(8 days)
Ideal Mimesys is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control. Ideal Mimesys must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal Mimesys is intended for use with the Stöckert Centrifugal Pump Console.
IDEAL MIMESYS System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter Mimesys Treated (PhosphoryIcholine coating hereinafter called PC coating) is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. IDEAL MIMESYS consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Mimesys Adult Membrane Oxygenator, K031223) connected to an active venous air removal device (defoamer), a centrifugal pump (Cobe Revolution Centrifugal Blood Pump with PC coating, K030462) and a pump bracket.
The provided text describes the 510(k) summary for the IDEAL MIMESYS System. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document, but rather are implicitly defined by meeting established specifications and demonstrating substantial equivalence to predicate devices. The reported device performance is described qualitatively.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - Hemolysis | Met established specifications after aging up to three years. |
| - Cytotoxicity | Met established specifications after aging up to three years. |
| - Irritation | Met established specifications after aging up to three years. |
| - Acute Systemic Toxicity | Met established specifications after aging up to three years. |
| - Mutagenicity | Met established specifications after aging up to three years. |
| Sterility & Safety: | |
| - Sterility | Met established specifications. Effectiveness of production techniques demonstrated to assure sterility. |
| - Pyrogenicity | Met established specifications. Effectiveness of production techniques demonstrated to assure non-pyrogenicity. |
| - ETO residuals | Met established specifications. |
| - Package Integrity | Met established specifications. |
| In Vitro Performance (Mechanical & Functional): | |
| - Mechanical Integrity | Met established specifications after aging up to 3 years. |
| - Connection Testing | Met established specifications after aging up to 3 years. |
| - Pressure Drop (venous bubble trap) | Met established specifications after aging up to 3 years. |
| - Microembolic Activity (venous bubble trap) | Met established specifications after aging up to 3 years. |
| - Hemolysis/Cell Depletion | Met established specifications after aging up to 3 years. |
| - Uniformity Test (PC coating) | Met established specifications after aging up to 3 years. |
| - Flaking/Leaching (PC coating) | Met established specifications after aging up to 3 years. |
| Substantial Equivalence (Comparative Performance): | The results of the study showed the device characteristics between IDEAL MIMESYS and IDEAL (predicate device) were comparable. Biocompatibility studies demonstrated the phosphorylcholine coating is biocompatible and functional tests demonstrated Ideal Mimesys performance is equivalent to the IDEAL predicate device. (This relies on cross-referenced performance data from K031223, K030462, and K022450 for specific components). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set. It mentions that "a complete battery of tests were carried out" and "in vitro testing were carried out."
- Data Provenance: Not explicitly stated regarding country of origin. The studies appear to be prospective in nature, as they involve performing tests on newly manufactured devices (including aged devices) to evaluate their performance against established specifications and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies are primarily focused on in vitro and biocompatibility testing of the medical device itself, rather than diagnostic interpretation requiring expert human assessment to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The studies involve laboratory and engineering testing, not human interpretation that requires 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
This information is not applicable and therefore not provided. The device is an extracorporeal blood circuit system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable and therefore not provided. The device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on:
- Established Specifications: Compliance with pre-defined performance and safety parameters.
- Predicate Device Performance: Demonstrating substantial equivalence to the performance of legally marketed predicate devices through comparative testing.
- Regulatory Guidance Documents: Adherence to requirements outlined in FDA guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions") and international standards (e.g., ISO 10993-1:1995, ISO 7199 (1996)).
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. As this is a medical device and not an AI/machine learning algorithm, there is no "training set" in the conventional sense. The development of the device would involve engineering, design, and manufacturing processes, with validation through the described testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided for the same reason as point 8.
§ 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.