(69 days)
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Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a standard hypodermic needle, with no mention of AI or ML.
No.
The device is a needle used for injecting or withdrawing fluids, which are procedural actions, not therapeutic treatments in themselves.
No
Explanation: The device description states its purpose is to "inject fluids into, or withdraw fluids from parts of the body below the surface of the skin." There is no mention of analysis, measurement, or diagnosis based on the injected or withdrawn fluids, only the mechanical action of fluid transfer.
No
The device description clearly states it is a sterile Hypodermic Single Lumen Needle, which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from parts of the body below the surface of the skin." This describes a procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a "sterile Hypodermic Single Lumen Needle." This is a tool for accessing the body, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on the analysis of a sample.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for administering or withdrawing substances from the body, which falls under the category of a medical device used for treatment or procedural purposes, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
Product codes
Not Found
Device Description
TSK STERIJEKT 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The following tests were performed to show the safety and efficacy of the device.
TEST: Protector Removal; RESULT: Meets Specification
TEST: Needle Bond Strength; RESULT: Meets Specification
TEST: Sensitization; RESULT: Pass
TEST: Intracutaneous; RESULT: Pass
TEST: Hemolysis; RESULT: Pass
TEST: Systemic Toxicity; RESULT: Pass
TEST: LAL Pyrogen Test; RESULT: Pass
TEST: Cytotoxicity; RESULT: Pass
Key Metrics
Not Found
Predicate Device(s)
Becton Dickinson & Company, 'B-D PrecisionGlide' needles
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).
0
Altachment VII
510 (k) S U M M A R Y
| 影
家 | 中国 | 福德 | 福德
్యాంగ్రెస్
TSK STERIJEKT Premium Disposable Hypodermic Needle
| Manufacturer: | Tochigi Seiko KK
2-1-5 Hirayanagi-cho
Tochigi-shi, Tochigi Ken 328
Japan | Telephone:
Fax: | +81 282 27 8426
+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:
Fax: | +81 282 27 8426
+81 282 27 1943 |
| Date Summary Prepared: January 10, 1997 | | | |
| Device Trade Name:
Common Name:
Classification Name: | TSK STERIJEKT Premium Disposable Hypodermic Needle
Hypodermic Needle
Hypodermic Single Lumen Needle (per 21CFR 880.5570) | | |
| Predicate Device: | Becton Dickinson & Company, 'B-D PrecisionGlide' needles | | |
| Description of Device: | TSK STERIJEKT 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
Protector Removal
Needle Bond Strength
Sensitization
Intracutaneous
Hemolysis
Systemic Toxicity
LAL Pyrogen Test
Cytotoxicity | RESULT
Meets Specification
Meets Specification
Pass
Pass
Pass
Pass
Pass
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.