FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog/NovoRapid or Humalog U-100 insulin.

Device Description

The t:slim X2 insulin pump with interoperable technology (as shown in Figure 1) is an ambulatory, battery operated, rate-programmable infusion pump designed for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The device includes a custom disposable cartridge which is motor-driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue.

The t:slim X2 insulin pump with interoperable technology consists of:

a user-operated interface display; ●
an electronic microprocessor software control system, including Bluetooth radio ● module and signal processing algorithms allowing the pump to communicate with digitally connected devices:
motor and encoder; ●
rack drive mechanism; and ●
an audible speaker and a vibrator to provide alarms, alerts and reminders to the user. ●

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies that prove the t:slim X2 insulin pump with interoperable technology meets those criteria, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines special controls that act as acceptance criteria for this device type. The reported device performance is extracted directly from the analytical performance studies.

Table 1: Acceptance Criteria and Device Performance for t.slim X2 Insulin Pump

Acceptance Criteria (from 21 CFR 880.5730, Section (b))	Reported Device Performance (from "I. Performance Characteristics")
1.a.i Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.	Basal Delivery Accuracy: Water was delivered at low (0.1 U/hr), medium (2.0 U/hr), and high (15 U/hr) basal rates into a container on a scale. Tested new and aged pumps, and new and aged cartridges. Data reported as median, min, and max total fluid delivered over 1, 6, and 12 hours for each rate. For example, at 15 U/hr, median delivered: 1 hr (15.4 U), 6 hrs (90.4 U), 12 hrs (181 U).
	Bolus Delivery Accuracy: Water was delivered at low (0.05 U), medium (2.5 U), and high (25 U) bolus volumes. Tested new and aged pumps, and new and aged cartridges. Data reported as the number (%) of boluses within specified ranges of the commanded volume. For example, for 2.5U bolus, 94.1% (753/800) were within 95-105% of expected.
1.a.ii Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.	Basal Delivery Accuracy: 32 pumps (16 new, 16 aged to simulate 4 years use). Varied cartridge age (new vs. 2 years aged). Results demonstrate delivery within expected ranges with reported median, min, and max.
	Bolus Delivery Accuracy: 32 pumps (16 new, 16 aged to simulate 4 years use). Varied cartridge age (new vs. 2 years aged). Results show a high percentage of boluses within 95-105% of commanded volumes for 2.5U (94.1%) and 25U (98.4%). Smallest bolus (0.05U) showed more variability but still majority within reasonable ranges.
1.b. Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.	Occlusion Detection: 29 pumps tested with a representative 110 cm infusion set. For bolus: 3U and 25U boluses; for basal: 2.0 U/hr. The distal end of the infusion set was occluded.

Bolus (3 units): Average time to detection 0:01:00, max 0:01:35
Bolus (25 units): Average time to detection 0:01:05, max 0:01:25
Basal (2.0 units/hour): Average time to detection 1:01:39, max 1:29 |
| 1.c. Validation testing results demonstrating compatibility with drugs which may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions which may affect drug stability (e.g., temperature, light exposure, or other factors as needed). | Insulin Compatibility and Stability: In vitro testing for extractables/leachables and insulin compatibility with Humalog and Novolog. Stability evaluated for 6 days at 25°C and 3 days at 37°C (stressed). Acceptable results for degradation products, extractables, and leachables. |
| 1.d. The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low. | Biocompatibility: Insulin cartridge tested per ISO-10993-1. Results: non-toxic (cytotoxicity, systemic toxicity), no sensitization, non-irritant (irritation/intracutaneous, implantation), non-hemolytic, negative subacute/subchronic toxicity, non-mutagenic/non-genotoxic (Ames, Chromosome Aberration, Mouse Micronucleus). |
| 1.e. Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance. | Mechanical Engineering: Referenced previous submissions (P140015, P180008) for mechanical reliability, stress, performance, packaging, shelf life, and storage testing. New hazard analysis accounted for interoperability risks. Specific tests mentioned include: Environmental Storage, Drop Resistance, Fluid Ingress (IPX7), Battery Verification, Random Vibration, Mechanical Shock, etc. |
| 1.f. The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment. | EMC and Wireless Coexistence: Passed IEC 60601-1-2 (EMC, EMI, wireless coexistence). Passed FCC Part 15 (Radiated Emissions, Occupied Bandwidth, Band-edge Measurement). Demonstrated communication with digitally connected device at max distance of 20 feet.
Electrical Safety and Essential Performance: Passed IEC 61010-1 (ed. 3) and collateral standards (IEC 60601-1-8, 1-11, 2-24). |
| 1.g. For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated. | Not explicitly addressed as a separate study point, but "Design mitigations to prevent cross-channeling" is listed as a mitigation measure for "Patient harm due to inadequate drug delivery accuracy" in Section K. |
| 1.h. For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing. | Not applicable; device is for single patient, home use (Section G.1). |
| 2.a. Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented. | Hazard Analysis: Revised hazard analysis to account for interoperability risks, unique design elements, and intended use. Traced all identified risks to adequate design controls and demonstrated appropriate implementation and validation. |
| 2.b. A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design. | Hazard Analysis: "traced all identified risks to adequate design controls, and demonstrated that design features were appropriately implemented and validated." |
| 3. The device shall include validated interface specifications for digitally connected devices... | Interoperability: Plan and approach for interoperability provided per FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices." Included secure, accurate, reliable communication, sharing state information, handling out-of-bounds data, and a process for sharing specs with connected devices. |
| 4. The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or reestablished after an interruption... Validation testing results must demonstrate that critical events that occur during a loss of communications... are handled appropriately... | Interoperability: Validated software protocols for failsafe design features to mitigate risks of communication interruption. The hazard analysis also covered scenarios where compatible/incompatible digital devices attempted communication and delivered commands. |
| 5. The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices... | Data Logging: Validated software protocols enable recording critical events: insulin delivery, pump commands/confirmations, connectivity states, malfunctions, alarms. These were reviewed and found adequate. |
| 6. Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. | Human Factors: Non-randomized, multicenter study with 30 representative participants (plus separate study with 36 participants aged 6-11) in a simulated use environment. Assessed comprehension and usability for critical tasks, alone and with a digitally connected device. Demonstrated safe use by intended users. |

2. Sample Size Used for the Test Set and Data Provenance

Basal Delivery Accuracy: 32 pumps (16 new, 16 aged to simulate 4 years use). For both aged and unaged, 8 tested with new cartridges, 8 with 2-year aged cartridges.
Bolus Delivery Accuracy: 32 pumps (16 new, 16 aged to simulate 4 years use). For both aged and unaged, 8 tested with new cartridges, 8 with 2-year aged cartridges.
Occlusion Detection: 29 pumps.
Human Factors: 30 representative participants for general use, plus an additional study with 36 representative participants aged 6-11.
Data Provenance: Not explicitly stated regarding country of origin, but the testing appears to be retrospective analytical and simulated use studies conducted by the manufacturer as part of the De Novo submission. "Simulated 4 years of typical regular use" and "2 years of real time aging" for cartridges indicate specific aging protocols rather than field data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable: The studies described for analytical performance (delivery accuracy, occlusion detection) and biocompatibility use physical measurements and laboratory standards (e.g., scales for fluid delivery, time measurement for occlusion, ISO standards for biocompatibility) to establish ground truth, not expert consensus.
For Human Factors studies, "ground truth" is typically defined by successful completion of critical tasks or identification of use errors based on pre-defined criteria, which don't require external experts to "establish ground truth" in the same way clinical image interpretation might. The design and validation of the Human Factors study would be overseen by human factors engineering specialists.

4. Adjudication Method for the Test Set

Not Applicable: The analytical performance and biocompatibility studies rely on direct measurement and established laboratory standards, not human interpretation requiring adjudication. Human Factors studies would identify use errors, but adjudication (e.g., 2+1, 3+1) is typically for disagreements in subjective interpretation, which isn't the primary method for these engineering and usability tests.

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

Not Applicable: This device is an insulin pump and not an AI-powered diagnostic imaging device or a system where "human readers" interpret data in the context of improving with or without AI assistance. The "AI" component mentioned is an "automated insulin dosing software" which is an external, interoperable device. This document focuses on the pump's ability to reliably act on commands from such devices, not on the performance of human readers assisted by AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, for the pump itself: The detailed analytical performance testing for basal delivery accuracy, bolus delivery accuracy, and occlusion detection represents the standalone performance of the t:slim X2 pump without human intervention during the measurement phase. Water was pumped, and weights/times were recorded. The pump's ability to receive, execute, and confirm commands from other devices (as per the interoperability section) also indicates standalone testing of specific functionalities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Objective Measurements and Standardized Testing:
- Basal/Bolus Delivery Accuracy: Measured weight of water delivered vs. expected volume. This is an objective, quantitative measurement.
- Occlusion Detection: Time elapsed between occlusion initiation and pump detection, an objective time measurement.
- Biocompatibility: Results of standardized lab tests according to ISO 10993-1 (e.g., "Non-toxic", "No evidence of sensitization").
- Electrical Safety, EMC, Wireless: Compliance with recognized international standards (IEC, FCC).
- Human Factors: Identification of critical use errors and successful completion rates based on predefined safety criteria during simulated use.

8. The Sample Size for the Training Set

Not Applicable for AI/Machine Learning Model Training: This document describes the evaluation of a medical device (insulin pump) through engineering, analytical, and human factors testing, not the training of an AI or machine learning algorithm. The pump's software includes "signal processing algorithms" but there's no indication that these algorithms are "trained" in the typical machine learning sense with a distinct training dataset. The development relied on hazard analyses and software development processes.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: As there's no indication of a machine learning training set in the conventional sense within this document, the method for establishing its ground truth is not applicable.

Summary

Regulation Number and Section

§ 880.5730 Alternate controller enabled infusion pump.

(a)
Identification. An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
e.g., temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
e.g., battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
e.g., reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
e.g., establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is 250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.