STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE

K090929 · Shanghai Double Dove Industrial Co., Ltd. · FMF · Jun 12, 2009 · General Hospital

Device Facts

• Record ID: K090929
• Device Name: STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE
• Applicant: Shanghai Double Dove Industrial Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jun 12, 2009
• 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 is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical. The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection 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

Double-Dove sterile syringes and needles are manual, single-use medical devices. Syringes consist of a piston-driven barrel (polypropylene) for fluid aspiration and injection; needles (stainless steel) attach via Luer slip or Luer lock mechanisms, or are fixed to the insulin syringe. Operated by clinicians or patients (for insulin) in clinical or home settings. Devices function mechanically to deliver or collect fluids. No electronic or software components. Benefit includes sterile, single-use delivery of medication or fluid sampling.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Medical grade polypropylene (syringes), stainless steel (needles). Energy source: Manual/mechanical. Form factor: Various volumes (0.3ml to 50ml) and needle gauges. Connectivity: None. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring fluid administration, fluid sampling, or insulin injection. Insulin syringes are for subcutaneous insulin delivery. Hypodermic needles are for general fluid injection or aspiration. 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

• Becton Dickinson Single Use Hypodermic Syringes (K980987)
• TERUMO 31G ThinPro Insulin Syringe (K071630)
• BD Hypoint (K070440)

Submission Summary (Full Text)

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## JUN 1 2 2009 Chapter III 510(k) Summary

(As required by 21 CFR 807.92)

The assigned 510(k) Number is:

- 1. Date Prepared: March 17, 2009
- 2. Sponsor Information

Shanghai Double-Dove Industry Co.,Ltd

No.1888 Huhang Road FengXian Economic Zone Shanghai, 201400, China

Contact Person: Mr. Sanba Yang, Quality Manager Tel: [phone] Fax: [phone] E-Mail: [e-mail]

### 3. Submission Correspondent

Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China

4. Device Name and Classification:

a. Sterile Hypodermic Syringe for single use

(1) Classification Name: Syringe, Piston

(2) Regulation Number: 880.5860

- (3) Product Code: FMF
- (4) Class: II

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Kogor29

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b. 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

c. 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

#### 5. Predicate Device Identification:

#### a. K number: K980987

Trade Name: Becton Dickinson Single Use Hypodermic Syringes

b. K number: K071630 Trade Name: TERUMO 31G ThinPro Insulin Syringe

c. K number: K070440 Trade Name: BD Hypoint

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| | Device Name | Intended Use | Nozzel | Volume | Material | Remark |
|--|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------------------------|
| | Sterile Hypodermic<br>Syringe for single use | The Sterile Hypodermic Syringe for Single<br>Use is intended for dispensing/<br>administering fluids, and collecting/<br>sampling of fluid in medical practice. Their<br>function is mechanical. | Luer Slip<br>Luer Lock | 1ml、3ml、5ml、10ml、20ml、<br>30ml、50ml | Medical Grade<br>Polypropylene | With or Without Needle |
| | Sterile Insulin<br>Syringe for single<br>use, with fixed needle | The sterile Insulin Syringe for single use<br>with fixed needle is a device intended for<br>medical purposes for the manual aspiration<br>of insulin, and for the injection of insulin<br>into parts of the body below the surface<br>skin. | Fixed | 0.3ml、0.5ml、1ml | Medical Grade<br>Polypropylene | With Fixed Needle |
| | Sterile Hypodermic<br>Needle for single use | The Sterile Hypodermic Needle for single<br>use is intended for use with syringes and<br>injection devices for general purpose fluid<br>injection/aspiration | Luer Slip<br>Luer Lock | 0.3*12.7; 0.3*25; 0.33*12.7;<br>0.33*12.7; 0.33*25;<br>0.4*12.7; 0.4*25; 0.45*16;<br>0.45*25; 0.5*16; 0.5*25;<br>0.55*16; 0.55*25; 0.6*25;<br>0.6*30; 0.7*25; 0.7*32;<br>0.8*25; 0.8*38; 0.9*25;<br>0.9*38; 1.1*25; 1.1*38;<br>1.2*25; 1.2*38 | Stainless Steel | |

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K090929

III-3

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K090929

4

Premarket Notification Submission - Chapter III 510(K) Summary Report No.: A2008-034-061

### 7. Test Conclusion

Laboratory testing was conducted to validate and verify that Double-Dove Syringes and Needle met all design specifications and was substantially equivalent to the predicate device.

### 8. Substantially Equivalent Conclusion:

The subject device, Double-Dove Syringes and Needle, is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Double-Dove Industry 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 CHINA 200030

JUN 1 2 2009

Re: K090929

Trade/Device Name: Sterile Insulin Syringe for Single Sue Needle, with Fixed Needle Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 31, 2009 Received: April 2, 2009

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.

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 - Ms. Hong

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), please go to http://www.fda.gov/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Susan Roane

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection_Control_and_Dental_Devices_ Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number:

Device Name: Sterile Hypodermic Syringe for Single Use

## Indications for Use:

The Sterile Hypodermic Syringe for Single Use is intended for dispensing/ administering fluids, and collecting/ sampling of fluid in medical practice. Their function is mechanical.

Prescription Use V (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)

sta Carlsson

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

510(k) Number: K090929

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## Indication for Use

510(k) Number:

Device Name: Sterile Insulin Syringe for single sue needle, with fixed needle

Indications for Use:

The sterile Insulin Syringe for single use with fixed needle is a device is a device intended for medical purposes for the manual aspiration of insulin, and for the injection 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 V (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)

Adall
(Division Sign-on)

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

510(k) Number: K090939

Page 2 of

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## Indication for Use

510(k) Number:

Device Name: Sterile Hypodermic Needle for single use

## Indications for Use:

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

Prescription Use N (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 Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090229

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