← Product Code [QJI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI) · K232603 # CamAPS FX (K232603) _Camdiab , Ltd. · QJI · May 23, 2024 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI/K232603 ## Device Facts - **Applicant:** Camdiab , Ltd. - **Product Code:** [QJI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI.md) - **Decision Date:** May 23, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1356 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry - **Attributes:** Software as a Medical Device, Therapeutic, PCCP, Pediatric ## Indications for Use CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump. CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual. CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy. CamAPS FX is for prescription use only. ## Device Story CamAPS FX is a mobile application functioning as an interoperable automated glycemic controller. It receives real-time glucose data from a compatible continuous glucose monitor (CGM) and communicates with an insulin pump to automate basal insulin delivery. The user performs manual bolusing for meals. The system operates as a hybrid closed-loop controller to manage glucose levels in patients with type 1 diabetes. It is intended for prescription use by patients or caregivers. The device output assists in glycemic control, aiming to improve patient outcomes by reducing glucose variability and hypoglycemia/hyperglycemia risks. The system includes a Predetermined Change Control Plan (PCCP) for future software modifications. ## Clinical Evidence Supported by 10 randomized clinical studies (AiDAPT, DAN06, KidsAP02, AP@home04 extension, DAN05, CLOuD, APCam11, FastKids, AP@home04 Phase 3/4) and real-world evidence (9,869 users). Studies evaluated glycemic outcomes (Time in Range, HbA1c) and safety (severe hypoglycemia, DKA). Results showed improved time-in-range and HbA1c compared to control/usual care. Real-world data supported safety of Boost/Ease-Off modes and personalized targets. FDA ordered a postmarket surveillance study to further assess risk/benefit in broader populations. ## Technological Characteristics Mobile application software; interoperable automated glycemic controller; hybrid closed-loop architecture; interfaces with external CGM and insulin pump via wireless connectivity; operates on mobile platform. ## Regulatory Identification An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control. ## Special Controls *Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) An appropriate, as determined by FDA, clinical implementation strategy, including data demonstrating appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (A) The clinical data must be representative of the performance of the device in the intended use population and in clinically relevant use scenarios and sufficient to demonstrate appropriate, as determined by FDA, clinical performance of the device for its intended use, including all of its indications for use. (B) For devices indicated for use with multiple therapeutic agents for the same therapeutic effect ( *e.g.,* more than one type of insulin), data demonstrating performance with each product or, alternatively, an appropriate, as determined by FDA, clinical justification for why such data are not needed.(C) When determined to be necessary by FDA, the strategy must include postmarket data collection to confirm safe real-world use and monitor for rare adverse events. (ii) Results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use. (iii) A detailed and appropriate, as determined by FDA, strategy to ensure secure and reliable means of data transmission with other intended connected devices. (iv) Specifications that are appropriate, as determined by FDA, for connected devices that shall be eligible to provide input to ( *e.g.,* specification of glucose sensor performance) or accept commands from (*e.g.,* specifications for drug infusion pump performance) the controller, and a detailed strategy for ensuring that connected devices meet these specifications.(v) Specifications for devices responsible for hosting the controller, and a detailed and appropriate, as determined by FDA, strategy for ensuring that the specifications are met by the hosting devices. (vi) Documentation demonstrating that appropriate, as determined by FDA, measures are in place ( *e.g.,* validated device design features) to ensure that safe therapy is maintained when communication with digitally connected devices is interrupted, lost, or re-established after an interruption. Validation testing results must demonstrate that critical events that occur during a loss of communications (*e.g.,* commands, device malfunctions, occlusions, etc.) are handled and logged appropriately during and after the interruption to maintain patient safety.(vii) A detailed plan and procedure for assigning postmarket responsibilities including adverse event reporting, complaint handling, and investigations with the manufacturers of devices that are digitally connected to the controller. (2) Design verification and validation documentation 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 to address device system hazards; (ii) Design decisions related to how the risk control measures impact essential performance; and (iii) 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 appropriate, as determined by FDA, and validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following: (i) Secure authentication (pairing) to connected devices; (ii) Secure, accurate, and reliable means of data transmission between the controller and connected devices; (iii) Sharing of necessary state information between the controller and any connected devices ( *e.g.,* battery level, reservoir level, sensor use life, pump status, error conditions);(iv) Ensuring that the controller continues to operate safely when data is received in a manner outside the bounds of the parameters specified; (v) A detailed process and procedures for sharing the controller's interface specification with connected devices and for validating the correct implementation of that protocol; and (vi) A mechanism for updating the controller software, including any software that is required for operation of the controller in a manner that ensures its safety and performance. (4) 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 controller must, at a minimum, include: (i) Commands issued by the controller, and associated confirmations the controller receives from digitally connected devices; (ii) Malfunctions of the controller and malfunctions reported to the controller by digitally connected devices ( *e.g.,* infusion pump occlusion, glucose sensor shut down);(iii) Alarms and alerts and associated acknowledgements from the controller as well as those reported to the controller by digitally connected devices; and (iv) Connectivity events ( *e.g.,* establishment or loss of communications).(5) The device must only receive glucose input from devices cleared under § 862.1355 (integrated continuous glucose monitoring system), unless FDA determines an alternate type of glucose input device is designed appropriately to allow the controller to meet the special controls contained within this section. (6) The device must only command drug delivery from devices cleared under § 880.5730 of this chapter (alternate controller enabled infusion pump), unless FDA determines an alternate type of drug infusion pump device is designed appropriately to allow the controller to meet the special controls contained within this section. (7) An appropriate, as determined by FDA, training plan must be established for users and healthcare providers to assure the safety and performance of the device when used. This may include, but not be limited to, training on device contraindications, situations in which the device should not be used, notable differences in device functionality or features compared to similar alternative therapies, and information to help prescribers identify suitable candidate patients, as applicable. (8) The labeling required under § 809.10(b) of this chapter must include: (i) A contraindication for use in pediatric populations except to the extent clinical performance data or other available information demonstrates that it can be safely used in pediatric populations in whole or in part. (ii) A prominent statement identifying any populations for which use of this device has been determined to be unsafe. (iii) A prominent statement identifying by name the therapeutic agents that are compatible with the controller, including their identity and concentration, as appropriate. (iv) The identity of those digitally connected devices with which the controller can be used, including descriptions of the specific system configurations that can be used, per the detailed strategy submitted under paragraph (b)(1)(iii) of this section. (v) A comprehensive description of representative clinical performance in the hands of the intended user, including information specific to use in the pediatric use population, as appropriate. (vi) A comprehensive description of safety of the device, including, for example, the incidence of severe hypoglycemia, diabetic ketoacidosis, and other relevant adverse events observed in a study conducted to satisfy paragraph (b)(1)(i) of this section. (vii) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device. (viii) For any controller with hardware components intended for multiple patient reuse, instructions for safely reprocessing the hardware components between uses. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY ## I Background Information: A 510(k) Number K232603 B Applicant CamDiab Ltd. C Proprietary and Established Names CamAPS FX D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | QJI | Class II | 21 CFR 862.1356 - Interoperable Automated Glycemic Controller | CH - Clinical Chemistry | | NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | CH - Clinical Chemistry | ## II Submission/Device Overview: A Purpose for Submission: New device. B Type of Test: Not applicable. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. B Indication(s) for Use: CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump. CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual. CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy. CamAPS FX is for prescription use only. C Special Conditions for Use Statement(s): Rx - For Prescription Use Only CamAPS FX is indicated for use with NovoLog and HumaLog U-100 insulin (age 2 years and over and including pregnancy), and Fiasp and Lyumjev U-100 (age 18 and over and excluding pregnancy). Pregnant users should only utilize the CamAPS FX app with a continuous glucose monitoring system suitable for use during pregnancy. Prior to initiating use of the CamAPS FX app, pregnant users should consult with their healthcare providers. CamAPS FX should not be used by anyone who is: - Unable to notice alerts, alarms and reminders because of physical limitations. - Unable to monitor glucose as recommended by their healthcare provider. - Unable to maintain contact with their healthcare provider - Unwilling or unable to follow the instructions for use and intended uses of compatible insulin pumps and continuous glucose monitor devices. CamAPS FX should not be used in clinical scenarios where the safety and effectiveness of CamAPS FX has not been evaluated, such as inpatient/hospitalized patient use. IV Device/System Characteristics: A Device Description: CamAPS FX is an Android App intended to receive glucose readings from an integrated continuous glucose monitoring (iCGM) device to control an insulin pump. The App has been evaluated in individuals aged 2 years and older including pregnant women. The App adopts a modular design. It comprises software items including Main Platform and Control Algorithm. The Main Platform manages data, implements user interface, bolus calculator, cloud upload K232603 - Page 2 of 15 {2} connectivity, alert/alarm management, and other pertinent aspects. The Control Algorithm implements an adaptive model-predictive control algorithm which processes sensor glucose data and generates advice on insulin dosing. Additional software items include insulin pump and CGM libraries. These software items implement secure wireless (Bluetooth or Low Energy Bluetooth) communication with insulin pumps and CGM transmitters. Insulin pump and CGM devices are manufactured by third parties and are not part of the App. The App has been designed to allow additional insulin pumps and CGM systems which meet the sponsor's predetermined specifications to be added to the App after they are cleared for use in the US. The CamAPS FX App operates in one of the following modes: - Auto Mode Off (open loop) - The pump operates at the pre-programmed basal profile, or as instructed by the user. The communication with the CGM is maintained and the sensor glucose information is displayed. - Auto Mode Off is the default mode of operation on system start-up. - Auto Mode On (closed loop) - A mode of operation where insulin delivery is directed by the app replacing pre-programmed basal insulin delivery. - Once Auto Mode On is activated by the user, the system will stay in this mode until the user deactivates it. - Auto Mode "Attempting" - A mode of operation when the app is attempting to enter Auto Mode but a condition is preventing it from doing so. The reasons leading to "Attempting" auto mode include: - Sensor glucose data unavailable (includes sensor warmup) - Loss of communication with insulin pump - Pump insulin delivery suspended - Total daily insulin dose exceeded - Bluetooth turned off (pump or smartphone) - Extended bolus disallowed on the pump - The 'Attempting' mode continues until the condition preventing the start of Auto Mode is resolved. When in 'Attempting' mode, insulin infusion will revert to the pre-programmed basal rate after approximately 30 minutes. - "Fail Safe" Mode - In the event of an unrecoverable error or your smart device depowering, your insulin pump will revert to the pre-programmed basal profile within 30 minutes. B Instrument Description Information: 1. Instrument Name: CamAPS FX 2. Specimen Identification: N/A K232603 - Page 3 of 15 {3} 3. Specimen Sampling and Handling: N/A 4. Calibration: N/A 5. Quality Control: N/A This medical device product has functions subject to FDA premarket review as well as functions that are not subject to FDA premarket review. For this application, if the product has functions that are not subject to FDA premarket review, FDA assessed those functions only to the extent that they either could adversely impact the safety and effectiveness of the functions subject to FDA premarket review or they are included as a labeled positive impact that was considered in the assessment of the functions subject to FDA premarket review. V Substantial Equivalence Information: A Predicate Device Name(s): Tidepool Loop B Predicate 510(k) Number(s): K203689 C Comparison with Predicate(s): | Device & Predicate Device(s): | K232603 | K203689 | | --- | --- | --- | | Device Trade Name | CamAPS FX | Tidepool Loop | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | Mobile app intended for managing glucose levels in people with type 1 diabetes using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfill its intended use. | Same | | Device hosting controller | Mobile app | Same | K232603 - Page 4 of 15 {4} | General Device Characteristic Differences | | | | --- | --- | --- | | Target patient population | Type 1 diabetes mellitus in persons 2 year of age and greater. | Type 1 diabetes mellitus in persons 6 years of age and greater. | | Mobile app platform | Android smart phone | iPhone | | User-controlled target range settings | Target range during auto mode: 80-198 mg/dL | Correction Range: 87 - 180 mg/dL Pre-Meal Range: Glucose Safety Limit (which can be set from 67-110 mg/dL) - 130 mg/dL Workout Range: the higher of 85 mg/dL or the Glucose Safety Limit (which can be set from 67-110 mg/dL) - 250 mg/dL | VI Standards/Guidance Documents Referenced: - IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes - IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices - IEC 60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers - IEC 60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment VII Performance Characteristics (if/when applicable): A Analytical Performance: 1. Precision/Reproducibility: Not applicable. K232603 - Page 5 of 15 {5} 2. Linearity: Not applicable. 3. Analytical Specificity/Interference: Not applicable. 4. Accuracy (Instrument): Not applicable. 5. Carry-Over: Not applicable. ## B Other Supportive Instrument Performance Characteristics Data: ### Summary of Clinical Testing: The CamAPS FX app has been evaluated in a series of randomized clinical studies. Ten key studies (AiDAPT, DAN06, KidsAP02, AP@home04 extension, DAN05, CLOuD, APCam11, FastKids, AP@home04 Phase 3, and AP@home04 Phase 4) were used to support substantial equivalence of the subject device. These studies utilized either the most recent, to-be-marketed version of the CamAPS FX algorithm, 0.3.71, or version 0.3.46, which is functionally identical. All studies were performed outside the United States (OUS) except for APCam11 and Dan05, which enrolled participants in the US. ### Baseline Demographics The majority of studies enrolled current pump users, with the exception of AiDAPT and CLOuD, which enrolled users on multiple daily injections (MDI) users. Subjects already on an insulin pump continued on their existing pump in the control arm or usual care phase of all studies. Similarly, subjects on MDI continued on their existing MDI regimen in the control arm of the AiDAPT and CLOuD studies. All studies included majority White/Caucasian subjects, with the lowest percentage of White participants being 80% in the Fastkids study, and the highest being 100% in the AP@home04 phase 4 study. K232603 - Page 6 of 15 {6} Table 1: Baseline characteristics at enrollment | Study (type) | Study Arm | N | Study Duration | Age, Mean years ± SD (range) | Sex, % female | | --- | --- | --- | --- | --- | --- | | AiDAPT (RCT) | Closed loop | 61 | From <16 weeks gestation to delivery | 32±5 (20 to 43) | 100 | | | Control | 63 | From <16 weeks gestation to delivery | 32±6 (20 to 45) | 100 | | DAN06 (Randomized crossover) | Overall | 37 | 2x16 weeks | 67±5 (60 to 80) | 43 | | KidsAP02 (Randomized crossover) | Overall | 74 | 2x16 weeks | 6±2 (2 to 8) | 42 | | AP@home04 extension (phase 2) (Randomized crossover) | Overall | 29 | 2x4 weeks | 41±13 (29 to 62) | 52 | | DAN05 (RCT) | Closed loop | 65 | 6 months | 13±3 (8 to 18) | 57 | | | Control | 68 | 6 months | 13±3 (6 to 18) | 57 | | CLOuD (RCT) | Closed loop | 51 | 2 years | 12±2 (10 to 16) | 49 | | | Control | 46 | 2 years | 12±2 (10 to 16) | 39 | | APCam11 (RCT) | Closed loop | 46 | 12 weeks | 25±14 (8 to 65) | 48 | | | Control | 40 | 12 weeks | 24±14 (6 to 60) | 55 | | FastKids (Randomized crossover) | Overall | 25 | 2x8 weeks | 5±1 (2 to 7) | 32 | | AP@home04 – Phase 3 (Randomized crossover) | Overall | 25 | 2x8 weeks | 38±9 (24 to 53) | 52 | | AP@home04 – Phase 4 (Randomized crossover) | Overall | 28 | 2x8 weeks | 44±11 (23 to 68) | 36 | N: number of subjects; SD: standard deviation; RCT: randomized controlled trial K232603 - Page 7 of 15 {7} # Safety Results The table below summarizes the incidence of severe hypoglycemic and diabetic ketoacidosis events throughout each clinical study. The duration of each study can be found in Table 1 above. Table 2: Adverse Events by Study Treatment Group in Each Clinical Study | Study | Study Arm/Phase | N | Severe Hypoglycemia, # of events | Diabetic Ketoacidosis (DKA), # of events | | --- | --- | --- | --- | --- | | AiDAPT | Closed loop | 61 | 6 | 1 | | | Control | 63 | 5 | 1 | | DAN06 | Closed loop | 36 | 0 | 0 | | | Control | 37 | 2 | 0 | | KidsAP02 | Closed loop | 73 | 1 | 0 | | | Control | 74 | 0 | 0 | | AP@home04 extension (phase 2) | Closed loop | 29 | 0 | 0 | | | Control | 28 | 0 | 0 | | DAN05 | Closed loop | 65 | 4 | 2 | | | Control | 68 | 3 | 0 | | CLOuD | Closed loop | 51 | 5 | 1 | | | Control | 46 | 1 | 0 | | APCam11 | Closed loop | 46 | 0 | 1 | | | Control | 40 | 0 | 0 | | FastKids | Closed loop with Fiasp | 25 | 0 | 0 | | | Closed loop with Novolog | 25 | 0 | 0 | | AP@home04 – Phase 3 | Closed loop with Fiasp | 25 | 0 | 0 | | | Closed loop with Novolog | 25 | 0 | 0 | | AP@home04 – Phase 4 | Closed loop with Lyumjev | 26 | 0 | 0 | | | Closed loop with Humalog | 27 | 0 | 0 | K232603 - Page 8 of 15 {8} # Observed Results The data below describes how the device performed during the studies. Table 3: Overall Glycemic Outcomes During the Clinical Studies | Study | Study Arm/Phase (number of subjects) | % time in range 70-180 mg/dL, mean ± SD | % time below 70 mg/dL, Median (IQR) | % time below 54 mg/dL, Median (IQR) | % time above 180 mg/dL, Mean ± SD | Mean Glucose (mg/dL), Mean ± SD | | --- | --- | --- | --- | --- | --- | --- | | AiDAPT | Closed loop (n=59) | 68±11* | 2.3** (1.5 to 3.3) | 0.7 (0.5 to 1.2) | 11±9 | 125±14 | | | Control (n=61) | 56±13* | 2.0** (1.3 to 4.4) | 0.7 (0.4 to 1.7) | 17±11 | 136±16 | | DAN06 | Closed loop (n=36) | 80±8 | 1.7 (1.3 to 2.4) | 0.2 (0.1 to 0.3) | 18±8 | 141±13 | | | Control (n=37) | 71±13 | 1.7 (0.9 to 2.7) | 0.2 (0.1 to 0.3) | 27±14 | 153±20 | | KidsAP02 | Closed loop (n=73) | 72±6 | 4.9 (3.3 to 6.7) | 1.0 (0.6 to 1.4) | 23±7 | 146±12 | | | Control (n=74) | 63±9 | 4.5 (2.9 to 7.3) | 0.9 (0.4 to 1.6) | 32±10 | 158±19 | | AP@home04 extension (phase 2) | Closed loop (n=29) | 76±6 | 2.9 (2.3 to 40) | 0.3 (0.1 to 0.5) | 20±6 | 142±9 | | | Control (n=28) | 66±8 | 5.3 (3.5 to 10.0) | 1.0 (0.5 to 2.6) | 27±10 | 150±16 | | DAN05† | Closed loop (n=19) | 63±9‡ | 10.8‡ (5.7 to 20.7) | 2.9‡ (1.6 to 6.1) | 24±8‡ | 141±18‡ | | | Control (n=24) | 39±13‡ | 6.3‡ (1.7 to 16.5) | 1.4‡ (0.2 to 6.2) | 47±17‡ | 177±38‡ | | CLOuD | Closed loop (n=42) | 64±15‡ | 8.1‡ (5.0 to 17.2) | 2.0‡ (0.4 to 4.7) | 22±11‡ | 142±34‡ | | | Control (n=30) | 49±18‡ | 4.8‡ (2.7 to 11.7) | 1.1‡ (0.1 to 3.4) | 42±19‡ | 176±47‡ | | APCam11 | Closed loop (n=46) | 65±8 | 2.6 (1.9 to 3.6) | 0.3 (0.2 to 0.6) | 32±8 | 160±13 | | | Control (n=40) | 54±9 | 3.9 (1.7 to 5.3) | 0.5 (0.2 to 0.9) | 42±10 | 175±18 | | FastKids | Closed loop Fiasp (n=25) | 64±9 | 3.5 (2.6 to 6.3) | 0.8 (0.5 to 1.8) | 31±9 | 160±16 | | | Closed loop Novolog (n=25) | 65±9 | 3.7 (2.6 to 6.2) | 0.8 (0.4 to 1.9) | 31±9 | 160±14 | K232603 - Page 9 of 15 {9} | Study | Study Arm/Phase (number of subjects) | % time in range 70-180 mg/dL, mean ± SD | % time below 70 mg/dL, Median (IQR) | % time below 54 mg/dL, Median (IQR) | % time above 180 mg/dL, Mean ± SD | Mean Glucose (mg/dL), Mean ± SD | | --- | --- | --- | --- | --- | --- | --- | | AP@home04 – Phase 3 | Closed loop with Fiasp (n=25) | 75±8 | 2.4 (1.2 to 3.2) | 0.4 (0.2 to 0.7) | 22±9 | 146±14 | | | Closed loop with Novolog (n=25) | 75±8 | 2.9 (1.7 to 4.0) | 0.7 (0.2 to 0.9) | 21±9 | 144±14 | | AP@home04 – Phase 4 | Closed loop with Lyumjev (n=26) | 79±10 | 2.3 (1.3 to 2.7) | 0.3 (0.2 to 0.5) | 19±10 | 142±14 | | | Closed loop with Humalog (n=27) | 76±10 | 2.1 (1.4 to 3.3) | 0.3 (0.2 to 0.5) | 22±10 | 146±16 | * pregnancy specific time in range 63 to 140 mg/dL ** < 63mg/dL †when using CamAPS FX ‡measured by multiple CGMs including the Dexcom G6 and the Abbott FreeStyle Libre Pro K232603 - Page 10 of 15 {10} Table 4: Available HbA1c Observed During the Clinical Studies | Study | Study Arm/Phase (# of subjects) | Baseline HbA1c (%), Mean ± SD | HbA1c at end of study (%), Mean ± SD | | --- | --- | --- | --- | | AiDAPT | Closed loop (n=59) | 7.6±1.1 | 6.0±0.5 | | | Control (n=61) | 7.9±1.3 | 6.4±0.5 | | DAN06 (cross-over) | Closed loop (n=36) | 7.4±0.9 | 6.7±0.7 | | | Control (n=37) | 7.4±0.9 | 6.9±0.9 | | KidsAP02 | Closed loop (n=73) | 7.3±0.7 | 6.6±0.6 | | | Control (n=74) | 7.3±0.7 | 7.0±0.7 | | AP@home04 extension (phase 2) | Closed loop (n=29) | 6.9±0.5 | NA | | | Control (n=28) | 6.9±0.5 | NA | | DAN05* | Closed loop (n=21) | 7.9±0.9 | 6.8±0.5 | | | Control (n=24) | 8.0±0.6 | 7.9±0.8 | | CLOuD | Closed loop (n=47) | 10.7±1.8 | 6.9±1.0 | | | Control (n=36) | 10.5±1.6 | 8.0±1.4 | | APCam11 | Closed loop (n=46) | 8.0±0.6 | 7.4±0.6 | | | Control (n=40) | 7.8±0.6 | 7.7±0.5 | | FastKids | Closed loop with Fiasp (n=25) | 7.2±0.8 | NA | | | Closed loop with Novolog (n=25) | 7.2±0.8 | NA | | AP@home04 - Phase 3 | Closed loop with Fiasp (n=25) | 7.4±0.8 | NA | | | Closed loop with Novolog (n=25) | 7.4±0.8 | NA | | AP@home04 - Phase 4 | Closed loop with Lyumjev (n=26) | 7.1±0.9 | NA | | | Closed loop with Humalog (n=27) | 7.1±0.9 | NA | * when using CamAPS FX # Real-World Evidence The sponsor also conducted analyses of real-world data to support the overall safety of CamAPS FX as well as specific features, such as Boost Mode and Ease-Off Mode. Real-world evidence (RWE) analyses were conducted in 9,869 users with type 1 diabetes who used the CamAPS FX app for a median of 265 days. Data analysis was performed using sensor glucose data collected between December 1, 2022, and November 30, 2023. This information was used to help support the safety and effectiveness of this device and support the substantial equivalence of CamAPS FX to its predicate device. K232603 - Page 11 of 15 {11} Specifically, this data provided information on the extended use (i.e. between 9-13 hours) of Boost mode, which was not utilized in the clinical studies. With the longer duration of use, there was no increase in reported severe hypoglycemia. However, as expected there was some increase in CGM % time below 70 mg/dL from 0.0% to around 1%. Similarly, RWE provided information on the extended use (i.e. between 9-13 hours) of Ease-off mode, which was not utilized in the clinical studies. While there was no increase in incidence of reported DKA, there was a gradual increase in CGM % time above range (>180 mg/dL) with longer duration of Ease-off mode use. Finally, RWE provided data on use of personal glucose targets <90 mg/dL or >160 mg/dL which were not utilized in the clinical studies. As expected, use of these low or high glucose targets resulted in increased time below range and time above range, respectively. There was no association of higher/lower targets with increased incidence of reported DKA/severe hypoglycemia. Although use of Boost or Ease off mode for more than 9 hours, or personal glucose targets at the very high or low ends did appear to be associated with an increase in time below or above range, use of these settings may be appropriate for certain clinical circumstances. For example, use of a lower personal target may be appropriate in pregnancy to achieve tighter glycemic targets, and use of Boost mode may be appropriate for patients who need to take steroid medications for a short period of time. The use of these features is important to allow for custom use of the device to adapt to the clinical needs and characteristics of the intended user population. Appropriate warnings and information regarding use of Boost mode, Ease-off mode, and personalized glucose targets are included in the User Manual, including examples of when to use these modes appropriately. All users are cautioned to discuss use of these settings with guidance from their healthcare provider. ## Human Factors Human factors validation testing was conducted with CamAPS FX installed on an Android phone. A total of two formative studies were conducted and the results were used to inform the user interface design, use-related risk analysis, and summative testing protocol. The summative human factors validation study was performed on the final device design with 50 representative participants which included adult users (18 years and older), adolescent users (13-17 years) with their caregivers, and pediatric users (2-12 years) with their caregivers. All study participants received in-app training that was consistent with the training that patients would receive with the commercial product. Simulated use testing assessed the usability and risk mitigations of the device by providing sufficient clinical context to simulate actual use scenarios representing all critical device tasks. Results of the study supported the substantial equivalence of CamAPS FX to its predicate. ## User and Provider Training Physician and user training as per the sponsor-provided training materials is important to ensure safe use of the device. When a new user (including healthcare professionals and caregivers) downloads the app and signs into the CamAPS FX for the first time, they will be immediately offered in-App training. This mandatory in-app training is designed to orient the user to the functionality of the app, covering all critical tasks that the user will need to perform safely when K232603 - Page 12 of 15 {12} using the app. The training includes mock tasks to pair with the pump and CGM in order to practice tasks such as giving a meal bolus and using Boost and Ease-off etc. without impacting on the user's actual insulin delivery. Once the required in-app training is completed, the user can choose to remain in virtual mode to use the app as a training resource. Users are able to revisit the in-App training at any time as well as review additional training information within the "Help" menu of the app. They are also able to download training factsheets as a resource should they wish to do so. Additional training resources (animations, factsheets and webinars) are available via the CamDiab website. ## Hazard Analysis A comprehensive hazard analysis was provided for this device, in which design inputs and outputs, risks, and risk mitigations for software and interoperable hardware components associated with the safe and effective functioning of the device were reviewed. The hazard analysis provided in this submission accounted for the unique design elements, intended use, and risks of the CamAPS FX design. In particular, this hazard analysis accounted for the risks associated with interoperability between the software device developed by the sponsor and commercial off-the-shelf (COTS) hardware device it was installed on, as well as with other third-party interoperable devices. This analysis identified hazards which could reasonably be anticipated to impact the proper use of the device, traced all identified risks to adequate design controls, and demonstrated that design features were appropriately implemented and validated. ## Data Logging The sponsor provided software and bench testing to demonstrate that the device is able to record critical events, including information related to its state (e.g., commanded delivery rates/volumes, all algorithm calculations, open loop/closed loop mode, power on/off events), user inputs, and device settings. In addition, the sponsor detailed the specific information that they would collect from all interoperable components connected to CamAPS FX including the iCGM and ACE pump components. All log entries are time stamped with the time of occurrence in originating device. These protocols were reviewed and found to be adequate. ## Predetermined Change Control Plan (PCCP) A predetermined change control plan (PCCP) for integrating with potential interoperable devices in the future was provided according to the FDA Guidance "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff." The PCCP includes a description of modifications, a modification protocol and an impact assessment, and was determined to be adequate to support and clearly specify expectations, requirements, and interface specifications for potential interoperable devices (e.g., iCGMs and ACE pumps). The sponsor has performed software and bench testing to verify and validate that these interface control specifications meet the special controls and their controller's requirements for performance, communications, and data logging. In addition, the plans provided by the sponsor covered their approach to working with connected device companies regarding contractual issues, interfaces for data communication and exchange, and post-market reporting procedures and responsibilities (e.g., who is responsible for investigating and reporting complaints, malfunctions, and adverse events). The sponsor additionally provided software protocols intended to ensure secure, accurate, and reliable communication with digital interfacing devices, as well as failsafe design features to mitigate the risks associated with interruption of communication with digitally connected K232603 - Page 13 of 15 {13} devices. These protocols were executed in the comprehensive software testing performed by the sponsor which included hardware prototype testing and software integration testing. By design, CamAPS FX can only be used with compatible iCGM and ACE Pump devices with which it has been validated for use. CamAPS FX will not allow use of an unvalidated ACE pump or iCGM. There are controls within the software to prevent use of CamAPS FX in these cases. To support the future integration of compatible ACE pumps and iCGMs with CamAPS FX, the sponsor also provided protocols (“APCam-FX-D36-RevA-US Predetermined Change Control Plan” and “P-606-Regulatory Filing Determination for FDA”) outlining their validation strategy for determining compatibility of new devices with the CamAPS FX. The protocols included pre-specified procedures, validation strategies, and acceptance criteria for software, cybersecurity, device interoperability, human factors, labeling, and training materials, with the anticipated features and specifications of ACE pumps and iCGMs as these are anticipated changes foreseen at the time of the submission. These protocols, along with the software testing conducted, were found to be adequate to support the robustness of the sponsor’s software test protocols to validate future integration of digitally connected devices that meet the pre-specified specifications and acceptance criteria. CamAPS FX must not be distributed until the pre-specified acceptance criteria in the PCCP are met. FDA has determined that when a modification is made in accordance with “APCam-FX-D36-RevA-US Predetermined Change Control Plan” and “P-606-Regulatory Filing Determination for FDA” and the validation strategy described in this 510(k), then the modification would not significantly affect safety or effectiveness of the device and no new 510(k) would be required. Changes made that are inconsistent with the modifications described in “APCam-FX-D36-RevA-US Predetermined Change Control Plan” and “P-606-Regulatory Filing Determination for FDA” that were reviewed in this submission could be significant modifications that could significantly affect the safety and/or effectiveness of this device (e.g., such changes could compromise the clinical functionality or performance specifications that are directly associated with the intended use of the device), in which case a new premarket submission would be required (see 21 CFR 807.81(a)(3)). ## Cybersecurity Detailed information on cybersecurity of the device was reviewed and found to be acceptable. The sponsor provided detailed information relating to the penetration testing conducted as part of their cybersecurity evaluation. The sponsor provided a software bill of materials, which provided details on all software used in the device and the COTS hardware platform that the Software-as-a-Medical-device (SAMD) was installed on. This included all manufacturer-developed, commercially licensed, open source, partner and off-the-shelf software components (including firmware, as relevant), along with an identification of the hardware runtime environment in which each resides, with relevant version and/or model information, as well as details on whether each component was actively supported by its manufacturer or legacy licensed. ## Postmarket Surveillance Study There is uncertainty remaining regarding the risk/benefit profile of the device when used in the broader intended use population. While the premarket clinical studies provided to support the 510(k) showed some benefits, the study included mostly well-educated white users, and they were not adequately powered to assess differences in the rates of safety events (e.g., diabetic ketoacidosis and severe hypoglycemia). Further, pump-naïve users were underrepresented in the studies, and there is residual uncertainty surrounding the safety of certain personalized glucose targets as well as the use of “Boost” and “Ease-Off” mode. Finally, although multiple studies were leveraged to support the substantial equivalence of CamAPS FX, the studies consisted of K232603 - Page 14 of 15 {14} various designs, durations, and study populations (i.e., different age groups were targeted in different studies), which contributes to the uncertainty in the device risk/benefit profile across the entire intended use population. Accordingly, a postmarket surveillance study will be ordered by FDA to confirm understanding of safety. ## VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. ## IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K232603 - Page 15 of 15 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI/K232603](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/QJI/K232603) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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