(254 days)
K#100704
Not Found
No
The summary describes a standard insulin infusion set and does not mention any AI or ML capabilities.
Yes
The device is an infusion set for the subcutaneous infusion of insulin, which is a therapeutic intervention for patients with insulin-dependent diabetes mellitus.
No
The device is an infusion set designed for delivering insulin, not for diagnosing a condition.
No
The device description clearly states it is a physical infusion set with a soft cannula and adhesive, designed to interface with insulin infusion pumps. This indicates it is a hardware medical device, not software-only.
Based on the provided information, the ACCU-CHEK® FlexLink Plus is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of insulin. This is a delivery mechanism for a therapeutic substance, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical components and function of delivering insulin into the subcutaneous tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.), detecting analytes, or providing diagnostic information. The device's function is purely mechanical delivery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ACCU-CHEK® FlexLink Plus does not fit this description.
N/A
Intended Use / Indications for Use
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro functional testing of the ACCU-CHEK FlexLink Plus infusion set was conducted. Biocompatibility testing was performed on the materials used in the device.
System validation testing included human factors usability testing of the requirements and primary operating function of the ACCU-CHEK FlexLink Plus infusion set. Individuals who participated in the evaluation included patients who routinely use insulin pump and infusion set. The usability evaluation determined the customer requirements and the primary operation functions were met.
Clinical studies:
Human clinical studies were not deemed necessary to evaluate the safety of effectiveness of the ACCU-CHEK FlexLink Plus infusion set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#100704
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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.
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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
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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) |
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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 GmbH |
| Sandhoferstrasse 116 | |
| 68305 Mannheim | |
| Germany |
Alexander Rügner
+49 621 7598395
alexander.ruegner@roche.com
Date Prepared: November 20, 2014 |
| Device name | Proprietary name: ACCU-CHEK® FlexLink Plus Infusion Set
Common name: subcutaneous infusion set
Classification name: intravascular administration set
Regulation number: 21 CFR §880.5440
Product 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 subcutaneous
infusion of insulin. |
| Data
demonstrating
substantial
equivalence | Testing demonstrated that the device meets the requirements for its intended
use. The data also demonstrates substantial equivalence to the predicate
device. |
| | The slight difference (omit "administered with micro dosage insulin pump") of
the indication for use between the modified Accu-Chek FlexLink Plus and the
predicate device does not affect the intended use. The infusion set intended for
subcutaneous infusion of insulin is a default accessory used together with a
micro dosage insulin pump. Functional testing to verify the intended use of the
modified Accu-Chek FlexLink Plus was conducted together with micro dosage
insulin pumps. |
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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 |
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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 |
| Sterilization
methodology | Ethylen Oxide | Same |
| Prescription use only | Prescription use only | Same |
| Single use | Single use | Same |
| Standard used
in testing | ISO 7864: 1993 | Sterile hypodermic needles for
single use |
|-----------------------------|------------------------------|------------------------------------------------------------------------------------------------------|
| | AAMI/ANSI/ISO 10993-1: 2003, | Biological evaluation of medical
devices - part 1: evaluation of
testing |
| | AAMI/ANSI/ISO 10993-7: 2008 | Biological evaluation of medical
devices - part 7: ethylene oxide
sterilization residuals |
| | AAMI/ANSI/ISO 11135-1:2007 | Sterilization of healthcare products-
ethylene oxide-part1:requirements
for the development |
| | AAMI/ANSI/ISO 11607-1:2006 | Packaging for terminally sterilized
medical devices-part1-requirements
for materials, sterile |
| | AAMI/ANSI/ISO 11607-2: 2006 | Packaging for terminally sterilized
medical devices-part 2-Validation
requirements for forming |
| | IEC 62366: 2007 | Medical devices - application of
usability engineering to medical
devices |
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| Device
comparisons | The ACCU-CHEK FlexLink Plus infusion set is compared to its predicate
device (K#100704). The ACCU-CHEK FlexLink Plus is substantially
equivalent to the predicate by having the same intended use, same operating
conditions, same luer connector, a flexible cannula and needle for insertion
into the subcutaneous tissue and separate extension tubing with a detachable
connector. Both sets have an adhesive patch that secures the headset to the
skin. Both sets incorporate a needle protection feature that retracts the needle
automatically following insertion of the needle and cannula. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summaries of
Studies | In vitro functional testing of the ACCU-CHEK FlexLink Plus infusion set
was conducted. Biocompatibility testing was performed on the materials used
in the device
System validation testing included human factors usability testing of the
requirements and primary operating function of the ACCU-CHEK FlexLink
Plus infusion set. Individuals who participated in the evaluation included
patients who routinely use insulin pump and infusion set. The usability
evaluation determined the customer requirements and the primary operation
functions were met.
Clinical studies:
Human clinical studies were not deemed necessary to evaluate the safety of
effectiveness of the ACCU-CHEK FlexLink Plus infusion set. |
| Study
conclusion | The results of the in vitro testing conducted indicate the ACCU-CHEK
FlexLink Plus infusion set function according to their specification and the
device 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. |
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