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

K130230 · Wuxi Yushou Medical Applicances Co., Ltd. · FMF · Nov 20, 2013 · General Hospital

Device Facts

• Record ID: K130230
• Device Name: STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
• Applicant: Wuxi Yushou Medical Applicances Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Nov 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Sterile Piston Hypodermic Syringes (With/Without Needle) 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.

Device Story

Device consists of calibrated hollow barrel, movable plunger, and male Luer connector (Slip/Lock). Used for fluid injection or withdrawal. Operated by healthcare professionals in clinical settings. Syringe attaches to hypodermic single lumen needle via female Luer hub. Device is sterile, single-use, and non-pyrogenic. Benefits include precise fluid delivery or extraction. No electronic or software components.

Clinical Evidence

Bench testing only. Device performance conforms to ISO 7886-1 for syringes and ISO 7864 for needles. Biocompatibility testing conforms to ISO 10993.

Technological Characteristics

Materials: PP (barrel, hub), PE (plunger, nozzle cap, sheath), rubber (piston), stainless steel (needle). Principle: Manual piston-driven fluid displacement. Connectivity: None. Sterilization: EtO gas. Standards: ISO 7886-1, ISO 7864, ISO 10993.

Indications for Use

Indicated for use by clinicians to inject fluids into or withdraw fluids from the body. Applicable to patients requiring fluid aspiration or injection via hypodermic single lumen needle.

Regulatory Classification

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.

Predicate Devices

• BD Single Use, Hypodermic Syringe (K110771)
• BD Hypoint™ Hypodermic Needle (K070440)

Submission Summary (Full Text)

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[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,<br>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:<br>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:

1. 80.

2. 80.

[PMN-510(K) SUBMISSION]

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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<br>Number | Model<br>Number | Description | Size |
|---------------|-----------------|----------------------------------------|-------------------------------------|
| YSPS001 | YSPS | Piston syringe<br>with/without needles | 0.5cc/ml≤Capacity of Syringe<2cc/ml |
| YSPS002 | YSPS | Piston syringe<br>with/without needles | 2cc/ml≤Capacity of Syringe<5cc/ml |
| YSPS003 | YSPS | Piston syringe<br>with/without needles | 5cc/ml≤Capacity of Syringe<10cc/ml |
| YSPS004 | YSPS | Piston syringe<br>with/without needles | 10cc/ml≤Capacity of Syringe<20cc/ml |
| YSPS005 | YSPS | Piston syringe<br>with/without needles | 20cc/ml≤Capacity of Syringe<30cc/ml |
| YSPS006 | YSPS | Piston syringe<br>with/without needles | 30cc/ml≤Capacity of Syringe<50cc/ml |
| YSPS007 | YSPS | Piston syringe<br>with/without needles | 50cc/ml≤Capacity of Syringe |

#### 4.2 Hypodermic Needles.

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.

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| | | | | |
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[PMN-510(K) SUBMISSION]

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510(k) Submission (PMN2012001) Rav 1.00 17/10/13

| Number | Number | | | |
|---------|--------|---------------------------------|-------------|-----|
| YSHN001 | YSHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 30G |
| YSHN002 | YSHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 29G |
| YSHN003 | YSHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 28G |
| YSHN004 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 27G |
| YSHN005 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 26G |
| YSHN006 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 25G |
| YSHN007 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 24G |
| YSHN008 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 23G |
| YSHN009 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 22G |
| YSHN010 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 21G |
| YSHN011 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 20G |
| YSHN012 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 19G |
| YSHN013 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 18G |
| YSHN014 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 17G |
| YSHN015 | YSHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 16G |

### 5. Intended Use:

### 5.1 Sterile Piston Hypodermic Syringes (With/Without Needle).

Sterile Piston Hypodermic Syringes (With/Without Needle) 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.

#### 5.2 Hypodermic Needles.

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.

#### 6. Technological Characteristics:

Through comparisons between the applicant devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices.

## 6.1 Sterile Piston Hypodermic Syringes (With/Without Needle) Comparison Table

| Element of Comparison | Submission Device | Predicate Device<br>K110771 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Sterile Piston Hypodermic<br>Syringes (With/Without Needle) is<br>a device intended for medical<br>purposes that consists of a<br>calibrated hollow barrel and a | The BD Single Use,<br>Hypodermic Syringe is intended<br>for use by health care<br>professionals for general<br>purpose fluid aspiration/ |

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.. . . . . . .

| | movable plunger. At one end of the<br>barrel there is a male connector<br>(nozzle) for fitting the female<br>connector (hub) of a hypodermic<br>single lumen needle. The device is<br>used to inject fluids into, or<br>withdraw fluids from, the body. | injection. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Principle of Operation | Normal | Normal |
| Syringe Capacity | Various Sizes | Various Sizes |
| Nozzle Type | Luer | Luer |
| Lubricant for Barrel | Silicone Oil | Silicone Oil |
| Barrel Transparency | Transparent and Clear | Transparent and Clear |
| Gradations Legibility | Legible | Legible |
| Needle Gauge and Length | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Materials | | |
| Barrel | PP | PP |
| Plunger | PE | PE |
| Piston | Rubber | Rubber |
| Nozzle Cap | PE | PE |
| Needle Hub | PP | PP |
| Needle | Stainless Steel | Stainless Steel |
| Performances | Conforms to ISO7886-1 | Conforms to ISO7886-1 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR<br>Part 801 | Meet the requirements of 21<br>CFR Part 801 |

··············································································································································································

# 6.2 Hypodermic Needles Comparison Table

| Element of Comparison | Submission Device | Predicate Device<br>K070440 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The hypodermic needle is a device<br>intended to inject fluids into, or<br>withdraw fluids from, parts of the<br>body below the surface of the skin.<br>The device consists of a metal<br>tube that is sharpened at one end<br>and at the other end joined to a<br>female connector (hub) designed<br>to mate with a male connector<br>(nozzle) of a piston syringe. | The BD Hypoint™ Hypodermic<br>Needle is intended for use with<br>Syringes and injection devices<br>for general purpose fluid<br>aspiration/ injection. |
| Principle of Operation | Normal | Normal |
| Needle Gauge and Length | Various Sizes | Various Sizes |
| Lubricant for Needle | Silicone Oil | Silicone Oil |
| Materials | | |
| Needle Hub | PP | PP |
| Needle | Stainless Steel | Stainless Steel |
| Needle Sheath | PE | PE |
| Performances | Conforms to ISO7864 | Conforms to ISO7864 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR<br>Part 801 | Meet the requirements of 21<br>CFR Part 801 |

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

.. ...

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# 7. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent. Our device and the predicate device are same in intended use, Essential Component, Material, Sterile, Function etc.

END

02 Page 5 of 5

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2013

Wuxi Yushou Medical Appliances Company, Limited C/O Garfield Wang Regulatory Associate 215 No. Xigang Road, Dongbeitang Wuxi City Jiangsu, China 21491

Re: K130230

Trade/Device Name: Sterile Piston Hypodermic Syringes (With/Without Needle) and Hypodermic Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF/FMI Dated: October 18, 2013 Received: October 21, 2013

Dear Mr. Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame
Ulmer

for

Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K130230

#### Device Name

Sterile Piston Hypodermic Syringes (With/Without Needle)

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PSC Institutios services ( 411) 44 1 1.71.

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Contract Contract Concerner Concerner Concerner Concerner Comments of the Super Market Concern Comments of Concern Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/7/Picture/12 description: The image shows the FDA logo. The letters "FDA" are stylized with a triple-line effect, giving them a bold and somewhat retro appearance. The logo is simple and monochromatic.

Digitally signed by Richard C. Chapman Date: 2013.11.19 13:00:19 -05'00'

FORM FDA 3881 (9/13)

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.