DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who: · use insulin pumps as their insulin delivery therapy; · monitor their glucose levels using continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter; • are above the age of 6; and · use rapid acting U-100 insulin analogs in their pump DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.
Device Story
DreaMed Advisor Pro is a decision-support software for healthcare professionals managing Type 1 diabetes. It ingests glucose readings (CGM/SMBG), insulin dosing logs, and meal data from third-party Diabetes Management Systems (DMS). The software analyzes this data to generate recommendations for insulin pump parameters: basal rates, carbohydrate ratios, correction factors, and active insulin time. It also provides behavioral reminders (e.g., infusion set changes). Recommendations are sent back to the DMS for physician review; the physician may approve, reject, or modify the treatment plan before implementation. By automating data analysis, the device assists clinicians in optimizing insulin therapy, potentially improving glycemic control. It is intended for clinical use by healthcare professionals and is not for direct patient use without physician oversight.
Clinical Evidence
No new clinical trials were conducted. The submission relied on a clinical impact assessment to support the removal of the upper age limit of 65 years, which was reviewed and found acceptable by the FDA.
Technological Characteristics
Software-based decision support system. Operates via algorithmic analysis of patient data. Integrates with third-party Diabetes Management Systems (DMS) for data input/output. Complies with ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62366-1 (usability).
Indications for Use
Indicated for patients >6 years old with Type 1 diabetes using insulin pumps and CGM/SMBG monitoring with rapid-acting U-100 insulin. Contraindicated for patients using automated insulin dosing (AID) systems, non-U-100 insulin, insulin injections/IV insulin, other glucose-lowering therapies, pregnant women, or patients taking medications affecting CGM/SMBG accuracy.
Regulatory Classification
Identification
An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.
Special Controls
(b) Classification: Class II (special controls). The special controls for this device are
- 1. Design verification and validation must include the following:
- (i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations.
- (ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated.
- (iii)Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations.
- (iv)A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification.
- (v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures.
- (vi)Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device.
- (vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
- 2. The device must not be intended for use in implementing automated insulin dosing.
- 3. Your 809.10(b) labeling must include:
- (i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device.
- (ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations.
- (iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device.
- (iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
INSTRUMENT ONLY
## I Background Information:
A 510(k) Number
K201476
B Applicant
DreaMed Diabetes Ltd
C Proprietary and Established Names
DreaMed Advisor Pro
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QCC | Class II | 21 CFR 862.1358 - Insulin Therapy Adjustment Device | Clinical Chemistry |
## II Submission/Device Overview:
A Purpose for Submission:
Modification to a previously cleared device to update the indications for use allowing patients over 65 years old to use the device.
B Type of Test:
Insulin Therapy Adjustment Device
## III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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B Indication(s) for Use:
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who:
- use insulin pumps as their insulin delivery therapy;
- monitor their glucose levels using continuous glucose monitoring (CGM) and/or self-monitoring blood glucose (SMBG) meter;
- are above the age of 6; and
- use rapid acting U-100 insulin analogs in their pump
DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient’s insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.
C Special Conditions for Use Statement(s):
- Rx - For Prescription Use Only
- For in vitro diagnostic use only
- This device is not intended to send recommendations directly to patients without initially being reviewed and approved by a healthcare professional (HCP).
- This device is not intended for use with patients who use automated insulin dosing systems. (e.g., "closed-loop", "artificial pancreas", see labeling for a list of the contraindicated devices). Advisor Pro hasn't been tested with these devices. Advisor Pro cannot identify the pump model or operating mode, and although Advisor Pro has some design mitigations to help detect when AID systems are used in closed loop mode and will usually prevent the system from providing recommendations for pump parameter changes, it cannot detect closed loop insulin delivery 100% of the time. Therefore, pay attention to pump information and the pump’s operating mode and do not accept Advisor Pro recommendations if the user was using the AID system in closed loop mode.
- This device is not intended for use with patients who use insulin(s) other than U-100. Advisor Pro hasn't been tested with other types of insulins and is designed to consider the pharmacodynamics and pharmacokinetics of U-100 insulin only. Using Advisor Pro with other types of insulin may lead to potential harm.
- This device is not intended for use with patients treated with insulin injections, intravenous (IV) insulin, or a combination of insulin injections and/or IV insulin and insulin pump therapy. Since Advisor Pro analyzes the insulin dosing history from the insulin pump, it will be blind to insulin delivered by injections and/or IV insulin. This could result to a false conclusion about the changes to the patient's insulin pump settings and may lead to potential harm.
- This device is not intended for patients using other concomitant glucose lowering therapies. Since Advisor Pro analyze the insulin dosing history from the insulin pump, reducing glucose levels by other means will not be taken into consideration by Advisor Pro. This could result
K201476 - Page 2 of 6
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to a false conclusion about the changes to the patient's insulin pump settings and may lead to potential harm.
- This device is not recommended for pregnant women. Advisor Pro hasn't been tested in this population.
- This device is not recommended for patients who are taking medications that might affect CGM/SMBG values. Please refer to the warnings and contraindications of the patient's CGM/ blood glucose meter to determine whether said medications may falsely raise glucose readings. The level of inaccuracy depends on the amount of said medication active in the patient's body and may be different for each person. Using Advisor Pro in these cases may lead to potential harm.
## IV Device/System Characteristics:
### A Device Description:
DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, and a continuous glucose monitoring (CGM) system and/or self-monitoring blood glucose (SMBG) system.
The DreaMed Advisor Pro gathers and analyzes information inputted through qualified third party Diabetes Management Systems (DMS), which collect biological input information from insulin pumps, glucose meters, and continuous glucose monitoring systems. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during routine care.
Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to a patient's insulin pump therapy parameters, including: basal insulin delivery rate(s), insulin to carbohydrate ratio, correction factor (insulin sensitivity), active insulin time and glucose targets. DreaMed Advisor Pro may also advise behavioral changes, such as reminders to change infusion sets every 2-3 days, to use current blood glucose information when calculating a bolus, and about the timing of meal boluses to avoid hyperglycemia. Results are sent to a qualified third party Diabetes Management System, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.
### B Instrument Description Information:
1. Instrument Name: DreaMed Advisor Pro
2. Specimen Identification: Not applicable.
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3. Specimen Sampling and Handling: Not applicable.
4. Calibration: Not applicable.
5. Quality Control: Not applicable.
## V Substantial Equivalence Information:
A Predicate Device Name(s): DreaMed Advisor Pro
B Predicate 510(k) Number(s): K191370
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K201476 | K191370 |
| --- | --- | --- |
| Device Trade Name | DreaMed Advisor Pro | DreaMed Advisor Pro |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | Decision-support for assisting healthcare professionals in the management of insulin pump therapy for patients with Type 1 diabetes who:
• use insulin pumps as their insulin delivery therapy;
• monitor their glucose levels using CGM and/or Self-Management Blood Glucose (SMBG) meter; and
• use rapid acting U-100 insulin analogs in their pump |
| Timeframe over which data inputs must be collected | Same | 21 days |
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| Device & Predicate Device(s): | K201476 | K191370 |
| --- | --- | --- |
| Device outputs and insulin therapy adjustment recommendations type | Same | Insulin therapy adjustment recommendations including basal rate, carbohydrate ratio (CR), correction factors (CF), and personal diabetes management tips. |
| Principles of Operation | Same | Algorithmic software device |
| Glucose Data Sources | Same | - Continuous glucose monitor data, or
- Continuous glucose monitor data and self-monitoring blood glucose meter values, or
- Self-monitoring blood glucose meter values (at least four per day, spaced at least 160 minutes apart) |
| Contraindications for Automated Insulin Dosing Systems | Same | - This device is not intended for use with patients who use automated insulin dosing systems. |
| General Device Characteristic Differences | | |
| Age Range of Intended Users | above the age of 6 | above the age of 6 and under 65 years old |
VI Standards/Guidance Documents Referenced:
21 CFR 862.1358 (Special controls established under DEN170043)
ISO 14971:2007; Medical Devices – Application of Risk Management to Medical Devices
ISO 15223-1:2016; Medical Devices – Symbols to be Used with Medical Device Labels, Labeling and Information to be Supplied – Part 1: General Requirements
IEC 62304:2006 – Medical Devices Software – Software Lifecycle Processes
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IEC 62366-1:2015 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices
ISO 14155 - Clinical Investigation Of Medical Devices For Human Subjects - Good Clinical Practice
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
1. **Precision/Reproducibility:**
Not Applicable.
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:
A Clinical Impact Assessment for removing the upper age limit of 65 years old was provided in the submission and found to be acceptable.
## 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.
K201476 - Page 6 of 6
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
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.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
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-only devices), then narrow by AI/ML (devices with AI).
2. The results table
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.
Where do you find a device's intended use without opening the PDF?
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.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
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.
5. Side-by-side comparison
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.
6. Collections
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.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
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.
8. Chart view
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.
