(20 days)
The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.
The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).
The only modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard / corrective action to prevent the inlet and/or outlet connector from disconnection. The holding clamp is applied by the perfusionist prior to use.
The holding clamp is applicable to all QUADROX-iR oxygenators which are subject to this submission.
The provided document describes a Special 510(k) submission for a modification to the MAQUET QUADROX-iR Oxygenators. The modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard. The information provided heavily focuses on design verification testing rather than a clinical study with an acceptance criterion in the traditional sense of a performance metric for a disease. Instead, the "acceptance criteria" are related to the mechanical performance and usability of the new holding clamp.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a modification to add a holding clamp), the acceptance criteria are based on mechanical and usability performance.
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Holding Forces: Clamp can be mounted and stays in place. | Tests designed to show the clamp stays in place during use. |
| Pull Off Forces: Force required to remove the clamp from the housing perpendicular to clamping force. | Confirmed the clamp would not detach even if bonding failed. | |
| Vibration Test with Shaker: Simulate impact forces up to 3G; confirm secure attachment under repeated impact. | Confirmed secure attachment of the clamp under repeated impact forces. | |
| Vibration Test with Cardiohelp: Clamp stays securely fixed over the total application time (up to 6 hours). | Demonstrated the clamp stays securely fixed over the 6-hour application. | |
| Usability | Usability Test: Clamp can be mounted using the Instruction for Use. | Evaluated whether the clamp could be mounted using the "Instruction for Use". |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for the mechanical tests (e.g., number of clamps or oxygenators tested for holding forces, pull-off forces, or vibration tests). It only states "The modified device was subjected to design verification tests."
For the Usability Test:
- Sample Size: "This test was performed in three hospitals." The number of individual users or attempts is not specified.
- Data Provenance: Prospective (as it was a dedicated test for this modification). The country of origin of the data is not specified beyond "three hospitals," but given the manufacturer's location (Germany) and contact person in the US, it could be either.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Mechanical Tests: The "ground truth" for the mechanical tests is inherent in the objective measurements of forces, vibrations, and secure attachment as per engineering design and risk assessment. No human "experts" in the sense of clinical reviewers are mentioned for establishing ground truth for these physical tests.
- Usability Test: While "three hospitals" performed the test, the number of individuals involved in evaluating the usability, or their specific qualifications (e.g., "perfusionists with X years of experience"), is not specified. The document states it was "evaluated as to whether the clamp could be mounted using the Instruction for Use," implying a practical assessment by users.
4. Adjudication Method for the Test Set
- Mechanical Tests: No adjudication method is mentioned as these are objective measurements against defined engineering specifications.
- Usability Test: No specific adjudication method (like 2+1 or 3+1 consensus) is described. The evaluation seems to be a direct assessment of whether the mounting was successful according to the instructions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission is for a mechanical modification (a holding clamp) and not for an AI/imaging diagnostic device that would typically involve a MRMC study. The document explicitly states: "Clinical results are not required for this submission to support substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a medical device (oxygenator with a holding clamp), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Mechanical Tests: The ground truth is based on engineering specifications and objective measurements (e.g., force required to remove, stability under vibration).
- Usability Test: The ground truth is based on the ability of users to successfully mount the clamp following the provided instructions for use. This is a practical, task-oriented ground truth.
8. The Sample Size for the Training Set
This question is not applicable. This submission is for a physical device modification, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 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.