(90 days)
No
The description focuses on basic monitoring functions (pressure, temperature, time, volume) and communication with other components of the perfusion system. There is no mention of AI, ML, or any learning or adaptive capabilities.
No
The device is a monitor that measures parameters and signals alarms, it does not directly treat a medical condition.
No
The device monitors physiological parameters and controls a pump rather than diagnosing a disease or condition.
No
The device description explicitly mentions "attached probes" for pressure and temperature measurements, indicating the presence of hardware components beyond just software.
Based on the provided information, the Sarns 8000 Cardioplegia Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The Sarns 8000 Cardioplegia Monitor's intended use and description clearly indicate it is used to monitor parameters within an extracorporeal circuit during a medical procedure (cardioplegia delivery). It measures pressure and temperature within the circuit and tracks time and volume of the delivered solution.
- The device interacts with the extracorporeal circuit and the patient indirectly through temperature probes, but it does not analyze biological specimens.
- The description focuses on monitoring and controlling the delivery of a solution (cardioplegia) within a medical procedure, not on analyzing patient samples.
Therefore, the Sarns 8000 Cardioplegia Monitor falls under the category of a medical device used in a clinical setting, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardiopleqia doses, and tracks the volume of cardioplegia delivered.
Product codes
Not Found
Device Description
The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The Sarns 8000 Cardioplegia Monitor can display two pressures and three temperatures from attached probes. The pressure has alert and alarm levels which are set by the operator. The Sarns 8000 Cardioplegia Monitor also has a timer for use in tracking the time during and between doses of cardioplegia. With the new added features, it also displays the volume of cardioplegia delivered to the patient. The Sarns 8000 Cardioplegia Monitor communicates with the Sarns 8000 Roller Pump for obtaining volume information and to stop the roller pump (designated for cardioplegia delivery) during a pressure alarm condition if set by the operator to do so. The Sarns 8000 Cardioplegia Monitor also communicates with the Sarns 8000 Data Communications Module for purposes of data acquisition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extracorporeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Nonclinical Performance: The performance of the Sarns 8000 Cardioplegia Monitor and its interface with the Sarns 8000 Modular Perfusion System was exhaustively tested. All new and existing software functions as defined in the Software Requirements Specification were completely validated.
Clinical Performance: Clinical testing was not performed on the device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1100 Blood pressure alarm.
(a)
Identification. A blood pressure alarm is a device that accepts the signal from a blood pressure transducer amplifier, processes the signal, and emits an alarm when the blood pressure falls outside a pre-set upper or lower limit.(b)
Classification. Class II (performance standards).
0
3M Health Care Cardiovascular Systems Sarns™ and CDI™ Products 6200 Jackson Road Ann Arbor, MI 48103-9300 IISA 800 521 2818 Telephone 313 663 4145 Telephone 313 663 7981 Fax
JUN - 4 1996
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is ____________________________________________________________________________________________________________________________________________________
Submitter's Name: Submitter's Address: Contact Person: Phone Number: FAX Number: Summary Date:
CM
3M Health Care 6200 Jackson Road, Ann Arbor, Michigan, 48103 Cheryl Rosenberg (313) 663-4145 (313) 663-5062 March 5, 1996
Device Trade Name: Sarns 8000 Cardioplegia Monitor
Device Classification Names:
"Blood Pressure Alarm" (21 CFR 870.1100), and "Blood Pressure Computer" (21 CFR 870.1110), and Monitoring Accessory to a "Roller-type cardiopulmonary bypass blood pump" (21 CFR 870.4370).
Predicate Devices:
The new Sarns 8000 Cardioplegia Monitor is substantially equivalent to the existing Sarns 8000 Cardioplegia Monitor (K915183) and the Sarns 9000 Cardioplegia Control (K871131).
Device Description:
The Sarns 8000 Cardioplegia Monitor is only compatible with the Sarns 8000 Modular Perfusion System. The Sarns 8000 Cardioplegia Monitor can display two pressures and three temperatures from attached probes. The pressure has alert and alarm levels which are set by the operator. The Sarns 8000 Cardioplegia Monitor also has a timer for use in tracking the time during and between doses of cardioplegia. With the new added features, it also displays the volume of cardioplegia delivered to the patient. The Sarns 8000 Cardioplegia Monitor communicates with the Sarns 8000 Roller Pump for obtaining volume information and to stop the roller pump (designated for cardioplegia delivery) during a pressure alarm condition if set by the operator to do so. The Sarns 8000 Cardioplegia Monitor also communicates with the Sarns 8000 Data Communications Module for purposes of data acquisition.
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Indications For Use:
The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit. either providing an alert or triggering an alarm which stops the cardioplegia pump only. The monitor also measures temperatures of the patient or extracorporeal circuit, counts the time during and between cardiopleqia doses, and tracks the volume of cardioplegia delivered.
Technological Characteristics:
Compared to the existing Sarns 8000 Cardioplegia Monitor, the software has undergone modifications to read and display volume information from the Sarns 8000 Roller Pump. The Sarns 9000 Cardioplegia Control, part of the Sarns 9000 Perfusion System, is also used as a predicate device since it has the same features which are being added to the Sarns 8000 Cardiopleaia Monitor. The modified Sarns 8000 Cardioplegia Monitor has no new technological characteristics compared to the predicate devices.
Nonclinical Performance:
The performance of the Sarns 8000 Cardioplegia Monitor and its interface with the Sarns 8000 Modular Perfusion System was exhaustively tested. All new and existing software functions as defined in the Software Requirements Specification were completely validated.
Clinical Performance:
Clinical testing was not performed on the device.
Conclusions from Nonclinical Tests:
The Sarns 8000 Cardioplegia Monitor performs as intended according to its performance specification. The Sarns 8000 Cardioplegia Monitor is substantially equivalent to the predicate devices.
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