(90 days)
INSPIRE 8M: Hollow Fiber Oxygenator: The 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 DUAL: Hardshell Venous/Cardiotomy Reservoir: The INSPIRE HVR DUAL 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 DUAL can be used post-operatively for chest drainage. INSPIRE HVR DUAL is intended to be used for 6 hours or less.
The INSPIRE 8 DUAL is consisting of an oxygenator, integrated with a heat exchanger (INSPIRE 8M), and a hardshell venous/cardiotomy reservoir (INSPIRE HVR DUAL). The reservoir is connected to the gas exchange module by means of a molded fitting joint. The INSPIRE 8 DUAL is a high efficiency microporous hollow fiber membrane oxygenator, integrated with a heat exchanger, connected to a hardshell venous/cardiotomy 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 or suctioned 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 DUAL is a modified version of the currently marketed integrated oxygenator/hardshell venous cardiotomy reservoir system D903 AVANT 2 Ph.I.S.I.O (hereinafter referred to as D903 AVANT).
This document describes the pre-market notification (510(k)) for the INSPIRE 8 DUAL device, which is an oxygenator with integrated heat exchanger and hardshell venous/cardiotomy reservoir. The submission focuses on demonstrating substantial equivalence to a predicate device (D903 AVANT 2 Ph.I.S.I.O) through non-clinical and in vitro testing.
There is no information in the provided text about an AI/ML-driven device or study involving human readers, therefore, sections 2, 3, 4, 5, 8, and 9 cannot be addressed.
Here's the information that can be extracted from the provided text regarding the device acceptance criteria and the study proving it meets these criteria:
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit numerical "acceptance criteria" for each test. Instead, it states that the device "passed each test" and that the results "demonstrate that the INSPIRE 8 DUAL performs in a manner substantially equivalent to the D903 AVANT predicate device with respect to the relevant functional parameters." The acceptance criteria implicitly refer to meeting established performance specifications or demonstrating equivalence to the predicate device.
| TEST | TEST CLASSIFICATION | TEST TITLE | Reported Device Performance/Conclusion |
|---|---|---|---|
| 1 | Physical/Mechanical | Oxygenating module structural integrity | Passed |
| 2 | Physical/Mechanical | Reservoir structural integrity | Passed |
| 3 | Physical/Mechanical | Oxygenating module blood, water, gas pathway integrity | Passed |
| 4 | Physical/Mechanical | Reservoir blood pathway integrity | Passed |
| 5 | Functional/Performance | Oxygenating module blood volume capacity | Passed |
| 6 | Functional/Performance | Reservoir blood rest volume | Passed |
| 7 | Functional/Performance | Oxygenating module gas transfer performance/blood side pressure drop | Passed |
| 8 | Functional/Performance | Oxygenating module heat exchange performance/water side pressure drop | Passed |
| 9 | Functional/Performance | Reservoir air handling | Passed |
| 10 | Functional/Performance | Reservoir break-through time and volume | Passed |
| 11 | Functional/Performance | Reservoir defoaming efficiency | Passed |
| 12 | Functional/Performance | Reservoir dynamic priming volume / Hold-up | Passed |
| 13 | Functional/Performance | Reservoir filtration efficiency - venous section | Passed |
| 14 | Functional/Performance | Reservoir filtration efficiency - cardiotomy section | Passed |
| 15 | Functional/Performance | Reservoir flow rate capacity | Passed |
| 16 | Functional/Performance | Reservoir pressure drop | Passed |
| 17 | Functional/Performance | Integrated device hemolysis | Passed |
| 18 | Functional/Performance | Integrated device blood compatibility | Passed |
| 19 | Functional/Performance | Oxygenating module leaching of coating | Passed |
| 20 | Functional/Performance | Reservoir leaching of coating | Passed |
| 21 | Functional/Performance | Integrated device flaking of coating | Passed |
| 22 | Functional/Performance | Oxygenating module uniformity of coating | Passed |
| 23 | Functional/Performance | Reservoir uniformity of coating | Passed |
| Biocompatibility | N/A | N/A (General Biocompatibility Testing) | Applicable tests carried out in accordance with ISO 10993-1 and FDA memorandum. |
| Sterilization/Pyrogen | N/A | N/A (Sterility and non-pyrogenicity) | Effectiveness of production techniques demonstrated to assure device is sterile and non-pyrogenic. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the in vitro tests. The data provenance is described as "In vitro testing was carried out" and "Applicable tests were carried out," but the location (country of origin) of these tests is not explicitly stated, although the submitter is Sorin Group Italia S.r.l. The studies are non-clinical/in vitro tests, not human data, so "retrospective or prospective" is not applicable in the human data sense.
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 is a submission for a medical device (oxygenator/reservoir) based on non-clinical and in vitro performance testing, not an AI/ML device relying on expert-established ground truth from medical images/data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this does not involve human readers or adjudication of medical 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
No. This is not an AI/ML device and no MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The performance described is the standalone performance of the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by validated in vitro test methods and established industry standards (ISO 7199, ISO 15675, ISO 15674, FDA Guidance documents) designed to measure the physical and functional parameters of cardiopulmonary bypass devices. The comparison is made against the performance of a predicate device (D903 AVANT 2 Ph.I.S.I.O).
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device requiring a training set.
§ 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.”