K991410 · Bci Intl., Inc. · DQA · Jun 9, 1999 · Cardiovascular
Device Facts
Record ID
K991410
Device Name
3402 HANDHELD PULSE OXIMETER
Applicant
Bci Intl., Inc.
Product Code
DQA · Cardiovascular
Decision Date
Jun 9, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.2700
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO2 and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals. The BCI 3402 is not designed or intended to be used as an apnea monitor.
Device Story
BCI 3402 Digital Handheld Oximeter is a battery-powered device for monitoring SpO2, pulse rate, and pulse strength. Input is derived from BCI oximetry sensors; device processes signals to calculate oxygen saturation and pulse metrics. Output is displayed on an LED screen; device includes an infra-red printer output port and adjustable visual/auditory alarms. Used by healthcare professionals in clinical, EMS, transport, sleep screening, and home settings. Provides real-time physiological data to assist clinicians in patient assessment and monitoring. Benefits include portable, reliable, low-cost monitoring across a broad patient population (neonate to adult).
Clinical Evidence
Controlled desaturation studies conducted on human subjects. Comparison against a co-oximeter (OSM-3) reference. Primary endpoints included accuracy of SpO2 measurements. Results: standard deviation of 1.49 for the 70-100% range; R-squared value of 0.98. Bench testing included EMC, electrical safety, mechanical durability, and environmental testing (temperature/humidity).
Technological Characteristics
Battery-powered (6 AA) handheld pulse oximeter. Features LED display, front/side keypads, and infra-red printer output port. Compatible with BCI oximetry sensors. Technology based on standard pulse oximetry principles. Compliant with respiratory device reviewer's guide standards for safety, EMC, and durability.
Indications for Use
Indicated for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength in patients ranging from neonates to adults. Suitable for use in clinical, EMS, patient transport, sleep screening, and home environments. Not indicated for use as an apnea monitor.
Regulatory Classification
Identification
An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
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9 1999 JUN
1991410
## Summary of Safety and Effectiveness
| Submitter:<br>Address: | BCI International, Inc.<br>N7 W22025 Johnson Road<br>Waukesha, WI 53186 |
|-----------------------------|---------------------------------------------------------------------------|
| Telephone: | (414) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | April 5, 1999 |
| Proprietary Name: | BCI Digital Handheld Oximeter (model 3402) |
| Common/Classification Name: | Pulse Oximeter |
| Predicate Devices: | BCI 3304 Pulse Oximeter (K962156)<br>BCI 3401 Handheld Oximeter (K980714) |
### New Device Description:
The BCI 3402 Digital Handheld Oximeter monitor is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of an oximeter sensor interface, LED display, front and side keypads, and an infra-red LED printer output port. The device is powered by six "AA" batteries.
### Intended Use:
The BCT 3402 Digital Hand Held Oximeter will be an enhanced, low cost Oximeter used for spot checking or monitoring of patients SpO2 and pulse rate. The 3402 is a battery powered pulse oximeter with a built in infra-red printer output port. The device will provide fast. reliable measurements on patients ranging from neonates to adults when using the appropriate BCI SpO2 sensors. The device is intended for use in both clinical and EMS environments by health care professionals, in sleep screening and in the home. The BCI 3402 is not designed or intended to be used as an apnea monitor.
#### Performance Data:
The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done previously to ensure that the BCI 3402 monitor 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 reviewer's guides for respiratory
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devices. Electromagnetic compatability (EMC), electrical, mechanical durability, safety (operator and patient), and temperature/humidity testing has been completed. The results demonstrated that the BCI 3402 monitor was in compliance with the guidelines and standards referenced in the reviewer's guides and that it performed within its specifications and functional requirements.
Additionally, clinically controlled desaturation studies were done to demonstrate that the 3402 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 1.49 for the measurement range of 70-100%. The R squared value was 0.98 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 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 Alexand
Donald Alexander VP Regulatory Affairs
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 1999
Mr. Donald J. Alexander BCI International N7 W22025 Johnson Road Waukesha, WI 53186
K991410 Re: BCI 3402 Handheld Pulse Oximeter Requlatory Class: II (two) Product Code: 74 DQA Dated: April 20, 1999 Received: April 22, 1999
Dear Mr. Alexander:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Donald J. Alexander
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications For Use
510(k) Number (if Known): _
Device Name: BCI Digital Handheld Pulse Oximeter. Model 3402, Pulse Oximeter.
Indications For Use:
Intended Use:
The 3402 Digital Handheld Oximeter is a handheld, low cost pulse oximeter for spot checking or continuous monitoring of SpO2, pulse rate, and pulse strength. It may be used in all critical environments, including clinical and EMS (Emergency Medical Services), patient ground transport, and for use in sleep screening or in the home. The oximetry parameter works with all BCI oximetry sensors, providing SpO2 and pulse rate on all patients from neonate to adult. The 3402 Digital Handheld Oximeter permits continuous patient monitoring with adjustable alarm limits as well as visual and auditory alarm signals.
The BCI 3402 is not designed or intended to be used 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)
Atle A. Cizlowski.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The_Counter Use
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.
