ULTRAFLEX INFUSION SET

K033892 · Disetronic Medical Systems AG · FPA · Mar 9, 2004 · General Hospital

Device Facts

• Record ID: K033892
• Device Name: ULTRAFLEX INFUSION SET
• Applicant: Disetronic Medical Systems AG
• Product Code: FPA · General Hospital
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

Device Story

Ultraflex is a disconnectable subcutaneous infusion set featuring a soft cannula oriented perpendicular to an adhesive base. It serves as the interface between a patient's commercially available microdosage insulin pump and their subcutaneous tissue. The device facilitates the delivery of insulin as prescribed by a healthcare professional to manage insulin-dependent diabetes mellitus. It is intended for use by patients who require continuous or intermittent insulin therapy via pump systems.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disconnectable infusion set with soft cannula; perpendicular insertion design; compatible with standard microdosage insulin pumps; adhesive interface for subcutaneous attachment.

Indications for Use

Indicated for patients with insulin dependent diabetes mellitus requiring subcutaneous insulin infusion via microdosage insulin pumps.

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.

Predicate Devices

• Ultraflex Infusion Set (K033892)

Submission Summary (Full Text)

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Ko33892

## 510(k) Summary According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. and the same of the same of the same of the same of the same of the same and the season of the season of the season of the season of the season of the season of the season of Submitted by: 1) Submitter Disetronic Medical Systems AG name, address, Kirchbergstrasse 190, Postfach contact CH-3401 Burgdorf, Switzerland United States Contact Person: Scott Thiel Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250 317-521-3362 scott.thiel(@roche.com Date Prepared: December 12, 2003 Proprietary name: Ultraflex Infusion Set 2) Device name Common name: subcutaneous infusion set Classification name: intravascular administration sct Product Code: FPA We claim substantial equivalence to the current legally marketed version of the 3) Predicate same device. device and the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the contribution of the co The Ultratlex is a disconnectable infusion set with soft cannula perpendicular 4) Device to the adhesive, for transfusion of insulin into the subcutaneous tissue. The Description unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus. Ultraflex™ is an infusion set for the subcutancous infusion of insulin 5) Intended use administered with microdosage insulin pumps.

MAR - 9 2004

Continued on next page

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# 510(k) Summary, Continued

6) Data demonstrating substantial equivalence

Testing of the modified Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the Ultraflex Infusion Set is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird, with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Disetronic Medical System AG C/O Mr. Scott Thiel Regulatory Affairs/Diabetes Specialist Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250

Re: K033892

Trade/Device Name: Ultraflex Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA. Dated: December 12, 2003 Received: December 16, 2003

Dear Mr. Thiel:

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. Thiel

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 Office of Compliance 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 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 vours.

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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K033892

# Indications for Use Statement

510(k) Number (if known): Device Name: Ultraflex Infusion Set

Indications for Use:

Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

William M. Burdick Sr
Arsene Nareau

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: A2252wmB

K033892