(196 days)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE 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 B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE 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.
Contraindications for using CARESCAPE B650:
The CARESCAPE B650 is not intended for use in a controlled MR environment.
CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650 includes the monitor with built-in CPU, power unit, a 15 inch touch display, the CARESCAPE Software and the battery. CARESCAPE B650 is equipped with two module slots where patient data acquisition modules (E-Module type) can be connected to perform patient monitoring. CARESCAPE B650 is equipped with the ePort interface that supports use of PDM or CARESCAPE ONE patient data acquisition devices. In addition to the ePort interface the PDM module can be also connected directly to the CARESCAPE B650 via special slide mount connector which is in the back of the monitor. The CARESCAPE B650 includes features and subsystems that are optional or configurable.
The provided text is a 510(k) Summary for the GE Healthcare CARESCAPE B650 patient monitor. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of acceptance criteria and device performance. Therefore, the information requested in your prompt is largely not available within this document.
Here's a breakdown of what can and cannot be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance values in the format you requested. It states: "Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the CARESCAPE B650, demonstrating the design meets the specifications." This is a general statement about testing without specific criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Bench testing related to software, hardware and performance," but does not detail the nature of the test sets, their size, or their origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As this is a 510(k) submission for a patient monitor, the primary evidence relies on engineering and performance testing against established standards, not typically on expert consensus for "ground truth" in the way it might be for an AI diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done, and it is not applicable to this submission. The device is a patient monitor, not an AI-assisted diagnostic tool that would involve human readers. The document explicitly states: "The subject of this premarket submission, CARESCAPE B650 did not require clinical studies to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes "Bench testing related to software, hardware and performance" and "Software testing included software design, development, verification, validation and traceability." This implies standalone testing of the device's algorithms and functionality. However, specific details about the results of such standalone performance are not provided in a quantifiable manner against acceptance criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a multi-parameter patient monitor), "ground truth" would likely be established through:
- Reference measurement devices/standards: For parameters like ECG, blood pressure, oxygen saturation, temperature, etc., the device's measurements would be compared against validated reference devices or established physical standards.
- Simulated physiological signals: For arrhythmia detection, the device would be tested with simulated ECG waveforms containing known arrhythmias.
However, the specific types of "ground truth" used are not explicitly elaborated beyond "bench testing" and "applicable consensus standards."
8. The sample size for the training set
This information is not provided and is generally not applicable in the context of a patient monitor's 510(k) submission unless specific machine learning algorithms requiring training data were a novel aspect of the submission, which is not indicated here. The document describes modifications to software and hardware, implying updates to existing functionalities rather than the introduction of new, data-trained AI models.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 13, 2022
GE Healthcare Finland Oy Joel Kent Senior Regulatory Affairs Manager Kuortaneenkatu 2 Helsinki, FI-00510 Finland
Re: K213181
Trade/Device Name: CARESCAPE B650, E-musb Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DOA, DOK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QEM Dated: March 11, 2022 Received: March 14, 2022
Dear Joel Kent:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name CARESCAPE B650
Indications for Use (Describe)
The CARESCAPE B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.
The CARESCAPE B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE B650 is indicated for monitoring of:
· hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE 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 B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE 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.
Contraindications for using CARESCAPE B650:
The CARESCAPE B650 is not intended for use in a controlled MR environment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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GE Healthcare Finland Oy Kuortaneenkatu 2
00510 Helsinki Finland T: +358 10 39411
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1)):
| Date: | September 27, 2021 |
|---|---|
| Owner/Submitter: | GE Healthcare Finland Oy.Kuortaneenkatu 200510 HelsinkiFINLANDPhone: +358 10 39411 |
| Primary Contact Person: | Joel KentSenior Regulatory Affairs ManagerGE HealthcarePhone: 617-851-0943E-mail: joel.kent@ge.com |
| Secondary Contact Person: | Karin MårtensonRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 200510 HelsinkiFinlandPhone: + 358 50 384 6646E-mail: karin.martenson@ge.com |
| Device names (807.92(a)(2)): |
Trade Name: CARESCAPE B650 Common/Usual Name: Multiparameter patient monitor (monitor, physiological, patient (with arrhythmia detection or alarms)
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Classification Names: 21 CFR 870.1025 Arrhythmia detector and alarm (including STsegment measurement and alarm) 21 CFR 868.1850 spirometer, monitoring (w/wo alarm) 21 CFR 868.1730 computer, oxygen-uptake 21 CFR 868.2375 monitor, breathing frequency 21 CFR 868.2600 monitor, airway pressure (includes gauge and/or alarm) 21 CFR 868.1500 analyzer, gas, enflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, desflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, sevoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1500 analyzer, gas, isoflurane, gaseous-phase (anesthetic conc.) 21 CFR 868.1700 analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.) 21 CFR 868.1620 analyzer, gas, halothane, gaseous-phase (anesthetic conc.) 21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-phase 21 CFR 868.1720 analyzer, gas, oxygen, gaseous-phase 21 CFR 870.2340 electrocardiograph 21 CFR 870.2710 oximeter, ear 21 CFR 870.2700 oximeter 21 CFR 870.1425 computer, diagnostic, programmable 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) 21 CFR 870.1025 detector and alarm, arrhythmia 21 CFR 870.1100 alarm, blood-pressure 21 CFR 870.1110 computer, blood-pressure 21 CFR 870.1435 computer, diagnostic, pre-programmed, single-function 21 CFR 870.1130 system, measurement, blood-pressure, noninvasive 21 CFR 870.2910 thermometer, electronic, clinical 21 CFR 882.1900 stimulator, auditory, evoked response 21 CFR 882.1400 full-montage standard electroencephalograph 21 CFR 870.2700 Oximeter, Tissue Saturation 21 CFR 868.2775 stimulator, nerve, peripheral, electric 21 CFR 870.1915 probe, thermodilution 21 CFR 870.1025 monitor, st segment with alarm 21 CFR 882.1400 non-normalizing quantitative electroencephalograph software 21 CFR 882.1400 index-generating electroencephalograph software 21 CFR 882.1400 reduced- montage standard electroencephalograph 21 CFR 882.1400 burst suppression detection software for electroencephalograph 21 CFR 870.2700 Cerebral Oximeter
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Product Code: MHX
| Subsequent Product Codes: | BZK, BZL, BZQ, CAP, CBQ, CBR, CBS, CCK, CCL, DPS, DPZ, DQA, DQK, DRT, DSI, DSJ, DSK, DXG, DXN, FLL, GWJ, GWQ, KOI, KRB, MLD, MUD, NHO, NHP, NHQ, OLT, OLW, OMC, ORT, QEM |
|---|---|
| Predicate Device(s)(807.92(a)(3)): | The primary predicate for this submission is K191149CARESCAPE B650 |
| Additional predicates / reference devices:K182868, INVOS PM7100 Patient Monitor, INVOS Adult rSO2SensorK110028, MASIMO RADICAL Y PULSE CO-OXIMETER | |
| Device Description(807.92(a)(4)): | CARESCAPE B650 is a new version of a portable multi-parameter patient monitoring system. The CARESCAPE B650includes the monitor with built-in CPU, power unit, a 15 inchtouch display, the CARESCAPE Software and the battery.CARESCAPE B650 is equipped with two module slots wherepatient data acquisition modules (E-Module type) can beconnected to perform patient monitoring. CARESCAPE B650 isequipped with the ePort interface that supports use of PDM orCARESCAPE ONE patient data acquisition devices. In additionto the ePort interface the PDM module can be also connecteddirectly to the CARESCAPE B650 via special slide mountconnector which is in the back of the monitor. TheCARESCAPE B650 includes features and subsystems that areoptional or configurable. |
| Intended Use: (807.92(a)(5)): | Indications (from labeling)The CARESCAPE B650 is a multi-parameter patient monitorintended for use in multiple areas and intrahospital transportwithin a professional healthcare facility. |
| The CARESCAPE B650 is intended for use on adult, pediatric,and neonatal patients and on one patient at a time. |
The CARESCAPE B650 is indicated for monitoring of:
• hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution and pulse contour), temperature, mixed
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venous oxygen saturation, and central venous oxygen saturation),
· respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), and
· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).
The CARESCAPE 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 B650 is able to detect and generate alarms for ECG arrhythmias: atrial fibrillation, accelerated ventricular rhythm, asystole, bigeminy, bradycardia, ventricular couplet, irregular, missing beat, multifocal premature ventricular contractions (PVCs), pause, R on T, supra ventricular tachycardia, tachycardia, trigeminy, ventricular bradycardia, ventricular fibrillation/ventricular tachycardia, ventricular tachycardia, and VT>2. The CARESCAPE B650 also shows alarms from other ECG sources.
The CARESCAPE B650 also provides other alarms, trends, snapshots and events, and calculations, and can be connected to displays, printers and recording devices.
The CARESCAPE 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.
Contraindications for using the monitor
The CARESCAPE B650 is not intended for use in a controlled MR environment.
Technology (807.92(a)(6)): CARESCAPE B650 incorporates updated software and minor modifications to the hardware.
The fundamental function and operation of the proposed CARESCAPE B650 monitor are unchanged compared to CARESCAPE B650 (K191149).
A summary of the main changes compared to the predicate are listed below in the comparison table.
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| Specification | CARESCAPE B650(K191149) | ProposedCARESCAPE B650 | Differences |
|---|---|---|---|
| Patient type | Adult, pediatric &neonatal | Adult, pediatric &neonatal | Identical |
| Useenvironments | Within a professionalhealthcare facility (Notintended for MRI) | Within a professionalhealthcare facility (Notintended for MRI) | Identical |
| Intrahospitaltransport | Intrahospital transportwithin a professionalhealthcare facility. | Intrahospital transportwithin a professionalhealthcare facility. | Identical |
| Size (H x W xD) & Weight | 360 x 370 x 220 mm (14.2x 14.6 x 8.7 in) andweight 9.2 kg (20.3 lbs) withbattery but without modules. | 360 x 370 x 220 mm(14.2 x 14.6 x 8.7 in) andweight 9.2 kg (20.3lbs)with battery but withoutmodules. | Identical |
| Module Housing | Two E-module slots fortwo single-width E-modules or one double-width E-module andoptional recorder. Oneslide mount foracquisition module. | Two E-module slots fortwo single-width E-modules and optionalrecorder. One slide mountfor acquisition module. | EquivalentAdded mechanical block to E-module housing mechanics andremoved related electroniccomponents, to prevent use ofdouble-width legacy modules, thatare no longer supported. There is nochange to functionality of the E-module frame itself, only preventingusers from connecting legacy E-modules that CARESCAPE B650does not support |
| Display/screen | 15" TFT color LCD | 15" TFT color LCD | Identical |
| Waveforms andparameterwindows | Standard view: Up to 8individual waveforms andup to 20 parameterwindows, if horizontalparameter area turned on. | Standard view: Up to 8individual waveforms andup to 20 parameterwindows, if horizontalparameter area turned on. | Identical |
| Modules | E-BIS, E-COP, E-COPSv, E-PiCCO, E-EEGX, E-Entropy, E-Masimo, E-miniC, E-NMT, E-NSATX, E-PP,E-PT, E-sCAIO, E-sCAIOV, E-sCAIOVX,E-sCO, E-sCOV, E-sCOVX, PDM,CARESCAPE ONE | E-BIS, E-COP, E-COPSv, E-PiCCO, E-EEGX, E-Entropy, E-Masimo, E-miniC, E-NMT, E-NSATX, E-PP,E-PT, E-sCAIO, E-sCAIOV, E-sCAIOVX,E-sCO, E-sCOV, E-sCOVX, PDM,CARESCAPE ONE | Identical |
| Optional systemcomponents | -Remote Control-CARESCAPE D19KTVER01 optional display-CARESCAPE RAD,Remote Alarm Device-Keyboard-Mouse-Barcode scanner-Laser Printer | -Remote Control-CARESCAPE D19KTVER01 optional display-CARESCAPE RAD,Remote Alarm Device-Keyboard-Mouse-Barcode scanner-Laser Printer-E-musb Interface module | EquivalentAdded E-musb Interface modulethat provides a communication pathfor the OEM owned devicesCARESCAPE rSO2 – INVOS andCARESCAPE CO2 – Microstreamto the CARESCAPE Bx50 hostmonitors |
| Availablemeasurementparameters | ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, cardiacoutput (thermodilutionand pulse contour),temperature, mixedvenous oxygen saturation,and central venousoxygen saturation,impedance respiration,airway gases (CO2, O2,N2O, and anestheticagents), spirometry, gasexchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission. | ECG, ST segment,arrhythmia detection,ECG diagnostic analysisand measurement,invasive pressure, non-invasive blood pressure,pulse oximetry, regionaloxygen saturation, totalhemoglobinconcentration, cardiacoutput (thermodilutionand pulse contour),temperature, mixedvenous oxygen saturation,and central venousoxygen saturation,impedance respiration,airway gases (CO2, O2,N2O, and anestheticagents), spirometry, gasexchange,electroencephalography,Entropy, Bispectral Index(BIS), neuromusculartransmission. | EquivalentAdded hemodynamic parameters (inbold) that are previously cleared butare new to the monitor:regional oxygen saturation and totalhemoglobin concentration, oftenreferred to as rSO2 and SpHb. TheIndications for Use were updatedaccordingly.The CARESCAPE B650 does notchange the measurement oralgorithm of these parameters butsimply displays the values from theOEM ownedCARESCAPE parameter devicesCARESCAPE SpO2 –Masimo andCARESCAPE rSO2 –INVOS. |
| EK-Proarrhythmiadetectionalgorithm | EK-Pro V14 | EK-Pro V14 | Identical |
| Printing | Built-in or central andnetworked laser printerPrintings for waveforms,alarms waveforms,numeric trends. | Built-in or central andnetworked laser printerPrintings for waveforms,alarms waveforms,numeric trends. | Identical |
| Mountingoptions | Multiple GCX mountingsystems, Roll Stand,Quick Mount | Multiple GCX mountingsystems, Roll Stand | EquivalentQuick Mount is obsolete and notsold anymore. |
| Alarms | Alarm management corefunctionalities:Classification and notification ofalarmsAdjustment of alarm settingsPossibility to set critical alarmlimitsAlarm On/Off functionality andaudio silencing | Alarm management corefunctionalities:Classification and notification ofalarmsAdjustment of alarm settingsPossibility to set critical alarmlimitsAlarm On/Off functionality andaudio silencing | Identical |
| Battery operation | Rechargeable Lithium-Ionbatteries | Rechargeable Lithium- Ionbatteries | Identical |
| Networkingcapability | CARESCAPE NetworkLAN/VLANOptional WLAN | CARESCAPE NetworkLAN/VLANOptional WLAN | Identical |
| Networkinterface | 10baseT, 100baseT,802.11 abgn, IEEE802.11r fast roaming issupported. | 10baseT, 100baseT,802.11 abgn, IEEE802.11r fast roaming issupported. | Identical |
Subject Device and Predicate Device Comparison
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| Determination ofSubstantial Equivalence(807.92(b)(1): | Summary of Non-Clinical Tests: | |
|---|---|---|
| Bench testing related to software, hardware and performanceincluding applicable consensus standards was conducted on theCARESCAPE B650, demonstrating the design meets thespecifications. | ||
| The hardware bench testing included electromagneticcompatibility, electrical safety, environmental, WLAN, andusability. | ||
| Software testing included software design, development,verification, validation and traceability. | ||
| Clinical (807.92(b)(2)): | Summary of Clinical Tests: | |
| The subject of this premarket submission, CARESCAPE B650did not require clinical studies to support substantial equivalence. | ||
| Conclusion (807.92(b)(3)): | GE Healthcare considers the CARESCAPE B650 to be as safe, aseffective, and the performance to be substantially equivalent tothe predicate device. |
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
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.(b)
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.