← Product Code [DSJ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ) · K960916 # SAMS 8000 CARDIOPLEGIA MONITOR (K960916) _3M Health Care, Sarns · DSJ · Jun 4, 1996 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K960916 ## Device Facts - **Applicant:** 3M Health Care, Sarns - **Product Code:** [DSJ](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ.md) - **Decision Date:** Jun 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1100 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## 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 cardioplegia doses, and tracks the volume of cardioplegia delivered. ## Device Story Sarns 8000 Cardioplegia Monitor is a component of the Sarns 8000 Modular Perfusion System; used in clinical settings (OR) by perfusionists/clinicians. Inputs: pressure signals from extracorporeal lines, temperature from probes, and volume data from Sarns 8000 Roller Pump. Device processes inputs to display real-time pressure, temperature, dose timing, and cumulative cardioplegia volume. Features operator-set pressure alerts/alarms; communicates with Sarns 8000 Roller Pump to automatically stop cardioplegia delivery upon alarm trigger. Communicates with Sarns 8000 Data Communications Module for data acquisition. Output allows clinicians to monitor cardioplegia delivery parameters, ensuring safe pressure limits and accurate dosing during bypass procedures. ## Clinical Evidence No clinical data. Bench testing only; software functions validated against Software Requirements Specification. ## Technological Characteristics Modular perfusion system component; interfaces with Sarns 8000 Roller Pump and Data Communications Module. Measures pressure, temperature, and volume. Software-controlled monitoring and alarm system. No new technological characteristics compared to predicates. ## Regulatory 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. ## Predicate Devices - Sarns 8000 Cardioplegia Monitor ([K915183](/device/K915183.md)) - Sarns 9000 Cardioplegia Control ([K871131](/device/K871131.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 3M Health Care Cardiovascular Systems Sarns™ and CDI™ Products 6200 Jackson Road Ann Arbor, MI 48103-9300 USA 800 521 2818 Telephone 313 663 4145 Telephone 313 663 7981 Fax JUN - 4 1996 # 3M # K960916 # 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: 3M Health Care Submitter's Address: 6200 Jackson Road, Ann Arbor, Michigan, 48103 Contact Person: Cheryl Rosenberg Phone Number: (313) 663-4145 FAX Number: (313) 663-5062 Summary Date: 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. Page 7 of 301 {1} Page 8 of 301 ## 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 cardioplegia 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 Cardioplegia 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. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K960916](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DSJ/K960916) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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