(240 days)
Not Found
No
The document describes standard physiological monitoring and analysis without mentioning AI or ML technologies. The analysis focuses on detecting predefined abnormal events based on thresholds, which is typical of traditional monitoring systems.
No.
The device is a monitor that acquires, analyzes, monitors, and displays clinical parameters; it does not provide any treatment or therapy.
No
The device is described as a "multi-parameter patient monitor" used to "acquire, analyze, monitor and display a variety of physiological parameters" for ongoing patient monitoring, not to diagnose a condition. While it detects "abnormal events" or "life-threatening events," this is part of monitoring and does not classify it as a diagnostic device.
No
The device description explicitly states it is a "multi-parameter patient monitor" capable of acquiring, analyzing, monitoring, and displaying physiological parameters. This implies the presence of hardware components for acquiring these parameters (e.g., ECG leads, blood pressure cuffs, SpO2 sensors, etc.), which are integral to the device's function and not solely software.
Based on the provided information, the Model 95000-A Bedside/Transport Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Model 95000-A monitors physiological parameters directly from the patient (ECG, respiration, blood pressure, SpO2, temperature, CO2, O2, cardiac output). It does not analyze samples like blood, urine, or tissue outside of the body.
- The parameters monitored are physiological measurements. These are real-time measurements of bodily functions, not analyses of biological samples.
Therefore, the Model 95000-A Bedside/Transport Monitor falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients.
The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.
The Model 95000-A Bedside/Transport Monitor supports product configurations with almost any combination of clinical parameters that provide the following:
- A means for continuous monitoring of:
- Electrocardiographic signals in order to detect:
- Normal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole and ventricular fibrillation.
- (Adult patients only) Additional abnormal cardiac rhythms, such as ventricular runs and tachycardia, and ST segment deviations.
- Respiratory effort in order to detect abnormal respiration events such as high and low respiration rates and episodes or apnea.
- Invasive blood pressure in order to detect abnormal events such as high and low blood pressure.
- Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or circulatory functions.
- Temperature in order to detect abnormal events such as high and low temperatures.
- Carbon dioxide.
- Oxygen.
- Electrocardiographic signals in order to detect:
- A means for episodic monitoring of:
- Non-invasive blood pressure signals to detect abnormal events such as high and low blood pressure.
- (Adult patients only) Various hemodynamic values to detect abnormal cardiac flow (CO) values.
Product codes (comma separated list FDA assigned to the subject device)
DSI, DRT, CCK, MHX, CCL
Device Description
The Model 95000-A Bedside/Transport Monitor is a multi-parameter patient monitor that is capable of acquiring, analyzing, monitoring and displaying a variety of physiological parameters including: electrocardiograph (ECG), respiratory effort, non-invasive blood pressure (NIBP), temperature, invasive blood pressure, pulse oxygen saturation (SpO2), cardiac output, carbon dioxide (CO2) and oxygen (O2).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, pediatric or neonatal patients.
Intended User / Care Setting
healthcare professional in a hospital, healthcare facility (ie, clinic), or intrahospital transport.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance: Spacelabs Medical performed non-clinical testing on the Model 95000-A Bedside/Transport Monitor to confirm the safe and effective performance of the device. The test results indicate that the device functions as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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
§ 870.1025 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.
0
Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "KO31124". The characters are written in a dark ink on a white background.
DFC = 4 2003
510(k) Summary of Safety and Effectiveness 1.5
Model 95000-A Bedside/Transport Monitor
| 510(k)
Summary | This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 CFR §807.92. |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Spacelabs Medical, A Division of Datex-Ohmeda, Inc. |
| Contact
Person | Al Van Houdt
Spacelabs Medical
5150 220th Ave. SE
P.O. Box 7018
Issaquah, WA 98027-7018
Telephone: 425-657-7200 x5970
FAX: 425-657-7210 |
| Date Prepared | April 4, 2003 |
| Name | Model 95000-A Bedside/Transport Monitor |
| Classification
Names and
Product Codes | Arrhythmia detector and alarm, DSI, §870.1025
Cardiac monitor, DRT, §870.2300
Carbon dioxide gas analyzer, CCK, §868.1400 |
| Device
Classification | Classification: Class III
Classification Panel: Cardiovascular Devices |
| Predicate
Devices | Spacelabs 95000 Bedside/Transport Monitor, K013046 (cleared 08/02) Spacelabs Comet Capnograph Module (90516), K941165 (cleared 10/94) Novametrix CO₂SMO Plus Monitor (8100), K963380 (cleared 01/97) |
| Performance
Standards | FDA has not established performance standards under sections 514 of the
Federal Food, Drug and Cosmetic Act. |
| Device
Description | The Model 95000-A Bedside/Transport Monitor is a multi-parameter patient
monitor that is capable of acquiring, analyzing, monitoring and displaying a
variety of physiological parameters including: electrocardiograph (ECG),
respiratory effort, non-invasive blood pressure (NIBP), temperature, invasive
blood pressure, pulse oxygen saturation (SpO2), cardiac output, carbon
dioxide (CO2) and oxygen (O2). |
1
The Model 95000-A Bedside/Transport Monitor is used at the patient's Indications for bedside to actively acquire, analyze, monitor and display a variety of clinical Use parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intrahospital transport. This product is not designed for home use or for use in transport vehicles. Bedside/Transport Monitor supports product Model 95000-A The configurations with almost any combination of clinical parameters that provide the following: A means for continuous monitoring of: t Electrocardiographic signals in order to detect: . Normal cardiac rhythms, including life-threatening events such as . high and low heart rates, asystole and ventricular fibrillation. (Adult patients only) Additional abnormal cardiac rhythms, such as . ventricular runs and tachycardia, and ST segment deviations. Respiratory effort in order to detect abnormal respiration events such ● as high and low respiration rates and episodes or apnea. Invasive blood pressure in order to detect abnormal events such as . high and low blood pressure. Pulse oxygen saturation in order to detect desaturation due to . abnormal pulmonary or circulatory functions. Temperature in order to detect abnormal events such as high and low . temperatures. . Carbon dioxide. . Oxygen. . A means for episodic monitoring of: Non-invasive blood pressure signals to detect abnormal events such . as high and low blood pressure. (Adult patients only) Various hemodynamic values to detect abnormal . cardiac flow (CO) values.
2
| Substantial
Equivalence | The Model 95000-A Bedside/Transport Monitor contains features and
functions that were previously cleared in Spacelabs Medical's devices
(K013046 and K941165). Therefore, The Model 95000-A Bedside/Transport
Monitor is similar to the predicate devices in its information display, storage,
trending and printing capabilities. Minor modifications were made to the
Model 95000-A Bedside/Transport Monitor to make the device more versatile
and to incorporate new technology. |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical
Performance | Spacelabs Medical performed non-clinical testing on the Model 95000-A
Bedside/Transport Monitor to confirm the safe and effective performance of
the device. The test results indicate that the device functions as expected. |
| Conclusion | The Model 95000-A Bedside/Transport Monitor is substantially equivalent to
the Spacelabs Medical's currently cleared and marketed devices. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape and features the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2003
Mr. Al Van Houdt Director, Regulatory Affairs & Quality Spacelabs Medical 5150 220th Avenue SE Issaquah, Washington 98029
Re: K031124
Trade/Device Name: Polaris 95000-A Bedside/Transport Monitor Regulation Number: 870.1025 Regulation Name: Physiological Patient Monitor (with Arrhythmia Detection or Alarms) Regulatory Class: III (three) Product Code: MHX, CCK, CCL Dated: September 5, 2003 Received: September 8, 2003
Dear Mr. Van Houdt:
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.
4
Page 2 - Mr. Van Houdt
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Subano
2
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K031124 510(k) Number (if known):
Model 95000-A Bedside/Transport Monitor Device Name:
Indications For Use:
The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients.
The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles.
The Model 95000-A Bedside/Transport Monitor supports product configurations with almost any combination of clinical parameters that provide the following:
- A means for continuous monitoring of: .
- Electrocardiographic signals in order to detect: .
- Normal cardiac rhythms, including life-threatening events such as high and low heart . rates, asystole and ventricular fibrillation.
- (Adult patients only) Additional abnormal cardiac rhythms, such as ventricular runs . and tachycardia, and ST segment deviations.
- Respiratory effort in order to detect abnormal respiration events such as high and low . respiration rates and episodes or apnea.
- Invasive blood pressure in order to detect abnormal events such as high and low blood . pressure.
- Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or . circulatory functions.
- Temperature in order to detect abnormal events such as high and low temperatures. .
- . Carbon dioxide.
- . Oxygen.
- Electrocardiographic signals in order to detect: .
- A means for episodic monitoring of: ◆
- Non-invasive blood pressure signals to detect abnormal events such as high and low . blood pressure.
- (Adult patients only) Various hemodynamic values to detect abnormal cardiac flow (CO) . values.
6
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
HW Ferl
sion Sign-Off ion of Anesthesiningy, General Hospital, Infection Control, Dental Devices
510(k) Number: K031124
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