(14 days)
INSPIRE 6M: Hollow Fiber Oxygenator
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 6F M: Hollow Fiber Oxygenator
The INSPIRE 6F 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 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F 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 6 and INSPIRE 6F are high efficiency microporous hollow fiber membrane oxygenators integrated with heat exchanger (INSPIRE 6M and INSPIRE 6F 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 6, the INSPIRE 6F oxygenating module is also integrated with an arterial filter.
The devices can be operated at flow rates up to 6 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 6/6F with modified HVR (Hardshell Venous Reservoir), are a modified version of the currently marketed INSPIRE 6 and INSPIRE 6F integrated systems.
Here's a summary of the acceptance criteria and the study details for the K130209 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "The modified hardshell venous/cardiotomy reservoir successfully met all acceptance criteria for each test." However, the specific acceptance criteria values are not provided in the document. Only the types of tests performed are listed.
| TEST | TEST CLASSIFICATION | Reported Device Performance |
|---|---|---|
| 1. Blood pathway integrity | Physical/Mechanical | Met all acceptance criteria |
| 2. Air handling | Functional/Performance | Met all acceptance criteria |
| 3. Break-through time and volume | Functional/Performance | Met all acceptance criteria |
| 4. Dynamic priming volume / Hold-up | Functional/Performance | Met all acceptance criteria |
| 5. Filtration efficiency - venous section | Functional/Performance | Met all acceptance criteria |
| 6. Flow rate capacity | Functional/Performance | Met all acceptance criteria |
| 7. Pressure drop | Functional/Performance | Met all acceptance criteria |
| 8. Hemolysis | Functional/Performance | Met all acceptance criteria |
| 9. Blood compatibility | Functional/Performance | Met all acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of units) used for the in vitro tests. The data provenance is retrospective, as the testing was conducted on the "modified reservoir" to demonstrate substantial equivalency to the "unmodified reservoir." The tests were conducted in accordance with specified ISO standards and FDA guidance, indicating controlled laboratory conditions rather than data from real-world patient or clinical settings. The country of origin for the testing is not specified, but the submitter is Sorin Group Italia, located in Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This study involves in vitro functional and performance testing of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
Not applicable, as this is an in vitro performance study, not a study requiring human interpretation or consensus for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is an in vitro bench testing study of hardware modifications to a medical device. There is no mention of human readers or AI assistance in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is an in vitro functional and performance study of a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on adherence to established performance specifications and industry standards for extracorporeal blood circuit defoamers and hard-shell cardiotomy/venous reservoir systems (specifically ISO 15674 and FDA guidance). The device's performance was compared against these predefined physical, mechanical, and functional criteria.
8. The Sample Size for the Training Set
Not applicable. This is an in vitro performance study of a physical device, not an AI/algorithm-based system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device in this context.
§ 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.”