(29 days)
The Capiox SP Pump is used to facilitate blood flow in the extracorporeal circuit for circulatory support during extracorporeal circulation for up to 6 hours.
The Capiox® SP Pump is a sterile, single use device. The pump is a non-roller type pump that couples magnetically to, and is magnetically driven by the BioMedicus BioConsole Models 540, 550 and 560 via the pumphead adaptor. The device is a hardshell housing that contains a blood compartment (blood chamber) and a non-blood compartment (rear chamber). Within the blood chamber is a rotating impeller-type component that imparts centrifugal force upon blood as it enters the device. These centrifugal forces move the blood out of the device via the outlet port - and propel the blood through the bypass circuit.
Here is a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Terumo Capiox® SP Pump
Reason for Submission: To add an indication for use with the BioMedicus BioConsole Model 560.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Evaluation) | Reported Device Performance |
|---|---|
| Pump Load (Pressure differential Inlet v. Outlet) testing (comparative testing v. predicate) | Performance was equivalent to the predicate Terumo device and the Medtronic BPX-80 Bio-Pump® when used on the 560 console. No significant differences were noted. |
| 9-hour Durability Testing (attribute evaluation / not compared to predicate) | Demonstrated satisfactory durability (specific results not detailed, but implied to meet an acceptable level). |
| BioMed Flow Probe & Pressure Meter Accuracy testing (comparative testing v. predicate) | Performance was equivalent to the predicate Terumo device and the Medtronic BPX-80 Bio-Pump® when used on the 560 console. No significant differences were noted. |
| Decoupling (separation from drive system) testing (attribute evaluation / not compared to predicate) | Demonstrated satisfactory performance (specific results not detailed, but implied to meet an acceptable level). |
| Sterilization conditions validated to provide a Sterility Assurance Level (SAL) of 10⁻⁶ | Sterilization conditions have been validated in accordance with AAMI guidelines to provide a SAL of 10⁻⁶. |
| Biocompatibility of blood-contacting materials according to ISO 10993 | Terumo maintains biocompatibility studies for all blood-contacting materials as recommended in FDA G95-1. The materials are considered biocompatible. |
| Polymer coating material safety and effectiveness (evaluated in in-vivo animal study) | The polymer coating material (polymethoxyethyl acrylate) has been evaluated in an in-vivo animal study for previous devices. No adverse conditions were noted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for the "test set" for the performance evaluations. Instead, it mentions "in-vitro performance evaluations" which are typically laboratory-based tests. The data provenance is not explicitly linked to specific countries or retrospective/prospective clinical data, as the studies are stated to be in-vitro (bench testing), not clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" here is based on engineering specifications and performance benchmarks for medical devices, rather than expert interpretation of medical images or clinical outcomes. The "experts" would be the engineers and scientists conducting the in-vitro performance evaluations and comparing them against established technical standards and predicate device performance. Their qualifications are implicitly assumed to be appropriate for conducting such technical evaluations.
4. Adjudication Method for the Test Set
This information is not applicable, as the studies are in-vitro performance evaluations, not studies involving human interpretation or adjudication. The "results" are quantitative measurements directly from the device's operation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the subject device to the predicate device." The evaluations were limited to in-vitro performance testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical pump (Capiox® SP Pump), not an algorithm or AI software. The performance evaluated refers to the physical operation of the pump.
7. The Type of Ground Truth Used
The "ground truth" for the in-vitro performance evaluations appears to be a combination of:
- Predicate Device Performance: Direct comparison to the established performance of Terumo's Capiox® SP Pump (K012209 and K962981) and Medtronic's BPX-80 Bio-Pump® (K973011) when used on the BioMed 560 console.
- Established Engineering/Regulatory Standards: Implied adherence to safety (e.g., decoupling) and durability requirements for such devices, as well as AAMI guidelines for sterilization.
- Biocompatibility Standards: Adherence to FDA General Program Memorandum #G95-1 and ISO 10993.
8. The Sample Size for the Training Set
This information is not applicable. The submission describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device submission.
§ 870.4360 Nonroller-type blood pump.
(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.