BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES

K083686 · Anhui Kangda Medical Products Co., Ltd. · FMF · Jul 2, 2009 · General Hospital

Device Facts

• Record ID: K083686
• Device Name: BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
• Applicant: Anhui Kangda Medical Products Co., Ltd.
• Product Code: FMF · General Hospital
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

Device Story

BAIXIN Disposable Syringe consists of a calibrated hollow barrel and a movable plunger; features a male Luer Lock connector for attaching hypodermic single lumen needles or other female Luer-compatible devices. Used by clinicians or patients for fluid injection or withdrawal. Device operates manually; provides precise fluid volume delivery/aspiration. Benefits include sterile, single-use fluid management.

Clinical Evidence

Bench testing only. Testing included syringe column sealing (300 Kpa positive/88 Kpa negative pressure), volume accuracy (±4%), tip sealing, tip separation strength (25N), residue contents (<0.075 cc), sliding property (<10N), appearance, sterility, pyrogen-free status, and non-toxicity.

Technological Characteristics

Piston syringe; materials evaluated for non-toxicity; male Luer Lock connector; manual operation; sterile, single-use; conforms to ISO 7886-1:1993.

Indications for Use

Indicated for the injection of fluids into or withdrawal of fluids from the body in patients requiring such procedures.

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.

Submission Summary (Full Text)

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# 510(K) SUMMARY

K083686
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### Submitted by:

Anhui Kangda Medical Products Co., Ltd.

JUL - 2 2009

88 Zhenxing Road,

Yangeun Town,

Tianchang City,

Anhui Province

P. R. China

Phone: [phone]

[phone] Fax:

Preparation Date: Jun. 10. 2008

## Contact Person/Prepared by:

### Official Correspondent:

bian wei giang SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. 1707 yinqiao bldg 58 jinxin road jinqiao, pudong, shanghai, CHINA 201206 Phone: [phone]

US Agent: ROBERTJ.EDWARDS BOCA MEDICAL PRODUCTS, INC. 3550 nw 126th ave coral springs, FL 33065 Phone: 954 346 Fax: 954 346 Email: [e-mail]

## 510(K) Summary of Safety and Effectiveness for the:

Trade/Proprietary Name: BAIXIN™ Disposable Syringe, Multiple Sizes Common Name: Piston Syringe, Hypodermic

Classification Name: Piston Syringe

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Class: Il

Panel: 80-

Procodes: FMF - Piston Syringe FMI - Hypodermic Single Lumen Needle

#### Device Description:

BAIXIN Disposable Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.

#### Intended Use:

The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

## Statement to conform to ISO 7886-1; 1993

Anhui Kangda Medical Products Co., Ltd. has established that its family of syringes corm to the FDA recognized consensus standard, ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use. Data supporting conformance with the standard is available from Anhui Kangda Medical Products Co., Lid.

### Summary of Testing:

All materials used in the fabrication of the Anhui Kangda piston syringe and hypodermic needles were evaluated for:

| Testing Items | Code Requirement |
|------------------------------------|---------------------------------------------------------------------------------------|
| Syringe Column<br>Sealing | 300 Kpa Positive Pressure - No<br>leakage<br>88 Kpa Negative Pressure - No<br>leakage |
| Volume | $\pm$ 4% |
| Tip Sealing Property | No Leakage |
| Indicating Ruler - 0<br>level line | Within 1/4 range |
| Tip Size | No separation at 25N |
| Draw Strength | |
| Residue Contents | < 0.075 cc |
| Sliding Property | Average < 10N |
| Appearance | Clean, Smooth |
| Non-bacteria | Non-bacteria |
| Pyrogen | Pyrogen-free |

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| Toxicity | Non-toxic, no toxicity reaction for human body |
|----------|------------------------------------------------|
|----------|------------------------------------------------|

K08 3686

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### Conclusion:

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The materials, performance, and operational features of both the submitted device rne materials, portormanos, and stantially equivalent and are safe and effective for . their intended use. . .

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three overlapping wing-like shapes.

#### JUL - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Anhui Kangda Medical Products Company, Limited C/O Mr. Bian Wei Qiang Shanghai Carelife International Trading Company, Limited 1707 Yinqiao Building 58 Jinxin Road Jinqiao, Pudong, Shanghai CHINA 201206

Re: K083686

Trade/Device Name: BAIXIN™ Disposable Syringe, Multiple Sizes (BAIXINI™) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: June 3, 2009 Received: June 3, 2009

Dear Mr. Qiang:

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 - Mr. Qiang

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,

Anthony D. Auster bu

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

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510(k) Number (if known): K083686

Device Name: BAIXIN™ Disposable Syringe, Multiple Sizes (BAIXIN™)

Indications for Use: The intended use of the BAIXIN Disposable Syringe is to inject fluids into or withdraw fluids from the body.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K083

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