(119 days)
INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less.
INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. INSPIRE HVR is intended to be used for 6 hours or less.
The INSPIRE 6 is consisting of an oxygenator (INSPIRE 6M) and a hardshell veo us/cardiotomy reservoir (INSPIRE HVR). The reservoir is connected to the gas exchange module by means of a molded fitting joint.
The INSPIRE 6 is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir.
The device can be operated at flow rates up to 6 liters per minute.
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
The integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 6 is a modified version of the currently marketed D905 EOS.
The provided document is a 510(k) summary for the INSPIRE 6 hollow fiber oxygenator with an integrated hardshell venous/cardiotomy reservoir. This document details the device's technical characteristics, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.
It's important to note that this document describes a medical device (an oxygenator and reservoir system) and not an AI/ML-enabled medical device. Therefore, many of the typical acceptance criteria and study aspects requested for AI/ML devices (like sample size for test sets, data provenance, ground truth experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of submission.
The "acceptance criteria" for this device are its performance in various in vitro tests to ensure its safety and effectiveness, and its substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the available information, tailored to what is provided in the document:
1. A table of acceptance criteria and the reported device performance
For a medical device like an oxygenator, "acceptance criteria" are typically defined by recognized standards and guidance documents, which specify performance benchmarks. The document states that testing was performed in accordance with relevant FDA guidance and ISO standards (ISO 10993-1, "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions," "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions," and ISO 15674). The device's "performance" is reported as having successfully passed all these tests.
| Test Category | Test Title | Acceptance Criteria (Implied by Standards/Guidance) | Reported Device Performance |
|---|---|---|---|
| Physical/Mechanical | Structural Integrity | Meets specified mechanical strength and design requirements for safe operation. | Passed |
| Physical/Mechanical | Blood, water, gas pathway integrity | No leaks or breaches in the system's pathways under operational conditions. | Passed |
| Physical/Mechanical | Blood pathway integrity | No leaks or breaches in the blood pathway under operational conditions. | Passed |
| Functional/Performance | Blood volume capacity | Meets specified volume capacity for intended use. | Passed |
| Functional/Performance | Reservoir blood rest volume | Meets specified residual blood volume after operation. | Passed |
| Functional/Performance | Gas transfer performance/blood side pressure drop | Achieves adequate oxygenation and CO2 removal, and acceptable pressure drop. | Passed |
| Functional/Performance | Heat exchange performance/water side pressure drop | Effectively controls blood temperature with an acceptable pressure drop. | Passed |
| Functional/Performance | Reservoir Air handling | Effectively removes air from the blood path. | Passed |
| Functional/Performance | Reservoir Break-through time and volume | Maintains integrity and prevents air breakthrough for specified duration/volume. | Passed |
| Functional/Performance | Reservoir Defoaming efficiency | Effectively defoams blood. | Passed |
| Functional/Performance | Reservoir Dynamic priming volume / Hold-up | Meets specified priming and hold-up volume requirements. | Passed |
| Functional/Performance | Reservoir Filtration Efficiency - venous section | Effectively filters particulates from venous blood. | Passed |
| Functional/Performance | Reservoir Filtration Efficiency - cardiotomy section | Effectively filters particulates from cardiotomy blood. | Passed |
| Functional/Performance | Reservoir Flow rate capacity | Operates effectively at intended flow rates (up to 6 L/min). | Passed |
| Functional/Performance | Reservoir Pressure drop | Maintains an acceptable pressure drop across the reservoir. | Passed |
| Functional/Performance | Hemolysis | Causes acceptable levels of blood cell damage (hemolysis). | Passed |
| Functional/Performance | Reservoir Hemolysis | Causes acceptable levels of blood cell damage within the reservoir. | Passed |
| Functional/Performance | Blood compatibility | Biocompatible with blood, causing no adverse reactions. | Passed |
| Functional/Performance | Reservoir Blood compatibility | Biocompatible with blood within the reservoir. | Passed |
| Functional/Performance | Leaching of coating | No unacceptable leaching of coating materials into the blood path. | Passed |
| Functional/Performance | Reservoir Leaching of coating | No unacceptable leaching of coating materials within the reservoir. | Passed |
| Functional/Performance | Flaking of coating | No unacceptable flaking of coating materials into the blood path. | Passed |
| Functional/Performance | Reservoir Flaking of coating | No unacceptable flaking of coating materials within the reservoir. | Passed |
| Functional/Performance | Flaking of coating on integrated device | No unacceptable flaking of coating materials on the entire integrated device. | Passed |
| Functional/Performance | Uniformity of coating | Coating is uniformly applied as specified. | Passed |
| Other | Sterility | Demonstrated to be sterile. | Passed (mentioned in conclusion) |
| Other | Non-pyrogenic | Demonstrated to be non-pyrogenic. | Passed (mentioned in conclusion) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the exact number of devices or test samples used for each in vitro test. For medical device testing, sample sizes are typically determined by statistical methods to ensure robustness and acceptable confidence levels, often referencing ISO or ASTM standards, but these details are not present in this 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are in vitro (laboratory-based) performance and mechanical integrity tests conducted by the manufacturer, Sorin Group Italia S.r.l., located in Mirandola (MO) Italy. The data is prospective as it was generated specifically for this submission.
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)
Not applicable. This device is not an AI/ML system that requires expert-established ground truth from clinical cases. The "ground truth" for these tests is the objective measurement of the device's physical and functional properties against predefined engineering and performance specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML system requiring human adjudication of clinical data.
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
Not applicable. This is not an AI/ML-enabled device. MRMC studies are used to evaluate the impact of AI on human reader performance, which is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the in vitro tests are the objective, measurable performance characteristics and physical properties of the device as defined by engineering specifications and recognized industry standards (e.g., specific thresholds for gas transfer rates, pressure drops, blood compatibility metrics, structural integrity limits, etc.).
8. The sample size for the training set
Not applicable. This is not an AI/ML-enabled device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML-enabled device.
§ 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.”