(25 days)
The A-Med Heparin Coated Miniature Centrifugal Blood Pump System is indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc). The A-Med Heparin Coated Miniature Centrifugal Blood Pump is indicated for use only with the A-Med Blood Pump Controller.
The A-Med Heparin Coated Miniature Centrifugal Blood Pump is a sterile, disposable, non-pulsatile, non-roller pump that utilizes an impeller to impart energy to the blood through centrifugal forces. The flow of the pump is "demand responsive" by automatically responding to the resistance against which it is pumping and to the amount of fluid returned to the large pump with the appropriate changes in flow and pressure. A drive cable and magnetic coupling are hermetically sealed components of the pump. The coating which A-Med propose to add to the pump will be a photoactivated hydrogel surface modification. The process uses light activated chemistry to coat the device. A motor ultrasonic flow sensor and a microcomputer-based control console are available separately.
The provided text is a 510(k) summary for a medical device called the "A-Med Heparin Coated Miniature Centrifugal Pump System." It describes the device, its intended use, and its similarities to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily due to the addition of a heparin coating. It does not include specific performance metrics, acceptance criteria, or their corresponding test results for the heparin-coated device.
2. Sample size used for the test set and the data provenance
This information is not present in the provided text. No specific test sets or study data are detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present in the provided text. Since no specific test set or study is described, there's no mention of experts establishing ground truth.
4. Adjudication method for the test set
This information is not present in the provided text.
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
A MRMC study is not applicable to this device. This device is a centrifugal blood pump, not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable to this device. This is a medical device (centrifugal pump), not an algorithm.
7. The type of ground truth used
This information is not present in the provided text.
8. The sample size for the training set
This information is not present in the provided text.
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of available information from the document:
- Device: A-Med Heparin Coated Miniature Centrifugal Pump System
- Predicate Device: A-Med Miniature Centrifugal Blood Pump System (K992592)
- Key Change: Addition of a photoactivated hydrogel surface modification (heparin coating).
- Basis for Equivalence: Similarities to the predicate device in intended use, material, design, performance, and physical characteristics. The heparin coating is the only change and is stated not to impact the currently cleared indication.
- Intended Use: Extracorporeal circulatory support systems (up to six hours) not requiring artificial oxygenation (e.g., valvuloplasty, circulatory support during surgery of the vena cava or aorta, liver transplants, etc.). For use only with the A-Med Blood Pump Controller.
Conclusion:
The provided 510(k) summary focuses on demonstrating substantial equivalence through a comparison of the modified device (with heparin coating) to an existing predicate device. It explicitly states that the modification (heparin coating) is the only change to the existing device and that it does not impact the currently cleared indication. This type of submission typically relies on showing that the new modification does not negatively alter the fundamental safety and effectiveness demonstrated by the predicate device, often without presenting new, extensive clinical or performance studies with detailed acceptance criteria in the summary itself. The detailed performance data, acceptance criteria, and specific study results that would typically answer your questions are not included in this high-level regulatory summary.
§ 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.