(98 days)
No
The document explicitly states that "No new software was designed for this device" and the modifications were limited to reusing existing software from a previously cleared device. There is no mention of AI, ML, or related concepts.
No
The device is described as a "Component Monitoring System" intended for "monitoring, recording, and alarming of multiple physiological parameters." This indicates a diagnostic or monitoring function rather than a therapeutic one.
No
The device is described as a "Component Monitoring System" for "monitoring, recording, and alarming of multiple physiological parameters." This indicates it is for ongoing observation of physiological states, not for the diagnosis of a specific condition.
Yes
The device description explicitly states that the modification was limited to "three of 29 functional blocks of software" and that "No new software was designed for this device." It also refers to the original device as a "Product" and the modification as being confined to "software." This strongly indicates the submission is for a software-only modification to an existing system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal and pediatric patients in the hospital environment." This describes a device that monitors physiological signals directly from the patient, not a device that analyzes samples outside the body (which is the definition of an IVD).
- Device Description: The description focuses on monitoring physiological parameters like ECG/Respiration, CO2, and SpO2/PLETH. These are all measurements taken from the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples.
Therefore, the M1205A OmniCare Component Monitoring System is a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The M1205A OmniCare Component Monitoring System is intended for monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal and pediatric patients in the hospital environment.
Product codes
Not Found
Device Description
HP M1205A OmniCare Component Monitoring System Rev. E (Rev. D is not used for this product) is a modification of OmniCare Model 24 Rev. C. Modification of the device was limited to three of 29 functional blocks of software that comprise the OmniCare Model 24 Product (originally cleared under K950821). Changes to the OmniCare Model 24 device software were confined to the ECG/ Respiration, CO2 and SpO2/PLETH functional blocks. Modification was accomplished by reusing and leveraging software originally developed for CMS Rev. D (K941811). No new software was designed for this device.
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, neonatal and pediatric
Intended User / Care Setting
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
Not Found
Summary of Performance Studies
OmniCare Model 24 was thoroughly validated in R&D and in the SQE department.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
[510(K)] SUMMARY OF SAFETY AND EFFECTIVENESS
The M1205A OmniCare Component Monitoring System is intended for monitoring, recording, and alarming of multiple physiological parameters for adult, neonatal and pediatric patients in the hospital environment. There was no change to the intended use statement.
HP M1205A OmniCare Component Monitoring System Rev. E (Rev. D is not used for this product) is a modification of OmniCare Model 24 Rev. C. Modification of the device was limited to three of 29 functional blocks of software that comprise the OmniCare Model 24 Product (originally cleared under K950821). Changes to the OmniCare Model 24 device software were confined to the ECG/ Respiration, CO2 and SpO2/PLETH functional blocks. Modification was accomplished by reusing and leveraging software originally developed for CMS Rev. D (K941811). No new software was designed for this device. For that reason, the modification and this notification are nearly identical to that of the previously modified CMS device.
OmniCare Model 24 was thoroughly validated in R&D and in the SQE department.
Description statements were not relied on alone to assure substantial equivalence to legally marketed devices; instead, performance data from device validation is used as well. The comparison of intended use and technological features of the modifications of this device to another legally marketed device taken together with the validation results and other information in this submission indicate that this device is substantially equivalent to legally marketed predicate devices in safety, effectiveness and intended use.