(204 days)
The Rotaflow Centrifygal Pump is a device that uses a method other to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
· Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels: or
· 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 RotaFlow Centrifugal Pump is 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 Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
This document is a 510(k) premarket notification summary for the RotaFlow Centrifugal Pump with Bioline Coating. It focuses on demonstrating substantial equivalence to pre-existing devices. This type of regulatory submission does not contain the detailed study results and acceptance criteria typically used to prove a device meets specific performance metrics in the way a clinical study for a novel diagnostic or treatment would.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner you've requested for a device that involved clinical performance testing with metrics like sensitivity, specificity, or AUC. The "acceptance criteria" here are based on demonstrating that the new device (with Bioline coating) performs similarly to the predicate devices and meets relevant safety standards (integrity, performance, biocompatibility, sterility) for a medical device of its class.
Here's an attempt to answer your questions based on the provided text, recognizing the limitations:
1. A table of acceptance criteria and the reported device performance
As explained above, this document describes a special 510(k) for a coating modification. The "acceptance criteria" are implied to be substantial equivalence to predicate devices regarding safety and effectiveness, demonstrated through evaluation of integrity, performance, biocompatibility, and sterility. The document does not provide quantitative performance metrics or a detailed acceptance criteria table as might be found in a clinical trial report.
| Performance Area | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Integrity | Similar to predicate devices (RotaFlow with Safeline Coating). | Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.) |
| Performance | Similar to predicate devices (RotaFlow with Safeline Coating). | Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.) |
| Biocompatibility | Appropriate for a device with Bioline coating, similar to Quadrox D Diffusion Membrane Oxygenator with Bioline Coating. | Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.) |
| Sterility | Achieves sterility similar to predicate devices. | Evaluated. Conclusion: Substantially equivalent. (Specific data not provided in summary.) |
| Functional Equivalence | Shares the same design, intended use, method of operation, components, packaging, and fundamental scientific technology as the RotaFlow Centrifugal Pump with Safeline Coating, except for the coating. | The RotaFlow Centrifugal Pump with Bioline Coating is identical to the RotaFlow Centrifugal Pump with Safeline Coating with the only exception that it has been coated with Bioline Coating. This coating is the same as with the Quadrox D Diffusion Membrane Oxygenator with Bioline. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of clinical or diagnostic performance. The evaluations mentioned (integrity, performance, biocompatibility, sterility) would typically involve laboratory testing. The provenance of this data (e.g., country of origin, retrospective/prospective) is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not relevant to a 510(k) submission for a device change related to a coating, particularly when the submission focuses on substantial equivalence through non-clinical testing (integrity, performance, biocompatibility, sterility). There isn't a "ground truth" established by human experts in the context of a diagnostic test set described here.
4. Adjudication method for the test set
Not applicable for this type of submission.
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
Not applicable. This device is a medical pump, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the evaluations of integrity, performance, biocompatibility, and sterility, the "ground truth" would be established by validated scientific methodologies and standards relevant to each of these areas (e.g., ISO standards for biocompatibility, engineering specifications for integrity and performance, validated sterilization methods). It does not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.