(254 days)
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin.
The ACCU-CHEK® FlexLink Plus 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 is NOT an AI device. This is a medical device for infusing insulin, and therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable. The provided text is a 510(k) summary for an infusion set, outlining its substantial equivalence to a predicate device, and includes performance data mostly related to physical characteristics and general medical device standards rather than AI-specific performance metrics.
{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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Mr. Alexander Rügner Regulatory Affairs Manager Roche Diagnostics GmbH Sandhofer Strasse 116 Mannheim, Germany, 68305
Re: K143446
Trade/Device Name: ACCU-ChEK® FlexLink Plus infusion set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: July 8, 2015 Received: July 9, 2015
Dear Mr. Rügner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{1}------------------------------------------------
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K143466
Device Name ACCU-CHEK FlexLink Plus Infusion Set
Indications for Use (Describe)
ACCU-CHEK FlexLink Plus is an infusion set for the subcutaneous infusion of insulin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary K143446
| Introduction | According to the requirements of 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter | Roche Diagnostics GmbHSandhoferstrasse 11668305 MannheimGermanyAlexander Rügner+49 621 7598395alexander.ruegner@roche.comDate Prepared: November 20, 2014 |
| Device name | Proprietary name: ACCU-CHEK® FlexLink Plus Infusion SetCommon name: subcutaneous infusion setClassification name: intravascular administration setRegulation number: 21 CFR §880.5440Product Code: FPA |
| Predicate device | We claim substantial equivalence to the cleared predecessor Accu-Chek FlexLink Plus (K#100704) infusion set |
| Device description | The ACCU-CHEK® FlexLink Plus 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. |
| Intended use | ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneousinfusion of insulin. |
| Datademonstratingsubstantialequivalence | Testing demonstrated that the device meets the requirements for its intendeduse. The data also demonstrates substantial equivalence to the predicatedevice. |
| The slight difference (omit "administered with micro dosage insulin pump") ofthe indication for use between the modified Accu-Chek FlexLink Plus and thepredicate device does not affect the intended use. The infusion set intended forsubcutaneous infusion of insulin is a default accessory used together with amicro dosage insulin pump. Functional testing to verify the intended use of themodified Accu-Chek FlexLink Plus was conducted together with micro dosageinsulin pumps. |
1
{4}------------------------------------------------
510(k) Summary K143446, Continued
Dimensional characteristics of the predicate as compared to the current subject device are listed below: -
| Feature | Predicate (K#100704) | Current subject device (K#143446) |
|---|---|---|
| Name | ACCU-CHEK FlexLink Plus | ACCU-CHEK FlexLink Plus |
| Tube length | 40, 70, 100 cm | Same |
| Needle length (to grind start) | 17.8, 19.8 or 21.8mm | 19.63, 21.63 or 23.23mm |
| Needle diameter | 0.36mm | 0.40mm |
| Soft cannula length | 6mm / 8mm / 10mm | Same |
| Soft cannula length (actual) | 8.6, 10.5 or 12.5mm | 8.5, 10.5 or 12.1mm |
| Soft cannula (ID/OD) | 0.4mm/0.62mm | 0.44 mm/0.68mm |
| Wall thickness | 0.11mm | 0.12mm |
| Distance Cannula tip to needle end | 0.7 mm | 2.43 mm |
| Priming volume (average for tube set + 1 IU for priming head set) | 7 U, 11 U, 15 U**U 100 insulin | Same |
| Tubing ID/OD | 0.4 mm x 1.47 mm | Same |
2
{5}------------------------------------------------
| Storage conditions | -20°C to +50 °C-4°F to +122°F | +5 °C to +45°C+41 °F to +113°F |
|---|---|---|
| Operating conditions | +5 °C to +45°C+41 °F to +113°F | Same |
| Connector | Luer connector | Same |
| Sterilizationmethodology | Ethylen Oxide | Same |
| Prescription use only | Prescription use only | Same |
| Single use | Single use | Same |
| Standard usedin testing | ISO 7864: 1993 | Sterile hypodermic needles forsingle use |
|---|---|---|
| AAMI/ANSI/ISO 10993-1: 2003, | Biological evaluation of medicaldevices - part 1: evaluation oftesting | |
| AAMI/ANSI/ISO 10993-7: 2008 | Biological evaluation of medicaldevices - part 7: ethylene oxidesterilization residuals | |
| AAMI/ANSI/ISO 11135-1:2007 | Sterilization of healthcare products-ethylene oxide-part1:requirementsfor the development | |
| AAMI/ANSI/ISO 11607-1:2006 | Packaging for terminally sterilizedmedical devices-part1-requirementsfor materials, sterile | |
| AAMI/ANSI/ISO 11607-2: 2006 | Packaging for terminally sterilizedmedical devices-part 2-Validationrequirements for forming | |
| IEC 62366: 2007 | Medical devices - application ofusability engineering to medicaldevices |
{6}------------------------------------------------
| Devicecomparisons | The ACCU-CHEK FlexLink Plus infusion set is compared to its predicatedevice (K#100704). The ACCU-CHEK FlexLink Plus is substantiallyequivalent to the predicate by having the same intended use, same operatingconditions, same luer connector, a flexible cannula and needle for insertioninto the subcutaneous tissue and separate extension tubing with a detachableconnector. Both sets have an adhesive patch that secures the headset to theskin. Both sets incorporate a needle protection feature that retracts the needleautomatically following insertion of the needle and cannula. |
|---|---|
| Summaries ofStudies | In vitro functional testing of the ACCU-CHEK FlexLink Plus infusion setwas conducted. Biocompatibility testing was performed on the materials usedin the deviceSystem validation testing included human factors usability testing of therequirements and primary operating function of the ACCU-CHEK FlexLinkPlus infusion set. Individuals who participated in the evaluation includedpatients who routinely use insulin pump and infusion set. The usabilityevaluation determined the customer requirements and the primary operationfunctions were met.Clinical studies:Human clinical studies were not deemed necessary to evaluate the safety ofeffectiveness of the ACCU-CHEK FlexLink Plus infusion set. |
| Studyconclusion | The results of the in vitro testing conducted indicate the ACCU-CHEKFlexLink Plus infusion set function according to their specification and thedevice materials are biocompatible.The design validation confirmed that the device fulfills its intended use,customer requirement and primary operating functions.Based on the comparison above, the proposed device, ACCU-CHEK®FlexLink Plus infusion set, is determined to be Substantially Equivalent (SE)to the predicate devices. |
4
§ 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.