(177 days)
The IMPELLA 5.0 Catheters are intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.
The IMPELLA 5.0 Catheters also provide pressure measure-ments which are useful in determining intravascular pressure.
The IMPELLA 5.0 catheter family (IMPELLA 5.0) is an extension of the IMPELLA Percutaneous Cardiac Support product line. The IMPELLA 5.0 is capable of providing up to 5 liters per minute blood flow. The IMPELLA 5.0 are catheter based pumps intended for placement in the left ventricle. There are currently two versions of IMPELLA 5.0 Catheters, one inserted through the femoral artery via cutdown (the IMPELLA 5.0 LP) and the other through the aorta (the IMPELLA 5.0 LD). The only difference between the two versions is the shape of the inflow cannula. The IMPELLA 5.0 catheters provide a means for temporary extracorporeal circulatory support that returns blood to the patient's systemic circulation.
Each IMPELLA 5.0 Catheter runs as a system comprised of: 1) a catheter which contains an integrated pump motor/ infusate lumen, integrated intravascular pressure sensor and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.
The provided text describes the IMPELLA 5.0 Catheters, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests and a general statement about clinical data.
Therefore, for aspects like "Acceptance Criteria," "Reported Device Performance," "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC study," "Standalone performance," and details about "Training set," the information is not available in the provided document.
However, I can extract information related to the pre-clinical and clinical testing performed to support the device's safety and effectiveness for its intended use, which indirectly serves to "prove" its suitability.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the format of a table with specific acceptance criteria (e.g., "flow rate > X L/min," "biocompatibility pass/fail") and corresponding reported performance metrics. The document generally states that "All tests were acceptable" for in vitro performance and biocompatibility.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size (Clinical Data): A combination of 88 OUS (Outside US) and 17 US patients, totaling 105 patients.
- Data Provenance: A combination of OUS (Outside US) and US patients. The document does not specify if the data was retrospective or prospective.
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 available in the provided text. The clinical data is described as "a detailed analysis," but the method of establishing ground truth or the involvement and qualifications of experts are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available 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:
This information is not applicable/available. The device described is a medical pump (Extracorporeal Circulatory Support System), not an AI-powered diagnostic 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/available. The device is a physical pump, not an algorithm. However, in vitro performance testing ("ABIOMED conducted a full range of testing demonstrating that the IMPELLA 5.0 Catheters operate as intended") could be considered "standalone" technical performance testing of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the clinical data, the "ground truth" is implied to be patient safety and the device's ability to provide circulatory support as intended, analogous to outcomes data. However, the exact methods for defining and evaluating this "ground truth" are not detailed. For pre-clinical tests, the ground truth is against established standards for sterilization, biocompatibility, and in vitro performance.
8. The sample size for the training set:
This information is not applicable/available as the document describes a physical medical device and its validation, not an AI or algorithm that typically uses a "training set."
9. How the ground truth for the training set was established:
This information is not applicable/available as there is no mention of a training set for an algorithm.
Summary of Device Performance and Supporting Studies (as described in the document):
The device's performance is demonstrated through a combination of pre-clinical and clinical data, primarily aiming to show substantial equivalence to predicate devices.
Pre-Clinical Studies:
- Sterilization, Packaging, and Shelf-life:
- Method: EtO gas sterilization with SAL of 10-6. Validated using EN 550.
- Performance: EtO sterilization residual values for EO and ECH were within allowable limits of ISO 10993-7. LAL test used for pyrogen-free determination. Packaging material integrity validated.
- Acceptance Criteria/Outcome: All results acceptable.
- Biocompatibility Testing:
- Method: Testing of all patient-contacting materials on finished sterilized devices. Conducted in accordance with ISO 10993, Part 1.
- Performance: Not specified in detail, but stated all testing results were acceptable.
- Acceptance Criteria/Outcome: All results acceptable.
- In Vitro Performance Testing:
- Method: A full range of testing conducted.
- Performance: Demonstrated that the IMPELLA 5.0 Catheters operate as intended.
- Acceptance Criteria/Outcome: All tests were acceptable. This demonstrates the device can achieve its stated flow rate of up to 5 liters per minute and other operational parameters.
Clinical Study:
- Purpose: To address patient safety.
- Sample Size: 105 patients (88 OUS, 17 US).
- Provenance: Combination of OUS and US data.
- Outcome: ABIOMED provided a "detailed analysis" based on this data, which was part of the submission to demonstrate substantial equivalence and acceptable patient safety for the intended use and duration (up to 6 hours). No specific performance metrics or statistical results from this clinical analysis are provided in the summary.
Conclusion stated by the manufacturer: The IMPELLA 5.0 catheters are substantially equivalent to the listed predicate devices. This implies that the performance data (pre-clinical and clinical) supported this claim to the FDA's satisfaction.
§ 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.