MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR

K051939 · Medegen Medical Manufacturing System · FPA · Aug 1, 2005 · General Hospital

Device Facts

• Record ID: K051939
• Device Name: MAXPLUS TRU-SWAB POSITIVE DISPLACEMENT CONNECTOR
• Applicant: Medegen Medical Manufacturing System
• Product Code: FPA · General Hospital
• Decision Date: Aug 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The MaxPlus Tru-Swab Positive Displacement Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

Device Story

MaxPlus Tru-Swab is a positive displacement connector acting as an accessory to intravascular administration sets. It serves as a secondary sterile injection site for fluid delivery into a patient's vascular system via a cannula. The device is used in clinical settings by healthcare professionals to facilitate secure, sterile access for fluid administration. It functions as a mechanical interface to maintain system integrity during connection and disconnection of IV lines.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Positive displacement connector; mechanical interface for intravascular administration sets; sterile injection site functionality.

Indications for Use

Indicated for use as a secondary sterile injection site for fluid delivery to a patient's vascular system via an intravascular administration set and cannula.

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)

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 - 2005

Medegen Medical Manufacturing System c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K051939

Trade/Device Name: Maxplus Tru-Swab Positive Displacement Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 14, 2005 Received: July 18, 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 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.

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

Page 2 - Mr. Job

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actives that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacar statutes and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, laoomig (DF OF RT 820); and if applicable, the electronic form in the quarty by sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only to begin marketing your device as described in your Section 510(k) I his icher will anow you to begin mains of substantial equivalence of your device to a legally prematicated predicated on " 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 If you desire specific acrioliance 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 other general 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,

Clu L
Sida 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

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

45/939 510(k) Number (if known):

Device Name: MaxPlus™ Tru-Swab™ Positive Displacement Connector.

Indications for Use:

The MaxPlus Tru-Swab Positive Displacement Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

(Per 21 CFR 801.109)

15431939 510(k) Number:_ Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)