(120 days)
The MECC Set with Bioline Coating 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.
The modified MECC SET with Bioline Coating follows the same concept of a minimized extracorporeal circuit as the Jostra MECC System (K023132) that is, the same operational principles and clinical application, benefits for the patient and risks during clinical application are comparable. The MECC SET with Bioline Coating corresponds to the HLM Tubing Set with Bioline Coating (K080592) with regards to the Bioline Coating of the components and with regards to the aspect that the MECC SET may be customized for the convenience of the customer.
The provided text is a 510(k) summary for the MECC Set with Bioline Coating. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting standalone performance data against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance evaluation is not explicitly available in the provided document.
Here's a breakdown of what can and cannot be answered based on the text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission aims to show "substantial equivalence" to existing predicate devices, implying that its performance is expected to be similar or at least not worse than those devices, but it does not list specific quantitative acceptance criteria or corresponding performance metrics for the MECC Set with Bioline Coating.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text does not describe a test set or clinical study conducted specifically to prove the MECC Set's performance. The "evaluation on safety and effectiveness" is mentioned as demonstrating substantial equivalence, but details of this evaluation (like sample size, type of study, or data provenance) are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as there is no mention of a test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a test set requiring 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 provided. The device is a medical device for cardiopulmonary bypass, not an AI-assisted diagnostic tool, so an MRMC study is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable to this type of medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no specific "ground truth" for a performance study is described. The "evaluation on safety and effectiveness" for substantial equivalence would likely rely on a comparison of device characteristics, materials, and intended use with the predicate devices, potentially referencing existing clinical literature or non-clinical tests for the predicate devices.
8. The sample size for the training set
This information is not provided. This device is not an AI/ML device that would typically have a "training set."
9. How the ground truth for the training set was established
This information is not provided as it's not applicable to this type of medical 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.