MEDEGEN PRESSURE RATED EXTENSION SETS

K083472 · Medegen, Inc. · FPA · Dec 9, 2008 · General Hospital

Device Facts

• Record ID: K083472
• Device Name: MEDEGEN PRESSURE RATED EXTENSION SETS
• Applicant: Medegen, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.

Device Story

Pressure Rated Extension Set is a medical tubing accessory used in infusion therapy. It connects to primary infusion lines to facilitate needle-free medication administration. Device is compatible with low-pressure power injectors rated up to 325 psi. Used in professional healthcare settings, home care, and medical transport. Operated by clinicians or trained caregivers. Provides a fluid path for delivery of fluids, medications, and blood products. Benefits include needle-free access and pressure compatibility for power injection, supporting clinical fluid management workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set; needle-free access port; pressure-rated for use with power injectors up to 325 psi. Materials and construction consistent with standard medical-grade tubing and connectors for infusion systems.

Indications for Use

Indicated for use in healthcare facilities, home care, and medical transport for the delivery of fluids, medications, blood, and blood products via infusion systems. Compatible with low-pressure power injectors up to 325 psi. No specific age or gender restrictions.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medegen, Incorporated C/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25" Street NW Buffalo, Minnesota 55313

K083472 Re:

> Trade/Device Name: Pressure Rated Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 18, 2008 Received: November 24, 2008

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.

DEC 0 9 2008

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

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Page 2 - Mr. Job

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Siyita Y. Michie Oms

Chiu S. Lin. Ph. D 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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510(k) Number (if known):

Device Name: Extension Set

Indications for Use:

The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.

K083472

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles L. Cox for ADW

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

Section 3-2

510(k) Number: K083472