Software as a Medical Device, Therapeutic, PCCP, Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K261896 · Sep 16, 2026
iOS CamAPS FX
CamDiab
Real-world assessment data (EU and Australia)
Real-world assessment data was used to support the clinical performance of the CamAPS FX system.
Real-world assessment; Clinical performance; EU and Australia
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Real world assessment; Real-world assessment
Users of CamAPS FX (children, adolescents, adults, older adults, and pregnant women)
Not applicable for this study
Clinical performance
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 fulfill its intended use. The list of supported insulin pumps and CGMs is provided in this User Manual. CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that linked continuous glucose monitoring system is approved for use in pregnancy. CamAPS FX is for prescription use only.
Device Story
Mobile app; receives glucose readings from integrated continuous glucose monitoring (iCGM) device; controls insulin pump. Adaptive model-predictive control algorithm processes sensor data; generates insulin dosing advice. Operates in Auto Mode (closed loop), Auto Mode Off (open loop), Attempting, or Fail Safe modes. Used by patients with type 1 diabetes; requires prescription. App manages data, user interface, bolus calculator, cloud connectivity, and alerts. Enables hybrid closed loop therapy; automates basal insulin delivery; requires manual meal bolusing. Designed for interoperability with third-party pumps/CGMs via Bluetooth/BLE. Includes Predetermined Change Control Plan (PCCP) for adding future compatible devices and iOS operating system updates.
Clinical Evidence
No new clinical studies performed. Clinical performance was validated in predicate K232603. Intended users, clinical workflow, and core insulin dosing algorithm remain unchanged.
Technological Characteristics
Mobile application software; adaptive model-predictive control algorithm. Connectivity: Bluetooth/BLE for interoperability with third-party iCGMs and ACE pumps. Software life cycle per IEC 62304; usability per IEC 62366-1; risk management per ISO 14971. Cybersecurity per AAMI TIR57. Operates on iOS mobile platform.
Indications for Use
Indicated for type 1 diabetes management in patients aged 2 years and older, including pregnancy. Requires compatible iCGM and ACE pump. Contraindicated for patients unable to notice alerts/alarms, unable to monitor glucose as recommended, unable to maintain contact with healthcare provider, or unwilling/unable to follow instructions. Not for inpatient/hospitalized use.
Regulatory Classification
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.
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
### I Background Information:
### A 510(k) Number
K261896
### 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 |
### E Purpose for Submission:
Predetermined change control plan
### II 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.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfill its intended use. The list of supported insulin pumps and CGMs is provided in this User Manual.
CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that linked continuous glucose monitoring system is approved 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 iOS CamAPS FX has not been evaluated, such as inpatient/hospitalized patient use.
# III Device Description
CamAPS FX is a mobile 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 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.
K261896 - Page 2 of 7
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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.
#### IV Substantial Equivalence Information:
##### A Predicate Device Name(s):
CamAPS FX
##### B Predicate 510(k) Number(s):
K232603
##### C Comparison with Predicate(s):
| Device & Predicate Device(s): | K261896 | K232603 |
| --- | --- | --- |
| Device Trade Name | CamAPS FX | CamAPS FX |
| General Device Characteristic Similarities | | |
K261896 - Page 3 of 7
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| 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 |
| Target patient population | Type 1 diabetes mellitus in persons 2 year of age and greater. | Same |
| User-controlled target range settings | Target range during auto mode: 80-198 mg/dL | Same |
| **General Device Characteristic Differences** | | |
| PCCP | Add compatible ACE pumps Add compatible iCGMs Add compatible iOS operating system | Add compatible ACE pumps Add compatible iCGMs |
**Predetermined Change Control Plan (PCCP):** In addition to the similarities and differences between the candidate and the predicate device listed in the table above, the candidate device has an authorized PCCP for qualifying and integrating new compatible FDA-cleared iCGMs and ACE pumps. While those modifications are unchanged from the PCCP approved in K232603 a new modification was added to the PCCP for the addition of supported iOS mobile operating system. The PCCP includes a description of the modifications, a modification protocol, and an impact assessment. The PCCP specifies the testing methods, validation activities, and performance requirements to implement the specified modifications such that CamAPS FX remains as safe and as effective as the predicate device and continues to comply with 21 CFR 862.1356(b). The sponsor's PCCP comprises the following for each subject iAGC and ACE pump:
- A new candidate iCGM must have demonstrated compatibility to established minimum iCGM performance, compatibility, and sensor specifications before proceeding with qualification. Once a compatible candidate iCGM is identified, the sponsor will conduct virtual clinical trial testing with virtual patients, with pre-defined acceptance criteria based on virtual patient equivalency testing and glycemic outcomes from the iAGC clinical study. Software design integration of the new iCGM with the subject iAGC will
K261896 - Page 4 of 7
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then be completed, and integration V&V testing will be conducted according to the established PCCP. If integration V&V testing meets the PCCP's prespecified acceptance criteria, the iCGM may be added as an interoperable component to the subject iAGC
- A new candidate ACE pump must have demonstrated compatibility to established minimum ACE pump compatibility and performance specifications defined in the PCCP before proceeding to software design integration with the subject iAGC. Integration V&V testing will then be conducted according to the established PCCP. If integration V&V testing meets the PCCP's prespecified acceptance criteria, the ACE pump may be added as an interoperable component to the subject iAGC.
- Related iAGC labeling will be revised as needed to identify new qualified and integrated compatible devices or to remove previously compatible devices found to no longer be compatible. Communication will be provided through various channels to notify users about a new compatible device or previously compatible but now incompatible device.
New in this PCCP the sponsor proposes users will be notified of software updates (including any user instructions for the update process) and labeling will be updated in accordance with the authorized PCCP to provide users with current information regarding the device's upgraded operating system compatibility.
# V Standards/Guidance Documents Referenced:
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes. Recognition Number: 13-79
- IEC 62366-1:2015 Medical Devices - Application of usability engineering to medical devices. Recognition Number: 5-129
- ISO 60601-1-10:2008+A1:2015 Medical electrical equipment- Part 1-10: General requirements for basic safety and essential performance. Recognition Number: 19-37
- ISO 60601-1-11:2015 General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical. Recognition Number: 19-47
- ISO 14971:2019 + A1:2021 Medical Devices- Application of risk management to medical devices. Recognition Number: 5-125
- ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice. Recognition Number: 2-282
- AAMI TIR57:2016/(R)2019 Principles for medical device security-Postmarket risk management for device manufacturers. Recognition Number: 13-83
# VI Performance Characteristics:
# A. Non-Clinical Performance
No new non-clinical studies were performed to support the subject device. Non-Clinical Performance was validated in K232603.
# B. Clinical Studies:
No new clinical studies were performed to support the subject device. Clinical performance was validated in K232603. The intended users, intended use, clinical workflow, and core insulin dosing algorithm remain unchanged from the predicate device. Therefore, additional clinical testing was not necessary to demonstrate substantial equivalence.
K261896 - Page 5 of 7
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### C. Other Supportive Device Performance Characteristics Data
Predetermined Change Control Plan (PCCP):
A predetermined change control plan (PCCP) for integrating with potential interoperable devices and adding iOS operating system compatibility 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 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-RevC-US Predetermined Change Control Plan” 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-RevC-US Predetermined Change Control Plan” 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-RevC-US Predetermined Change Control Plan” 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
K261896 - Page 6 of 7
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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)).
# **VII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
# **VIII Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K261896 - Page 7 of 7
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1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
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Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (Software as a Medical Device), then narrow by AI/ML (devices with AI).
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Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
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Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
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Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
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Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
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With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
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What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
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Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
