INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

K051499 · Medegen Medical Manufacturing Services · FPA · Jun 22, 2005 · General Hospital

Device Facts

• Record ID: K051499
• Device Name: INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
• Applicant: Medegen Medical Manufacturing Services
• Product Code: FPA · General Hospital
• Decision Date: Jun 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componently that aid in the prevention of accidental needle sticks.

Device Story

Intravascular administration set and extension set; used to deliver fluids from container to patient vascular system via needle or catheter. Components include bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve, injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors, and bag hanger. Custom configurations available based on customer specifications for length, priming volume, and componentry. Used in clinical settings; operated by healthcare professionals. May incorporate safety features to prevent accidental needle sticks.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, intended use, and material biocompatibility consistent with legally marketed predicate devices.

Technological Characteristics

Components include bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve, injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors, and bag hanger. Materials are used in legally marketed devices under comparable conditions. Mechanical fluid delivery system; no energy source or software.

Indications for Use

Indicated for patients requiring fluid administration into the vascular system via needle or catheter into an artery or vein.

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

• Intravascular Administration Set (K991932)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.

| Name: | Medegen Medical Manufacturing Services |
|-----------------|-----------------------------------------|
| Address: | 930 Wanamaker Ave.<br>Ontario, CA 91761 |
| CONTACT PERSON: | SALVADORE F. PALOMARES, RAC |

510(k) Summary of Safety and Effectiveness

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:

| Trade Name: | Intravascular Administration Set and Extension Set |
|----------------------|----------------------------------------------------|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Same |

| Equivalent Devices: | |
|---------------------|----------------------------------|
| Manufacturer: | Kipp Group |
| Name: | Intravascular Administration Set |
| 510(k) #: | K991932 |

Device Description:

The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications.

Components will be assembled into standard configurations specified by the customer and packaged.

| Bag Spike | Clamp | Filter | Check Valve |
|--------------|---------------------------|------------|-------------|
| Drip Chamber | Flow Controller | Flash Bulb | Y-site |
| Burette | Injection Site | Luer | Stopcock |
| Tubing | Needleless Injection Site | Bag Hanger | Manifold |

Types of components that may be contained in a set include:

### Intended Use:

The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componently that aid in the prevention of accidental needle sticks.

### Biocompatibility:

The materials used to manufacture the Intravascular Administration Set and Extension Set are used in legally marketed devices under comparable conditions of use.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines, symbolizing health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2005

Medegen Medical Manufacturing Services C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K051499

Trade/Device Name: Intravascular Administration Set and Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 4, 2005 Received: June 7, 2005 :

Dear Mr. Job:

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 (1 will), it inche 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 Eederal Register.

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## Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvrsed that I Dr. b lookines on that your device complies with other requirements Incall that 1127 mas mace a autes and regulations administered by other Federal agencies. of the Act of ally I oderal barates and systements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in at at 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) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification - 11 - 11 - 11 - 11 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to for your 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 may obtain 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,

Chien-Lin Liu, Ph.D.

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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#### 510(k): << \$ 14 9 4

Intravascular Administration Set and Extension Device Name: Set

The Intravascular Administration Set and Indications for Use: Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.

Prescription Use
(Per 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)

Cus 20

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

510(k) Number: K051499