Software as a Medical Device, Therapeutic, Pediatric
Indications for Use
The Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 SmartBolus Calculator is intended for single patient, home use and requires a prescription.
Device Story
Software-based bolus calculator residing in Omnipod 5 App; used for diabetes management in home settings by patients. Inputs: user-entered carbohydrates, iCGM sensor glucose or manual blood glucose (BG) readings, glucose rate-of-change, insulin-on-board (IOB), and programmed settings (correction factor, insulin-to-carbohydrate ratio, target glucose). Operation: calculates suggested insulin bolus dose in both open-loop (manual) and closed-loop (automated) modes. Output: suggested bolus dose displayed to user. Clinical impact: assists patients in determining insulin dosing to improve glycemic control; reduces time spent in hypoglycemia (<70 mg/dL) compared to manual BG entry methods.
Clinical Evidence
Prospective, single-arm, multicenter study (N=25, ages 6-70) compared manual BG entry (Phase 1) vs. CGM-informed bolus calculation (Phase 2). Primary endpoint: safety via time in glucose ranges post-bolus. Results showed CGM-informed bolus calculator reduced time <70 mg/dL (2.1% vs 2.8%, p-value not specified). Zero deaths or UADEs reported. Supplemented by in silico simulations of edge cases to ensure safe output recommendations.
Technological Characteristics
Software-only device; resides in Omnipod 5 App. Interoperable with iCGM systems. Uses algorithmic calculation based on user-defined insulin parameters and real-time glucose data. Complies with IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62366 (usability).
Indications for Use
Indicated for diabetes management in patients aged 6+ requiring rapid-acting U-100 insulin. Intended for single-patient, home use via prescription.
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).
Omnipod DASH Insulin Management System (K180045, K192659)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
INSTRUMENT ONLY
## I Background Information:
A 510(k) Number
K203772
B Applicant
Insulet Corporation
C Proprietary and Established Names
Omnipod 5 SmartBolus Calculator
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QRX | Class II | 21 CFR 862.1358 - Insulin Therapy Adjustment Device | 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:
Continuous Glucose Monitor Informed Insulin Dose Calculator
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
{1}
K203772 - Page 2 of 6
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
The Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 SmartBolus Calculator is intended for single patient, home use and requires a prescription.
### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
This device resides in the Omnipod 5 App and requires the App to function
The Omnipod 5 SmartBolus works with the following rapid-acting U-100 insulins. : NovoLog® (insulin aspart), Humalog® (insulin lispro), and Admelog® (insulin lispro).
## IV Device/System Characteristics:
### A Device Description:
The Omnipod 5 SmartBolus Calculator is a software device that resides in the Omnipod 5 App. It requires input parameters and settings from the SmartAdjust Technology, an interoperable automated glycemic (iAGC) and glucose values from a compatible integrated continuous glucose monitoring system (iCGM) or blood glucose (BG) values from a blood glucose meter to calculate suggested insulin bolus doses. The Omnipod 5 SmartBolus Calculator can be used in both open-loop (manual mode) and closed-loop (automated mode). When used with a compatible iCGM, the Omnipod 5 SmartBolus Calculator can use the sensor glucose values and trend information to calculate a suggested bolus dose. When the Omnipod 5 SmartBolus Calculator is used with manually entered BG readings it suggests a bolus dose based on the same calculations as the currently cleared Omnipod DASH Insulin Management System bolus calculator (K180045, K192659).
### B Instrument Description Information:
1. Instrument Name: Omnipod 5 SmartBolus Calculator
2. Specimen Identification: Not applicable
3. Specimen Sampling and Handling: Not applicable
{2}
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): K201476
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K203772 | K201476 |
| --- | --- | --- |
| Device Trade Name | Omnipod 5 SmartBolus Calculator | DreaMed Advisor Pro |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same | Software intended for the management of diabetes |
| Principle of operation | Same | Algorithmic software device |
| Age Range of Intended Users | Same | 6 years and older |
| Glucose Data Sources | Same | Sensor glucose data from a compatible integrated continuous glucose monitor (iCGM) and/or self-monitoring blood glucose (SMBG) meter values |
| General Device Characteristic Differences | | |
| Device Outputs | The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose output and calculates the insulin-on-board. | Insulin therapy adjustment recommendations including basal rate, carbohydrate ratio (CR), correction factors |
K203772 - Page 3 of 6
{3}
K203772 - Page 4 of 6
VI Standards/Guidance Documents Referenced:
- 21 CFR 862.1358 (Special controls established under DEN170043)
- IEC 62366:2015; Medical Devices – Park 1: Application of Usability Engineering
- HE75:2009, Human Factors Engineering – Design of Medical Devices
- ISO 14971:2007; Medical devices – Application of Risk Management to Medical Devices
- IEC 62304 Ed. 1.1 2015; Medical device software – Software life cycle processes
- FDA Guidance “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” dated May 11, 2005
- FDA Guidance “Applying Human Factors and Usability Engineering to Medical Devices” dated February 3, 2016
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
This is a software only device for insulin bolus dose calculation. The following analytical performance characteristics are not applicable.
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.
{4}
K203772 - Page 5 of 6
# B Other Supportive Instrument Performance Characteristics Data:
## Summary of Clinical Testing:
A single-arm, multicenter, prospective clinical study was conducted to evaluate the Omnipod 5 SmartBolus Calculator in patients with type 1 diabetes during Manual Mode operation. The study enrolled 25 evaluable subjects aged 6-70 years across 3 clinical sites, and consisted of two 7-day outpatient phases of Omnipod 5 use:
- Phase 1: 7 days of Omnipod 5 use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses, followed by;
- Phase 2: 7 days of Omnipod 5 use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
The primary objective of the study was to evaluate the safety of the CGM-informed bolus calculator using glucose metrics of percentage of time < 70 mg/dL and percentage of time > 180 mg/dL during the 4-hour post bolus period from Phase 1 as compared to Phase 2. Data from the clinical study is presented in the tables below. In the 25 subjects enrolled in the combined age cohort of 6.0-70.0 years, there were zero (0) deaths and zero (0) unanticipated adverse device effects (UADE) reported. One (1) serious adverse event (SAE) was reported that occurred in the aged 18.0-70.0 years cohort and was indicated as not related to the study procedures or study device. There were no non-serious adverse events reported.
Comparison of glycemic measures from Phase 1 (Standard SmartBolus Calculator) and Phase 2 (CGM-Informed SmartBolus Calculator) for the 4 hours after any bolus (N=25)
| Percent time in glucose range as measured by CGM | Standard SmartBolus Calculator | CGM-Informed SmartBolus Calculator | Difference |
| --- | --- | --- | --- |
| 70-180 mg/dL | 65.1% | 63.8% | -1.3% |
| | (15.4) | (15.7) | |
| < 70 mg/dL | 2.8% | 2.1% | -0.6%* |
| | (2.7) | (2.0) | |
| < 54 mg/dL | 0.5% | 0.3% | -0.2% |
| | (1.0) | (0.7) | |
| > 180 mg/dL | 32.1% | 34.0% | 1.9% |
| | (15.7) | (16.0) | |
| ≥ 250 mg/dL | 8.2% | 9.7% | 1.4% |
| | (6.9) | (10.3) | |
| ≥ 300 mg/dL | 2.0% | 2.6% | 0.6% |
| | (2.6) | (3.7) | |
In Silico Testing: Simulations of possible input and output combinations were run to supplement information collected in the clinical study. These simulations evaluated additional types and/or ranges of variables in order to assess that potential edge cases (including physiologically improbable edge cases) will produce either a safe output (e.g., bolus recommendation), or an error alerting the user to an unsafe condition.
{5}
Human Factors:
The Omnipod 5 SmartBolus Calculator is a component of the Omnipod 5 System. Human Factors validation study was conducted on the Omnipod 5 System as a whole and described in the Decision Summary for K203774.
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.
K203772 - Page 6 of 6
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
Learn the FDA Browser
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.
