I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT

K083429 · Weihai Jierui Medical Products Co., Ltd. · FOZ · Aug 7, 2009 · General Hospital

Device Facts

• Record ID: K083429
• Device Name: I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT
• Applicant: Weihai Jierui Medical Products Co., Ltd.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 7, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

Device Story

I.V. Catheter for Single Use is a sterile, single-use intravascular device available in Type I (open system), Type Y, and Type Straight (closed system) configurations. It consists of a catheter tubing, stainless steel needle, hub, and associated connectors/wings. Used by clinicians to access the vascular system for short-term fluid administration, blood sampling, or monitoring equipment placement. The device is inserted into the patient's vasculature; the needle is removed, leaving the catheter in place for therapy or monitoring. It is provided EO sterilized, latex-free, pyrogen-free, and DEHP-free. Available in 18G, 20G, 22G, and 24G sizes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Intravascular catheter; stainless steel needle; plastic catheter tubing/hub; EO sterilized; latex-free; pyrogen-free; DEHP-free. Available in 18G, 20G, 22G, 24G. Configurations: Type I (open), Type Y (closed), Type Straight (closed).

Indications for Use

Indicated for patients requiring short-term vascular access for blood sampling, intravenous fluid administration, or placement of monitoring equipment (e.g., blood pressure monitors).

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• TERUMO Surflo Flex I.V. Catheter (K991406)

Submission Summary (Full Text)

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K083429

Premarket Notification 510(k) Submission -- Chapter III 510(k) Summary Report No .: A2008-030-035

AUG 0 7 2009

# Chapter III 510(k) Summary

I.V. Catheter for Single Use

As required by 21 CFR 807.92(k)

The assigned 510(k) Number is:

1. Date Prepared: November 15, 2008;

2. Sponsor Information

Weihai Jierui Medical Products Co., Ltd. No.348, Shichang Road, Weihai, Shandong, 264209, China

Contact Person: Mrs. Zhao Suxia, 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

Device Name and Classification: 4.

Device Trade Name: I.V. Catheter for Single Use Type: Type I, Type Y and Type Straight Device Classification Name: Intravascular Catheter . Product Code: FOZ Regulation Number: 880.5200 Device Class: II

Pg 1 of 2

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Premarket Notification 510(k) Submission - Chapter III 510(k) Summary Report No .: A2008-030-035

- 5. Predicate Device Identification:
## K991406

Trade/Proprietary Name: TERUMO Surflo Flex I.V. Catheter Submitter Name: Terumo Medical Corporation

### 6. Intended Use:

I.V. Catheter for Single Use, including Type I, Type V and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

### 7. Device Description:

The proposed device, I.V. Catheter for Single Use including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. It is provided EO sterilized, latex free, prygon-free and DEHP-free. All types are available in four sized, which are 18G, 20G, 22G and 24G.

Type Straight Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and straight connector. Type Y I.V. Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and Y connector. And Type I I.V. Catheter for single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle handle and vent fitting, Type Straight and Type Y are closed system while Type I is open system.

8. Test Conclusion

Laboratory testing was conducted to validate and verify that I.V. Catheter for Single Use met all design specifications and was substantially equivalent to the predicate device.

#### 9. Substantially Equivalent Conclusion:

The proposed device, Blood Transfusion Set, is substantially equivalent to the predicate device.

Ko&3429 pg z ofz
III-2

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AUG 0 7 2009

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

Weihai Jierui Medical Products Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongshan Zhongxin Mansion No. 19, Lane 999, Zhongshan No. 2 Road(S) Shanghai, 200030 CHINA

Re: K083429

Trade/Device Name: I.V. Catheter for Single Use Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 17, 2009 Received: July 22, 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 (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

for

Susan Runner, D.D.S., M.A. Acting Division 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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Premarket Notification Submission - Chapter II Indication fur Use Form Report No.: A2008-030-035

## Indication for Use

## 510(k) Number:

Ko83429

Device Name: I.V. Catheter for Single Use

## Indications for Use:

I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

Prescription Use (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)

Charles B. Day

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

510(k) Number: K083429