(43 days)
Not Found
No
The description focuses on data forwarding and formatting, with no mention of AI/ML algorithms for analysis or decision-making.
No.
The device is a secondary alarm and notification system for patient events, not a device that directly treats or diagnoses a medical condition.
No
The device is an interface system that forwards patient alarm and status information from a primary monitoring system to mobile healthcare providers. It is explicitly stated that it is a "secondary alarm" and "does not replace the primary alarm function on the monitor," indicating its role is to disseminate existing alarms, not to generate diagnoses itself.
No
The device description explicitly states that the Spacelabs Medical Clinical Event Interface (CEI) "provides a complete, end-to-end solution for paging and incorporates all of these components in a single offering," which includes the software module, an OTS messaging system, a paging encoder (an OTS component), and a pager base station. While the core Spacelabs contribution is a software module, the overall system, as described and offered, includes hardware components necessary for its function (paging encoder, pager base station, and the pagers themselves).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to interface with a patient monitoring network to provide secondary alarm and patient information to healthcare providers via pagers. This is focused on real-time patient status and alarm events, not on analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The device is a software module that processes and forwards patient data from a monitoring system to a messaging system for delivery to pagers. It does not involve the analysis of in vitro samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens (blood, urine, tissue, etc.), diagnostic testing, or any function related to determining the presence or absence of a disease or condition through in vitro means.
The device is clearly described as a secondary alarm notification system that supplements a primary patient monitoring system. This falls under the category of patient monitoring and communication devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Spacelabs Medical Clinical Event Interface is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events The Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient monitoring network The Clinical Event Interface supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Clinical Event Interface is a secondary alarm. It does not replace the primary alarm function on the monitor.
Product codes (comma separated list FDA assigned to the subject device)
MSX
Device Description
The Spacelabs Medical Clinical Event Interface (CEI), model 91847, is a software module intended to be installed on an Off-The-Shelf (OTS) computer system utilizing a Microsoft operating system. The primarv purpose of the CEI is to forward patient monitor alarm event information, originating from a Spacelabs Patient Monitoring network, to a messaging and notification system for delivery to the healthcare provider via wireless pagers. The system is also capable of providing vital signs updates at regular intervals. CEI allows nurses to be aware of their patients' alarm conditions when they are away from the patient and the monitoring system.
CEI is an open design utilizing an OTS messaging system that is compatible with the Motorola CP1250 paging systems. The Clinical Event Interface includes a software module, created by Spacelabs Medical, that accesses patient data acquired from a Spacelabs Medical Patient Monitoring System. The monitoring system forwards the data to a database. The Spacelabs Medical software module recognizes when new information has become available. It accesses and formats that data for delivery to the Emergin Integrated Messaging System, an OTS software package. The Emergin software accepts input from the Spacelabs program, reformats it and passes it on to the paging encoder, an OTS component of the system. The paging encoder formats the data for the Motorola CP1250 pager and forwards it to the pager base station for transmission to the pager. The Spacelabs Medical CEI provides a complete, end-to-end solution for paging and incorporates all of these components in a single offering.
The CEI messaging system provides for the sending patient information in a text only or text and graphic format to the Motorola CP1250 pager. The CEI system is designed to forward alarm information as the alarms are recognized by the patient monitoring network. The system is also cable of being set up to periodically forward a patient's physiological data at predetermined intervals.
The Spacelabs Medical ICS Clinical Event Interface (CEI), model 91847, system is a secondary alarm notification system. It does not replace the primary alarm function of the bedside monitor.
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
Not Found
Intended User / Care Setting
mobile healthcare providers, clinical staff / any hospital environment
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
The CEI was validated through rigorous testing which supported compliance of the CEI software module and its OTS components to relevant standards. The CEI software was developed following a robust software development process and was fully specified and validated. The test program included all of the components of the system and verified that as data became available to CEI it was acquired and forwarded through to the pager.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Spacelabs Medical Clinical Event Interface (CEI), Model 91847 and the Spacelabs Medical Clinical Messenger, model 91841, K992749 are substantially equivalent in design concepts, technologies and materials. Testing demonstrates that CEI is as safe and effective as Spacelabs Medical Clinical Messenger, model 91841, K992749.
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.
Spacelabs Medical Clinical Messenger, model 91841, K992749
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
K062278
p1/3
SEP 1 9 2006
510(k) Premarket Notification Spacelabs Medical Clinical Event Interface (CEI), Model 91847 Summary of Safety and Effectiveness
System, Network and Communication, Physiological Monitors Classification Information: Specialty Cardiovascular Product Code MSX Regulation 21CFR $870.2300 Class II Remote Alarm Notification System Common/Usual Name: Proprietary Name: Spacelabs Medical Clinical Event Interface (CEI), Model 91847 Est. Registration Number: 3023361 Performance Standard: No special controls have been identified for this product under 21CFR §870.2300
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Spacelabs Medical Clinical Event Interface (CEI), Model 91847 |
|---|---|
| Submitter: | Spacelabs Medical, Inc. |
| PO Box 7018 | |
| Issaquah, WA 98029 | |
| David J. Geraghty | |
| Phone: 1 425 657 7200 | |
| Fax: 1 425 657 7207 | |
| david.geraghty@slmd.com | |
| Proprietary Name: | Spacelabs Medical Clinical Event Interface (CEI), Model 91847 |
| Common Name and Classification: | Remote Alarm Notification System |
| (Cardiovascular, Product Code MSX, 21CFR §870.2300, Class II) |
Spacelabs Medical 510(k) CEI Summary of Safety and Effectiveness
030012
1
Device Description:
The Spacelabs Medical Clinical Event Interface (CEI), model 91847, is a software module intended to be installed on an Off-The-Shelf (OTS) computer system utilizing a Microsoft operating system. The primarv purpose of the CEI is to forward patient monitor alarm event information, originating from a Spacelabs Patient Monitoring network, to a messaging and notification system for delivery to the healthcare provider via wireless pagers. The system is also capable of providing vital signs updates at regular intervals. CEI allows nurses to be aware of their patients' alarm conditions when they are away from the patient and the monitoring system.
CEI is an open design utilizing an OTS messaging system that is compatible with the Motorola CP1250 paging systems. The Clinical Event Interface includes a software module, created by Spacelabs Medical, that accesses patient data acquired from a Spacelabs Medical Patient Monitoring System. The monitoring system forwards the data to a database. The Spacelabs Medical software module recognizes when new information has become available. It accesses and formats that data for delivery to the Emergin Integrated Messaging System, an OTS software package. The Emergin software accepts input from the Spacelabs program, reformats it and passes it on to the paging encoder, an OTS component of the system. The paging encoder formats the data for the Motorola CP1250 pager and forwards it to the pager base station for transmission to the pager. The Spacelabs Medical CEI provides a complete, end-to-end solution for paging and incorporates all of these components in a single offering.
The CEI messaging system provides for the sending patient information in a text only or text and graphic format to the Motorola CP1250 pager. The CEI system is designed to forward alarm information as the alarms are recognized by the patient monitoring network. The system is also cable of being set up to periodically forward a patient's physiological data at predetermined intervals.
The Spacelabs Medical ICS Clinical Event Interface (CEI), model 91847, system is a secondary alarm notification system. It does not replace the primary alarm function of the bedside monitor.
Spacelabs Medical 510(k) Notification CEI - Executive Summary
000013
July 24, 2006 Page 2 of 3
2
K062278
P3/3
Intended Use:
The intended use of the Spacelabs Medical Clinical Event Interface is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events The Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient monitoring network The Clinical Event Interface supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Clinical Event Interface is a secondary alarm. It does not replace the primary alarm function on the monitor. -
T`est Discussion:
The Spacelabs Medical Clinical Event Interface (CEI), Model 91847 and the Spacelabs Mcdical Clinical Messenger, model 91841, K992749 are substantially equivalent in design concepts, technologics and materials. CEI was validated through rigorous testing that, in part, support the compliance of the CEI software module and its OTS components to the Standards mentioned in Scction 6 of this submission. Additionally, the CEI software was developed following a robust software development process and was fully specified and validated. The test program included all of the components of the system and verified that as data became available to CEI it was acquired and forwarded through to the pager.
Test Conclusion:
The Spacelabs Medical Clinical Event Interface (CEI), Model 91847, is substantially equivalent to its predicate devices in design concepts, technologies and materials. Testing demonstrates that CEI is as safe and effective as Spacclabs Medical Clinical Messenger, model 91841, K992749.
Spacelabs Medical 510(k) Notification CEI - Executive Summary
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2006
Spacelabs Medical Inc. c/o Mr. David J. Geraghty Manager, Regulatory and Quality 5150 220th Ave SE PO Box 7018 Issaquah, WA 98027-7018
Re: K062278
Trade Name: Spacelabs Medical Clinical Event Interface (CEI), Model 91847 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II (two) Product Code: MSX Dated: August 22, 2006 Received: August 24, 2006
Dear Mr. Geraghty:
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. David J. Geraghty
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B.J. Arminio for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Spacelabs Medical Clinical Event Interface (CEI), Model 91847 Device Name: ___
Indications for Use:
The intended use of the Spacelabs Medical Clinical Event Interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Clinical Event Interface System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient monitoring network. The Clinical Event Interface supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot.
The Spacelabs Medical Clinical Event Interface is a secondary alarm. It does not replace the primary alarm function on the monitor.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use -------(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Blumermo
(Division Sign Off)
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