D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES

K101368 · Dragon Heart Medical, Inc. · FPA · Nov 18, 2010 · General Hospital

Device Facts

• Record ID: K101368
• Device Name: D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES
• Applicant: Dragon Heart Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

D. Heart Medical intravascular administration set, safety access device and accessories are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Each device is comprised of components commonly found in intravascular administration sets and extension sets. Incorporation of safety access device aid in the prevention of accidental needle sticks to healthcare workers and patients.

Device Story

Device consists of intravascular administration sets, extension sets, and safety access devices. Used to deliver fluids from containers to patient vascular systems via venous access. Safety access components incorporate mechanisms to prevent accidental needle sticks for healthcare workers and patients. Operated by clinicians in clinical settings. Device facilitates fluid therapy while enhancing safety through needle-stick prevention features.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set and extension set components. Includes safety access mechanisms for needle-stick prevention. 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 a needle or catheter inserted into a vein. Intended for use in patients requiring intravenous fluid therapy.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ms. Jina Yu President Dragon Heart Medical, Incorporated 205 W Grand Avenue, Suite 105 Bensenville, Illinois 60106

NOV 1 8 2010

Re: K101368

Trade/Device Name: D. Heart Medical Intravascular Administration Set. Safety Access Device, and Accessories Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 4, 2010 Received: October 28, 2010

#### 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. Please note: CDRH does 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. 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); 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hum 2.2. Sot
fos

Anthony D. Watson, B.S., M.S., M.B.A. 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, Inc. Intravascular Administrative Set, Safety Access Device and Accessories Abbreviated 510(k) Application

... ... .. ..

# Statement of Indications for Use

NOV 1 8 2010

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510(k) Number:

# Device Name: D. Heart Medical Intravascular Administration Set, Safety Access Device, and Accessories

Intended Use & Device Description:

D. Heart Medical intravascular administration set, safety access device and accessories are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Each device is comprised of components commonly found in intravascular administration sets and extension sets. Incorporation of safety access device aid in the prevention of accidental needle sticks to healthcare workers and patients.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | ✓ and/or Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Anesthesiology, General Hospital

510k Number: K101655 Infection Control, Dental Devices

Family IV Sets & Accessories Application, Version 1 page 3 of 45

| 510(k) Number: | K101368 |
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