U&U STERILE HYPODERMIC NEEDLE

K132552 · U&U Medical Technology Co, Ltd. · FMI · Nov 13, 2013 · General Hospital

Device Facts

• Record ID: K132552
• Device Name: U&U STERILE HYPODERMIC NEEDLE
• Applicant: U&U Medical Technology Co, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Nov 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

U&U Sterile Hypodermic Needles is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.

Device Story

The U&U Sterile Hypodermic Needle is a single-lumen, disposable device designed for fluid injection or aspiration when attached to a syringe. It consists of a stainless steel needle with a bevel tip, a polypropylene (PP) hub, and a PP needle cover. The device is lubricated with silicone oil and assembled using UV glue. It is sterilized via EtO gas. The needle is available in various gauge sizes (16G to 30G) and lengths. It is intended for use by healthcare professionals in clinical settings. The device functions as a standard conduit for fluid transfer between a syringe and a patient. By providing a sterile, sharp interface, it facilitates the delivery of medications or the withdrawal of bodily fluids, aiding in diagnostic or therapeutic clinical decision-making.

Clinical Evidence

Bench testing only. The device conforms to ISO 7864 for performance and ISO 10993 for biocompatibility. No clinical data was required or provided.

Technological Characteristics

Single-lumen hypodermic needle; stainless steel needle; polypropylene (PP) hub; PP needle cover; silicone oil lubricant; UV glue adhesive; bevel tip configuration. Sterilized by EtO gas. Conforms to ISO 7864 (performance) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for use with syringes and injection devices for general purpose fluid injection or aspiration in patients requiring such procedures.

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

• BD Hypoint™ Hypodermic Needle (K070440)

Submission Summary (Full Text)

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KI32 SS2

610(k) Submission

U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medica! Technology Co., Limited RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG

..

(U&U Hypodermic Needle)

Rev 0.00 12/08/13

# Section_005 510(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: 12, 08,2013

# 1. Submitter Name and Address:

| Owner Name: | U&U Medical Technology Co., Ltd |
|-----------------|-------------------------------------------------------------|
| Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China |
| | RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN |
| | HONG KONG |
| Contactor Name: | Xuebo Wang |
| TEL: | [phone] |
| E-mail: | [e-mail] |

Contract Manufacturer Name; ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD. Address: No 20 south renhe road tianchang, CHINA 239300 Web: www.tkmedical.com

#### US Agent:

| US Agent: | Pan Angels Corp. |
|------------------|-------------------------------------------------|
| Address: | 3330 Fowler Street, Los Angeles, CA 90063,U.S.A |
| TEL: | [phone] |
| Contact person : | Mr. Michael Kim |

# 2. Submission Devices Information:

NOV 1 3 2013

Trade/Proprietary Name: U&U Sterile Hypodermic Needle Common Name: Hypodermic Needle Classification name: Hypodermic Needle. Class: 2. Panel: 80. Product codes: FMI - Hypodermic Single Lumen Needle Submission Type; 510(k) Regulation Number: 880 5570

# 3. Predicate Devices Information:

Hypodermic Needle: BD Hypoint™ Hypodermic Needle. Trade Name: K070440 510(K) Number:

# 4. Devices Description:

# U&U Sterile Hypodermic Needle

The U&U Sterile Hypodermic Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The U&U Sterile Hypodernic Needle are offered in various gauge sizes and needle lengths. The U&U Sterlie

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510(k) Submission

U&U Medical Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China U&U (HONGKONG) Medical Technology Co., Limited RM C1-D BIF WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG [U&U Hypodermic Needle]

Rev 0.00 12/08/13

Hypodermic Needle is sterilized by EtO gas. The U&U Sterile Hypodermic Needle is Non-Pyrogenic, disposable and intended for single use.

| Ref<br>Number | Model<br>Number | Description | Length | Gauge |
|---------------|-----------------|---------------------------------|-------------|-------|
| TKHN_001 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 30G |
| TKHN_002 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 29G |
| TKHN_003 | TKHN | Hypodermic Needle Normal-walled | 1/2 to 1" | 28G |
| TKHN_004 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 27G |
| TKHN_005 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 26G |
| TKHN_006 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 25G |
| TKHN_007 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 24G |
| TKHN_008 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 23G |
| TKHN_009 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 22G |
| TKHN_010 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 21G |
| TKHN_011 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 20G |
| TKHN_012 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 19G |
| TKHN_013 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 18G |
| TKHN_014 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 17G |
| TKHN_015 | TKHN | Hypodermic Needle Normal-walled | 1 to 1 1/2" | 16G |

#### 5. Intended Use:

U&U Sterile Hypodernic Needle Is intended for use with syringes and Injection devices for general purpose fluid injection/aspiration.

#### 6. Technological Characteristics:

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Through compansons between the submitted 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>K110771 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | U&U Sterile Hypodermic Needle is<br>intended for use with syringes and<br>injection devices for general<br>purpose fluid injection/aspiration | The BD HypointTM 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 |
| Adhesive | UV Glue | Epoxy Resin |
| Needle Hub Colors | Various Colors | Various Colors |
| Tip configuration | Bevel | Bevel |
| Materials | | |
| Needle Hub | PP | PP |
| Needle | Stainless Steel | Stainless Steel |
| Needle Cover | PP | PE |
| Performances | Conforms to ISO7864 | Conforms to ISO7864 |
| Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 |
| Labeling | Meet the requirements of 21 CFR | Meet the requirements of 21 |

· 000017

[PMN-510(K) SUBMISSION]

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| U&U Medical Technology Co., Ltd | 510(k) Submission |
|-----------------------------------------------------------------------|------------------------|
| Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China | |
| U&U (HONGKONG) Medical Technology Co., Limited | |
| RM C1-D 6/F WING HING IND BLDG 14 HING YIP ST KWUN TONG KLN HONG KONG | |
| [U&U Hypodermic Needle] | Rev 0.00      12/08/13 |

| Part 801 | CFR Part 801 |
|----------|--------------|
|----------|--------------|

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………

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# 7. Conclusion:

The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent.

END

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# · 000018

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

ood and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

# November 13, 2013

U&U Medical Technology Company, Limited Mr. Xuebo Wang Dongzhou Village, Hengshanqiao, Changzhou, Jiangsu, China RM C1-D 6/F Wing Hing Industrial 14 Hing Yip Street Kwun Tong KIn HONG KONG

Re: K132552

Trade/Device Name: U&U Sterile Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Il Product Code: FMI Dated: August 12, 2013 Received: August 13, 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 10 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

MarylFDAer-S

Kwame Ulmer 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) K132552

Device Name U&U Sterile Hypodermic Needles

Indications for Use (Describe)

U&U Sterile Hypodermic Needles is intended for use with syringes and injection devices for general purpose fluid injection/ aspiration.

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)

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.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Richard C. Chapman 2013.11.13 13:26:42 -05'00'

FORM FDA 3881 (9/13)