(27 days)
INSPIRE 8M: Hollow Fiber Oxygenator
INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8M is intended to be used for 6 hours or less.
INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
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.
INSPIRE 8F M: Hollow Fiber Oxygenator
The INSPIRE 8F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 8F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 8F M is intended to be used for 6 hours or less.
INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
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 8 and INSPIRE 8F are high efficiency microporous hollow fiber membrane oxygenators integrated with heat exchanger (INSPIRE 8M and INSPIRE 8F M, respectively) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR). A molded fitting joint connects the oxygenator to the reservoir. As compared to the INSPIRE 8, the INSPIRE 8F oxygenating module is also integrated with an arterial filter.
The devices can be operated at flow rates up to 8 liters per minute (I/min).
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood or suction 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 arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The modified devices, hereafter referred to as INSPIRE 8/8F with modified HVR (Hardshell Venous Reservoir), are a modified version of the currently marketed INSPIRE 8 and INSPIRE 8F integrated systems.
The provided text describes the acceptance criteria and a study demonstrating the substantial equivalence of the modified INSPIRE 8/8F with modified HVR device to its unmodified predecessors.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Test Classification | Test Title | Reported Device Performance |
|---|---|---|---|
| 1 | Physical/Mechanical | Blood pathway integrity | Successfully met all acceptance criteria |
| 2 | Functional/Performance | Air handling | Successfully met all acceptance criteria |
| 3 | Functional/Performance | Break-through time and volume | Successfully met all acceptance criteria |
| 4 | Functional/Performance | Dynamic priming volume / Hold-up | Successfully met all acceptance criteria |
| 5 | Functional/Performance | Filtration efficiency - venous section | Successfully met all acceptance criteria |
| 6 | Functional/Performance | Flow rate capacity | Successfully met all acceptance criteria |
| 7 | Functional/Performance | Pressure drop | Successfully met all acceptance criteria |
| 8 | Functional/Performance | Hemolysis | Successfully met all acceptance criteria |
| 9 | Functional/Performance | Blood compatibility | Successfully met all acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for each specific in-vitro test. However, it indicates that "In vitro testing was conducted on the modified reservoir to demonstrate unmodified reservoir substantial equivalency and compliance to safety and effectiveness requirements."
The data provenance is from Italy, as the submitter is "Sorin Group Italia 86, Via Statale 12 Nord 41037 Mirandola (MO) Italy." The tests conducted are in vitro, meaning they were performed in a controlled laboratory environment rather than on live subjects. This implies the data is prospective within the context of the in-vitro study design, as it's generated specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. The study is based on in-vitro performance testing of a medical device against established engineering and regulatory standards, not on expert interpretation of observational data.
4. Adjudication Method for the Test Set:
Not applicable. The "adjudication method" typically refers to the process of resolving discrepancies among multiple human readers in diagnostic studies. This study involves automated or standardized in-vitro tests, where results are measured against predefined acceptance criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study involves evaluating the performance of human readers, sometimes with and without AI assistance, on a collection of cases. The current submission focuses on the in-vitro performance of a modified medical device.
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone study was done. The "in vitro test results" section describes tests conducted on the modified reservoir itself to "demonstrate unmodified reservoir substantial equivalency and compliance to safety and effectiveness requirements." This represents the performance of the device in isolation, without human-in-the-loop directly influencing its functional aspects during the tests.
7. Type of Ground Truth Used:
The ground truth used for these tests consists of performance specifications and regulatory requirements (e.g., ISO 15674, "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions; Final Guidance for Industry and FDA"). The device's performance was measured against these predefined and objective criteria.
8. Sample Size for the Training Set:
Not applicable. This study is not based on a machine learning algorithm that requires a training set. The evaluation is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
§ 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.”