TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE

K970370 · Tsk Laboratory, Japan · FMI · Apr 10, 1997 · General Hospital

Device Facts

• Record ID: K970370
• Device Name: TSK STERIJEKT PREMIUM DISPOSABLE HYPODERMIC NEEDLE
• Applicant: Tsk Laboratory, Japan
• Product Code: FMI · General Hospital
• Decision Date: Apr 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Technological Characteristics

Stainless steel cannula; plastic hub; luer lock/luer slip compatible; sizes 14G-31G; sterile, single-use; removable plastic protector.

Indications for Use

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.

Predicate Devices

• Becton Dickinson & Company, 'B-D PrecisionGlide' needles

Submission Summary (Full Text)

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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: [phone]
Fax: [phone]

510 (k) submitted by: Norman Shane Johnson
Distribution Manager
TSK Laboratory, Japan
2-1-5 Hirayanagi-cho
Tochigi-shi, Tochigi Ken 328
Japan
Telephone: [phone]
Fax: [phone]

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.