HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24

K960934 · Hewlett-Packard Co. · MLD · Jun 14, 1996 · Cardiovascular

Device Facts

• Record ID: K960934
• Device Name: HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
• Applicant: Hewlett-Packard Co.
• Product Code: MLD · Cardiovascular
• Decision Date: Jun 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

M1205A OmniCare Component Monitoring System; hospital-based multi-parameter monitor. Inputs: ECG, respiration, CO2, SpO2/PLETH signals. Operation: software-based processing of physiological signals to provide real-time monitoring, recording, and alarming. Output: visual/audible patient data and alarms for clinical staff. Modification: reuse of software modules from CMS Rev. D (K941811) within ECG/Respiration, CO2, and SpO2/PLETH functional blocks. Benefit: enables continuous patient surveillance to support clinical decision-making.

Clinical Evidence

Bench testing only; device validated in R&D and SQE departments. No clinical data presented.

Technological Characteristics

Multi-parameter physiological monitor; software-based signal processing for ECG, respiration, CO2, and SpO2/PLETH. System architecture consists of 29 functional software blocks. Device is hospital-grade equipment.

Indications for Use

Indicated for adult, neonatal, and pediatric patients in hospital settings requiring physiological monitoring, recording, and alarming.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OmniCare Model 24 Rev. C (K950821)
• CMS Rev. D (K941811)

Submission Summary (Full Text)

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JUN 14 1996
K960934
page 199

# [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, $\mathrm{CO}_{2}$ and $\mathrm{SpO}_{2}/\mathrm{PLETH}$ 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.

March 5, 1996 4PM [510(K)]
HP Confidential
OmniCare Model 24