(16 days)
In general, these devices are intended for use during cardiopulmonary bypass surgery for up to 6 hours. No changes were made to the intended use of the individual devices.
The Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
The MYOtherm XP is a device intended for the mixing, warming/ cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio.
The Affinity Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
The Affinity NT Hollow Fiber Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
The AFFINITY NT Integrated CVR Membrane Oxygenator (Plasma Resistant Fiber [PRF] Oxygenator) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.
This product, MVR Collapsible Venous Reservoir Bag, is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.
Medtronic Coated Accessories (Flow Probes) is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.
Medtronic Coated Accessories (Tri-Optic Measurement Cells) is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.
Medtronic Packs and Accessories (Tubing and Connectors) is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery.
The Medtronic Resting Heart Module is indicated for use in surgical procedures requiring extracorporeal circulatory support, gas exchange, and thermal regulation. The device is indicated for use in procedures requiring blood flow rate of 1-6 lpm and lasting up to six hours. The system is indicated for use only with the Bio-Console. The VARD is indicated for use only with the AAR1000. The Bio-Pump+ Blood Pump in the Medtronic Resting Heart Module is indicated for use only with the Bio-Console. The Carmeda AFFINITY NT Oxygenator and Carmeda AFFINITY Arterial Filter in the Medtronic Resting Heart Module have the same indications for use as a Carmeda AFFINITY NT Oxygenator and Carmeda AFFINITY Arterial Filter used in other extracorporeal circuits.
Medtronic DLP "Y" Adapter - Coronary Perfusion is intended for use in conjunction with the delivery of cardioplegia solution.
Medtronic DLP Aortic Root Cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The #23009 cannula may also be used to monitor pressure in the aorta.
Medtronic EOPA 3D Arterial Cannula are intended for use in perfusion of the ascending aorta during short term (6 hours or less) cardiopulmonary bypass.
Medtronic DLP Single Stage Venous Cannula are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Medtronic DLP Femoral Arterial and Venous Cannula is intended for rapid femoral venous and arterial access for short term cardiopulmonary bypass.
No changes to the devices are being made. An additional source of the raw material used to make USP heparin used in Carmeda and Trillium coatings is being added.
The provided text does NOT include details about a study evaluating a device's performance against acceptance criteria using AI or machine learning. Instead, it is a 510(k) summary for various Medtronic cardiopulmonary bypass devices, focusing on demonstrating substantial equivalence to predicate devices, primarily due to an additional source of raw material for heparin used in coatings.
Therefore, many of the requested sections (sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types) cannot be fulfilled from the provided document as they relate to AI/ML device performance studies, which are not described here.
However, based on the text, I can infer the acceptance criteria and how the device (specifically, the modified heparin coating) meets them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Coating Performance: Maintain equivalent function and integrity of Carmeda and Trillium coatings with the new heparin raw material source. | "Testing demonstrates that there is no coating performance difference between the two sources of raw material for heparin." (Implicitly accepted if no difference is found). Coating testing was performed. |
| Potency of Heparin: Ensure the heparin retains its intended anticoagulant activity. | Potency of Heparin testing was conducted. (Implicitly accepted if results demonstrate equivalent potency to the current source and predicate devices.) |
| Chemistry: Ensure the new raw material does not introduce detrimental chemical changes or contaminants in the final product. | Chemistry testing was conducted. (Implicitly accepted if results demonstrate equivalent chemical profile and safety to the current source and predicate devices.) |
| Intended Use: The overall devices (e.g., blood pumps, oxygenators, filters) continue to meet their existing Indications for Use. | "No changes were made to the intended use of the individual devices." The current Indications for Use (up to 6 hours for most devices during cardiopulmonary bypass) are maintained, indicating the new raw material does not alter this. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not quantify the number of units or batches tested.
- Data Provenance: The testing appears to be internal Medtronic bench testing, likely conducted at their facilities in Minneapolis, MN, USA. It is prospective testing designed to evaluate the new raw material source.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The "ground truth" for this type of performance testing (coating, chemistry, potency) would typically be established by established laboratory methods and validated instrumentation, overseen by qualified laboratory personnel and engineers, rather than expert consensus on clinical data.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where reviewers (e.g., radiologists) are assessing images or clinical outcomes. For bench testing of material properties, performance is determined by adherence to pre-defined physical and chemical specifications.
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:
- No. This is not an AI/ML device, and no MRMC study was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The performance described is for physical medical devices and their material properties.
7. The type of ground truth used:
- The "ground truth" would be the physical and chemical specifications and performance characteristics of the existing, predicate devices' heparin-coated components. The new raw material's performance was compared against these established benchmarks. This is essentially a comparison to a known standard/predicate device performance.
8. The sample size for the training set:
- Not applicable. There is no AI/ML training set. The "training" for this context would be the historical data and manufacturing processes of the existing heparin-coated devices.
9. How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set. The "ground truth" for the predicate devices' performance would have been established through their initial regulatory clearances, involving a combination of bench testing, biocompatibility studies, and potentially clinical data (though not explicitly detailed for the specific heparin coating formulation in this 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.