NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS

K021080 · Cardio Med Supplies, Inc. · FPA · Aug 29, 2002 · General Hospital

Device Facts

• Record ID: K021080
• Device Name: NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
• Applicant: Cardio Med Supplies, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CMS Noncor Infusion Set(s) with or without Injection Site are designed for easy insertion into vascular access devices for safe administration of continuous and/or boulus infusion of pain control medications, chemotherapeutic agents and pharmaceuticals. CMS Noncor infusion set(s) are available in all commonly used needle gauges and lengths, sets include mascrobore or microbore tubing with or without injection site.

Device Story

CMS Noncor Infusion Sets are sterile, single-use medical devices designed for vascular access. They consist of a needle, tubing (microbore or macrobore), and optional injection site. The device is inserted into an implanted vascular access port or catheter by a clinician to facilitate the delivery of medications, including pain management drugs and chemotherapeutic agents. The device acts as a conduit between the medication source (e.g., infusion pump or syringe) and the patient's vascular system. It does not contain electronic components or software; it functions via mechanical connection to existing vascular access infrastructure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set; includes needle, tubing (microbore/macrobore), and optional injection site. Materials are standard medical-grade plastics and stainless steel. Sterile, single-use. No electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring continuous or bolus infusion of pain control medications, chemotherapeutic agents, or other pharmaceuticals via vascular access devices.

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}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 9 2002

Ms. Donna McComb OSM Co-ordinator Cardiomed Supplies, Incorporated Gormley, Ontario, CANADA

Re: K021080

Trade/Device Name: CMS Noncor Infusion Set(s) and CMS Noncor Infusion Set(s) with Injection Site Regulation Number: 880.5440 and 880.5965 Regulation Name: Intravascular Administration Set and Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: FPA and LJT Dated: July 19, 2002 Received: July 23, 2002

Dear McComb:

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.

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.

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

### Page 2 - Ms. McComb

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 (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

U.S. Food and Drug Administration - Genter for Devices and Kadlologie all Teall in

Page of

510(k) Number (if known): ___ KQ21080

Device Name: CMS Noncor Infusion Set(s) CMS Noncor Infusion Set(s) with Injection Site

Indications for Use:

CMS Noncor Infusion Set(s) with or without Injection Site are designedifor easy insertion inoto vascular access devices for safe administration of continuous and/or boulus infusion of pain control medications, chemotherapeutic agents and pharmaceuticals. CMS Noncor infusion set(s) are available in all commonly used needle gauges and lengths, sets include mascrobore or microbore tubing with or without injection site.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Ciacerite

ion of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K021080

1 0

http://www.fda.gov/cdrh/ode/indicate.html