
- equivalent materials - stainless steel cannula and plastic hub.
- equivalent design - metal cannula with bonded plastic hub; removable plastic protector on needle tip; sufficient physical integrity for the intended use; fits Luer Lock or Luer Slip hypodermic tips.
- similar size range - TSK 14G-31G; B-D 16G-30G.
- needle tip selection - both brands are available with several bevels.
