HARD PACK SYRINGE

K141359 · Jiangyin Caina Technology Co., Ltd. · FMF · Jul 25, 2014 · General Hospital

Device Facts

• Record ID: K141359
• Device Name: HARD PACK SYRINGE
• Applicant: Jiangyin Caina Technology Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jul 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 intended to inject fluids into or withdraw fluids from the body.

Device Story

Hard pack syringe consists of piston syringe and needle components; used to inject or withdraw fluids from body. Available as syringe with needle or syringe without needle. Operated by clinicians or patients for single-use applications. Device provides fluid delivery or aspiration functionality. Hard pack packaging maintains sterility for five years. Sterilized via radiation (Co60).

Clinical Evidence

Bench testing only. Compliance verified against ISO 7886-1 (syringes), ISO 7864 (needles), ISO 9626 (needle tubing), ISO 594-1/2 (luer fittings), and ISO 11137-2 (sterilization). Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Piston syringe and needle assembly. Materials include stainless steel needle tubing (ISO 9626). Features 6% (Luer) taper fittings (ISO 594-1/2). Sterilized via Co60 radiation (ISO 11137-2). Hard pack packaging. Single-use.

Indications for Use

Indicated for patients requiring fluid injection or withdrawal via syringe and needle. No specific age or disease state contraindications 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

• Syringes with or without needles: Needles (K113091)

Submission Summary (Full Text)

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Premarket Notification 510(k) Submission

## JUL 2 5 2014

## Exhibit #3 510(k) Summary

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

K141359 The assigned 510(k) Number:

1. Date the summary was prepared: April 5, 2014

Sponsor Identification 2.

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

Establishment Registration Number: 3005670221

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

#### 3. Submission Correspondent

.

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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Proposed Device Identification 4.

> Proposed Device Name: Hard pack syringe Proposed Device Common Name: Syringe with or without needle

Regulatory Information: Classification Name: Piston Syringe; Classification: II; Product Code: FMF; Additional Product Code: FMI; Regulation Number: 21CFR 880.5860 Review Panel: General Hospital:

Indications for 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 intended to inject fluids into or withdraw fluids from the body.

- 5. Predicate Device Identification
510(k) Number: K113091 Product Name: Syringes with or without needles: Needles Manufacturer: Jiangyin Caina Technology Co., Ltd.

- Device Description 6.
The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body.

The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle.

Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.

- 7. Non-Clinical Test Conclusion
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Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, The test results demonstrated that the proposed device complies with the following standards:

- A 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.
- 产 ISO 9626:1991, AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices.
- /A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements;
- A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
- A ISO11137-2:2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.
- 8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Devices | Predicate Devices |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K113091 |
| Product Code | FMF& FMI; | FMF& FMI; |
| Regulation Number | 21CFR 880.5860 & 21 CFR 880.5570 | 21CFR 880.5860 & 21 CFR 880.5570 |
| Intended Use | Syringes with or without needle are<br>intended to inject fluids into or withdraw<br>fluids from the body.<br>Needles are intended to be used with a<br>legally marketed syringe intended to<br>inject fluids into or withdraw fluids from<br>the body. | Syringes with or without needle are<br>intended to inject fluids into or<br>withdraw fluids from the body.<br>Needles are intended to be used with a<br>legally marketed syringe intended to<br>inject fluids into or withdraw fluids<br>from the body. |
| Component | Syringes and Needles | Same |
| Sterile | Yes | Same |
| Single Use | Yes | Same |
| Shelf Life | Five year | Same |
| Biocompatibility | ISO 10993:5 Standard<br>ISO 10993:10 Standard | Same |

| Table 3-1 Comparison of Technology Characteristics | | |
|----------------------------------------------------|--|--|
| | | |

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·

.

| Performance | ISO 7864 Standard<br>ISO 7886 Standard<br>ISO 9626 Standard<br>ISO 594-1 Standard<br>SIO 594-2 Standard | Same |
|-------------------|---------------------------------------------------------------------------------------------------------|--------------|
| Immediate Package | Hard pack package | Soft package |

The proposed devices, Hard pack syringe, are determined to be Substantially Equivalent (SE) to the predicate devices. Syringes and needles (K113091). in respect of safety and effectiveness.

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Image /page/4/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter, reading "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". In the center is a stylized emblem of an eagle with three lines representing its body and wings.

Public Health Service

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

July 25. 2014

Jiangyin Caina Technology Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited Post Office Box 120-119 Shanghai CHINA 200120

### Re: K141359

Trade/Device Name: Hard pack syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 23, 2014 Received: June 30, 2014

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. Please note: CDRH docs 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 - 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 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/ResourcesforYou/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.

# Mary S. Runner -S

Erin I. Keith, M.S. 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K141359

Device Name Hard pack svringe

Indications for Use (Describe)

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

Necdles are intended to be used with a legally marketed syrings intended to injoct fluids into or withdraw fluids from the body.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
| Digitally signed by<br>Richard C. Chapman -S |
| Date: 2014.07.25 |
| 08:45:03 -04'00' |

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