(240 days)
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. 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.
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).
The provided text is a 510(k) summary for the Model 95000-A Bedside/Transport Monitor. It describes the device, its indications for use, and a statement of substantial equivalence to predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study data that rigorously proves the device meets those criteria.
Instead, the document states:
- "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."
This is a general statement and does not provide the specific details requested in your prompt regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text.
Here's what can be inferred and explicitly stated:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safe and effective performance | "The test results indicate that the device functions as expected." |
| Substantial equivalence to predicate devices (K013046 and K941165) | "The Model 95000-A Bedside/Transport Monitor is substantially equivalent to Spacelabs Medical's currently cleared and marketed devices." |
| Capability to acquire, analyze, monitor, and display specific physiological parameters (ECG, respiration, NIBP, temperature, invasive BP, SpO2, CO, CO2, O2) | "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..." |
| Detection of normal and abnormal cardiac rhythms (adults only for some) | Device provides "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." |
| Detection of abnormal respiration events | Device provides "A means for continuous monitoring of: Respiratory effort in order to detect abnormal respiration events such as high and low respiration rates and episodes or apnea." |
| Detection of abnormal invasive blood pressure events | Device provides "A means for continuous monitoring of: Invasive blood pressure in order to detect abnormal events such as high and low blood pressure." |
| Detection of desaturation due to abnormal pulmonary or circulatory functions | Device provides "A means for continuous monitoring of: Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or circulatory functions." |
| Detection of abnormal temperatures | Device provides "A means for continuous monitoring of: Temperature in order to detect abnormal events such as high and low temperatures." |
| Continuous monitoring of Carbon Dioxide | Device provides "A means for continuous monitoring of: Carbon dioxide." |
| Continuous monitoring of Oxygen | Device provides "A means for continuous monitoring of: Oxygen." |
| Detection of abnormal non-invasive blood pressure events (adults only for some) | Device provides "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." |
Questions with Answers/Inferences from the Text:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document only mentions "non-clinical testing" was performed, but no details on sample size, type of data (simulated, real patient data), or data provenance.
-
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 specified. There is no mention of expert involvement in establishing ground truth for testing. This type of detail is generally not included in a 510(k) summary for a patient monitor unless specifically required for a novel alarm algorithm or diagnostic feature.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
-
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 device is a physiological patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study is not relevant here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implied, but not detailed. The "non-clinical testing" likely assessed the device's algorithms and sensors directly. However, the details of such standalone performance are not provided. The device's function is inherently "standalone" in its data acquisition, analysis, and display, designed for use by a healthcare professional.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. For a patient monitor, ground truth would typically be established through highly calibrated reference equipment or simulated physiological signals to verify accuracy against known values. The document doesn't provide these specifics.
-
The sample size for the training set:
- Not applicable/Not specified. This device is a traditional patient monitor, not explicitly described as having an AI/machine learning component that would require a "training set" in the common sense. Its algorithms are likely deterministic and based on established physiological principles and signal processing.
-
How the ground truth for the training set was established:
- Not applicable/Not specified. (See point 7.)
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and generally states that "non-clinical testing" confirmed safe and effective performance. It lacks the granular detail about specific performance studies, acceptance criteria, and methodology that would be expected for a detailed study report.
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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 beingsubmitted in accordance with the requirements of 21 CFR §807.92. |
|---|---|
| Submitter | Spacelabs Medical, A Division of Datex-Ohmeda, Inc. |
| ContactPerson | Al Van HoudtSpacelabs Medical5150 220th Ave. SEP.O. Box 7018Issaquah, WA 98027-7018Telephone: 425-657-7200 x5970FAX: 425-657-7210 |
| Date Prepared | April 4, 2003 |
| Name | Model 95000-A Bedside/Transport Monitor |
| ClassificationNames andProduct Codes | Arrhythmia detector and alarm, DSI, §870.1025Cardiac monitor, DRT, §870.2300Carbon dioxide gas analyzer, CCK, §868.1400 |
| DeviceClassification | Classification: Class IIIClassification Panel: Cardiovascular Devices |
| PredicateDevices | 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) |
| PerformanceStandards | FDA has not established performance standards under sections 514 of theFederal Food, Drug and Cosmetic Act. |
| DeviceDescription | The Model 95000-A Bedside/Transport Monitor is a multi-parameter patientmonitor that is capable of acquiring, analyzing, monitoring and displaying avariety of physiological parameters including: electrocardiograph (ECG),respiratory effort, non-invasive blood pressure (NIBP), temperature, invasiveblood pressure, pulse oxygen saturation (SpO2), cardiac output, carbondioxide (CO2) and oxygen (O2). |
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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.
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| SubstantialEquivalence | The Model 95000-A Bedside/Transport Monitor contains features andfunctions that were previously cleared in Spacelabs Medical's devices(K013046 and K941165). Therefore, The Model 95000-A Bedside/TransportMonitor is similar to the predicate devices in its information display, storage,trending and printing capabilities. Minor modifications were made to theModel 95000-A Bedside/Transport Monitor to make the device more versatileand to incorporate new technology. |
|---|---|
| Non-clinicalPerformance | Spacelabs Medical performed non-clinical testing on the Model 95000-ABedside/Transport Monitor to confirm the safe and effective performance ofthe device. The test results indicate that the device functions as expected. |
| Conclusion | The Model 95000-A Bedside/Transport Monitor is substantially equivalent tothe Spacelabs Medical's currently cleared and marketed devices. |
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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.
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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
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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.
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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
Page 2 of 2
§ 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.