K102239 · GE Healthcare Finland Oy · MHX · Oct 18, 2010 · Cardiovascular
Device Facts
Record ID
K102239
Device Name
CARESCAPE MONITOR B650
Applicant
GE Healthcare Finland Oy
Product Code
MHX · Cardiovascular
Decision Date
Oct 18, 2010
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 870.1025
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.
Device Story
Multi-parameter patient monitor for professional healthcare facilities; monitors adult, pediatric, and neonatal patients. Inputs: physiological signals via connected modules (ECG, invasive/non-invasive pressure, pulse oximetry, cardiac output, temperature, venous oxygen saturation, impedance respiration, airway gases, spirometry, neurophysiological signals). Operation: processes inputs via CARESCAPE Software Platform (ESP) and EK-Pro V12 arrhythmia detection algorithm; displays data on 15-inch screen (optional touch). Output: real-time physiological data, diagnostic analysis, and alarms. Used by clinicians for patient status assessment; supports stand-alone use, remote viewing, and network integration with other medical devices/data management systems. Benefits: continuous patient monitoring, early detection of physiological changes, and centralized data access.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including module verification, system integration testing, performance testing, safety testing, and design/risk analysis.
Technological Characteristics
Multi-parameter monitor with 15-inch display, integrated keypad, and modular frame. Connectivity: cabled/wireless network interface for remote viewing and data management. Software: CARESCAPE Software Platform (ESP) and EK-Pro V12 arrhythmia detection algorithm. Power: battery-operated or AC. Intended for professional healthcare environment.
Indications for Use
Indicated for monitoring, recording, and alarming of hemodynamic, respiratory, gas exchange, and neurophysiological status in adult, pediatric, and neonatal patients within professional healthcare facilities. Contraindicated for use during MRI.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE07 AND L-ANE07A SOFTWARE (K092680)
Submission Summary (Full Text)
{0}------------------------------------------------
K102239
P1/3
OCT 1 8 2010
CE Healthcare Finland Ov
Ki-000031 GES
FI-00031 GES
Ti-00031 GES
Ti-00031 GES
Ti-00031 GES
Ti-1-358 10 30411
F: +358 9 14633110
510(k) Summary
:
In accordance with 21 CFR 807.92 the following summary of information is provided:
| <b>Date:</b> | August 5, 2010 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Submitter:</b> | GE Healthcare Finland Oy. Kuortaneenkatu 2 Helsinki, Finland FIN-00510 |
| <b>Primary Contact Person:</b> | Päivi Roiha Regulatory Affairs Leader GE Healthcare Finland Oy Kuortaneenkatu 2 Helsinki, Finland FIN-00510 Phone: + 358 10 394 3731 Fax: +358-92726532 E-mail: paivi.roiha@ge.com |
| <b>Secondary Contact Person:</b> | Joel Kent Manager, Quality and regulatory Affairs GE Healthcare Phone: 781-449-8685 Fax: 781-433-1344 |
| <b>Device:</b> | CARESCAPE <sup>TM</sup> Monitor B650 |
| <b>Common/Usual Name:</b> | multi-parameter patient monitor |
| <b>Classification Names:</b> | 21 CFR 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm) |
| <b>Product Code:</b> | MHX |
Product Code:
:
. . . .
. ·
Image /page/0/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The logo is black and white.
: .
{1}------------------------------------------------
K102239
p2/3
## K092027 CARESCAPE™ Monitor B850 Predicate Device(s):
K061185 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05(A) SOFTWARE
K031320 EK-PRO ARRHYTHMIA DETECTION ALGORITHM (EK-Pro VII)
K092680 DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE07 AND L-ANE07A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS AND E-EXT EXTENSION MODULE AND E-REC RECORDER MODULE
- The CARESCAPE Monitor B650 is a multi-parameter patient monitor Device Description: including both new and existing subsystems. The CARESCAPE Monitor B650 includes the monitor itself, the CARESCAPE Software Platform (also called ESP software) and the battery. The CARESCAPE Monitor B650 itself has 15 inch display (optional touch screen) with integrated keypad and a frame for parameter measurement modules. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader, and corded remote control), and physiological parameter measurement modules, which are existing subsystems. The CARESCAPE Monitor B650 communicates to a variety of existing OEM medical devices. The CARESCAPE Monitor B650 interfaces to a variety of other existing patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B650 includes features and subsystems that are optional or configurable.
The CARESCAPE Monitor B650 is a multi-parameter patient monitor Intended Use: intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
> The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status.
The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The CARESCAPE Monitor B650 is not intended for use during MRI.
Technology:
The CARESCAPE Monitor B650 is a new monitor that essentially is a combination of the features and parameters of two existing predicate monitor
{2}------------------------------------------------
K102239
p3/3
platforms. The predicate monitors are CARESCAPE™ Monitor B850 (K092027) and the DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05(A) SOFTWARE (K061185).
The CARESCAPE Monitor B650 has the EK-Pro Arrhythmia Detection Algorithm, EK- Pro V12 that employs the same functional technology as the predicate device(s) in the monitoring of ECG parameter data. The predicate algorithms are EK-PRO ARRHYTHMIA DETECTION ALGORITHM, EK-Pro V11 (K031320) and DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE07 AND L-ANE07A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS AND E-EXT EXTENSION MODULE AND E-REC RECORDER MODULE (K092680).
The fundamental technology of the CARESCAPE Monitor B650 is the same as the predicate devices.
The CARESCAPE Monitor B650 device is as safe and effective the predicate devices.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The CARESCAPETM Monitor B650 and its applications comply with voluntary standards as detailed in this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
Summary of Clinical Tests:
The subject of this premarket submission. CARESCAPE™ Monitor B650 did not require clinical studies to support substantial equivalence.
GE Healthcare considers the CARESCAPE™ Monitor B650 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
22
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
GE Healthcare Finland Oy c/o Ms. Paiva Roiha Regulatory Affairs Leader Kuortaneenkatu 2 Helsinki, Finland FIN-00510
OCT 1 8 2010
K102239 Re:
Trade/Device Name: CARESCAPE™ Monitor B650 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MHX Dated: August 5, 2010 Received: August 9, 2010
Dear Ms. Roiha:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
{4}------------------------------------------------
Page 2 - Ms. Paiva Roiha
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
K102239
## Indications for Use
510(k) Number (if known):
OCT 1 8 2010
## Device Name: CARESCAPE™ Monitor B650
Indications for use:
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.
The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission) status.
The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network.
The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The CARESCAPE Monitor B650 is not intended for use during MRI.
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.S.
510(k) Number K102235
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.
