Syringes, With or without Needles

K113091 · Jiangyin Caina Technology Co., Ltd. · FMF · Oct 28, 2011 · General Hospital

Device Facts

• Record ID: K113091
• Device Name: Syringes, With or without Needles
• Applicant: Jiangyin Caina Technology Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.

Device Story

Manual piston syringes and hypodermic needles; used for fluid injection or withdrawal. Syringes consist of barrel, piston, and plunger rod; needles consist of tube, hub, and sheath. Available as syringe-needle combinations, syringes alone, or needles alone. Designed for use with standard luer slip or luer lock connectors (ISO 594-1/594-2). Operated by clinicians or patients in clinical or home settings. Manual operation; no electronic or automated components. Provides physical conduit for fluid transfer; aids in medication delivery or sample collection.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against ISO 7886-1:1993 (syringes), ISO 7864:1993 (needles), ISO 9626:1991 (tubing), and ISO 594-1/2 (luer fittings).

Technological Characteristics

Manual piston syringe and hypodermic needle. Materials: Stainless steel (ISO 9626). Connectivity: Luer slip (ISO 594-1) and luer lock (ISO 594-2) compatible. Sterilization: Validated to achieve required SAL. No energy source, software, or electronic components.

Indications for Use

Indicated for patients requiring fluid injection into or withdrawal from the body via syringe and needle. No specific age or gender restrictions.

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

• Sterile Hypodermic Syringe for single use, with/without needle and Sterile Hypodermic Needle for single use (K072739)

Submission Summary (Full Text)

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# OCT 2 8 2011

1

#### 510(k) Summary Section III

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. -

The assigned 510(k) Number: _ K 11 30 91

- Date of Submission: 27 AUG 2011 . 1.
- Sponsor 2.

Jiangyin Caina Technology Co., Ltd. No.2, Taifu Road, Huashi Town, Jiangyin Jiangsu, 214421, China

Contact Person: Mr. Jun Lu Position: General Manager Tel: [phone] Fax: [phone] Email: [e-mail]

- Submission Correspondent 3. Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- Proposed Device Identification 4,

Proposed Device Name: Syringes with or without needles Classification: Class II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital Intended Use Statement: Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.

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Proposed Device Name: Needles Classification: Class II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital Intended Use Statement: Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.

- 5. Predicate Device Identification
#### 510(k) Number: K072739

Product Name: Sterile Hypodermic Syringe for single use, with/without needle and Sterile Hypodermic Needle for single use

Manufacturer: Shandong Weigao Group Medical Polymer Products Co., Ltd

- Device Description 6.
The proposed devices include: a standard piston syringes consisting of the proposed syringes consist of three components: (1) barrel, (2) piston and (3) plunger rod, and a needle consists of (1) needle tube, (2) needle hub and (3) needle sheath. They would be available in three different configurations respectively as follows:

### Configuration 1 Syringes with Needle

Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.

#### Configuration 2 Syringes without Needle

Proposed syringes will be provided without a needle. The combination of sizes are various upon the It could be used together with any other U.S. legally marketed request of the users. a) hypodermic needle with luer slip female connector complied with ISO594-1:1988 or 'iver lock female connector complied with ISO 594-2:1996.

#### Configuration 3 Needles

Proposed needles will be provided alone, which could be used together with any other U.S. legally marketed syringes with luer slip male connector complied with ISO594-1:1988 or luer lock male connector complied with ISO 594-2:1996 to complete its intended use.

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Section III 510(k) Summary_

### 7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device per the following standards:

- ISO 7886-1:1993 Sterile hypodermic syringes for single use Part 1: Syringes for manual use; A
- ISO 7864:1993 Sterile hypodermic needles for single use. ア
- ISO 9626:1991, AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of ♪ medical devices.
- ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other >
- medical equipment Part 1: General requirements; .
- ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other > medical equipment - Part 2: Lock fittings.
- Substantially Equivalent Conclusion 8.

Compared with the predicate devices, the proposed devices are mainly different in size specifications and sterilization method from the predicate devices. But the sterilization was performed to demonstrate that the SAL of the proposed device were the same to that of the predicate devices, and the performance of both proposed and predicate device complied with same performance standards.

The proposed devices, are determined to be Substantially Equivalent (SE) to the predicate devices, in respect of safety and effectiveness.

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

OCT 2 8 2011

Jiangyin Caina Technology Company, Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories. Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

Re: K113091

Trade/Device Name: Syringes, With or without Needles Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: September 28, 2011 Received: October 19, 2011

Dear Mr. Mouser:

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. Mouser

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/ ucm 1 15809.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

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

Enclosure

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## Section II Indications for Use

510(k) Number: K (1 3091 Device Name: Syringes, with or without needles

Indications for Use:

Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-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)

Page 1 of 2

Rell (Chymer 10/28/1

livision Sign-Off) Isjon of Anesthesiology, General Hospital iection Control, Dental Devices

510(k) Number: K113091

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Indication for Use

510(k) Number: K11 3091 Device Name: Needles

Indications for Use:

Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.

&PRESCRIPTION USE (Part 21 CFR 801 Subpart D) 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)

Page 2 of 2

Rill C. Oly 10/28/11

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

510(k) Number: K113091

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