JIERUI SYRINGES AND NEEDLES

K072739 · Shandong Weigao Group Medical Polymer Co., Ltd. · MEG · Mar 21, 2008 · General Hospital

Device Facts

• Record ID: K072739
• Device Name: JIERUI SYRINGES AND NEEDLES
• Applicant: Shandong Weigao Group Medical Polymer Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Mar 21, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterile Hypodermic Syringe for Single Use With/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. The Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contaminated needle and aid in the prevention of accidental needle stick injuries. The sterile Insulin Syringe for single use with fixed needle is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Device Story

Manual syringes and hypodermic needles for fluid injection or aspiration. Includes standard piston syringes, retractable auto-disable safety syringes, and insulin syringes with fixed needles. Operated by clinicians or patients for insulin delivery. Retractable models feature a safety mechanism to retract the needle into the barrel post-injection to prevent needle stick injuries. Devices are single-use, sterile, and disposable. Output is the delivery or withdrawal of fluids. Benefits include accurate dosing and reduced risk of accidental injury via safety features.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1:2003(E), including cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and haemo-compatibility. All results met standard requirements.

Technological Characteristics

Materials: Polypropylene (PP) for syringes, stainless steel for needles. Luer slip and Luer lock nozzle configurations. Sizes: 0.5ml to 100ml syringes; 16G to 29G needles. Sterilization: Not specified. Energy source: Manual. Connectivity: None.

Indications for Use

Indicated for medical professionals to inject or withdraw fluids from the body, including insulin administration for diabetic patients. No specific age or gender restrictions provided.

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

• Welmed Hypodermic Syringe (K070936)
• TERUMO 31G ThinPro Insulin Syringe (K071630)
• Safety Syringe (K053519)
• BD Hypoint (K070440)

Submission Summary (Full Text)

{0}------------------------------------------------

K072739
l of 5

# 510(k) Summary

## MAR 2 1 2008

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is

## 1. Applicant Device Information

Trade/Proprietary Name: Jierui Syringes and Needle

#### Classification Information:

- a. Sterile Hypodermic Syringe for single use, with/without needle
- (1) Classification Name: Syringe, Piston
- (2) Regulation Number: 880.5860
- (3) Product Code: FMF
- (4) Class: II
- (5) Review Panel: General Hospital

b. Retractable Auto-Disable Syringe for single use, with/without needle

- (1) Classification Name: Syringe, Antistick
- (2) Regulation Number: 880.5860
- (3) Product Code: MEG
- (4) Class: II
- (5) Review Panel: General Hospital

c. Sterile Insulin Syringe for single use, with fixed needle

(1) Classification Name: Syringe, Piston

- (2) Regulation Number: 880.5860
- (3) Product Code: FMF
- (4) Class: II
- (5) Review Panel: General Hospital

d. Sterile Hypodermic Needle for single use

- (1) Classification Name: Needle, Hypodermic, Single Lumen
- (2) Regulation Number: 880.5570
- (3) Product Code: FMI
- (4) Class: II
- (5) Review Panel: General Hospital

{1}------------------------------------------------

K07739

2 of 5

## 2. Submitter Information

#### Manufacturer Name:

ShanDong WeiGao Group Medical Polymer Products Co., LTD No.312, Shichang Road Weihai, Shandong, China, 264209

#### Contact Person of the Submission:

Ms. Diana. Hong

Mr. Eric. Chen

Suite 8D, Zhongxin Zhongshan Mansion,

No. 19, Lane 999, Zhongshan No.2 Road(S)

Shanghai, China 20030

Phone: [phone] x 152

Fax: [phone] x 809

- Email: [e-mail] [e-mail]
## 3. Predicate Device

#### a. K number: K070936

Trade Name: Welmed Hypodermic Syringe (various sizes) Common Name: Syringes, Hypodermic Classification Name: Piston Syringe Product Code: FMF

#### b. K number: K071630

Trade Name: TERUMO 31G ThinPro Insulin Syringe Classification Name: Piston syringe with fixed hypodermic single lumen needle Product Code: FMF

#### c. K number: K053519

Trade Name: Safety Syringe Common Name: Syringe Classification Name: Syringe, Antistick Product Code: MEG

#### d. K number: K070440

Trade Name: BD Hypoint Common Name: Hypodermic Needle Classification Name: Single Lumen Hypodermic Needle Product Code: FMI

{2}------------------------------------------------

Premarket Notification 510(k) Submission—510(k) Summar
Report No.: A20071005

# Device Descriptio 4.

| Device Name | Intended Use | Nozzel | Volume | Material | Remark |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|---------------------------------------------------------|--------------------|---------------------------|
| Sterile Hypodermic<br>Syringe for single use | The Sterile Hypodermic Syringe for Single Use<br>With/without needle is intended to be used for medical<br>purposes to inject fluid into or withdraw fluid from<br>body. | Luer Slip | 1,2,3,5,10,20,30,50,100<br>(ml) | PP | With or Without<br>Needle |
| Sterile Insulin<br>Syringe for single use | The sterile Insulin Syringe for single use with needle is<br>a device intended for medical purposes for the manual<br>aspiration of insulin, and for the injection of insulin into<br>parts of the body below the surface skin. | Fixed | 0.5,1<br>(ml) | PP | With Fixed Needle |
| Retractable<br>Auto-Disable Syringe<br>for single use | The Retractable Auto-Disable Syringe for single use<br>with/without needle is intended to be used for medical<br>purposes to inject fluid into or withdraw fluid from<br>body. Its secondary intended use is to retract inside the<br>safety barrel, contain the contaminated needle and aid in<br>the prevention of accidental needle stick injuries. | Luer Lock | 3,5,10<br>(ml) | PP | With or Without<br>Needle |
| Sterile Hypodermic<br>Needle for single use | The Sterile Hypodermic Needle for single use is<br>intended for use with syringes and injection devices for<br>general purpose fluid injection/aspiration | Luer Slip<br>Luer Lock | 16G,18G,19G,20G,<br>21G,22G,23G,24G,<br>25G,26G,27G,29G | Stainless<br>Steel | |

K072739

3 of 5

3

{3}------------------------------------------------

| Premarket Notification 510(k) Submission—510(k) Summary<br>Report No.: A20071005 | 4 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|
| <b>5. Substantially Equivalence Determination</b> | |
| Comparison Analysis:<br>The Applicant device has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical<br>specifications and similar physical and mechanical specifications with the predicate device. The only difference between applicant device and predicate<br>device is some physical specifications variant which is too slight to influence the effectiveness and safety. | |
| Conclusion:<br>The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety. | |
| Shanghai Midlink Business Consulting Co.,Ltd | |

{4}------------------------------------------------

K072733
5 of 5

## 6. Effectiveness and Safety Considerations

#### Effectiveness:

All the variant models of the applicant device are evaluated regarding the performance.

#### Safety Considerations:

With accordance with the Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility.

Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness,

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAR 2 1 2008

ShanDong WeiGao Group Medical Polymer Products Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19, Lane 999 Zhongshan No. 2 Road (S) Shanghai 200030 CHINA

Re: K072739

Trade/Device Name: Sterile Hypodermic Syringe for Single Use With/Without Needle Retractable Auto-Disable Syringe for Single Use With/Without Needle Sterile Insulin Syringe for Single Use With Fixed Needle Sterile Hypodermic Needle for Single Use

Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, MEG, FMI Dated: March 11, 2008 Received: March 11, 2008

Dear Ms. Hong:

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.

{6}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Senate Y. Michael Yeds.
Chia-Lin Pi, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{7}------------------------------------------------

510(k) Number: ___ K072739 ___________________________________________________________________________________________________________________________________________________

Device Name: Sterile Hypodermic Syringe for Single Use With/without need le

Indications for Use:

The Sterile Hypodermic Syringe for Single Use With/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Prescription Use _ √ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Anestheslology, General Hospital Infection Control, Dental Devices

Page

510(k) Number: _ K472739

{8}------------------------------------------------

510(k) Number:

Device Name: Retractable Auto-Disable Syringe for single use With/without needle

Indications for Use:

The Retractable Auto-Disable Syringe for single use with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body. Its secondary intended use is to retract inside the safety barrel, contaminated needle and aid in the prevention of accidental needle stick injuries.

Prescription Use _ √ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinta Veres

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 2_of 4

510(k) Number: __ Kyn 2039

2

{9}------------------------------------------------

510(k) Number: K072739

Device Name: Sterile Insulin Syringe for single use with fixed needle

Indications for Use:

The sterile Insulin Syringe for single use with fixed needle is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Camen ha

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 3_ of __ 4

510(k) Number: Kyn2739 -----

:

{10}------------------------------------------------

510(k) Number: K072739

Device Name: Sterile Hypodermic Needle for single use

Indications for Use:

The Sterile Hypodernic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton vr. my

Page _4_ of __ 4

4

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: __ K472734