TRU-SWAB STOCOCK

K052330 · Medegen Medical Manufacturing Services · FMG · Sep 9, 2005 · General Hospital

Device Facts

• Record ID: K052330
• Device Name: TRU-SWAB STOCOCK
• Applicant: Medegen Medical Manufacturing Services
• Product Code: FMG · General Hospital
• Decision Date: Sep 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Tru-Swab™ Stopcock 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

Tru-Swab™ Stopcock functions as accessory to intravascular administration sets; provides secondary sterile injection site for fluid delivery to patient vascular system via cannula. Used in clinical settings by healthcare professionals. Device facilitates fluid administration; maintains sterility of injection site.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Accessory to intravascular administration set; mechanical stopcock design. Materials and sterilization methods consistent with class II intravascular administration set requirements.

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)

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Public Health Service

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SEP - 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052330

Trade/Device Name: Tru-SwabTM Stopcock Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FMG Dated: August 23, 2005 Received: August 26, 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.

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Page 2 - Mr. Mark 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 vour 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]. Aso, 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/dsma/dsmamain.html

Sincerely yours,

Supite y. Michuions.

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) Number (if known): _ (52523) ت

Device Name: Tru-Swab™ Stopcock

Indications for Use:

The Tru-Swab™ Stopcock 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109)

510(k) ORnber. K052330
Over-The-Counter Use

(Optional Format 12.06)

(Optional Format 1-2-96)