CARESCAPE V100

K073203 · Ge Medical Systems Information Technologies · MHX · Nov 29, 2007 · Cardiovascular

Device Facts

• Record ID: K073203
• Device Name: CARESCAPE V100
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 29, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 noninvasive 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 Story

Portable multi-parameter monitor for adult, pediatric, neonatal patients; used in hospital departments (emergency, recovery, etc.) and physician offices. Inputs: NIBP (oscillometric), pulse rate, SpO2 (via compatible sensors), and temperature. Device processes signals to provide real-time vital sign measurements; features optional integrated printer. Operated by clinicians; no patient-controlled features. Output displayed on monitor for clinical decision-making regarding patient status during bedside monitoring or intra-hospital transport.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including risk analysis, requirements/design reviews, subsystem verification, integration testing, final acceptance/validation testing, performance testing, safety testing, and environmental testing.

Technological Characteristics

Portable multi-parameter monitor. Measures NIBP (oscillometric), pulse rate, SpO2, and temperature. Configurations include optional integrated printer. Connectivity for various SpO2 sensor types (Ohmeda TruSignal, Nellcor, Masimo). Battery-operated. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for monitoring vital signs in adult, pediatric, and neonatal patients in hospital, clinical, or alternate care settings. Parameters include NIBP, pulse rate, SpO2, and temperature.

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.

Predicate Devices

• DINAMAP® ProCare Series 100N-400N Monitor (K022193)
• DINAMAP® Pro 1000 Monitor with SuperSTAT (K022834)
• Datex-Ohmeda TruSat Pulse Oximeter and Accessories (K040831)

Submission Summary (Full Text)

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K073203

## 510(k) Summary of Safety and Effectiveness

Date: November 9, 2007 Submitter: GE Medical Systems Information Technologies NOV 2 9 2007 4502 Woodland Corporation Boulevard Tampa, FL 33614 USA Contact Person: Karen Russell Requlatory Affairs Specialist GE Medical Systems Information Technologies Phone: [phone] Fax: [phone] E-mail: [e-mail] Secondary Contact Person: Sharon Untz Senior Director, Global Quality and Regulatory Affairs Systems GE Medical Systems Information Technologies Phone: [phone] Fax: [phone] E-mail: [e-mail] Device Trade Name: CARESCAPE V100 Vital Signs Monitor Common /Usual Name: Physiological or Vital Signs Monitor, Patient Monitor Classification Names: Patient Physiological Monitor (without Arrhythmia Detection) System, Measurement, Blood Pressure, Noninvasive Computer, Blood Pressure Alarm, Blood Pressure Oximeter Oximeter, Ear Thermometer, Clinical Electronic Recorder, Paper Chart Predicate Devices: DINAMAP® ProCare Series 100N-400N Monitor (K022193) DINAMAP® Pro 1000 Monitor with SuperSTAT (K022834) Datex-Ohmeda TruSat Pulse Oximeter and Accessories (K040831) Device Description: The CARESCAPE V100 Vital Signs Monitor is a small, portable monitor for use in a sub-acute hospital and non-hospital settings. The CARESCAPE V100 is for use on adult, pediatric, or neonatal patients -

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one at a time. The battery operated monitor provides noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, oxygen saturation, and temperature.

The CARESCAPE V100 is a multi-parameter device that provides Sp02 monitoring for use in spot-checking or continuous monitoring. The CARESCAPE V100 also measures NIBP using the oscillometric method. There are no features of CARESCAPE V100 that can be controlled by the patient.

The CARESCAPE V100 monitor is available in four standard configurations with or without an integrated printer:

- CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or . SuperSTAT), Pulse
- CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or . SuperSTAT), Pulse, and Temperature
- . CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or SuperSTAT), Pulse, and Sp02 (Ohmeda TruSignal, Nellcor, or Masimo)
- . CARESCAPE V100 with NIBP (Classic, Classic Auscultatory, or SuperSTAT), Pulse, Temperature, and Sp02 (Ohmeda TruSignal, Nellcor, or Masimo)
- Intended Use: 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 noninvasive 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.

## Technology:

The CARESCAPE V100 Vital Signs Monitor employs the same functional scientific technology as its predicate device(s).

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## Test Summary:

The subject of this 510(k) is a design modification for the ProCare V1 Vital Signs Monitor. The CARESCAPE V100 Vital Signs Monitor complies with the voluntary standards as detailed in Section 4.2 of this submission. The following quality assurance measures were applied to the development of the CARESCAPE V100 Vital Signs Monitor:

- Risk Analysis ●
- Requirements Reviews ●
- Design Reviews .
- Subsystern Verification .
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- . Performance testing
- Safety testing .
- Environmental testing .

## Conclusion:

The results of these measurements demonstrated that the CARESCAPE V100 Vital Signs Monitor is as safe, as effective, and performs as well as the predicate device(s),

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three stripes representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 2007

GE Medical Systems Information Technologies c/o Ms. Karen Russell Regulatory Affairs Specialist 4502 Woodland Corporate Blvd. Tampa, FL 33614

Re: K073203

Trade Name: CARESCAPETM V100 Vital Signs Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: November 9, 2007 Received: November 14, 2007

Dear Ms. Russell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Karen Russell

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blymmimata 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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Indications for Use K073203

510(k) Number (if known):

Device Name:

CARESCAPE V100 Vital Signs Monitor

Indications for Use:

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 stepdown. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (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)

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Blymmuma
(Div Sign-Off)
Div n of Cardiovascular Devices
510 Number K073203