(28 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.
The INSPIRE 8 is a high efficiency microporous hollow fiber membrane oxygenator integrated with heat exchanger (INSPIRE 8M) and connected to a hardshell venous/cardiotomy reservoir (INSPIRE HVR). A molded fitting joint connects the oxygenator to the reservoir.
The device 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 hardshell reservoir collects, defoams, filters venous and suction blood, and can be used post-operatively for chest drainage.
The INSPIRE 8 is a modified version of the currently marketed INSPIRE 8 DUAL integrated oxygenator/hardshell venous cardiotomy reservoir system.
The provided document describes a Special 510(k) submission for the INSPIRE 8 hollow fiber oxygenator with an integrated hardshell venous/cardiotomy reservoir. This submission is for a modified version of an already marketed device, the INSPIRE 8 DUAL. The core of the submission is to demonstrate substantial equivalence between the modified device and the predicate device through non-clinical testing.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with corresponding performance values for each individual test. Instead, it states that "The INSPIRE 8 successfully met all acceptance criteria for each test." The tests conducted are primarily focused on demonstrating substantial equivalence to the predicate device and compliance with relevant ISO standards and FDA guidance.
Here's a table summarizing the types of tests conducted and the general performance statement:
| Test (Classification) | Test Title | Acceptance Criteria (General) | Reported Device Performance |
|---|---|---|---|
| Physical/Mechanical | Structural integrity | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Physical/Mechanical | Blood pathway integrity | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Blood rest volume | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Air handling | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Break-through time and volume | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Defoaming efficiency | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Dynamic priming volume / Hold-up | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Filtration efficiency - venous section | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Filtration efficiency - cardiotomy section | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Flow rate capacity | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Pressure drop | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Hemolysis | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Blood compatibility | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Leaching of coating | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Flaking of coating | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Functional/Performance | Uniformity of coating | Meet established safety and functionality standards | Successfully met all acceptance criteria. |
| Biocompatibility (Not listed in table but mentioned) | (Various per ISO 10993-1) | Meet ISO 10993-1 and FDA memorandum requirements | Conducted and met requirements. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria consists of in vitro non-clinical tests. These tests were conducted according to:
- ISO 10993-1 ("Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process") and the FDA May 1st, 1995 Memorandum for biocompatibility.
- "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions: Final Guidance for Industry and FDA" issued on November 29, 2000 for relevant defoamer requirements.
- ISO 15674, "Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags" for the hardshell venous/cardiotomy reservoir.
The primary goal of these tests was to demonstrate the substantial equivalence of the modified INSPIRE 8 to the predicate device, INSPIRE 8 DUAL, and compliance with general safety and effectiveness requirements.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact number of devices or replicates used for each in vitro test. It refers to "in vitro testing" without providing specific sample sizes.
- Data Provenance: The tests were conducted by Sorin Group Italia S.r.I. (the submitter) in Italy (Mirandola, MO). The data is retrospective in the sense that it was generated for the purpose of the 510(k) submission, not as a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable as this is a non-clinical, in vitro study of a physical medical device. There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests is defined by the technical specifications and performance characteristics outlined in the relevant ISO standards and FDA guidance documents.
4. Adjudication Method for the Test Set
This section is not applicable as this is a non-clinical, in vitro study. There are no human "readings" or interpretations that would require adjudication. The test results are objectively measured parameters.
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
This section is not applicable. This submission is for a physical medical device (oxygenator and reservoir) and does not involve AI or human readers for diagnostic interpretation. Therefore, no MRMC study or AI-assisted improvement effect size is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This device is a physical medical component for cardiopulmonary bypass and does not involve any algorithms or standalone AI performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this engineering and performance study is the technical specifications and performance requirements established by international standards (ISO 10993-1, ISO 15674) and regulatory guidance documents (FDA guidance for Extracorporeal Blood Circuit Defoamer, FDA 1995 Biocompatibility Memorandum). The device's performance metrics were measured and compared against these predefined physical, chemical, and functional requirements.
8. The sample size for the training set
This section is not applicable. This is not an AI/machine learning device; therefore, there is no "training set." The testing involved physical samples of the modified device.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.”