The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO₂ and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122°F (0 to 50°C).
Device Story
Capnocheck Plus (Model 9004) is a transportable, tabletop capnograph with optional pulse oximetry (SpO2) and fractional inspired oxygen (FiO2) monitoring. Device inputs include sidestream breath samples via gas inlet port/moisture trap, SpO2 probe signals, and FiO2 sensor data. System processes these inputs to display real-time CO2, SpO2, pulse rate, pulse strength, and FiO2 on a VFD screen. Operated by clinicians in hospitals, clinics, or during emergency transport. Provides continuous monitoring with adjustable audible/visible alarms for patient status. Serial/PC port supports data communication and analog output. Benefits include real-time physiological monitoring to assist clinical decision-making in critical care, anesthesia, and transport settings.
Clinical Evidence
Clinical evidence includes controlled desaturation studies comparing the device's SpO2 measurements to a co-oximeter (OSM-3). Results showed a standard deviation of 2.0 for the 70-100% range and 2.7 for the 50-69% range, with an R-squared value of 0.97. Extensive bench testing was also performed, covering EMC, electrical safety, mechanical durability, CO2 response time, linearity, breath rate, and FiO2 accuracy at 0%, 21%, 60%, and 100% O2 concentrations.
Technological Characteristics
Tabletop capnograph with sidestream gas sampling, moisture trap, SpO2 probe interface, and FiO2 sensor. Features VFD display, LED status indicators, and 6-key keypad. Connectivity includes serial/PC port and 3 analog output channels. Operates in 32-122°F range. Testing performed per respiratory device reviewer guidelines (EMC, electrical, mechanical, environmental).
Indications for Use
Indicated for continuous monitoring of CO2, SpO2, pulse rate, and FiO2 in pediatric to adult patients in hospital, clinical, and emergency land transport environments.
Regulatory Classification
Identification
A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.
Predicate Devices
BCI 9000 Capnograph-Oximeter
BCI 9100 Multigas Monitor
Reference Devices
OSM-3 co-oximeter
Submission Summary (Full Text)
{0}
BCI INTERNATIONAL
K970209
APR 18 1997
# Summary of Safety and Effectiveness
Submitter: BCI International, Inc.
Address: W238 N1650 Rockwood Drive
Waukesha, WI 53188
Telephone: (414) 542-3100
Contact: VP Regulatory Affairs
Prepared: January 20, 1997
Proprietary Name: Capnocheck® Plus, Model 9004
Common/Classification Name: Capnograph
Predicate Devices: BCI 9000 Capnograph-Oximeter
BCI 9100 Multigas Monitor
## New Device Description:
The BCI Capnocheck Plus capnograph with optional pulse oximetry (SpO₂) and fractional inspired oxygen (FiO₂) is an updated version of existing devices legally marketed by BCI International. This updated device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top capnograph with a wall mount charger. The system features a gas inlet port with moisture trap for the breath sample (sidestream capnograph), an SpO₂ probe interface, the FiO₂ sensor connector, display of patient data via a VFD display (CO₂, SpO₂, Pulse Rate, Pulse Strength, FiO₂, alarm information), system status LEDs (Battery, Alarm Silence, Alarm, & Alert), and the function keypad area consisting of six keys (STNBY/ON, WAVE/TREND, Up and Down Arrows, MENU/ENTER, & Alarm Silence). The capnograph has a serial printer / pc port that is used for data communication. Three analog output channels are supported on the same connector.
## Intended Use:
The 9004 may be used in the hospital or clinical environment, and during emergency land transport. It is not intended for use in the home. It is intended to be used in all critical environments, including ventilatory applications, patient transport and anesthesia environments. The oximetry option works with all BCI oximetry probes providing SpO₂ and pulse rate. The patient population is defined to be pediatric to adults. The 9004 permits continuous patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. It is not intended or designed to be used as an apnea monitor. The 9004 will operate accurately over an ambient temperature range of 32 to 122°F (0 to 50°C).
BCI International
W238 N1650 Rockwood Drive
Waukesha, WI 53188-1199 USA
{1}
Performance Data:
The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that it would perform within the environment(s) for which it is to be marketed. The testing was performed in accordance with the guidelines and standards found in the reviewers guide for respiratory devices. This testing included EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide and that it performed within its specifications and functional requirements.
Performance testing between the new 9004 and the predicate 9000 was done to show that the performance of the two devices is the same (CO₂, RR, SpO₂ & HR). All the results of each parameter of each device were the same or within one count of each other.
An in-house performance test of the 9004 was run. It tested CO₂ response time, accuracy & linearity with humidity & over temperature & at altitude, temperature shock, interfering gases, breath rate, contamination and water trap testing. The testing to determine how often the unit needs to be recalibrated was also completed. The FiO₂ function was tested with O₂ values of 0%, 21%, 60% and 100% oxygen. The 9004 passed all the tests.
Additionally, clinically controlled desaturation studies of the optional oximeter were done to demonstrate that the 9004 accurately displays the patient’s blood oxygen level within its accuracy limits as compared to a co-oximeter (OSM-3). Statistical analysis on the data collected from the studies were compared to those from a co-oximeter during the controlled subject desaturation runs. The results from the clinical studies support the accuracy claims of the device, with a standard deviation of 2.0 for the measurement range of 70-100% and 2.7 for the range of 50-69%. The R squared value was 0.97 over the entire range. (R squared - measure of how true the regression line is. R squared = 1 is a perfect fit.)
On the basis of these results and the above-referenced testing it is our determination that the device is safe, effective, and performs as well as or better than the legally marketed predicate device(s).
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Respectfully,
Donald Alexander
VP Regulatory Affairs
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.
