(195 days)
The t:slim® 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 6 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin.
The t:slim® 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 scope of this Traditional 510(k) is limited to expansion of the indications for use to include individuals 6 years of age and greater. The device is indicated for use with NovoLog or Humalog U-100 insulin. No changes have been made to the device components to accommodate the modified indications for use.
The t:slim System, like the predicate device, consists of the following components and accessories:
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- a software-controlled, programmable insulin infusion pump ("t:slim Pump" or "Pump");
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- a dedicated, disposable 3.0 mL (300 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 3 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:slim Pump is a battery operated infusion pump capable of both basal and bolus delivery of insulin. The Pump 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:slim Pump is a touch screen that displays information used to control the t:slim System. The delivery of insulin is accomplished through a micro-syringe within the head of the cartridge.
Identical to the predicate device, the t:slim cartridge is a single-use device, individually packaged and sealed, and is provided sterile. The cartridge attaches to the t:slim Pump and is designed to hold up to 3.0 mL (300 units) of insulin. Both in the predicate and in the device that is the subject of this 510(k) notice, 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.
The provided text describes a 510(k) submission for the t:slim® Insulin Delivery System, focusing on expanding its indications for use to include individuals 6 years of age and greater. This is a regulatory document rather than a study report detailing specific performance criteria and a study to prove they are met in a quantitative sense as might be expected for an AI/ML medical device.
Therefore, many of the requested elements for acceptance criteria and study details are not directly applicable or available in the provided text, as this document is about establishing substantial equivalence based on existing data and human factors testing for a wider age range, rather than presenting a novel clinical performance study with specific device metrics.
However, I can extract information related to the safety assurance case and human factors testing, as these touch upon aspects of "acceptance criteria" in a broader sense for this type of regulatory submission.
Here's an attempt to answer based on the provided text, noting where information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or reported device performance metrics in the way one would see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are framed in terms of general safety, reliability, and substantial equivalence, particularly concerning the expanded age range.
| Acceptance Criteria (Implied from Safety Assurance Case & Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Safety risk reduced to acceptable levels (ALARP) | A comprehensive safety assurance case was provided, addressing operational, environmental, electrical, hardware, software, mechanical, biological/chemical, and use hazards. Mitigating technologies are used, and risks are deemed substantially equivalent to the predicate device. |
| Adequate device reliability | Documented as part of the assurance case. |
| Adequate design verification and validation of device specifications | Documented as part of the assurance case. |
| Maintain substantially equivalent use for individuals 6 years and greater | Human Factors testing supports substantially equivalent use of the device in individuals from 6 years of age and greater. Updated labeling, warnings, and precautions provide further information regarding the risks for pediatric users. The device has identical technological characteristics to the predicate device for this expanded indication. |
| Supported by peer-reviewed literature for CSII in ages 6-11 | A summary of peer-reviewed literature supports the use of Continuous Subcutaneous Insulin Infusion (CSII) in ages 6 through 11. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for the human factors testing or the peer-reviewed literature summary.
- Data Provenance: Not specified for human factors testing. The peer-reviewed literature would be drawn from various studies, likely international, but this is not detailed. The human factors testing is implied to be relevant to the U.S. market.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Not specified. This document describes a 510(k) submission for an insulin pump, not for a diagnostic device that requires expert-established ground truth for a test set in the same manner as an AI/ML imaging system. The "ground truth" here is the established safety and efficacy of CSII, and the device's equivalent performance to its predicate and suitability for a broader age range, assessed through engineering principles, human factors, and literature review.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/None specified. No adjudication method is mentioned as this is not a study involving human reader interpretations that require adjudication.
5. 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
- No. An MRMC study was not done. This device is an insulin pump, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not directly addressed in this framework. The device itself is a standalone insulin pump. The "performance" being evaluated is its safety and functionality for an expanded age range, not an algorithm's diagnostic accuracy in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" used for this submission is multifaceted:
- Peer-reviewed medical literature: Supporting the general efficacy and safety of CSII in pediatric populations (ages 6-11).
- Device specifications and design verification/validation: Demonstrating the device meets its intended functional requirements.
- Human Factors testing: Confirming that the device can be used safely and effectively by the intended user population, including the expanded pediatric group, and that updated labeling is sufficient.
- Predicate device's established safety and performance: The t:slim System is shown to have identical technological characteristics and similar intended use to the predicate device, implying its "ground truth" is aligned with the predicate's proven track record.
8. The sample size for the training set
- Not applicable/Not specified. This document does not describe a machine learning model or a training set in the conventional sense. The "training" for the device's expanded indication relies on existing engineering documentation, human factors insights, and clinical literature.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for a machine learning model described, this question is not relevant to the provided text.
§ 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).