SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE

K111841 · Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd. · FMF · Mar 1, 2012 · General Hospital

Device Facts

• Record ID: K111841
• Device Name: SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE
• Applicant: Chengdu Xinjin Shifeng Med Appratus Inst Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Mar 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.

Device Story

Manual piston syringe consisting of calibrated hollow barrel, movable plunger, and piston; optionally includes hypodermic needle. Operates by manual push/pull of plunger to inject or withdraw fluids. Used in clinical settings by healthcare professionals for subcutaneous, intramuscular, or intravenous access. Benefits patient by enabling controlled fluid delivery or aspiration. Device is sterile, single-use, and disposable.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 7886-1:1993/Cor. 1:1995, covering cleanliness, acidity/alkalinity, extractable metals, lubricant, scale accuracy, dimensions, design, fit, conical fitting, dead space, and leakage. Biocompatibility testing performed per ISO 10993. Sterilization validated per ISO 11135-1:2007.

Technological Characteristics

Manual piston syringe. Materials: Polypropylene barrel (K4912) and plunger (V30G), polydimethylsiloxane lubricant (HC-SS36), synthetic rubber piston (SK1). Needle: Shangdong Qiaopai (K073705). Sizes: 1ml to 10ml. Luer slip tip. Sterilization: Ethylene Oxide (EtO) per ISO 11135. Complies with ISO 7886-1 for design and performance.

Indications for Use

Indicated for injection of fluids into or withdrawal of fluids from the body below the skin surface. Suitable for human skin, muscle, and intravenous use.

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

• IMC Piston syringe with Hypodermic Lumen Needle (K102969)

Reference Devices

• Shangdong Qiaopai needle (510(K) 073705)

Submission Summary (Full Text)

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Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product:

No.46, 7ª group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address: [phone], Fax: [phone], Email: xjshifeng2011(@163.com Tel:

MAR - 1 2012

#### 240 (K) Summary

#### Device Name

Proprietary Name:

Shifeng Disposable Syringe with or without needle

Classification Name:

Piston Syringe 21 CFR, Section 880.5860 21 CFR, Section 880.5570 Classification: Class II

Common Name;

Piston Syringe with or without needle

#### Intended Use

The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.

#### Device Description

The ShiFeng Disposable Syringe is a sterile, single use device consisting of a needle attached to a syringe. The ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to the IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969. (Refer to Pic 1)

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Company: Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Shifeng Piston Syringe with or without needle Product: Address: No.46; 740 group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China [phone], Fax: [phone], Email: [e-mail] Tel:

The device consists of a metal tube that is sharpened at one end and the end joined to a female connector (hub) designated to mate with a male connector ( nozzle ) of a piston syringe consisting of a calibrated hollow barrel and a movable plunger

XinJin Shifeng buy the Shangdong Qiaopai needle (510(K) 073705) and do the assembly with the syringe together.

Image /page/1/Figure/3 description: The image shows a diagram of a syringe with labels. The syringe consists of four parts: needle, piston, plunger, and barrel. The needle is labeled as "1. Needle", the piston is labeled as "2. Piston", the plunger is labeled as "3. Plunger", and the barrel is labeled as "4. Barrel".

Pic 1

#### Predicate Device Name and 510(K) No. :

IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969

#### Substantial Equivalence

The ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969.

### Principle of Operation/Technology

Both devices are operated manually

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Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product: No.46, 7ª group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address: [phone], Fax: [phone], Email: [e-mail] Tel:

### Materials

The materials used in the ShiFeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China are same as the predicate devices, which do not raise any new issues of safety or effectives.

| Parts | Material | Specification |
|--------------------------|----------------------------------------------|----------------------------------------------|
| Barrel | Polypropylene | K4912 |
| Plunger | Polypropylene | V30G |
| Lubricant | Polydimethysiloxane | HC-SS36 |
| Piston | Synthetic rubber | SK1 |
| Primary Package Material | Medical rubberizing Dialysis paper<br>and PE | 65g/m² Medical rubberizing<br>Dialysis paper |
| Needle | Qiaopai needle ( 510(K) 073705) | |

#### Specifications

| Syringe | Needle |
|------------------------|------------------------|
| 1ml Luer Slip_sterile | 0.45 (26G) |
| 2ml Luer Slip_sterile | 0.50 (25G) |
| 3ml Luer Slip_sterile | 0.60 (23G) |
| 5ml Luer slip_sterile | 0.60 (23G) , 0.7 (22G) |
| 10ml Luer Slip_sterile | 0.90 (20G), 1.2 (18G) |

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| Company: | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. |
|----------|------------------------------------------------------------------------------------------|
| Product: | Shifeng Piston Syringe with or without needle |
| Address: | No.46, 7th group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China |
| Tel: | [phone], Fax: [phone], Email: [e-mail] |

# Performance

The following tests were performed on the Shifeng Disposable Syringe manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd, China in accordance with ISO 7886-1:1993/Cor. 1: 1995:

| ISO Clause No. | Test Items |
|----------------|--------------------------------------------------|
| 5 | Cleanliness |
| 6 | Limits for acidity or alkalinity |
| 7 | Limits for extractable metals |
| 8 | Lubricant |
| 9 | Tolerance on graduated capacity |
| 10.1 | Scale |
| 10.2 | Numbering of scale |
| 10.3 | Overall length of scale to nominal capacity line |
| 10.4 | Position of scale |
| 11.1 | Dimensions |
| 11.2 | Finger grips |
| 12.1 | Design |
| 12.2 | Fit of piston in barrel |
| 12.3 | Fiducial line |
| 13.1 | Conical fitting |
| 13.1 | Conical fitting |
| 13.2 | Position of nozzle on end of barrel |
| 13.2 | Position of nozzle on end of barrel |
| 13.3 | Nozzle lumen |
| 14.1 | Dead space |
| 14.2 | Freedom from air and liquid leakage past piston |
| 14.2 | Freedom from air and liquid leakage past piston |
| 15.1 | Primary container |
| 15.2 | Secondary container |
| 16.1 | Primary container |
| 16.2 | Secondary container |
| 16.3 | Storage container |
| 16.4 | Transport wrapping |

.

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| Company: | Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. |
|----------|------------------------------------------------------------------------------------------|
| Product: | Shifeng Piston Syringe with or without needle |
| Address: | No.46, 7th group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China |
| Tel: | [phone], Fax: [phone], Email: [e-mail] |

None of the data raises any new issues of safety and effectiveness.

The Shifeng Disposable Syringe with or without needle manufactured by Chengdu Xinjin Shifeng Medical Apparatus & Instruments Co., Ltd., China is substantially equivalent to IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969.

### Comparison table:

The Shifeng Disposable syringe with or without needle manufactured by XinJin Shifeng in Sichuang, China is substantially equivalent to the IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969.

| Element of Comparison | Subject Device | Claimed SE Device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Syringe Type | Piston Syringe<br>Classification II, FMF | Same |
| Intended Use (s) | are intended to be used to inject<br>fluid into or withdraw fluids from,<br>the body. | Same |
| Principle of Operation | The operation principle is<br>pushing or pulling the plunger to<br>inject fluid into or withdraw fluids<br>from the body, suitable for<br>human skin, muscle,<br>intravenous injection, etc | Same |
| Specific Drug Use | NO | Same |
| Length | Various sizes complying with<br>ISO 7886-1, 11.1 | Same |
| Barrel Diameter | 1ml: 4.65-4.70mm<br>2ml: 8.85-8.90mm<br>3ml: 9.00-9.05mm<br>5ml: 12.40-12.45mm<br>10ml: 14.95-15.00mm | Similar |
| Tip Type | Centric | Same |
| Volume | Size various from 1ml to 10 ml | Same |
| Nozzle Type | Slip tip | Same |
| Barrel Marking Specs | Complying with ISO7886-1 | Same |
| Gradations legibility | Legible | Same |
| Lubricant amount / cm2 | Not exceed 0.25mg | Same |
| Barrel Transparency | Transparent | Same |

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Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Product: Shifeng Piston Syringe with or without needle

No.46, 7ª group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address:

Tel:

[phone], Fax: [phone], Email: xjshifeng2011(@163.com

| Delivery Accuracy | Complying with ISO 7886-1,<br>10.1 ~10.4 | Same |
|-----------------------|-------------------------------------------|---------------------------------------------|
| Reuse Durability | Not applicable, single use<br>device | Same |
| Biocompatibility | Complying with ISO 10993 | Same |
| Materials | | |
| • Lubricant | Polydimethylsiloxane | Similar<br>See Section VIII, A.1,<br>page 5 |
| • Barrel | Polypropylene | Same |
| • Plunger | Polypropylene | Same |
| • Piston | Synthetic rubber | Similar<br>See Section VIII, A.2,<br>page 9 |
| Labeling | Complying with ISO7886-1:<br>1993 | Same |
| Sterilization | ETO, ISO 11135 compliance | Same |
| Needle & Needle Cover | Shangdong Qiaopai needle<br>510(K) 073705 | Similar |

#### Additional Safety Information

The sterilization conditions are validated according to ISO 11135-1:2007 to provide a Sterility Assurance Level (SAL) of 10-8.

Ethylene Oxide residual levels after 7 days aeration resulting from EtO sterilization will not exceed the maximum daily dose levels proposed 10993-7:2008 and indicated as follows:

| Ethylene Oxide | 1.501ug/device (Lot. 20100301) |
|----------------|--------------------------------|
| | 10.9ug/device (Lot. 20110926) |
| ECH | 10.9ug/device (Lot. 20110926) |

The device's materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #g95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation

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Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product:

No.46, 70 group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address:

Tel:

[phone], Fax: [phone], Email: xjshifeng2011(@163.com

and Testing. Results of the testing demonstrate that the blood contacting materials are biocompatible.

### Conclusion

The Shifeng Disposable Syringe with or without needle manufactured by XinJin Shifeng in Sichuang, China is substantially to the Disposable Hypodermic Syringe manufactured by IMC Piston syringe with Hypodermic Lumen Needle manufactured by IMC and cleared under K102969 with respect to intended use, design, technology/principles of operation, materials and performance. Differences between the devices do not raise any new issues of safety or effectiveness.

Date Prepared:

2011-11-15

Prepared by:

Name: Position: Tel: Fax: E-mail:

Mr. Xinglong Tian QA & RA Vice President [phone] [phone] [e-mail]

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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is in all caps. To the left of the text is a symbol that appears to be three lines that are curved.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Document Control Room -WO
- 1 2012 Silver Spring, MD 20993-0002

Mr. Xinglong Tian Ouality Assurance & Regulatory Affairs Vice President Chengdu Xinjin Shifeng Medical Apparatus & Instrument Company, Limited No.46, 7th Group Wanjie Village, Xinping Town Xinjin County Chengdu City P.R. CHINA

Re: K111841

Trade/Device Name: Shifeng Disposable Syringe with or without Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF / FMI Dated: February 16, 2012 Received: February 16, 2012

Dear Mr. Tian:

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. Tian

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/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,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Company: Shifeng Piston Syringe with or without needle Product:

No.46, 7th group, Wanjie Village, Xinping town, Xinjin County, Chengdu City, P. R. China Address:

Tel:

[phone], Fax: [phone], Email: [e-mail]

510(k) Number (if known): K111841

Shifeng Disposable Syringe with or without needle Device Name:

Indications for Use:

The Shifeng Disposable Syringe with or without needle are intended to be used to inject fluid into, or withdraw fluids from, part of the body below the surface of the skin.

# (PLRASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109vision Sign-Off)
OR
Over-The-Counter Use
3/1/12

(Per 21 CFR 807.19)Vision Sign-On

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

(Optional Format 1-2-96)

510(k) Number. K111841

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