BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K962103 · Bio-Logic Systems Corp. · MNR · Aug 22, 1996 · Anesthesiology
Device Facts
Record ID
K962103
Device Name
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
Applicant
Bio-Logic Systems Corp.
Product Code
MNR · Anesthesiology
Decision Date
Aug 22, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 868.2375
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional (for example, a Respiratory or EEG Technologist) to perform a Sleep diagnostic study on a patient with a possible Sleep disorder. This test consists of monitoring and recording various electrical signals from the patient, such as EEG signals from the brain, EOG, respiratory signals from transducers which measure air flow, effort, etc., arm and leg movement, body position while sleeping, pulse rate, and level of oxygen in the blood. Analysis features of the Sleepscan product allow for manipulation and presentation of this data in ways which enhance the physician's ability to reach informed diagnostic decisions quickly and efficiently. Although the addition of an internal oximeter does not, in itself, add to the features or capabilities of the Sleepscan product, it provides a simplification in hardware design which results in faster patient setup with fewer potential errors in setup. This latest modification to the Sleepscan product with Built-In Oximeter does not introduce any changes to the intended use of the product. Sleepscan with Built-In Oximeter can be used for patients of all ages, although most Sleep disorders occur in adults. The equipment does not provide alarms and cannot be used as an automated apnea monitor.
Device Story
Device is a portable sleep and EEG recorder; collects/stores up to 24 channels of patient data (EEG, EOG, respiratory, movement, body position, pulse, blood oxygen). Inputs: patient electrodes and sensors; internal NONIN oximeter. Operation: setup via serial link to computer; device records data to PCMCIA hard disk; data analyzed post-recording using Bio-logic Sleepscan analysis software. Used in clinical/home settings by trained healthcare professionals (technologists). Features proprietary lossless data compression (SMART-PACK) for 12-hour storage. Benefits: enhanced transportability; simplified hardware setup; reduced setup errors. Output: digital data file for physician review to support diagnostic decisions. Device is not an automated apnea monitor and provides no alarms.
Clinical Evidence
Bench testing only. Verified EMI/ESD compliance (CISPR 11, EN55011, IEC 801-2/3, RE101, RS101). Software validated per IEEE Standards for Software Engineering and internal Bio-logic procedures. No clinical data presented.
Technological Characteristics
Enclosure: ULTEM 1000 plastic (4.9"x6.4"x2.35"); weight 2.1 lb. Power: internal batteries. Connectivity: serial link for setup; PCMCIA storage. Data: 24-channel digital recording; 256 Hz sample rate; SMART-PACK lossless compression. Safety: IEC 529 IPX4 splash-proof; optical isolation (2500V RMS) for AC-powered setup. Software: watchdog timer for system reset on failure.
Indications for Use
Indicated for patients of all ages, typically adults, undergoing sleep diagnostic evaluation for possible sleep disorders.
Regulatory Classification
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
Predicate Devices
Bio-logic Sleepscan with Internal Oximeter (K930790)
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Bio-logic
AUB 22 1996
K962103
One Bio-logic Plaza
Mundelein, Illinois 60060-3700
1-800-323-8326
Fax: 847-949-8615
# SECTION 2: SUMMARY AND CERTIFICATION
510 (K) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
Safety and effectiveness information concerning the Modification to the Bio-logic Sleepscan product with Built-In Oximeter is summarized below.
Because this is not a CLASS III device, the special certification defined for this section is not required.
PREPARED BY:
Bio-logic Systems Corp
One Bio-logic Plaza
Mundelein, IL 60060
TELEPHONE:
(847)-949-5200
CONTACT PERSON:
Norman E. Brunner
DATE ON WHICH THE SUMMARY WAS PREPARED:
May 24, 1996
NAME OF DEVICE:
Modification to the Bio-logic Sleepscan product with Built-In Oximeter.
COMMON NAME:
Sleep and EEG Recorder
CLASSIFICATION NAME:
Electroencephalograph (per CFR 882.1400). — class II
PREDICATE DEVICES:
Bio-logic Sleepscan with Internal Oximeter (K930790)
Bio-logic CEEGRAPH TRAVELER Ambulatory EEG Recorder (K954954)
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Modification to Bio-logic Sleepscan Product with Built-In Oximeter
Section 2 - Page 2
# DESCRIPTION OF THE DEVICE:
This Modification to the Bio-logic Sleepscan product with Internal Oximeter (Sleepscan Recorder) consists of a newly-designed hardware device for data recording. It is intended to complement the predicate device hardware in the Bio-logic Sleepscan product line, offering new features which enhance ease-of-use and transportability. The design of this new device is nearly identical to that of the Bio-logic CEEGRAPH TRAVELER (tm) Ambulatory EEG Recorder (K954954), in that it provides for the data collection and storage of up to 24 channels of patient data in a digital form. The only significant difference in the design of these two devices is that the Sleepscan device includes the addition of an internal oximeter made by NONIN, Inc. The oximeter provides heartrate and blood oxygen level data to the Bio-logic data recording electronics, and this data is recorded along with the other patient data (EEG, body position, etc.). After the recording is completed, it can be analyzed using the existing Sleepscan (tm) analysis system, since the data file format is compatible with that employed in current Bio-logic Sleepscan equipment. It provides an improvement in data recording capacity through the use of the Bio-logic proprietary lossless data compression technique (SMART-PACK). This allows for the storage of up to 12 hours of typical Sleep patient data (EEG, oximetry, etc.) onto a single high-capacity PCMCIA hard disk. Power for the device is supplied by batteries inside the unit. Patient setup is accomplished by connecting the Sleepscan Recorder through an isolated serial link to a computer system running the patient setup program. After the electrodes are attached to the patient and other setup functions are completed (ie, impedance and calibration), the computer is disconnected, the Recorder is closed up, and it is placed close to the patient bedside for the duration of the Sleep recording. All setup functions, including periodic replacement of hard disk and batteries, must be performed by a qualified health care professional trained in the use of this product.
The Sleepscan Recorder is housed in a 2-part enclosure made of high-strength ULTEM 1000 plastic. This material was selected due to its high impact strength over a wide temperature range, resistance to alcohol, acetone and other chemicals, and non-flammability. The size of the enclosure is approximately 4.9" W x 6.4" L x 2.35" H (115 mm x 150 mm x 55 mm). The total weight with hard disk and batteries installed is approximately 2.1 lb (955 g). When closed, the Recorder is water-resistant, conforming to the IEC 529 IPX4 Splash-Proof specification.
The initial patient setup of the Sleepscan Recorder is accomplished through the connection of a computer system running the Sleepscan patient setup program. This connection is made between the serial port on the Recorder and a serial port on the computer system. When the computer used is a battery operated laptop, the connection is made via a standard "null modem" cable. If an AC-powered desktop computer is used, the connection to the Recorder must be made through the serial cable isolation device which provides for proper patient isolation.
There is a 62-pin cable connector on the Recorder which is used to connect to the patient electrodes and sensors. A variety of these cable-electrode assemblies are available, depending on the specific collection montage being used. The Recorder automatically senses which montage cable is in use, and records this in the data file
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Modification to Bio-logic Sleepscan Product with Built-In Oximeter
Section 2 - Page 3
being recorded. Recording of patient data starts at a pre-specified time defined at setup. The ending time is also specified, or the recording will stop when the montage (electrode) cable is unplugged from the unit.
After the Sleep Recording period has been completed (typically 8 hours), the PCMCIA hard disk containing the patient data is analyzed using the standard Bio-logic Sleepscan Analysis programs. The data is first decompressed and transferred to a file format identical to that used by the predicate Sleepscan with Oximeter device. All analysis functions currently used in existing Bio-logic Sleepscan systems are available to use in the analysis of the data from the Sleepscan Recorder.
## INTENDED USE:
The Bio-logic Sleepscan Product is intended for use when it is necessary for a trained health care professional (for example, a Respiratory or EEG Technologist) to perform a Sleep diagnostic study on a patient with a possible Sleep disorder. This test consists of monitoring and recording various electrical signals from the patient, such as EEG signals from the brain, EOG, respiratory signals from transducers which measure air flow, effort, etc., arm and leg movement, body position while sleeping, pulse rate, and level of oxygen in the blood. Analysis features of the Sleepscan product allow for manipulation and presentation of this data in ways which enhance the physician's ability to reach informed diagnostic decisions quickly and efficiently. Although the addition of an internal oximeter does not, in itself, add to the features or capabilities of the Sleepscan product, it provides a simplification in hardware design which results in faster patient setup with fewer potential errors in setup. This latest modification to the Sleepscan product with Built-In Oximeter does not introduce any changes to the intended use of the product.
Sleepscan with Built-In Oximeter can be used for patients of all ages, although most Sleep disorders occur in adults. The equipment does not provide alarms and cannot be used as an automated apnea monitor.
## PATIENT POPULATION:
The Sleepscan Recorder can be used for any patient who is a candidate for sleep diagnostic evaluation. This will typically be an adult population, but it can be used for patients of all ages.
## SAFETY AND EFFECTIVENESS:
In the normal operation of the Sleepscan Recorder with Internal Oximeter, the power source is only from the internal batteries, and no voltage inside the unit is greater than 9 Volts DC. DC signals from externally-powered transducers used in routine Sleep patient recordings can be connected to the Recorder through the serial cable isolation device. Therefore, there is no danger to the patient of serious injury due to electrical shock.
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Modification to Bio-logic Sleepscan Product with Built-In Oximeter
Section 2 - Page 4
During patient setup, the Sleepscan Recorder is connected to the computer running the Sleepscan patient setup software through a standard RS-232 serial data communications link. There are two types of computer which can be used for this purpose.
1. If the computer is a battery-powered laptop with no connection to the AC line source, and no externally-powered transducers are used, there is no voltage present in the system which can inflict serious harm to the patient, so no special patient isolation is required.
2. If the computer is an AC-powered system, such as a desktop unit, the serial cable isolation device is required to be used. This device provides optical isolation of all wires in the cable, up to 2500 Volts RMS.
Because of the low-voltage and isolated nature of the hardware design, there are no failure modes in the Sleepscan Recorder software which can cause the hardware to cause injury to the patient. The overall unit is designed to withstand the electrical environments found in typical clinical, office and home use situations, such as interference from other electrical devices and static electricity.
In the event that a failure occurs in normal software operation, either because of a latent design defect or externally-caused, a "watchdog timer" circuit is included in the hardware design. When the software is properly functioning, it periodically resets the timer before it times out, so that under proper operation it will never time out. If the software fails to perform correctly, this reset will not occur, and the timer will time out, causing a general reset to the microprocessor system which acts the same as a start from power up. This effectively prevents a "runaway software" condition of unknown consequences.
Laboratory testing was performed on the Sleepscan Recorder with Internal Oximeter to verify proper operation with respect to EMI and ESD standards. The following testing was performed, with satisfactory results:
Electromagnetic Compatibility:
Radiated Emissions CISPR 11 / EN55011
Electrostatic Discharge Immunity: IEC 801-2
Radiated RF Immunity: IEC 801-3
Magnetic Fields Emissions: RE101
Magnetic Field Immunity: RS101
Quasi-Static Electric Fields: Tested per Reviewer's Guide
To establish the safety and effectiveness of the software which controls the Sleepscan Recorder with Internal Oximeter, the system was validated in accordance with the IEEE Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. The program in the Sleepscan Recorder, the patient setup program necessary to accommodate the communication to and setup of the unit, and the data decompression/transfer program, were all developed and tested as specified in these procedures. The system, for which this 510(k) notification is submitted, was verified and validated; it was found to perform in accordance with specifications.
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Modification to Bio-logic Sleepscan Product with Built-In Oximeter
Section 2 - Page 5
The following comparison is provided as a summary of technological characteristics relative to the predicate device (Bio-logic Sleepscan with Oximeter (K930790). This is to demonstrate that this Sleepscan Recorder with Oximeter Modification has no significant differences which would adversely affect product safety and effectiveness.
| Parameter for comparison. | Similarity or Difference. |
| --- | --- |
| Intended Use | No differences. |
| Population | No differences. |
| Storage Sample Rate | Predicate device: 256 Hz.
Subject device: 256 Hz. |
| Size and weight | The predicate device is over twice as large and weighs considerably more. |
| Internal oximeter | The internal oximeter in the predicate device is made by Ohmeda. The oximeter in the subject device is made by Nonin, Inc. |
| Number of Channels | Predicate device: 32 channels.
Subject device: 24 channels. |
| Electrode Connection | Predicate device uses touchproof pin connectors for electrodes. Subject device does not use individual pins for electrode connections. |
| Power source. | Predicate device receives power through cable connected to the computer interface board. Subject device is battery-operated. |
| Safety Characteristics | Both devices provide for patient isolation and are designed to meet applicable international safety and EMC standards. |
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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.
