The BroadMaster HealthCare System is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USB, stores, and uses patient data for display and reporting, sets meter date, time and alarm. The software is designed for multiple users use and only compatible with personal computer. It's not compatible with other devices such as PDAs or smartphones.
Device Story
BroadMaster HealthCare System is PC-based software for diabetes management; collects raw blood glucose data via USB from compatible BroadMaster Biotech glucose meters; stores data in local database under user profiles; transforms raw data into trend graphs and reports; exports data to .csv files; allows configuration of meter date, time, and alarms; used by patients in home settings; provides visual data representation to assist in diabetes management decisions.
Clinical Evidence
Bench testing verified data upload accuracy (100%) and meter memory rollover across Windows XP, Vista, and 7. Human factors study (n=36, ages 48-88) evaluated software installation, data syncing, transmission, and report generation. Participant-generated reports matched stored meter data in 100% of cases. Usability survey (14 items) yielded average response rate of 3.86 (>3 criterion).
Technological Characteristics
PC-based software; requires USB connectivity to compatible glucose meters. Compatible with Windows XP, Vista, and 7. Minimum requirements: 1GHz Pentium processor, 256MB RAM, 600MB hard drive space, 1024x768 resolution. Standards: IEC 601-1-4, IEC 60601-1-4, IEC 62304, ISO 13485:2009.
Indications for Use
Indicated for people with diabetes in the home setting to aid in review, analysis, and evaluation of patient data to support diabetes management.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
Clever Check Health System Software (k070941)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE
A. 510(k) Number:
k130621
B. Purpose for Submission:
New Diabetes Data Manager for use with the Glucose Shepherd Blood Glucose Monitoring System (k102316) and ADVOCATE Redi-Code+ BMB-EA001S Blood Glucose Monitoring System (k120183)
C. Manufacturer and Instrument Name:
BroadMaster Biotech Corp.
BroadMaster HealthCare System
D. Type of Test or Tests Performed:
Diabetes data management system
E. System Descriptions:
1. Device Description:
The BroadMaster HealthCare System, a PC-based software system, is an optional accessory to the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE Redi-Code+ BMB-EA001S Blood Glucose Monitoring System that aids in diabetes care and management. The BroadMaster HealthCare System receives test results from the indicated BroadMaster blood glucose meters via USB cable, and stores these results in a local database on the user's PC.
2. Principles of Operation:
The BroadMaster HealthCare System intakes user raw glucose data generated on the Glucose Shepherd Blood Glucose Monitoring System (k102316) and ADVOCATE Redi-Code+ BMB-EA001S Blood Glucose Monitoring System (k120183), allows analysis of results with trend graphs, and save glucose raw data for export. The BroadMaster HealthCare System uses a database to store glucose raw data downloaded via USB from the indicated BroadMaster glucose meters. Glucose raw data downloaded to the software system are stored under distinct user profiles. The software also allows the setting of the meter's time.
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3. **Modes of Operation:**
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device? Yes ☑ or No ☐.
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission: Yes ☐ or No ☑.
4. **Specimen Identification:**
Specimen identification is based on time and date of testing
5. **Specimen Sampling and Handling:**
Data transmission from glucose meters using capillary whole blood samples.
6. **Calibration:**
Glucose meter specific. See statement below under section J.
7. **Quality Control:**
Glucose meter specific. See statement below under section J.
8. **Software:**
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☑ or No ☐
F. **Regulatory Information:**
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW - Glucose test system, Over-the-Counter | Class II | 21 CFR § 862.1345 | Clinical Chemistry (75) |
| JQP – Calculator/data processing module, for clinical use | Class I | 21 CFR § 862.2100 | Clinical Chemistry (75) |
G. **Intended Use:**
1. **Indication(s) for Use:**
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The BroadMaster HealthCare System is a software accessory compatible with legally marketed BroadMaster Biotech glucose meters, such as the Glucose Shepherd Blood Glucose Monitoring System and ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The BroadMaster HealthCare System receives via USB, stores, and uses patient data for display and reporting, sets meter date, time and alarm. The software is designed for multiple users use and only compatible with personal computer. It's not compatible with other devices such as PDAs or smartphones.
2. Special Conditions for Use Statement(s):
Over-the-counter use
H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
Clever Check Health System Software, k070941
2. Comparison with Predicate Device:
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Candidate Device
BroadMaster
HealthCare System | Predicate Device
(k070941) |
| Intended Use | Same | Optional accessory to cleared glucose meters and is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. |
| Over-the-Counter | Same | Yes |
| Connectivity to Meter | USB | RS232 |
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| System Requirements | IBM® and Intel®-compatible PC; 1G MHz or higher Pentium® compatible processor 256 MB RAM; 600 MB of available hard drive space CD-ROM drive; keyboard and mouse or compatible pointing device; available USB port Minimum display resolution of 1024 x 768 | Personal computer with 400 megahertz (MHz) or higher processor clock speed recommended; the software does not run on Apple computers. Random access memory (RAM) of 64 megabytes (MB) or more recommended. Available hard disk space of 30 MB for running the program. Monitor with 1024 x 768 or higher resolution. |
| --- | --- | --- |
| Operating System | Windows XP, Vista (32- and 64-bit), 7 (32- and 64-bit) | Windows 98 SE, 2000, NT, ME, XP |
| Compatible Blood Glucose meters | Glucose Shepherd Blood Glucose Monitoring System (k102316) and ADVOCATE Redi-Code+ BMB-EA001S Blood Glucose Monitoring System (k120183) | TaiDoc glucose and glucose/blood pressure monitors (k061181, k062235, k063212, k070239, k070472, k062800, k070641, k051703 |
| Graphic Data Displays | Same | Yes |
| Editing of Patient Data | Same | No |
| Database location | Same | Local computer |
I. Special Control/Guidance Document Referenced (if applicable):
1. US FDA guidance document, General Principles of Software Validation
2. IEC 601-1-4, Safety Requirements for Programmable Electronic Medical Systems
3. IEC 60601-1-4, Medical electrical equipment- Part 1-4: General requirements for safety
4. IEC 62304, Medical device software- Software life cycle processes
5. ISO 13485:2009, Medical devices- Quality management systems- Requirements for regulatory purposes
6. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf
7. Software Use in Medical Devices", Sep. 9, 1999, CD
J. Performance Characteristics:
1. Analytical Performance:
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The performance characteristics listed below as applicable, were presented in the specific glucose meter clearances under k102316 and k120183.
a. Accuracy:
See above statement under section J.1.
b. Precision/Reproducibility:
See above statement under section J.1.
c. Linearity:
See above statement under section J.1.
d. Carryover:
See above statement under section J.1.
e. Interfering Substances:
See above statement under section J.1.
2. Other Supportive Instrument Performance Data Not Covered Above:
A. Bench testing was conducted during design verification activities. Data was uploaded from compatible meters to the BroadMaster HealthCare System via USB cable on Windows based systems. Verification was performed on the following Operating systems:
Windows XP
Windows Vista (32- and 64-bit)
Windows 7 (32- and 64-bit)
Meter memory capacity and data rollover was performed on data from the Glucose Shepherd Blood Glucose meter and ADVOCATE Redi-Code+ BMB-EA001S Blood Glucose meter connected simultaneously to test meter memory rollover and data transmission. BroadMaster HealthCare System was verified to meet data upload accuracy (100%) and data management requirements.
B. Human Factors Study
36 subjects with typical computer experience and ages (age range 48 to 88 years old) were enrolled in the Human Factors study conducted for the BroadMaster HealthCare System. Participants were accessed on: installation of the software on their test computer syncing the meter date and time, data transmission, viewing data, generating and exporting reports. The data in participant created reports
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matched the stored meter data in 100% of cases.
The ease-of-use study consisted of 36 lay-users with varying demographics (age, sex, and education level) were included in a usability study for installing, uploading data from glucose meters, and using features of the software. The participants were provided the user manual and no further instruction. Following the study the participants also completed a questionnaire in response to whether the data transmission feature is easy to use.
Study Feedback: The proportions of neutral-or-better responses (ranked 1-5) for all 14 items on the Survey Questionnaire for Usability meet the acceptance criterion of average response rate of >3 (average 3.86).
B. Software documentation was reviewed and demonstrated that the device was developed under appropriate software lifecycle processes. The following documentation related to the software was reviewed and found to be acceptable: level of concern, software description, device hazard analysis, software requirements specifications, software design specification, software development environment description, and verification and validation testing.
C. The BroadMaster HealthCare System User's Guide Readability Assessment was at a 6.9 grade level using the Flesch-Kincaid readability assessment.
K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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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.
