K Number

Device Name

Manufacturer

Date Cleared

2013-12-04

(114 days)

Product Code

MHX,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,NHO,NHP,NHQ,OLT,OLW,OMC,ORT

Regulation Number

870.1025

Type

Traditional

Panel

Cardiovascular

Reference & Predicate Devices

K102239

Predicate For

K190008,K191249

Intended Use

The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B450 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, 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), and spirometry)

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE Monitor B450 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor B450 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 B450 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 B450 is not intended for use during MRI.

Device Description

The CARESCAPE Monitor B450, including both new and existing subsystems interconnected forms a low acuity, portable multi-parameter patient monitoring system. The CARESCAPE Monitor B450 includes the monitor itself with built-in CPU and power unit, the CARESCAPE Software Platform (ESP software version 2 in this submission) and one or two batteries. The CARESCAPE Monitor B450 has a 12 inch touch screen display, mounting for a PSM/PDM hemodynamic module and a frame for one additional parameter measurement module. A variety of options are available to the customer including additional displays, various input devices (keyboard, mouse, bar code reader and USB remote control), and additional modules. The CARESCAPE Monitor B450 supports a variety of existing physiological parameter measurement modules and also can connect to OEM medical devices via the existing network infrastructure. The CARESCAPE Monitor B450 interfaces to a variety of other patient monitoring systems via a cabled or wireless network interface. The CARESCAPE Monitor B450 includes features and subsystems that are optional or configurable.

AI/ML Overview

The provided text describes a 510(k) submission for the GE Healthcare CARESCAPE Monitor B450. However, it explicitly states, "The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence."

This means that a study proving the device meets specific acceptance criteria, as typically described for a new or significantly modified device, was not conducted in the context of this 510(k) review. The device's safety and effectiveness were established primarily through non-clinical tests (compliance with standards) and by demonstrating substantial equivalence to a predicate device (CARESCAPE Monitor B650) which used an earlier version of the algorithm (EK-Pro v12 vs. EK-Pro v13).

Therefore, I cannot provide the information requested in points 1-9 as no such study is detailed in the provided document.

Here's a breakdown based on the information provided (or not provided) in the text:

1. A table of acceptance criteria and the reported device performance:

Not provided. No specific acceptance criteria for performance were listed, nor were direct device performance results from a clinical study included. The submission focuses on compliance with general safety and performance standards for medical electrical equipment.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No clinical test set was used or described.

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):

Not applicable. No clinical test set requiring expert ground truth was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication was described.

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:

No. This type of study was not mentioned or performed. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable in the context of clinical performance evaluation. The document mentions an "improved arrhythmia and ST analysis algorithm called EK-Pro v13," but its performance was not evaluated through a standalone clinical study for this 510(k). Its substantial equivalence was based on its predecessor (EK-Pro v12) in the predicate device and non-clinical testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. As no clinical study was conducted for this submission, no ground truth was established from clinical data.

8. The sample size for the training set:

Not provided. No information about a training set for the algorithm was included.

9. How the ground truth for the training set was established:

Not provided. As no training set information was included, how ground truth might have been established is also not provided.

Summary based on given document:

The GE Healthcare CARESCAPE Monitor B450's substantial equivalence was established by:

Demonstrating that its technology (including the new EK-Pro v13 algorithm) is "essentially the same" as the predicate device (CARESCAPE Monitor B650) which used the EK-Pro v12 algorithm.
Mentioning that the EK-Pro v13 algorithm is "based on the previous algorithm version EK-Pro v12, which has been cleared as part of the predicate device."
Undergoing comprehensive non-clinical testing for compliance with numerous international safety, performance, and EMC standards (e.g., IEC 60601 series, AAMI EC standards).

The crucial statement is "The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence." This indicates that for this specific 510(k), the FDA did not deem a new clinical performance study necessary to prove the device met acceptance criteria, likely due to its similarity to the already cleared predicate.

Summary

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K132533 Page 1 of 5

GE Healthcare Finland Oy
Kuortaneenkatu 2, P.O. Box 900
F1-0003 1 GE Finland T: +358 10 39411
F: +358 10 39411
F: +358 9 1463310

510(k) Summary

In accordance with 21 CFR 807.92(c) the following summary of information is provided:

Owner/Contact/Date (807.92(a)(1):Date:	August 20, 2013	DEC 04 2013
Submitter:	GE Healthcare Finland Oy.Kuortaneenkatu 2Helsinki, FinlandFIN-00510Phone: + 358 10 394 11Fax: +3589 2726532
Primary Contact Person:	Joel KentManager, Quality and regulatory AffairsGE HealthcarePhone 781-449-8685Fax 781-433-1344E-mail: joel.kent@ge.com
Secondary Contact Person:	Päivi RoihaRegulatory Affairs LeaderGE Healthcare Finland OyKuortaneenkatu 2Helsinki, FinlandFIN-00510Phone: + 358 10 394 3731Fax: +358 9 2726532E-mail: paivi.roiha@ge.com
Device names (807.92(a)(2):
Trade Name:	CARESCAPE Monitor B450
Common/Usual Name:	multi-parameter patient monitor
Classification Names:	21 CFR 870.1025 Arrhythmia detector and alarm (including ST-segmentmeasurement and alarm)
Primary Product Code:	MHX.
Secondary Product Code:	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, NHO, NHP, NHQ, OLT, OLW, OMC, ORT

Image /page/0/Picture/6 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The frame has decorative swirls or flourishes around the letters, giving it a classic or vintage appearance. The logo is black and white.

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Predicate Device(s) (807.92(a)(3):

K 102239 CARESCAPE Monitor B650

Device Description (807.92(a)(4)):

Intended Use (807.92(a)(5)):

The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B450 is indicated for monitoring of:

· respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry)

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE Monitor B450 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor B450 is not intended for use during MRI.

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K132533

Page 3 of 5

Technology (807.92(a)(6)): The CARESCAPE Monitor B450 is a new monitor where features and parameters are essentially same as in predicate monitor platform CARESCAPE Monitor B650 (K102239). The CARESCAPE Monitor B450 uses the CARESCAPE Software Platform (also called ESP software) version 2 whereas the predicate monitor CARESCAPE Monitor B650 (K102239) has software version 1.

The fundamental technology of the CARESCAPE Monitor B450 is the same as the predicate device.

The CARESCAPE Monitor B450 with ESP v2 software uses an improved arrhythmia and ST analysis algorithm called EK-Pro v13 in the Monitor Software. It is based on the previous algorithm version EK-Pro v12, which has been cleared as part of the predicate device CARESCAPE Monitor B650 with ESP VI software (K102239).

The CARESCAPE Monitor B450 device is as safe and effective as the predicate device.

Summary of Non-Clinical Tests:

The CARESCAPE Monitor B450 and its applications comply with voluntary standards as detailed below. The following quality assurance measures were applied in the development of the system:

. Risk Analysis
. Requirements Reviews
. Design Reviews
. Testing on unit level (Module verification)
t Integration testing (System verification)
. Final acceptance testing (Validation)
Performance testing (Verification) .
. Safety testing (Verification)

The CARESCAPE Monitor B450 was designed and tested for compliance to the following standards:

1. IEC 60601-1:1988. A1:1991. A2:1995. Corr]:1995. Medical Electrical Equipment Part 1: General Requirements for Safety -Second Edition
1. IEC 60601-1-1:2000, Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems-Edition 2.0
1. IEC 60601-1-2:2001 + A.2004, Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests - Edition 2
1. IEC 60601-1-4: 2000, Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable
electrical medical systems
న్. IEC60601-1-6:2006, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - collateral Standard: Usability - Edition 2
IEC 62366: 2007, Medical devices Application of usability 6. engineering to medical devices

510(k) Summary K132533 CARESCAPE Monitor B450 Page 3 of 5

Determination of Substantial Equivalence (807.92(b)(1):

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K132533

Page 4 of 5

1. IEC 60601-1-8:2006. Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance -Collateral Standard: General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems, Second Edition
1. IEC 60601-2-10:1987 + A1:2001, Medical Electrical Equipment Part 2-10: Particular Requirements for the Safety of Nerve and Muscle Stimulators-First Edition
ﮨﮯ IEC 60601-2-25:1993 + A1:1999, Medical electrical equipment Part 2-25- Particular requirements for the safety of electrocardiographs -First Edition
1. IEC 60601-2-26:2002. Medical electrical equipment Particular requirements for the safety of electroencephalographs
1. IEC 60601-2-27:2005, Medical electrical equipment Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
1. IEC 60601-2-30:1999, Medical electrical equipment Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment-Second Edition
1. IEC 60601-2-34:2000, Medical electrical equipment Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment-Edition 2
1. IEC 60601-2-40:1998, Medical electrical equipment Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
1. IEC 60601-2-49:2001, Medical electrical equipment Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment-Edition 1
1. IEC 60601-2-51:2003, Medical electrical equipment Part 2-51: Particular requirements for safety, including essential performance, of recording and analyzing single channel and multichannel electrocardiographs-Edition 1
1. AAMI EC11:1991/(R)2001/(R)2007, Diagnostic Electrocardiographic Devices ·
1. AAMI EC13: 2002/(R)2007, Cardiac monitors, heart rate meters, and alarms.
1. AAMI EC57:1998, A1:2008, Testing and reporting performance results of cardiac thythm and ST segment measurement algorithms
1. AAMI SP10:2002 + A1:2003 + A2:2006, Manual, electronic, or automated sphygmomanometers.
1. EN1060-1:1995 +A1:2002, Non-invasive sphygmomanometers- Part 1: General requirements
1. EN1060-3:1997 +A1:2005, Non-invasive sphygmomanometers- Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems

Except for the following clause:

ಂ 7.9: Testing performed in accordance with EN 1060-4 failed by PDM module
ﺎ ﻣ

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1. EN 12470-4:2000, A1:2009, Clinical Thermometers Part 4; Performance of Electrical Thermometers for Continuous Measurement
  Except for the following clauses:
6.3 b) Temperature measurement error with single use probes o exceeded maximum permissible error.
6.4: The response time of the Esophageal stethoscope with o temperature probe exceeds 150s for the probe sizes 18F and 24F.
1. ISO 21647:2004 + C1:2005, Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors
1. ISO9919:2005, Medical electrical equipment Particular requirements for the safety and essential performance of pulse oximeter equipment for medical use - Second Edition
1. EN 1041: 2008, Information supplied by the manufacturer of medical devices
1. IEC 62304:2006. Medical device software Software life cycle processes

Clinical (807.92(b)(2)): Summary of Clinical Tests:

. ﺍ

The subject of this premarket submission, CARESCAPE Monitor B450 did not require clinical studies to support substantial equivalence.

Conclusion (807.92(b)(3)): GE Healthcare considers the CARESCAPE Monitor B450 to be as safe, as effective, and performance is substantially equivalent to the predicate device.

510(k) Summary K132533 CARESCAPE Monitor B450 Page 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

[Image of the Department of Health and Human Services logo]

December 4, 2013

Ge Healthcare Finland Oy Joel Kent Manager, Quality and Regulatory Affairs Kuortaneenkatu 2 Helsinki, FIN-00510 FI

K132533 Trade/Device Name: Carescape Monitor B450 Regulation Number: 21 CFR 870.1025 Regulation Name: Multiparameter Patient Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms) Regulatory Class: Class II Product Code: MHX, 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, NHO, NHP, NHQ, OLT, OLW, OMC, ORT Dated: November 1. 2013 Received: November 4, 2013

Dear Joel Kent:

Re:

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.

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Page 2 - Joel Kent

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

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,

Owen PDFaris -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K132533 Page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: CARESCAPE Monitor B450

Indications for Use:

The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility.

The CARESCAPE Monitor B450 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time.

The CARESCAPE Monitor B450 is indicated for monitoring of:

· respiratory (impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), and spirometry)

· neurophysiological status (including electroencephalography, Entropy, Bispectral Index (BIS), and neuromuscular transmission).

The CARESCAPE Monitor B450 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices.

The CARESCAPE Monitor B450 is not intended for use during MRI.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) stoned by l

Regulation Number and Section

§ 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.