(532 days)
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.
The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System (IMPELLA RECOVER LP 2.5 System) provides circulatory support with the ability to deliver anticoagulant through an infusion system. The System is comprised of: 1) a catheter which contains an integrated pump motor/infusate lumen, integrated intravascular pressure lumen and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.
The provided text describes a 510(k) premarket notification for the IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance against such criteria.
Therefore, the requested information (acceptance criteria, device performance, sample size, ground truth details, MRMC study, standalone performance) is not available in the provided text.
The document mainly includes:
- Device Description: The IMPELLA RECOVER® LP 2.5 System comprises a catheter with an integrated pump motor/infusate lumen and intravascular pressure lumen, a controller/console, an infusion system, and accessories.
- Intended Use: Partial circulatory support for up to 6 hours, including during procedures not requiring cardiopulmonary bypass, and for intravascular pressure measurements.
- Technological Characteristics and Comparison to Predicate Devices: Similar to TANDEM HEART systems and the Vascular Solutions Langston catheter, with differences in pump location, certain materials, and pump speed.
- Test Results (Pre-Clinical):
- Sterilization: EtO gas, validated by EN 550, residuals within ISO 10993-7 limits. LAL test for pyrogen-free determination. Packaging integrity validated.
- Biocompatibility: Tested per ISO-10993 on finished sterilized devices; all results acceptable.
- Software Validation: Compliant with FDA 2005 guidance for premarket submissions for software in medical devices.
- Electromagnetic Compatibility & Electrical Safety: Tested per EN 60601 and EN 61000; conformance demonstrated.
- In vitro performance testing: Full range of testing demonstrating the system operates as intended; all tests acceptable.
- Test Results (Clinical): A detailed analysis based on clinical data from 109 OUS (Outside US) and 20 US patients to address patient safety was provided. No specific performance metrics or acceptance criteria for this clinical data are mentioned.
- Predicate Devices: TandemHeart PTVA System (K991783, K052570), Medtronic Biomedicus 15F arterial cannula and introducer (K924642, K924643), and Vascular Solutions Langston Dual Lumen Catheter (K050168).
In summary, the provided document does not contain the specific information requested regarding acceptance criteria, quantitative device performance against those criteria, or the details of ground truth establishment relevant to an AI/algorithm-based device study. The review is for a conventional medical device, not an AI/ML-driven one.
§ 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.