EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE

K012879 · Exelint Intl. Co. · FPA · Jan 17, 2002 · General Hospital

Device Facts

• Record ID: K012879
• Device Name: EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE
• Applicant: Exelint Intl. Co.
• Product Code: FPA · General Hospital
• Decision Date: Jan 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Huber Infusion Sets are used for infusion of medication to a patient. This particular device is used for Oncology/Chemotherapy treatment.

Device Story

Huber Infusion Set with Needleless Injection Site; used for delivery of medication to patients undergoing oncology/chemotherapy treatment. Device facilitates infusion via a needleless access point. Operated by healthcare professionals in clinical settings. Provides a pathway for fluid administration; reduces risk of needle-stick injuries through needleless design.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Huber infusion set featuring a needleless injection site. Class II device (Product Code: FPA).

Indications for Use

Indicated for patients requiring infusion of medication, specifically for oncology/chemotherapy treatment.

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 symbol that resembles a human figure embracing another, or possibly a stylized representation of an eagle or bird in flight.

'JAN 1 7 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Armand Hamid Director Exelint International Corporation 5840 West Centinela Avenue Los Angeles, California 90045

Re: K012879

Trade/Device Name: Exel Huber Infusion Set with Needleless Injection Site Regulation Number: 880.5440 Regulation Name: Huber Infusion Set with Needledless Injection Site Regulatory Class: II Product Code: FPA Dated: November 10, 2001 Received: November 20, 2001

Dear Mr. Hamid:

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 vour 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 - Mr. Hamid

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 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timotky A. Ulatowski

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

Enclosure

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

## ATTACHMENT1C

Page 1 of 1

## 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Huber Infusion Set with Needleless Injection Site

Indications For Use:

Huber Infusion Sets are used for infusion of medication to a patient. This particular device is used for Oncology/Chemotherapy treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paltaux Vincent

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ---

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)