SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE

K130212 · Wuxi Yushou Medical Applicances Co., Ltd. · FMI · Nov 20, 2013 · General Hospital

Device Facts

• Record ID: K130212
• Device Name: SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
• Applicant: Wuxi Yushou Medical Applicances Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Nov 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Safety Hypodermic Needle (With/Without Syringe) device is intended for use in the aspiration and injection of fluids for medical purposes. The Safety Hypodermic Needle (With/Without Syringe) is compatible for use with standard luer slip and luer lock syringes.

Device Story

Device consists of hypodermic needle with hinged safety sheath attached to connector hub, optionally including hypodermic syringe. Used by medical practitioners for fluid aspiration or injection. After needle withdrawal, practitioner manually activates hinged safety sheath via finger, thumb, or surface contact to cover needle, reducing sharps injury risk. Device features locking mechanism in sheath center/proximal end; hinge allows adjustment to desired position. Compatible with standard luer slip/lock syringes. Benefits include enhanced protection against accidental needle-sticks for healthcare personnel.

Clinical Evidence

Bench testing only. Device performance verified through conformance to ISO 7864 for hypodermic needles, ISO 7886-1 for piston syringes, and ISO 10993 for biocompatibility. No clinical data provided.

Technological Characteristics

Materials: Stainless steel needle, polypropylene (PP) hub/barrel, polyethylene (PE) sheath/plunger, rubber piston. Lubricant: Silicone oil. Features: Hinged safety sheath for sharps injury prevention. Connectivity: None. Sterilization: Not specified. Standards: ISO 7864, ISO 7886-1, ISO 10993. Form factor: Various gauges (16G-30G) and lengths (0.5-1.5 inch).

Indications for Use

Indicated for aspiration and injection of fluids for medical purposes in patients requiring hypodermic delivery or withdrawal. Compatible with standard luer slip and luer lock syringes. Includes a manual safety shield to minimize risk of accidental needle-stick after withdrawal from the body.

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

• TERUMO SurGuard 3 Safety Needle (K113422)
• BD Single Use, Hypodermic Syringe (K110771)

Submission Summary (Full Text)

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## 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: Jan. 01.2013

## 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] | NOV 2 0 2013 |
| US Agent: | | |
| Contact Name: | QIAN SHEN | |
| Business Name: | P&L SCIENTIFIC INC. | |
| Address: | 6840 SW 45TH LN, UNIT 5 Miami, Florida, 33155, UNITED<br>STATES | |
| Phone: | 305-6094701 | |
| Fax: | 305 -3970289 | |
| E-mail Address: | [e-mail] | |

# 2. Submission Devices Information:

Trade/Proprietary Name: Safty Hypodermic Needles With/Without Syringe.

Common Name: Hypodermic Needle and Piston Syringe

Classification name: Hypodermic Single Lumen Needle and Piston Syringe.

Class: II and II.

Panel: 80 and 80.

Procodes: FMI - Hypodermic Single Lumen Needle and FMF - Piston Syringe and FMI - Hypodermic Single Lumen Needle

# 3. Predicate Devices Information:

Safety Hypodermic Needle With/Without Syringe. TERUMO® SurGuard®3 Safety Needle Trade Name: 510(K) Number: K113422 Trade Name: BD Single Use, Hypodermic Syringe

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510(K) Number: K110771

### 4. Devices Description:

## Safety Hypodermic Needle With/Without Syringe

The Safety Hypodermic Needle With/Without Syringe consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation.

The locking mechanisms are positioned within the center and proximal end of the Sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use.

| Ref<br>Number | Model<br>Number | Description | Length | Gauge | Syringe |
|---------------|-----------------|--------------------------|-------------|-------|-------------|
| YSSN001 | YSSN | Safety Hypodermic Needle | 1/2 to 1" | 30G | 0.5 to 10cc |
| YSSN002 | YSSN | Safety Hypodermic Needle | 1/2 to 1" | 29G | 0.5 to 10cc |
| YSSN003 | YSSN | Safety Hypodermic Needle | 1/2 to 1" | 28G | 0.5 to 10cc |
| YSSN004 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 27G | 0.5 to 10cc |
| YSSN005 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 26G | 0.5 to 10cc |
| YSSN006 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 25G | 0.5 to 10cc |
| YSSN007 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 24G | 0.5 to 10cc |
| YSSN008 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 23G | 0.5 to 10cc |
| YSSN009 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 22G | 0.5 to 10cc |
| YSSN010 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 21G | 0.5 to 10cc |
| YSSN011 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 20G | 0.5 to 10cc |
| YSSN012 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 19G | 0.5 to 10cc |
| YSSN013 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 18G | 0.5 to 10cc |
| YSSN014 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 17G | 0.5 to 10cc |
| YSSN015 | YSSN | Safety Hypodermic Needle | 1 to 1 1/2" | 16G | 0.5 to 10cc |

### 5. Intended Use:

### Safety Hypodermic Needle With/Without Syringe

The Safety Hypodermic Needle (With/Without Syringe) device is intended for use in the aspiration and injection of fluids for medical purposes. The Safety Hypodermic Needle (With/Without Syringe) is compatible for use with standard luer slip and luer lock syringes.

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Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

# 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.

| Element of Comparison | Submission Device | Predicate Device<br>K113422 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 TERUMOO SurGuard®3<br>Safety Needle device is<br>intended for use in the<br>aspiration and injection of fluids<br>for medical purposes. The<br>TERUMO SurGuard®3 Safety<br>Needle is compatible for use<br>with standard luer slip and luer<br>lock syringes.<br>Additionally, after withdrawal of<br>the needle from the body, the<br>attached needle safety<br>shield can be manually<br>activated to cover the needle<br>immediately after use to<br>minimize risk of accidental<br>needlestick. |
| 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 |
| Sharps Injury Prevention | Needle safety shield | Needle safety shield |
| Features | | |
| 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 |

# Safety Hypodermic Needle With Syringe 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 | The BD Single Use,<br>Hypodermic Syringe is intended<br>for use by health care |

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| | purposes that consists of a<br>calibrated hollow barrel and a<br>movable plunger. At one end of the<br>barrel there is a male connector<br>(nozzle) for fitting the female | professionals for general<br>purpose fluid aspiration/<br>injection. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| | connector (hub) of a hypodermic<br>single lumen needle. The device is | |
| | used to inject fluids into, or | |
| | withdraw fluids from, the body. | |
| 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 |

7. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use. The new device is safety.

Our device and the predicate device are same in intended use, Essential Component, Material, Sterile, Function etc.

END

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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: K130212

Trade/Device Name: Safety Hypodermic Needles With/Without Syringe Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodernic Single Lumen Needle Regulatory Class: II Product Code: FMI/FMF 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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Page 2 - Mr. Wang

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/CDRH/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), piease 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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for

Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device and 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) K130212

#### Device Name

Safety Hypodermic Needles With/Without Syringe

#### Indications for Use (Describe)

The Safety Hypodermic Needle With/Without Syringe device is intended for use in the aspiration of fluids for medical purposes. The Safety Hypodernic Needle With/Without Syringe is compatible for use with standard her lock syringes.

Additionally, after withdraval of the needle from the body, the attached can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

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

2017 YOU WE BE BE ME FOR FDATUSEIONLY FOR FDATUSEIONEY ME BEAT BE BEAR BEAR BEAR BEAR BEAR CONSERVED Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

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Digitally signed by Richard C. Chapman Date: 2013.11.19 12:50:38 -05:00,