The CARESCAPE V100 Vital Signs Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygen saturation (pulse oximetry) and/or temperature.

The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.

Device Description

The CARESCAPE V100 vital signs monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and non-hospital settings. The monitor is for use on adult, pediatric, or neonatal patients-one at a time. The battery-operated monitor offers noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature. Monitors are available with or without integrated printers as well as the following parameters and technologies.
• NIBP, Pulse: SuperSTAT, Auscultatory, or Classic
• SpO2: Ohmeda TruSignal, Nellcor OxiMax, or Masimo SET
• Temperature: Alaris Turbo Temp, Alaris Tri-Site, or Exergen TemporalScanner Thermometer

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for the GE CARESCAPE V100 Vital Signs Monitor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and device performance. Here's what can be extracted and what information is not available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not include a table of acceptance criteria or reported device performance in the way typically found in a clinical study report for new AI/algorithm-based devices. The submission focuses on demonstrating compliance with voluntary standards and substantial equivalence, not specific performance metrics against pre-defined clinical thresholds.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable/not provided. The document explicitly states: "The subject of this premarket submission, CARESCAPE V100 Vital Signs Monitor, did not require clinical studies to support substantial equivalence." This means there was no clinical "test set" in the context of evaluating algorithm performance on patient data.
Data Provenance: Not applicable/not provided for a clinical test set. The submission is based on non-clinical tests and comparisons to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable/not provided. Since no clinical studies were performed, there was no need for expert-established ground truth on a test set.

4. Adjudication Method for the Test Set:

Not applicable/not provided. No clinical test set required adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document explicitly states: "The subject of this premarket submission, CARESCAPE V100 Vital Signs Monitor, did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No. The submission states that "The CARESCAPE V100 Vital Signs Monitor employs the same fundamental Technology: scientific technology as its predicate devices." and relies on non-clinical tests and compliance with voluntary standards. There is no mention of a standalone algorithm performance study.

7. The Type of Ground Truth Used:

Not applicable/not provided. No clinical ground truth (expert consensus, pathology, outcomes data) was used or established for this submission. The device's performance is assumed to be substantially equivalent to predicates based on its design and non-clinical testing.

8. The Sample Size for the Training Set:

Not applicable/not provided. This device is a vital signs monitor and its submission focuses on demonstrating equivalence to existing technology, not on an AI/machine learning algorithm requiring a "training set" in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/not provided. There is no mention of an algorithm requiring a training set or associated ground truth establishment.

Summary of Device Evaluation (based on the provided text):

The GE CARESCAPE V100 Vital Signs Monitor achieved 510(k) clearance by demonstrating substantial equivalence to predicate devices (K073203 CARESCAPE V100, K011291 Exergen TemporalScanner Thermometer, K050230 TurboTemp Trio).

The basis for this substantial equivalence was:

The device employs the "same fundamental Technology: scientific technology as its predicate devices."
Compliance with voluntary standards (as detailed in Sections 9, 11, and 17, though these sections are not included in the provided text).
Non-clinical tests including:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Unit level testing (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)

The submission explicitly states that clinical studies were not required to support substantial equivalence. Therefore, the detailed information requested regarding clinical study design, test set characteristics, expert involvement, and ground truth establishment is not present in this document.

Summary

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510(k) Premarket Notification Submission

510(k) Summary

OCT 2 0 2010

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

Date:	August 12, 2010
Submitter:	GE Medical Systems Information Technologies, Inc.8200 Tower AvenueMilwaukee, WI 53223
Primary Contact Person:	Mary CarterRegulatory Affairs LeaderGE Healthcare414-362-2626414-362 2585
Secondary Contact Person:	David WahligDirector, Regulatory AffairsGE Healthcare414-362-3242414-362 2585
Device:Trade Name:	CARESCAPE V100 Vital Signs Monitor
Common/Usual Name:	Physiological or Vital Signs Monitor, Patient Monitor
Classification Names:	21 CFR 870.2300
Product Code:	MWI
Predicate Device(s):	K073203 CARESCAPE V100K011291 Exergen TemporalScanner Thermometer, SensorTouchK050230 TurboTemp Trio
Device Description:	The CARESCAPE V100 vital signs monitor provides a small, portable, easy-to-use monitoring alternative for sub-acute hospital and non-hospital settings.The monitor is for use on adult, pediatric, or neonatal patients-one at a time.The battery-operated monitor offers noninvasive determination of systolicblood pressure, diastolic blood pressure, mean arterial pressure, pulse rate,oxygen saturation, and temperature. Monitors are available with or withoutintegrated printers as well as the following parameters and technologies.• NIBP, Pulse: SuperSTAT, Auscultatory, or Classic• SpO2: Ohmeda TruSignal, Nellcor OxiMax, or Masimo SET• Temperature: Alaris Turbo Temp, Alaris Tri-Site, or ExergenTemporalScanner Thermometer
Intended Use:	The CARESCAPE V100 Vital Signs Monitor is intended to monitor a singleadult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure(systolic, diastolic, and mean arterial pressure), pulse rate, and/or oxygensaturation (pulse oximetry) and/or temperature.The portable device is designed for use in numerous clinical settings in varioushospital departments such as emergency, radiology, recovery,medical/surgical, labor and delivery, endoscopy, cardiac step-down. TheCARESCAPE V100 Vital Signs Monitor can also be used in satellite areas,

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GE Healthcare

510(k) Premarket Notification Submission

The CARESCAPE V100 Vital Signs Monitor employs the same fundamental Technology: scientific technology as its predicate devices.

Summary of Non-Clinical Tests:

Determination of Substantial Equivalence:

The CARESCAPE V100 Vital Signs Monitor and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of 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) .
◆ Performance testing (Verification)
Safety testing (Verification) .
- Simulated use testing (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, CARESCAPE V100 Vital Signs Monitor, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the CARESCAPE V100 Vital Signs Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

Ms. Mary Carter Regulatory Affairs Leader GE Healthcare GE Medical Systems Information Technologies, Inc. 8200 Tower Avenue Milwaukee, WI 53223

OCT 2 0 2010

Re: K102426

Device Name: CARESCAPE V100 Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Patient physiological monitor (without arrhythmia detection or alarms) Regulatory Class: Class II (Two) Product Codes: MWI, DQA, DXN, FLL Dated: September 20. 2010 Received: October 8, 2010

Dear Ms. Carter:

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. Ilsting 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 – Ms. Mary Carter

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 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/ReportalProblem/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

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, circular design. The logo is black and white and has a vintage look.

GE Healthcare 510(k) Premarket Notification Submission

K102426 : 510(k) Number (if known): OCT 2 0 2010

CARESCAPE V100 Vital Signs Monitor Device Name:

Indications for Use:

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)

(Division Sign-Off)Division of Cardiovascular Devices
510(k) Number	K102426

1071

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).