(65 days)
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.
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:
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- a software-controlled, programmable insulin infusion pump ("t:flex Pump" or "Pump");
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- a dedicated, disposable 4.8 mL (480 unit) insulin cartridge ("cartridge");
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- an UnoMedical Comfort™ Infusion Set (K051264), or an equivalently FDA cleared infusion set ("infusion set"); and
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- 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.
This document is a 510(k) premarket notification for the t:flex Insulin Delivery System, an insulin infusion pump. It outlines the device's technical characteristics, intended use, and substantial equivalence to a predicate device. However, the provided text does NOT contain specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.
While it mentions that "Hardware changes were supported by verification testing per previously established acceptance criteria" and outlines the types of testing performed (pump software, aged mechanical, water ingress, current consumption, battery runtime, EMC, electrical safety, cartridge verification, mechanical, package, and distribution testing, and human factors studies), it does not provide the actual acceptance criteria (e.g., "accuracy within X%," "occlusion detection time less than Y seconds") nor does it present a table of reported device performance against those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: This information is not explicitly stated for individual tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not mentioned. Human factors studies are mentioned, but details about expert involvement or qualifications are absent.
- Adjudication method for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is an insulin pump, not an AI diagnostic imaging device, so an MRMC study is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an insulin pump, not an AI algorithm in the typical sense of standalone performance evaluation.
- The type of ground truth used: Not explicitly stated for specific tests. For mechanical or electrical tests, ground truth would be established by reference standards or direct measurement.
- The sample size for the training set: This is not an AI/machine learning device in the context of training data, so this concept is not applicable and information is not present.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding testing:
- Types of tests performed:
- Software verification and validation
- Aged mechanical verification
- Pump aged water ingress
- Average current consumption testing
- Battery runtime verification
- EMC testing
- Electrical safety testing
- Cartridge verification testing
- Mechanical testing (for cartridge)
- Package and distribution testing (for cartridge)
- Human factor formative and summative studies (for user interface)
- Guidance followed: 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.
In summary, while the document confirms various tests were conducted to support substantial equivalence, it lacks the specific, quantitative details requested regarding acceptance criteria, study methodologies, and performance outcomes.
§ 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).