(27 days)
The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.
The ECC.O System with Integrated Venous Air Removal Device, Centrifugal Blood Pump, Pump Bracket. Hollow Fiber Oxygenator and Heat Exchanger is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. ECC.O consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger connected to a venous air removal device (defoamer) (Ideal Mimesys' Venous Air Removal Device, K032040), a centrifugal pump (Ideal Mimesys' Centrifugal Pump, K032040) and a pump bracket.
The acceptance criteria and the study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to compliance with established specifications and guidance documents. The reported device performance is presented as meeting these specifications.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met established specifications (ISO 10993-1:1995 and FDA May 1, 1995 Memorandum). |
| Sterility | Met established specifications. |
| Pyrogenicity | Met established specifications. |
| ETO Residuals | Met established specifications. |
| Package Integrity | Met established specifications. |
| Hemolysis/Cell Depletion | Met established specifications. |
| Operating Blood Volume | Met established specifications. |
| Mechanical Integrity | Met established specifications. |
| Flaking and Leaching | Met established specifications. |
| Air Handling Characterization | Met established specifications. |
| Functional Equivalence | Performed in a manner substantially equivalent to predicate devices for gas exchange, blood temperature control, blood propulsion, and air removal. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size for the test set in terms of number of devices or data points used for each specific in vitro test. It generally states that "Applicable tests were carried out" and "In vitro testing was carried out."
Regarding data provenance:
- Country of Origin: Not specified for the test data, but the submitter (Dideco S.r.l.) is based in Mirandola (MO), Italy.
- Retrospective or Prospective: The testing described appears to be prospective as it involves new in vitro tests on the ECC.O system, as well as comparative testing with the D 905 EOS assembled with predicate devices. The biocompatibility data from predicate devices are used as a reference, which could be considered retrospective in a way, as it leverages prior testing. The ECC.O devices were "accelerated aged to an equivalent of three years real time aging" for some tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable in this context. This submission describes non-clinical (in vitro) testing and substantial equivalence to predicate devices, not studies involving human interpretation or clinical outcomes where expert ground truth would be established.
4. Adjudication Method for the Test Set:
Not applicable, as this is a non-clinical evaluation based on laboratory testing against established specifications and comparative performance with predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for a medical device (extracorporeal circulation system), not an AI-powered diagnostic or imaging interpretation tool where such studies would be relevant.
6. Standalone Performance:
Yes, a standalone performance evaluation was conducted in the sense that the ECC.O system was subjected to various in vitro tests to assess its algorithm-only equivalent performance (i.e., the device's functional and safety performance without human intervention during the test itself). The results were then compared to established specifications and the performance of predicate devices.
7. Type of Ground Truth Used:
The "ground truth" for this device evaluation is primarily based on:
- Established Specifications: Predetermined performance targets and safety limits derived from regulatory standards (e.g., ISO 10993-1, ISO 7199), FDA guidance documents (e.g., for Cardiopulmonary Bypass Oxygenators, Blood Extracorporeal Blood Circuit Defoamers), and internal validated engineering and design specifications.
- Predicate Device Performance: The functional performance of the predicate devices (D 905 EOS, Ideal Mimesys' Centrifugal Pump, Ideal Mimesys' Venous Air Removal Device) served as the benchmark for demonstrating substantial equivalence.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML model that requires a "training set." The testing described is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as 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.