K030407 · Bci, Inc. · CCK · Aug 19, 2003 · Anesthesiology
Device Facts
Record ID
K030407
Device Name
ADVISOR, MODEL 9200
Applicant
Bci, Inc.
Product Code
CCK · Anesthesiology
Decision Date
Aug 19, 2003
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.1400
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
Device Story
Tabletop vital signs monitor (model 9200) provides multi-parameter patient monitoring. Inputs include ECG leads, invasive pressure transducers, YSI 400/700 temperature probes, NIBP cuff, SpO2 sensor, and capnography tubing/filters. Device processes signals to display waveforms and numerical data on color LCD; features internal printer and alarm system. Operated by clinicians in hospital settings; supports data output to external PCs, printers, or HTS 820 Central Station. Capnography option added to existing platform. Clinicians use real-time data and adjustable alarm limits to assess patient status and guide clinical interventions. Benefits include continuous monitoring of physiological parameters to detect changes in patient condition.
Clinical Evidence
Clinical testing performed for ETCO2 and respiration rate measurements. Bench testing conducted for all other parameters, including electromagnetic compatibility, electrical safety, mechanical durability, and environmental testing. Capnography performance validated against EN 864 standards. Human factors review and long-term alarm testing completed. Software validation confirmed modifications operate as intended.
Indicated for patient monitoring in hospital/clinic settings (ICU, CCU, OR, ER, RR, Labor/Delivery). Supports neonate to adult patients for basic parameters (ECG, NIBP, SpO2, IBP, Temp). Impedance respiration and capnography (ETCO2, inCO2, RR) indicated for adult and pediatric patients only; not for neonates. Not indicated for home use or as an apnea monitor.
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.
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Image /page/0/Picture/0 description: The image shows a logo with a circular design on the left and the letters 'BCI' on the right. The circular design consists of vertical lines that are closely spaced together. The letters 'BCI' are in a bold, sans-serif font, with a small dot above and to the right of the 'I'. The logo appears to be for a company or organization with the initials 'BCI'.
# AUG 1 9 2003
# Summary of Safety and Effectiveness
| Submitter: | BCI, Inc. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Address: | N7 W22025 Johnson Road<br>Waukesha, WI 53186 |
| Telephone: | (262) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | January 31, 2003 |
| Proprietary Name: | BCIT™ Advisor® vital signs monitor (model 9200) with new capnography option. |
| Common/Classification Name: | Vital signs monitor |
| Predicate Devices: | BCIT™ 9200 vital signs monitor (K982279, K010770, K011177)<br>BCITM 9004 monitor (K970209)<br>BCIT™ 9000 monitor (K873856) |
## New Device Description:
The BCI 9200 vital signs monitor has been updated to include a new capnography option. This new feature uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a table top design. The full system features an ECG cable interface, two invasive pressure interfaces, two YSI 400/700 compatible temperature interfaces, an NIBP cuff hose connection, an SpO2 sensor interface, a capnography tubing interface and filters, an internal printer, display of patient and waveform data via a color liquid crystal display (LCD), system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, IP zero, NIBP start/stop, print start/stop and alarm silence). The monitor has analog and serial output ports that are used for data communications to personal computers, printers, chart recorders, or the Life Sensing Instrument Company, Inc. HTS 820 Central Station.
#### Intended Use:
The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where
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Image /page/1/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle made up of vertical lines on the left, followed by the letters "BCI" in bold, sans-serif font on the right. There is a small dot to the right of the "I". The logo is black and white.
low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
## Performance Data:
The design of this device utilizes currently available technology found in many legally marketed devices. Both hardware and software changes were made to the device. Testing was done to ensure that BC10 9200 vital signs monitor was safe and would perform within the environments for which it is to be marketed.
Testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices. Electromagnetic compatibility (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BC10 9200 vital signs monitor is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements.
Tests were performed to show substantial equivalence of the new device to the predicate devices. Comparison of the new capnography feature was made to BCI® 9000 monitor's capnography function using both bench and clinical tests. Comparisons of all other parameters were made with the previous BCI® 9200 vital signs monitor using bench tests.
Testing of device performance included clinical testing of the ETCO2 and respiration rate measurements made by the BC10 9200 vital signs monitor. Further performance testing of the capnography parameter was also conducted in accordance with EN 864 (international standard for capnography). In addition, a human factors review and long term alarm test were performed to demonstrate overall device performance. The results demonstrated that the BCI® 9200 vital signs monitor performed within its specifications.
A full software validation test of the BC1® 9200 vital signs monitor with new capnography option was completed. These tests showed that the device modifications operate as intended and that the changes made do not compromise the overall performance of the monitor.
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On the basis of these results, it is our determination that the device is safe, effective, and performs as well as 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
Donald Alexander VP Regulatory Affairs
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BCI, Inc. c/o Mr. Donald J. Alexander VP Regulatory Affairs N7 W22025 Johnson Road Waukesha, WI 53186
Re: K030407
Trade Name: BCI™ Advisor® Vital Signs monitor (model 9200) with new capnography option Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon-Dioxide Gas Analyzer, Gaseous-Phase Regulatory Class: Class II (two) Product Code: CCK Dated: June 6, 2003 Received: June 9, 2003
Dear Mr. Alexander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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### Page 2 - Mr. Donald J. Alexander
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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# Indications For Use
K030407 510(k) Number (if known):
Device Name: BCI 9200 Vital Signs Monitor with Capnography.
Indications For Use:
Intended Use
The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER. RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP). non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Hacerta
(Division Sign-Off)
Division of Cardiovascular Devices
**510(k) Number** K030407
Prescription Use
X
(Per 21 CFR 801.109)
Over-The Counter Use
605.000
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.
