ACCU-CHEK ULTRAFLEX INFUSION SET

K070189 · Disetronic Medical Systems AG · FPA · Feb 21, 2007 · General Hospital

Device Facts

• Record ID: K070189
• Device Name: ACCU-CHEK ULTRAFLEX INFUSION SET
• Applicant: Disetronic Medical Systems AG
• Product Code: FPA · General Hospital
• Decision Date: Feb 21, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

Device Story

ACCU-CHEK Ultraflex is a disconnectable subcutaneous infusion set; features soft cannula perpendicular to adhesive; interfaces with commercially available insulin infusion pumps. Device delivers insulin from pump to subcutaneous tissue. Used by patients with insulin-dependent diabetes mellitus; prescribed by healthcare professionals. System components include infusion set, insulin pump, and insulin. Device facilitates continuous insulin delivery to manage blood glucose levels.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disconnectable infusion set; soft cannula; perpendicular insertion design; compatible with microdosage insulin pumps.

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.

Submission Summary (Full Text)

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K070189

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| 510(k) Summary | | | FEB 2 1 2007 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. | | |
| 1) Submitter<br>name, address,<br>contact | Submitted by:<br>Disetronic Medical Systems AG<br>Kirchbergstrasse 190, Postfach<br>CH-3401 Burgdorf, Switzerland | | |
| | United States Contact Person:<br>Mike Flis<br>Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, Indiana 46250<br>317-521-2110<br>[e-mail]<br>Date Prepared: January 15, 2007 | | |
| 2) Device name | Proprietary name: ACCU-CHEK Ultraflex Infusion Set<br>Common name: subcutaneous infusion set<br>Classification name: intravascular administration set<br>Product Code: FPA | | |
| 3) Predicate<br>device | We claim substantial equivalence to the current legally marketed version of the<br>same device. | | |
| 4) Device<br>Description | The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannula<br>perpendicular to the adhesive, for transfusion of insulin into the subcutaneous<br>tissue. The unit is designed to interface with commercially available insulin<br>infusion pumps with suitable connections. The insulin infusion pump systems<br>are designed to control the delivery of insulin as prescribed by a health care<br>professional. The system (infusion set, insulin infusion pump, and insulin) is<br>indicated for patients with insulin dependent diabetes mellitus. | | |
| 5) Intended use | ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin<br>administered with microdosage insulin pumps. | | |

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## 510(k) Summary, Continued

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6) Data demonstrating substantial equivalence

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

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2007

Disetronic Medical Systems AG C/O Mr. Mike Flis Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250

Re: K070189

Trade/Device Name: ACCU-CHEK Ultraflex Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 15, 2007 Received: January 22, 2007

Dear Mr. Flis:

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. Flis

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/industry/support/index.html.

Sincerely yours,

Chiu-Lien, 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

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ≤070189

## Device Name: ACCU-CHEK Ultraflex Infusion Set

The ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

Prescription Use _X (Per 21 CFR 801.109)

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

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

Cim Vong

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