STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES

• K Number: K130230
• Device Name: STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
• Manufacturer: WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
• Date Cleared: 2013-11-20 ( 295 days)
• Product Code: FMF
• Regulation Number: 880.5860

Intended Use

Sterile Piston Hypodermic Syringes (With/Without Needed 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 fennector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body. The hypodermic 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.

Device Description

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber. The Hypodermic Needle is a single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection. The needle is sterilized by EtO gas. and it is a Non-Pyrogenic and single use device. The mainly raw materials are PP and stainless steel.

Predicate Devices

K110771, K070440

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for standard hypodermic syringes and needles, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No.
The device is used to inject or withdraw fluids, which are procedures rather than therapeutic actions performed by the device itself.

Diagnostic

No
The device is used to inject or withdraw fluids from the body; it does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of materials like PP, PE, rubber, and stainless steel, and describes sterilization methods, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is used to "inject fluids into, or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
• IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the body (like blood, urine, tissue) outside the body to provide information about a person's health.
• Device Description: The description focuses on the physical components and function of a syringe and needle for injecting or withdrawing substances from the body. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.

The device described is a standard medical device used for administering or collecting substances directly from a patient, which falls under the category of in vivo medical devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sterile Piston Hypodermic Syringes (With/Without Needed 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 fennector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.

Product codes

FMF, FMI

Device Description

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.

The Hypodermic Needle is a single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection. The needle is sterilized by EtO gas. and it is a Non-Pyrogenic and single use device. The mainly raw materials are PP and stainless steel.

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K110771, K070440

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

[WUXI YUSHOU MEDICAL APPLICANCES CO., LTD] (WUXI CITY, JIANGSU, CHINA] Iston Syringe With/Without Needle]

510(k) Submission [PMN2012001] Rev 1.00 17/10/13

HACHASZET 002

510(K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

Date Prepared: Oct. 17.2013

1. Submitter Name and Address:

Name:	WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
Address:	215NO. XIGANG ROAD, DONGBEITANG WUXI CITY,
JIANGSU, JIANGSU, 214191, CHINA
Contactor Name:	Garfield Wang
TEL:	[phone]
E-mail:	[e-mail]
US Agent:
Contact Name:	QIAN SHEN
Business Name:	P&L SCIENTIFIC INC.
Address:
STATES	6840 SW 45TH LN, UNIT 5 Miami, Florida, 33155, UNITED
Phone:	305-6094701
Fax:	305 -3970289
E-mail Address:	[e-mail]

2. Submission Devices Information:

NOV 20 2013

Trade/Proprietary Name:

• 1. Sterile Piston Hypodermic Syringes (With/Without Needle).
• 2. Hypodermic Needles.

Common Name:

• 1. Piston Syringe
• 2. Hypodermic Needle.

Classification name:

• 1. Piston Syringe.
• 2. Hypodermic Single Lumen Needle.

Class:

• 1. II.
• 2. II.

Panel:

[PMN-510(K) SUBMISSION]

1

510(k) Submission [PMN2012001] 17/10/13

Procodes:

• 1. FMF Piston Syringe and FMI Hypodermic Single Lumen Needle
• 2. FMI Hypodermic Single Lumen Needle

3. Predicate Devices Information:

• 1. Piston Syringe: Trade Name: BD Single Use, Hypodermic Syringe 510(K) Number: K110771 2. Hypodermic Needle: BD Hypoint™ Trade Name: 510(K) Number: K070440

4. Devices Description:

4.1 Sterile Piston Hypodermic Syringes (With/Without Needle).

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.

| Ref
Number | Model
Number | Description | Size |
|---------------|-----------------|----------------------------------------|-------------------------------------|
| YSPS001 | YSPS | Piston syringe
with/without needles | 0.5cc/ml≤Capacity of Syringe