DRAGON HEART I.V. SET

K043235 · Dragon Heart Medical Devices Co., Ltd. · FPA · Mar 8, 2005 · General Hospital

Device Facts

• Record ID: K043235
• Device Name: DRAGON HEART I.V. SET
• Applicant: Dragon Heart Medical Devices Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Mar 8, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

Device Story

The Dragon Heart Intravascular Administration Set is a fluid delivery system used to transport fluids from a container to a patient's vascular system via an intravenous catheter. It is intended for clinical use by healthcare professionals to facilitate fluid therapy. The device functions as a conduit for fluid administration; it does not incorporate electronic, software, or algorithmic components. It is a mechanical device used in clinical settings to support patient hydration or medication delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set; mechanical fluid delivery conduit. No electronic, software, or algorithmic components. Class II device under 21 CFR 880.5440 (Product Code FPA).

Indications for Use

Indicated for the administration of fluids from a container to a patient's vascular system via an intravenous catheter. For prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

MAR 8 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dragon Heart Medical Devices Company Limited C/O Ms. Jina Yu President Dragon Heart Medical, Incorporated 188 Industrial Drive, Suite 108 Elmhurst, Illinois 60126

Re: K043235

Trade/Device Name: Dragon Heart Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 24, 2005 Received: February 25, 2005

Dear Ms. Yu:

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 such 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, IDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -- Ms. Yu

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

Chiu Lin, Ph.D.

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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Dragon Heart Medical Device Co., Ltd.

Intravascular Administration Set 510(k) Application

## Statement of Indications for Use

510(k) Number : K043235

Device Name: Dragon Heart Intravascular Administration Set

Indications For Use:

The Dragon Heart Intravascular Administration Set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">✓</span> |
|-------------------------------------------------------|----------------------------------------------------|
| and/or Over-The-Counter Use<br>(21 CFR 807 Subpart C) | <span style="text-decoration: underline;"></span> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Bauer

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