(116 days)
The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is a component of the Terumo Advanced Perfusion System 1. It is a large roller pump with a 6" race that can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. It uses commercially available medical grade PVC tubing with 11/16" OD (max) and 1/16" - 3/32" wall thickness. It has a front panel for user interface controls, functional displays, and alarm conditions. The pump can be configured using the System 1 Central Control Monitor (CCM) as an Arterial pump or Cardioplegia pump. The Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. The pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. The pump can be mounted on System 1 base or pole.
The Terumo Cardiovascular Systems Corporation Large (6") Roller Pump K131618 is substantially equivalent to the predicate device K112587. The modification made to the device involved software updates.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The submission states that the modified device has the "same intended use, substantially equivalent indications for use, and the same or substantially equivalent operating principles and technical specifications" as the predicate device. The performance specifications are identical to the predicate device, K112587.
| Item | Acceptance Criteria (Predicate Device K112587) | Reported Device Performance (Modified Device) |
|---|---|---|
| Indication for Use | The large (6") roller pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. | The large (6") roller pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. (Identical to predicate) |
| Functional Summary | Large roller pump with 6" race can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. | Large roller pump with 6" race can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. (Identical to predicate) |
| Tubing Requirements | • Medical Grade PVC tubing | |
| • 11/16" OD (max) | ||
| • 1/16" – 3/32" wall thickness | • Medical Grade PVC | |
| • 11/16" OD (max) | ||
| • 1/16" - 3/32" wall thickness (Identical to predicate) | ||
| Panel Displays and Controls | Front panel for user interface controls, functional displays, and alarm conditions. | Front panel for user interface controls, functional displays, and alarm conditions. (Identical to predicate) |
| Pump Configurations / Modes | Pump can be configured using the System 1 Central Control Monitor (CCM) as: Arterial pump, Cardioplegia pump. Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. | Pump can be configured using the System 1 Central Control Monitor (CCM) as: Arterial pump, Cardioplegia pump. Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. (Identical to predicate) |
| Internal Monitoring, Controls & Safety | Pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. | Pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. (Identical to predicate) |
| Mounting | Pump can be mounted on System 1 base or pole. The attachment mechanism is integral to the back of the lower pump housing. | Pump can be mounted on System 1 base or pole. The attachment mechanism is integral to the back of the lower pump housing. (Identical to predicate) |
| Dimensions (nominal) | Height: 12.5 in (31.8 cm) | |
| Width: 8.5 in (21.6 cm) | ||
| Depth: 13.1 in (33.3 cm) | Height: 12.5 in (31.8 cm) | |
| Width: 8.5 in (21.6 cm) | ||
| Depth: 13.1 in (33.3 cm). (Identical to predicate) | ||
| Weight (nominal) | 26 lb (11.7 kg) | 26 lb (11.7 kg). (Identical to predicate) |
| Housing | External: Molded ABS plastic. Internal: Metal with EMC coating. | External: Molded ABS plastic. Internal: Metal with EMC coating. (Identical to predicate) |
| Cover | Clear plastic cover with safety interlock. | Clear plastic cover with safety interlock. (Identical to predicate) |
| Pump Control Assembly | A two-board assembly, consisting of a computer board and a motor control board are mounted to the frame. | A two-board assembly, consisting of a computer board and a motor control board are mounted to the frame. (Identical to predicate) |
| Power | Low voltage, 24 VDC power and battery backup supplied from APS1 via the pump power cable. | Low voltage, 24 VDC power and battery backup supplied from APS1 via the pump power cable. (Identical to predicate) |
| Flow Range Accuracy | • 0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual | |
| • 0.01 L/min for 1.0 – 10.0 L/min ± 8% of actual | • 0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual | |
| • 0.01 L/min for 1.0 – 10.0 L/min ± 8% of actual. (Identical to predicate) | ||
| Speed Range / Accuracy | 0 - 250 RPM ± 2 RPM or 1% of actual, whichever is greater. | 0 - 250 RPM ± 2 RPM or 1% of actual, whichever is greater. (Identical to predicate) |
| Environmental Conditions (Operation) | • 10°C to 40°C | |
| • ≤ 75%RH | ||
| • Non-condensing | • 10°C to 40°C | |
| • ≤ 75%RH | ||
| • Non-condensing. (Identical to predicate) | ||
| Environmental Conditions (Storage) | • Store in ventilated area | |
| • -30°C to 54°C | ||
| • ≤ 95%RH | ||
| • Non-condensing | • Store in ventilated area | |
| • -30°C to 54°C | ||
| • ≤ 95%RH | ||
| • Non-condensing. (Identical to predicate) | ||
| Electrical Rating | • 24 VDC (nominal) | |
| • +5 VDC | ||
| • 10A maximum @ 24 VDC | • 24 VDC (nominal) | |
| • +5 VDC | ||
| • 10A maximum @ 24 VDC. (Identical to predicate) |
The study supporting the acceptance criteria explicitly states: "Software and system testing have confirmed that the modifications improve device performance."
2. Sample size used for the test set and the data provenance
The submission does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described relates to software verification and validation testing at unit, integration, and system levels. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) typically associated with clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance testing was for software verification and validation, not for establishing clinical ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The testing was for software and system performance, not for clinical assessment requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical pump, not an AI-assisted diagnostic or interpretive system that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing focused on the software modifications to the device, confirming improved device performance through unit, integration, and system level testing. This implies a "standalone" evaluation of the software's functionality and its impact on the device's overall operation, without direct human interaction as part of the performance measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For software verification and validation, the "ground truth" would be established specifications, requirements, and expected operational parameters of the device. The software was tested against these predefined functional and performance requirements.
8. The sample size for the training set
Not applicable. This device is a medical pump with software modifications; there is no indication of a machine learning or AI model that would require a "training set" in the context of image analysis or similar applications. The software was developed and then verified/validated.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set." The software's correct functioning is validated against engineering specifications and expected device behavior.
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).