(65 days)
No
The description focuses on standard insulin pump functionality, hardware components, and software control based on user input and pressure sensing. There is no mention of AI or ML algorithms for decision-making, pattern recognition, or predictive capabilities.
Yes
The device is described as an "Insulin Delivery System" intended for "subcutaneous delivery of insulin" for the "management of diabetes mellitus," which directly indicates it is used for treatment, thus making it a therapeutic device.
No
The device is an insulin delivery system that regulates the administration of insulin; it does not diagnose a medical condition.
No
The device description explicitly lists hardware components like the insulin infusion pump, cartridge, infusion set, syringe, needle, and power supplies. The performance studies also include hardware verification testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The t:flex™ Insulin Delivery System is an insulin infusion pump. Its primary function is to deliver insulin subcutaneously into the patient's body. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use is for the "subcutaneous delivery of insulin... for the management of diabetes mellitus". This describes a therapeutic delivery system, not a diagnostic test.
- Device Description: The description details the components of an insulin pump system (pump, cartridge, infusion set, accessories) and how it delivers insulin. There is no mention of analyzing biological samples.
Therefore, the t:flex™ Insulin Delivery System is a medical device for therapeutic delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The t:flex Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
Product codes (comma separated list FDA assigned to the subject device)
LZG
Device Description
The t:flex Insulin Delivery System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The t:flex System, like the predicate device, consists of the following components and accessories:
-
- a software-controlled, programmable insulin infusion pump ("t:flex Pump" or "Pump");
-
- a dedicated, disposable 4.8 mL (480 unit) insulin cartridge ("cartridge");
-
- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
-
- accessories, including a 5 mL sterile syringe and 26 gauge sterile needle, as well as an AC power supply and DC car adapter power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:flex Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). The graphical user interface ("GUI") of the t:flex Pump is a capacitive touch screen that displays information used to control the t:flex System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
The t:flex cartridge is a single-use device, individually packaged and sealed, and is provided sterile. The cartridge attaches to the t:flex Pump and is designed to hold up to 4.8 mL, or 480 units of insulin. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
Indicated Patient Age Range
12 years of age and greater
Intended User / Care Setting
user (i.e., the patient)
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)
Software verification and validation testing was performed per FDA’s guidance document, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Draft Guidance, issued on April 23, 2010 ("Draft Guidance"). Hardware changes were supported by verification testing per previously established acceptance criteria. Completed testing to support substantial equivalence determination included pump software, aged mechanical verification, pump aged water ingress, average current consumption testing, battery runtime verification, EMC testing and electrical safety testing. Cartridge testing includes cartridge verification testing, mechanical testing and package and distribution testing. Tandem completed verification of the t:flex System’s user interface through human factor formative and summative studies.
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9,2015
Tandem Diabetes Care, Incorporated c/o Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 1910
Re: K143189
Trade/Device Name: t:flex Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LZG Dated: November 5, 2014 Received: November 5, 2014
Dear Ms. Hogan:
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.
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
1
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 yours.
Susan Runno DDS, MA
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
510(k) Number (if known)
Device Name
t:flex™ Insulin Delivery System
Indications for Use (Describe)
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
Tandem Diabetes Care, Inc. t:flex™ Insulin Delivery System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 Phone: 858-366-6900 Facsimile: 858-362-7070
Contact Person: John Sheridan Contact Email: jsheridan@tandemdiabetes.com
Date Prepared: November 5, 2014
Common or Usual Name
Insulin infusion pump
Classification Name
Infusion Pump per 21 CFR 880.5725
Predicate Devices
Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System (K141758)
Purpose of the 510(k) notification
The t:flex™ Insulin Delivery System is a modification to the previously cleared t:slim® Insulin Delivery System. Specifically, t:flex™ System includes a larger cartridge (4.8 mL vs 3.0 mL) to accommodate patients with higher needs of daily insulin intake.
Intended Use
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.
Device Description
The t:flex™ Insulin Delivery System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The t:flex System, like the predicate device, consists of the following components and accessories:
-
- a software-controlled, programmable insulin infusion pump ("t:flex Pump" or "Pump");
-
- a dedicated, disposable 4.8 mL (480 unit) insulin cartridge ("cartridge");
4
-
- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
-
- accessories, including a 5 mL sterile syringe and 26 gauge sterile needle, as well as an AC power supply and DC car adapter power supply with USB for charging the Pump's internal battery, cartridge Instructions for Use, and User's Guide.
The t:flex Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. It utilizes a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient's subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). The graphical user interface ("GUI") of the t:flex Pump is a capacitive touch screen that displays information used to control the t:flex System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
The t:flex cartridge is a single-use device, individually packaged and sealed, and is provided sterile. The cartridge attaches to the t:flex Pump and is designed to hold up to 4.8 mL, or 480 units of insulin. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge. The Pump has a pressure measurement sensor to estimate the volume of insulin in the insulin reservoir by measuring air pressure in the cartridge. This information is used to provide feedback to the software to determine the insulin volume, detect occlusions and cartridge removal.
Technological Characteristics
The t:flex Insulin Delivery System has the same technological characteristics as the predicate device. The t:flex System consists of: (1) a software-controlled, programmable insulin infusion pump capable of both basal and bolus delivery of insulin ("t:flex Pump"); (2) a dedicated disposable 4.8 mL (480 unit) insulin cartridge; (3) UnoMedical's Comfort™ Infusion Set (K051264), or an equivalently cleared set; and (4) additional device accessories including a sterile syringe and needle (for cartridge filling) an AC power supply and DC car adapter power supply with USB.
Performance Data
Software verification and validation testing was performed per FDA's guidance document, Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions Draft Guidance, issued on April 23, 2010 ("Draft Guidance"). Hardware changes were supported by verification testing per previously established acceptance criteria. Completed testing to support substantial equivalence determination included pump software, aged mechanical verification, pump aged water ingress, average current consumption testing, battery runtime verification, EMC testing and electrical safety testing. Cartridge testing includes cartridge verification testing, mechanical testing and package and distribution testing. Tandem completed verification of the t:flex System's user interface through human factor formative and summative studies.
Substantial Equivalence
The t:flex System has the same intended use and indications for use, the same principles of operation, and same technological characteristics as the previously cleared predicate device. The purpose of this 510(k) is to introduce a pump with a larger insulin cartridge, minor software and hardware changes. The changes made to the device are those necessary to accommodate the
5
larger insulin cartridge. The verification and validation testing, including human factors testing, confirms that the t:flex System is substantially equivalent to its predicate.