DISPOSABLE TPE INFUSION SET

K090459 · Shan Dong Wei Gao Group Medical Polymer Products · FPA · Oct 13, 2009 · General Hospital

Device Facts

• Record ID: K090459
• Device Name: DISPOSABLE TPE INFUSION SET
• Applicant: Shan Dong Wei Gao Group Medical Polymer Products
• Product Code: FPA · General Hospital
• Decision Date: Oct 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Disposable TPE infusion set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Device Story

Disposable, single-use, sterile infusion set; administers fluids from container to patient vascular system. Components: polyethylene puncturing needle for container access; TPE (thermoplastic elastomer) catheter; transparent drip chamber with 200 um filtration mesh to prevent micro-particle entry; flow regulator for rate adjustment; stainless steel infusion needle for venous access. Device is DEHP-free. Used in clinical settings; operated by healthcare professionals. Provides visual monitoring of fluid flow; enables controlled fluid delivery to patient.

Clinical Evidence

Bench testing only. Laboratory testing validated that the device met all design specifications and demonstrated substantial equivalence to the predicate device.

Technological Characteristics

Materials: Polyethylene (puncturing needle), TPE (catheter), stainless steel (infusion needle). Features: 200 um filtration mesh, flow regulator, transparent drip chamber. DEHP-free. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for administration of fluids from a container to a patient's vascular system via intravenous needle or catheter.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Tianjin Medis Disposable Infusion Set (K060082)

Submission Summary (Full Text)

{0}------------------------------------------------

K090459

# Chapter III 510(k) Summary

OCT 1 3 2009

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

The assigned 510(k) Number is:

1. Date Prepared: February 1, 2009

2. Sponsor Information

ShanDong WeiGao Group Medical Polymer Co., Ltd No.312 Shichang Road Weihai City, Shangdong, 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 Consulting Co., Ltd Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S) . Shanghai, 200030, China

4. Device Name and Classification:

Device Trade Name: Disposable TPE infusion set Device Common Name: Disposable infusion device Device Classification Name: Set, administration, intravascular Product Code: FPA Regulation Number: 880.5440 Device Class; II

{1}------------------------------------------------

- 5. Predicate Device Identification: Tianjin Medis Disposable Infusion Set K-number: K060082
- 6. Intended Use:

Disposable TPE infusion set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

- 7. Device Description:
The applicant device is single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel.

The proposed device is provided sterilized.

- 8. Test Conclusion resignation
Laboratory testing was conducted to validate and verify that disposable infusion set met all design specifications and was substantially equivalent to the predicate device.

- 9. Substantially Equivalent Conclusion:
The subject device, disposable infusion set is substantially equivalent to the predicate device.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

### OCT 1 3 2009

Shan Dong Wei Gao Group Medical Polymer Products C/O Ms. Diana Hong General Manager Shanghai Midlink Business Consulting Company, Limited Suite 8D, No. 19, Line 999, Zhongshan No.2 Road (S) Shanghai, 200030, CHINA

Re: K090459

Trade/Device Name: Disposable TPE Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 24, 2009 Received: September 28, 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.

{3}------------------------------------------------

### 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 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 vours.

Susan Runser

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

### Enclosure

{4}------------------------------------------------

## Indication for Use

510(k) Number:

Device Name: Disposable TPE Infusion Set

### Indications for Use:

Disposable TPE Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Prescription Use V (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)

Antimony L.a. an

Page 1 of

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

1-494459 510(k) Number: J