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510(k) Data Aggregation
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The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (CGM) and an interoperable automated glycemic controller (iAGC), in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump is intended for single-person use; it is not to be shared.
The iLet ACE Pump described herein includes changes to the graphic user interface (GUI) and alarms to improve the safety of the device. Instructions were added to the User Guide and Quick Reference Guide to advise users regarding CGM sensor calibration.
No significant changes have been made to the technological characteristics of the device.
The iLet ACE Pump is an alternate controller enabled (ACE) pump intended to deliver insulin under the skin based on input from an integrated continuous glucose monitor (CGM) and an interoperable automated glycemic controller (iAGC) in people 6 years of age or older with diabetes mellitus. The iLet ACE Pump provides a graphical user interface and alerts to interact with the iLet delivery system and an iAGC. The iLet Bionic Pancreas System is a collection of wearable medical devices that work together to deliver insulin with minimal user oversight. The iLet System is made up of the iLet bionic pancreas (consisting of the iLet ACE Pump (with accessories) and iAGC which resides on the ACE pump hardware), ACE pump disposables and accessories, CGM and infusion set. The insulin is filled for iLet use by a user, in a ready-to-fill cartridge (from an insulin vial supplied by a drug manufacturer) with the use of the syringe and needle.
The iLet System consists of the iLet ACE Pump (K231485) with iLet Dosing Decision Software (K232224) and disposable consumables.
The iLet System is only for use with a compatible CGM and U-100 rapid acting insulin.
The CGM communicates with the iLet via Bluetooth. The iLet ACE Pump gets glucose readings from the CGM every 5 minutes and the iAGC uses that information as one of the inputs to calculate the person's insulin needs.
The iLet ACE Pump includes a motor–drivetrain pumping mechanism, which independently actuates the delivery of insulin from a cartridge that is separately loaded into the iLet. Insulin is injected under the skin via continuous infusion. The infusion set must be placed at least 3 inches away from the CGM sensor.
The iLet ACE Pump has a wirelessly rechargeable battery and is designed to be used by a single person and have a useful life of at least 4 years. The iLet is charged on a wireless charging pad which comes with the device. The Luer connector and drug cartridge need to be changed every 3 days. The insulin infusion set and CGM sensor need to be changed as indicated in the manufacturers' labeling.
The provided FDA 510(k) Clearance Letter for the iLet ACE Pump (K252770) describes a device modification to an already cleared predicate device (iLet ACE Pump, K231485). As such, the information regarding acceptance criteria and the study that proves the device meets the acceptance criteria is focused on verifying that the changes did not introduce new safety or effectiveness concerns and that the device remains substantially equivalent to its predicate.
Based on the provided document, the focus of the clearance is on non-clinical testing related to software and labeling changes, rather than a new clinical performance study establishing general efficacy and safety from scratch.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for a device modification, the "acceptance criteria" are predominantly related to the successful verification of the specific changes made and continuous compliance with existing standards. The "reported device performance" refers to the outcome of these verification activities.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software Functionality | Changes to Graphic User Interface (GUI) and alarms perform as expected. | All software verification tests passed. Changes performed as expected and did not produce unintended consequences. |
| Safety - Unintended Consequences | No unintended consequences from GUI and alarm software changes. | All software verification tests passed. No unintended consequences reported. |
| Labeling Compliance | Labeling is sufficient and satisfies applicable requirements of 21 CFR 801, 21 CFR 809, and 21 CFR 880.5730. | Labeling was reviewed by the FDA and found to be sufficient and satisfying applicable requirements. |
| Special Controls Compliance | Device meets all Special Controls for 21 CFR 880.5730 (Alternate controller enabled infusion pumps, product code QFG). | Device meets all Special Controls. |
| Substantial Equivalence | Modified device is as safe and effective as the Predicate Device and does not raise new or different questions of safety or effectiveness. | The modified device has been evaluated to be as safe and effective as the Predicate Device. Modifications do not raise any new or different questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for software verification testing (e.g., number of test cases, number of alarm scenarios). It broadly states "Software design verification testing was performed."
- Data Provenance: The data is generated from non-clinical software verification testing performed internally by Beta Bionics, Inc. The document does not specify country of origin for this testing but implies it aligns with internal design controls and regulatory requirements. It is a "prospective" evaluation of the modified software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. For software verification testing of GUI and alarms, the "ground truth" is defined by the device's functional specifications and regulatory requirements. The testing is performed against these engineering and regulatory specifications, not against expert clinical consensus or pathology findings.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Software verification testing involves comparing observed software behavior against predefined requirements and expected outcomes, not an adjudication process by experts.
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 Alternate Controller Enabled (ACE) infusion pump, which delivers insulin based on CGM input and an automated glycemic controller (iAGC). It is not an AI-assisted diagnostic imaging device that involves human readers interpreting results. Therefore, an MRMC study with human readers is not relevant to this specific clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "Software Design Verification Testing" implies a standalone evaluation of the modified GUI and alarms. This testing would assess the functionality of these software components in a controlled environment, confirming they operate according to specifications without direct real-time human intervention in the loop of the test itself (though a human designed and executed the tests). The iAGC (automated glycemic controller) within the pump itself operates autonomously based on CGM input, representing an "algorithm only" component that was part of the original device's clearance. This specific 510(k) did not require new clinical performance testing for the iAGC algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the software modifications addressed in this 510(k), the "ground truth" is primarily based on:
- Functional Specifications: The intended design and behavior of the GUI and alarms as defined by Beta Bionics.
- Regulatory Requirements: Compliance with relevant FDA regulations for medical device software and labeling.
8. The sample size for the training set
Not applicable. This 510(k) is for a device modification involving GUI and alarm changes. The underlying iAGC algorithm (which would have had a "training set" in its development phase) was previously cleared (K231485 & K232224). No new training or re-training of the core control algorithm was indicated by these specific modifications.
9. How the ground truth for the training set was established
Not applicable to this specific 510(k). For the original iAGC algorithm, the "ground truth" for its training (if an AI/ML approach was used) would have been established through extensive physiological modeling, clinical trial data, and expert endocrinologist input regarding optimal glycemic control targets and safety parameters. However, this information is not part of the provided document for this modification submission.
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(194 days)
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 in individuals 2 years of age and greater.
The Subject Device, t:slim X2 insulin pump with interoperable technology ("t:slim X2 insulin pump", "the pump") is an 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 front of the pump includes a color touch screen display that has a capacitive touch panel that detects a finger touch. The Screen On Button on the side of the insulin pump is surrounded by an LED indicator light. This button is used to turn on the touch screen display so that the user can operate their System. The Screen On Button also provides users with a quick bolus option, which is a feature that allows a user to program and deliver a bolus of insulin through a sequence of presses, without using the touch screen. The System provides audio and vibratory feedback to the user to confirm the delivery. In the case of an incomplete sequence, the bolus is canceled.
The t:slim X2 insulin pump with interoperable technology system also includes: the Tandem t:slim mobile application and a 3mL (300 insulin unit) t:slim X2 cartridge and a compatible FDA cleared infusion set. The Tandem t:slim mobile application ("mobile app") enables a user to connect a smartphone to the pump using Bluetooth® wireless technology to display pump information and perform some pump functions on the smartphone as well as display pump notifications. The Tandem t:slim mobile application will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The Tandem t:slim mobile application will be made available via the Apple® App Store for iOS compatible smartphones and the Android Play Store for Android compatible smartphones based on completed device verification and validation. The t:slim X2 cartridge is a disposable insulin cartridge compatible only with the t:slim X2 pump.
The t:slim X2 pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.
The pump may be used in combination with a compatible continuous glucose monitor (CGM) system. Use of CGM is optional.
Based on the provided document, here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence and testing) | Reported Device Performance |
|---|---|---|
| Insulin Compatibility | The device must demonstrate safe and effective compatibility with Lyumjev U-100 Insulin. | "The testing demonstrated that Lyumjev is a compatible insulin with t:slim X2 insulin pump with interoperable technology." |
| Leachable Testing | Leachable levels must be within acceptable safety limits when used with Lyumjev U-100 Insulin. | "The outcome of the insulin compatibility and leachable testing demonstrates that the Subject Device is as safe and as effective as the Predicate Device." |
| Usability/Human Factors | No new usability/human factors issues introduced by the change (Lyumjev compatibility). | "No new Usability/Human Factors testing was performed to support this 510(k) Notification." (Implies satisfactory existing usability and no new risks from the change). |
| Software Verification & Validation | No new software issues introduced by the change (Lyumjev compatibility). | "No new software testing was performed to support this 510(k) Notification." (Implies satisfactory existing software and no new risks from the change). |
| Special Controls | Continued adherence to the Special Controls established for the predicate device. | "Evaluation and adherence to the Special Controls of the Predicate Device (K232380) demonstrates continued assurance of the safety and effectiveness of the Subject Device." |
| Overall Equivalence | The Subject Device (with Lyumjev compatibility) is as safe and effective as the Predicate Device. | "The required technical documentation provided in this 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "insulin compatibility and leachable testing." It only mentions that the testing was performed.
Data provenance is not specified (e.g., country of origin). The testing described appears to be retrospective in the sense that it's focusing on confirming compatibility of a new insulin with an existing device, rather than a de novo clinical trial with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The testing described (insulin compatibility and leachables) would typically involve laboratory analysis and chemical/material science experts, rather than medical experts establishing ground truth in a clinical sense.
4. Adjudication Method for the Test Set
This information is not provided in the document. For the type of testing described (insulin compatibility, leachables), an adjudication method in the context of expert review for ground truth is not typically applicable. Results would be determined by scientific measurement against predefined physicochemical standards.
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 MRMC comparative effectiveness study was mentioned or performed. This device is an insulin pump; the study is focused on insulin compatibility, not diagnostic imaging or AI-assisted interpretation by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned. The device is a physical insulin pump, and the study concerned its compatibility with a new insulin type. While it has "interoperable technology" and a "mobile application," the submitted 510(k) is specifically for the compatibility with Lyumjev U-100 Insulin, not the performance of any new AI algorithms.
7. The Type of Ground Truth Used
For the insulin compatibility and leachable testing, the ground truth would be established by:
- Physicochemical Standards: Referring to established limits for leached substances, and objective measurements of insulin stability, potency, and any physical changes when in contact with the device materials.
- Comparison to Predicate: Demonstrating that the subject device's performance with Lyumjev insulin is equivalent to or better than the predicate device's performance with its approved insulins, according to predefined scientific criteria.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This premarket notification is not for an AI/ML device that requires a training set in the typical sense. It's for an update to an existing medical device to allow compatibility with a new insulin type.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm within the context of this 510(k) summary.
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(270 days)
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(265 days)
Vivatmo pro-S nitric oxide test is a portable, non-invasive device to measure fractional exhaled nitric oxide (FeNO) in human breath. FeNO is increased in some airway inflammatory processes, such as asthma, and often decreases in response to anti-inflammatory treatment. Measurement of FeNO by Vivatmo pro-S is a method to measure the decrease in FeNO concentration in asthma patients that often occurs after treatment with anti-inflammatory pharmacological therapy as an indication of therapeutic effect in patients with elevated FeNO levels. FeNO measurements are to be used as an adjunct to established clinical assessments.
Vivatmo pro-S is suitable for children, approximately 7-17 years, and adults 18 years and older.
Testing using the Vivatmo pro-S should only be done in a point-of-care healthcare setting under professional supervision. Vivatmo pro-S should not be used in critical care, emergency care or in anesthesiology.
The Vivatmo pro-S system is a automated, non-invasive (in-vitro diagnostic) medical device for professional environment for the quantitative measurement of FeNO (fractional exhaled Nitric Oxide) in human breath.
Measurement of changes in the fractional nitric oxide concentration in expired breath aids in evaluating a patient's response to anti-inflammatory therapy, as an adjunct to establish clinical and laboratory assessments of inflammatory processes such as asthma.
FeNO is recommended by the American Thoracic Society (ATS) in the diagnosis of eosinophilic airway inflammation and in determining the likelihood of responsiveness to anti-inflammatory pharmacological therapy in individuals with chronic respiratory symptoms possibly due to airway inflammation [ATS, 2011].
The Vivatmo pro-S device consists of the following main elements:
- Vivatmo pro-S handheld which holds the measuring module with electronics, display and a battery including software to drive the handheld.
- Vivatmo pro Oxycap/Vivatmo me Oxycap, which is a disposable mouthpiece to prepare the exhaled air for the measurement
- Vivatmo pro Level 0, a disposable mouthpiece to facilitate a measurement with 0 ppb FeNO for QC purpose (optional)
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(159 days)
MissLan® Early Detection Digital Pregnancy Test is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.
MissLan® Early Result Digital Pregnancy Test is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use.
The MissLan® Early Detection Digital Pregnancy Test and the MissLan® Early Result Digital Pregnancy Test are both over-the-counter (OTC) digital pregnancy tests with a sensitivity of 10 mIU/mL hCG. They are powered by battery and display test results on an LCD screen. The MissLan® Early Detection Digital Pregnancy Test displays test results with graphic symbols, including "+" (pregnant), "-" (not pregnant) and " " (invalid); the MissLan® Early Result Digital Pregnancy Test displays test results with text, including "Pregnant", "Not Pregnant" and "Error".
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