(74 days)
Ideal is intended to be used in surgical procedures requiring extracorporeal gas exchange support. Ideal is intended for use in operations on adult patients. Ideal must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal is intended for use with the Stöckert Centrifugal Pump Console.
The Ideal, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The Ideal consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Adult Membrane Oxygenator, K022450), connected to an active venous air removal device (defoamer), a centrifuqal pump (Cobe Revolution Centrifyial Blood Pump. K011835) and a pump bracket.
The provided text describes the Dideco S.p.A. IDEAL System, an extracorporeal hemodynamic and gas exchange support system, seeking 510(k) clearance. The submission focuses on demonstrating substantial equivalence to predicate devices (Synthesis Adult Membrane Oxygenator and Cobe Revolution Centrifugal Blood Pump) rather than establishing new performance criteria or conducting a standalone effectiveness study.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't define explicit acceptance criteria in terms of specific thresholds for the IDEAL system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices across several characteristics. The reported device performance is primarily a statement of comparability.
| Characteristic/Test Category | Acceptance Criteria (Implicit from Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Identical raw materials to predicate devices (Synthesis and Revolution) | Biocompatibility testing on Synthesis and Revolution predicate devices was taken as reference, as raw materials are identical. Sterility, Pyrogenicity, ETO residuals, and package integrity met established specifications. |
| Operating Blood Volumes | Comparable to predicate devices | Testing conducted; results met established specifications. Integration of defoamer and centrifugal pump to oxygenating module is "advantageous in terms of lower operating blood volumes." |
| Hemolysis/Cell Depletion | Comparable to predicate devices | Testing conducted; results met established specifications. |
| Mechanical Integrity | Comparable to predicate devices | Testing conducted; results met established specifications. |
| Air Handling Characterization (Venous Air Removal) | Substantially equivalent to Synthesis predicate's defoaming system | Testing conducted; results met established specifications. Air bubbles are "equally well handled and purged from venous blood" by the IDEAL's integrated device compared to traditional systems. |
| Oxygen Transfer | Substantially equivalent to Synthesis predicate | Previous in-vitro data showed substantial equivalence to Synthesis for "transfer of oxygen." |
| Carbon Dioxide Removal | Substantially equivalent to Synthesis predicate | Previous in-vitro data showed substantial equivalence to Synthesis for "removal of carbon dioxide." |
| Blood Temperature Control | Substantially equivalent to Synthesis predicate | Previous in-vitro data showed substantial equivalence to Synthesis for "blood temperature control." |
| Arterial Filter Performance | Substantially equivalent to Synthesis predicate | Previous in-vitro data showed substantial equivalence to Synthesis for "removal of arterial blood components aggregates larger than 40 u." |
| Blood Propulsion (Centrifugal Pump) | Substantially identical to Revolution predicate | Performs in a "substantially identical" manner to the Revolution predicate for propulsion of blood. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state numerical sample sizes for the "in vitro test results." It mentions that "the device aged up to 3 years was tested for operating blood volumes, hemolysis/cell depletion, mechanical integrity and air handling characterization." It also states "the same testing, when applicable, has been conducted also on the Synthesis and Revolution predicate" for comparative purposes. This implies tests were performed on at least one IDEAL device and comparable predicate devices, but exact numbers of units tested are not provided.
- Data Provenance: The testing was carried out in vitro, following FDA guidance documents and ISO standards. The country of origin of the data is not specified beyond the manufacturer being Dideco S.p.A. (Italy). The data is presumably prospective for the IDEAL system tests performed for this submission, although some reference is made to "previous in-vitro data" for the Synthesis predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The "ground truth" for this device is based on physical and chemical performance measurements (e.g., blood volumes, hemolysis, air removal) against established engineering specifications and comparison to predicate devices, not on expert interpretations of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. The "adjudication method" concept is typically used in clinical studies or studies involving human readers, where discrepancies in interpretation need to be resolved. This submission describes in-vitro performance testing, which does not involve human readers for ground truth establishment or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance, which is irrelevant for a device like the IDEAL system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone study (in vitro testing) was done. The entire "In Vitro Test Results" section describes the performance of the IDEAL device itself (without human intervention in its function) against specific standards and in comparison to predicate devices. This testing evaluated the device's functional performance directly.
7. The Type of Ground Truth Used
The ground truth for the in-vitro performance tests was based on:
- Established specifications derived from relevant FDA guidance documents ("Guidance for Cardiopulmonary Bypass Oxygenators," "Guidance for Blood Extracorporeal Blood Circuit Defoamer," "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter") and ISO 7199 (1996) standard.
- Performance data from the legally marketed predicate devices (Synthesis Adult Membrane Oxygenator and Cobe Revolution Centrifugal Blood Pump), which served as the benchmark for "substantial equivalence."
8. The Sample Size for the Training Set
Not applicable. This device is a medical mechanical/biological system, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, there is no training set for this type of device.
§ 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.