(29 days)
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours.
The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours.
The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours.
The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 Vmin and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours.
The QUADROX-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours.
The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dicxide and regulates the blood temperature. The utilization period for this device is restricted 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-i / -iD oxygenators which are subject to this submission.
The given submission (K132829) is a Special 510(k) for a device modification of existing MAQUET oxygenators. The modification consists of adding a reusable stainless steel holding clamp. Due to the nature of this submission (a device modification for an existing, already cleared device), the study design and acceptance criteria differ significantly from submissions for novel AI/ML devices or diagnostic tools.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Holding Forces (Clamp in place) | The clamp will stay in place during its use, preventing disconnection of inlet/outlet connectors if bonding fails. | Demonstrated that the clamp can be mounted on the Oxygenator and will stay in place, preventing connector detachment even if the bonding to the housing fails. |
| Pull-off Forces (Clamp removal) | The clamp should not be easily removed by forces perpendicular to the clamping force, yet allow for intentional removal. (Implied, as the purpose is to "hold the clamp in place" and prevent accidental detachment). | No specific numerical performance is provided, but the document states these tests confirm the secure attachment. |
| Vibration Test with Shaker (up to 3G) | Secure attachment of the clamp under repeated impact forces of up to 3G. | Confirmed the secure attachment of the clamp under repeated impact forces up to 3G. |
| Vibration Test with Roller Pumps | Simulate influence of repeated tubing motions without compromising clamp security. | No specific numerical performance is provided, but these tests were relevant for QUADROX-i/iD products to simulate the influence of repeated motions of the tubing. (Implied successful simulation and secure attachment). |
| Leakage Test with Reduction Adapter | The clamp can be used with pediatric/neonatal reduction adapters (09844-s) without causing leakage or compromising their function. | Confirmed that the clamp can be used with the pediatric/neonatal reduction adapters. (Implied no leakage or functional compromise). |
| Usability Test (mounting the clamp) | The clamp can be mounted using the Instruction for Use. (Implied ease of use and clarity of instructions for perfusionists). | Evaluated as to whether the clamp could be mounted using the Instruction for Use. (Implied successful mounting and usability). |
2. Sample Size for Test Set and Data Provenance:
- The document describes non-clinical mechanical and usability tests for the holding clamp. This is not a study involving human subjects or medical data in the traditional sense of AI/ML device testing.
- Sample Size: The specific number of clamps or oxygenators tested for each mechanical test is not provided in detail. The usability test was performed in "three hospitals," but the number of perfusionists or units tested within those hospitals is not specified.
- Data Provenance: The tests were conducted by the manufacturer, MAQUET Cardiopulmonary AG. The country of origin for the data is implicitly Germany (headquarters of submitter) or potentially associated testing facilities. These are prospective tests performed specifically to support this regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable in the context of this submission. "Ground truth" in the sense of expert consensus on medical images or patient outcomes is not relevant here.
- For the Usability Test, "perfusionists" were involved. While not explicitly defined as "experts" establishing a "ground truth," their feedback on the ability to mount the clamp according to instructions serves as a form of expert user validation for a usability aspect. Their specific qualifications (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set:
- Not applicable as there is no "test set" in the context of expert review of data for a diagnostic or prognostic decision. The non-clinical tests have pass/fail criteria based on engineering and safety standards, not expert adjudication. The usability test likely involved qualitative feedback or direct observation, but no formal adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or screening devices where the performance of human readers with and without AI assistance is compared. The device in this submission (a mechanical holding clamp for an oxygenator) does not involve human readers interpreting medical data or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a mechanical accessory, not an algorithm. The "performance" is its mechanical function and usability, which is inherently tied to human interaction (mounting by a perfusionist) but does not involve an AI algorithm operating independently.
7. The Type of Ground Truth Used:
- For the mechanical tests (Holding Forces, Pull-off Forces, Vibration Tests, Leakage Test): The "ground truth" is derived from predefined engineering specifications, safety requirements, and risk assessment. The tests are designed to demonstrate that the clamp maintains structural integrity, remains securely attached, and does not compromise the primary function or safety of the oxygenator under simulated use conditions.
- For the Usability Test: The "ground truth" is the successful and correct mounting of the clamp by perfusionists following the provided Instructions for Use.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense. The "training" for such a device would be its engineering design and iterative development, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML algorithm. The design and manufacturing processes of medical devices inherently follow quality management systems and engineering principles, but this is distinct from establishing ground truth for machine learning.
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”