(56 days)
Not Found
No
The document does not mention AI, DNN, or ML, and the device description focuses on standard vital signs monitoring technologies.
No
This device is a vital signs monitor, intended for monitoring patient parameters rather than directly treating a condition or disease.
No
The device is a vital signs monitor that measures physiological parameters. While these measurements can be used by a clinician to aid in diagnosis, the device itself does not interpret raw data to identify the nature or cause of a disease or condition; it simply provides measurements.
No
The device description explicitly states it is a "vital signs monitor" and lists various hardware components and technologies for measuring vital signs (NIBP, SpO2, Temperature), indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the CARESCAPE V100 Vital Signs Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. The CARESCAPE V100 directly monitors physiological parameters (blood pressure, pulse rate, oxygen saturation, temperature) from the patient's body, not from a specimen.
- The intended use and device description clearly state that it monitors a patient's vital signs at the bedside or during transport. This involves direct interaction with the patient, not laboratory analysis of samples.
- There is no mention of analyzing biological specimens or performing tests on samples.
Therefore, the CARESCAPE V100 Vital Signs Monitor falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / 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 step-down. The CARESCAPE V100 Vital Signs Monitor can also be used in satellite areas, physicians' office, or alternate care settings.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN, FLL
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric or neonatal
Intended User / Care Setting
bedside or during intra-hospital transport, 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, CARESCAPE V100 Vital Signs Monitor, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073203 CARESCAPE V100, K011291 Exergen TemporalScanner Thermometer, SensorTouch, K050230 TurboTemp Trio
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Avenue | |
| Milwaukee, WI 53223 | |
| Primary Contact Person: | Mary Carter |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| 414-362-2626 | |
| 414-362 2585 | |
| Secondary Contact Person: | David Wahlig |
| Director, Regulatory Affairs | |
| GE Healthcare | |
| 414-362-3242 | |
| 414-362 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 V100 |
| K011291 Exergen TemporalScanner Thermometer, SensorTouch | |
| K050230 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 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 | |
| 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 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, |
1
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).
2
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.
3
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:
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.
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 |
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