(30 days)
ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The 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.
This document is a 510(k) summary for the ACCU-CHEK Ultraflex Infusion Set. It states that the device meets the requirements for its intended use and is substantially equivalent to a predicate device. However, it does not contain any data, acceptance criteria, or study details about device performance.
Therefore, I cannot provide the requested information. The document explicitly states:
"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."
This is a summary statement, not a presentation of the actual data or the study design. To answer your questions, I would need access to the full test report or detailed data provided within the 510(k) submission, which is not present in the provided text.
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| 510(k) Summary | FEB 2 1 2007 | ||
|---|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | ||
| 1) Submittername, address,contact | Submitted by:Disetronic Medical Systems AGKirchbergstrasse 190, PostfachCH-3401 Burgdorf, Switzerland | ||
| United States Contact Person:Mike FlisRoche Diagnostics9115 Hague RoadIndianapolis, Indiana 46250317-521-2110Mike.flis@roche.comDate Prepared: January 15, 2007 | |||
| 2) Device name | Proprietary name: ACCU-CHEK Ultraflex Infusion SetCommon name: subcutaneous infusion setClassification name: intravascular administration setProduct Code: FPA | ||
| 3) Predicatedevice | We claim substantial equivalence to the current legally marketed version of thesame device. | ||
| 4) DeviceDescription | The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannulaperpendicular to the adhesive, for transfusion of insulin into the subcutaneoustissue. The unit is designed to interface with commercially available insulininfusion pumps with suitable connections. The insulin infusion pump systemsare designed to control the delivery of insulin as prescribed by a health careprofessional. The system (infusion set, insulin infusion pump, and insulin) isindicated for patients with insulin dependent diabetes mellitus. | ||
| 5) Intended use | ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulinadministered with microdosage insulin pumps. |
Continued on next page
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510(k) Summary, Continued
. . .
- 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
Kψηφιδι
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.