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Cardiac Infusion Pump System
Advanced infusion pump system intended for controlled cardiac drug administration in hospital and critical care environments.
Regulatory Information
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Device Class
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Class IIb devices are moderate-to-high risk medical devices requiring increased regulatory oversight, risk management, and technical documentation.
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Class IIb |
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Intended Use
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Regulatory intended use defines the specific medical purpose and clinical application of the device.
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Controlled infusion administration in hospital environments. |
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Indications for Use
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Indications for use describe the medical conditions or situations for which the device is intended.
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Critical care and cardiac drug infusion management. |
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Contraindications
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Contraindications specify situations where the device should not be used due to safety concerns.
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Not intended for unsupervised home use. |
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Prescription Status
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Prescription status indicates whether the device is restricted to professional or regulated use.
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Professional use only. |
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Sterility Status
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Sterile devices require validated sterilization processes, packaging integrity validation, and microbiological controls.
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Sterile |
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Reusable / Single Use
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Reusable devices require validated cleaning, disinfection, and reprocessing procedures to maintain safety and performance.
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Reusable |
Device Description
| Device Overview | Advanced infusion pump system intended for controlled cardiac drug administration in hospital and critical care environments. |
| Principle of Operation | Electronic controlled fluid delivery using programmable infusion parameters. |
| Technology Type | Software-enabled electro-mechanical system. |
| Mechanism of Action | Precision-controlled infusion delivery for therapeutic administration. |
| Novel Features / Technology | Integrated dosing intelligence and real-time monitoring. |
| Components | Infusion controller, pump assembly, monitoring interface. |
| Accessories | Compatible infusion sets and monitoring accessories. |
| Software / Firmware Version | FW v4.2.1 |
| Connectivity | WiFi / Bluetooth enabled. |
| Power Source | Rechargeable battery and AC power. |
| Operating Environment | Hospital and controlled healthcare environments. |
| Shelf Life | 3 years |
| Clinical Workflow | Used in ICU and cardiac care settings by trained healthcare professionals. |
| User Profile | Healthcare professionals and critical care specialists. |
Materials & Composition
| Material Composition | Medical grade polycarbonate and silicone. |
| Active Components | Not applicable. |
| Coatings | Biocompatible protective surface coating. |
| Biological Origin | Non-biological origin materials. |
| Absorbable / Non-Absorbable | Non-absorbable. |
| Drug-Eluting | No |
| Tissue Contact Duration | Limited contact. |
| Implant Duration | Temporary. |
| MRI Compatibility | MR Conditional |
| Latex Content | Latex-free. |
| DEHP / Phthalates | Not detected. |
| Nanomaterials | Not present. |
| Animal Tissue Derivatives | None. |
Risk & Safety
| Hazard Categories | Biological, electrical, and software-related hazards. |
| Known Risks | Infusion interruption, dosing inaccuracies, electrical failure. |
| Residual Risks | Residual operational and software-related risks remain after mitigation. |
| Warnings | Use only by trained healthcare professionals. |
| Precautions | Routine maintenance and calibration required. |
| Adverse Events | Potential infusion delays and alarm failures. |
| Cybersecurity Risks | Network communication vulnerabilities in connected environments. |
Device Performance Attributes
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Attribute
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Class IIb devices are moderate-to-high risk medical devices requiring increased regulatory oversight, risk management, and technical documentation.
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Specification |
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Flow Rate Accuracy
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Regulatory intended use defines the specific medical purpose and clinical application of the device.
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Controlled infusion administration in hospital environments. |
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Occlusion Detection
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Indications for use describe the medical conditions or situations for which the device is intended.
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Critical care and cardiac drug infusion management. |
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Mechanical Durability
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Contraindications specify situations where the device should not be used due to safety concerns.
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Not intended for unsupervised home use. |
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Connectivity Protocol
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Prescription status indicates whether the device is restricted to professional or regulated use.
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Professional use only. |
IVD-Specific Information
| Analyte | Not applicable for this device. |
| Specimen Type | Not applicable. |
| Intended Population | Not applicable. |
| Assay Principle | Not applicable. |
| Analytical Sensitivity | Not applicable. |
| Analytical Specificity | Not applicable. |
| Clinical Sensitivity | Not applicable. |
| Clinical Specificity | Not applicable. |
| Interfering Substances | Not applicable. |
| Reference Range | Not applicable. |
| Cut-off Values | Not applicable. |
Clinical & Performance
| Clinical Endpoints | Controlled and accurate therapeutic infusion delivery. |
| Anticipated Events | Expected operational alarms and monitoring notifications. |
| Human Factors | IEC 62366 usability engineering considerations applied. |
Standards & Compliance
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ISO 14971
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ISO 14971 is the international standard for medical device risk management throughout the product lifecycle.
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ISO 13485
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ISO 13485 is the international standard for medical device quality management throughout the product lifecycle.
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IEC 62304
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IEC 62304 defines lifecycle requirements for medical device software development and maintenance.
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Deviceopoeia Intelligence
Regulatory Complexity
ADVANCED
8.2 / 10
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Advanced regulatory complexity indicates high compliance burden involving software controls, clinical evidence, post-market surveillance, and extensive technical documentation.
Standards Coverage
86% COMPLIANT
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Standards coverage represents the extent of applicable safety, software, biocompatibility, electrical, environmental, and regulatory standards addressed by the device.
Lifecycle Status
Innovation Category
Comparative Devices
Predicate Devices
Previously approved or cleared devices used as reference devices in regulatory submissions to demonstrate substantial equivalence.
Equivalent Devices
Devices that are functionally or technologically similar to the selected device and intended for comparable clinical use. These devices may share similar design characteristics, performance attributes, or regulatory classifications.
Market Competitors
Commercially competing products from other manufacturers that target the same clinical application, healthcare segment, or user market as the selected device.
Competing Technologies
Alternative technological approaches or platforms developed to achieve the same medical, diagnostic, or therapeutic objective using different mechanisms or methodologies.
Alternative Therapies
Other medical treatments, procedures, diagnostics, or interventions that may be used instead of the selected device for managing the same condition or clinical purpose.
Technology Class Peers
Devices belonging to the same technological category or engineering class, sharing similar operating principles, technical architecture, or device type characteristics.
