(90 days)
The intended use for the two elements that constitute the integrated device are:
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 8F consists of an oxygenator, integrated with an arterial filter and a heat exchanger (INSPIRE 8F M), and a hardshell venous/cardiotomy reservoir (INSPIRE HVR). The reservoir is connected to the gas exchange module by means of a molded fitting joint.
The INSPIRE 8F is a high efficiency microporous hollow fiber membrane oxygenator, integrated with an arterial filter and a heat exchanger, connected to a hardshell venous/cardiotomy reservoir.
The device can be operated at flow rates up to 8 liters per minute (l/min).
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous blood 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 arterial filter provides additional protection against air and solid emboli and the integrated hardshell reservoir collects, defoams, filters venous and suctioned blood, and can be used post-operatively for chest drainage. The INSPIRE 8F is a modified version of the currently marketed integrated oxvgenator/hardshell venous cardiotomy reservoir system (D903 AVANT 2 Ph.I.S.I.O., hereinafter referred to as D903 AVANT) combined with the arterial filter (Micro 40 Ph.I.S.I.O. Adult Arterial Filter, hereinafter referred to as D734). Currently, these products are offered as separate units.
Here's an analysis of the provided information regarding the INSPIRE 8F device, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list specific quantitative acceptance criteria or numerical performance metrics for each test. Instead, it states that "The INSPIRE 8F successfully met all acceptance criteria for each test." The study's conclusion is that the device "performs in a manner substantially equivalent to the D903 AVANT predicate device" and "substantially equivalent to the D734 predicate device."
Therefore, the "acceptance criteria" are implied to be the performance levels demonstrated by the predicate devices, and the "reported device performance" is that INSPIRE 8F achieved these equivalent levels.
| TEST | Test Classification | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|---|
| Oxygenating module structural integrity | Physical/Mechanical | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir structural integrity | Physical/Mechanical | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module blood, water, gas pathway integrity | Physical/Mechanical | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir blood pathway integrity | Physical/Mechanical | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module blood volume capacity | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir blood rest volume | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module gas transfer performance/blood side pressure drop | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module heat exchange performance/water side pressure drop | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module air handling capability | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir air handling | Functional/Performance | Equivalent to predicate device (D734) | Met acceptance criteria / Substantially equivalent |
| Reservoir break-through time and volume | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir defoaming efficiency | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir dynamic priming volume / Hold-up | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module filtration efficiency | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir filtration efficiency - venous section | Functional/Performance | Equivalent to predicate device (D734) | Met acceptance criteria / Substantially equivalent |
| Reservoir filtration efficiency - cardiotomy section | Functional/Performance | Equivalent to predicate device (D734) | Met acceptance criteria / Substantially equivalent |
| Reservoir flow rate capacity | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir pressure drop | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Integrated device hemolysis | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Integrated device blood compatibility | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module leaching of coating | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir leaching of coating | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Integrated device flaking of coating | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Oxygenating module uniformity of coating | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
| Reservoir uniformity of coating | Functional/Performance | Equivalent to predicate device (D903 AVANT) | Met acceptance criteria / Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "in vitro testing" conducted in accordance with various ISO standards and FDA guidance documents. These are laboratory-based tests.
- Sample Size for Test Set: Not explicitly stated. For in vitro device testing, this typically refers to the number of individual units tested for each specific test. The document does not provide these numbers.
- Data Provenance: The tests were conducted by Sorin Group Italia S.r.l. in their labs (implied), following international and FDA standards. This is likely laboratory-controlled, experimental data rather than clinical patient data. The country of origin for the testing would be Italy, where Sorin Group Italia S.r.l. is based. The data is prospective in nature, as it involves testing a newly developed or modified device against established standards and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device approval (Traditional 510(k)) relies on performance testing against established engineering and biological standards, and comparison to predicate devices, rather than human expert interpretation of clinical images or data for ground truth.
- Number of Experts: Not applicable in the context of expert ground truth for interpretation. The "ground truth" here is objective physical and functional performance measurements and compliance with engineering specifications.
- Qualifications of Experts: The experts involved would be engineers, scientists, and technicians conducting the specified in vitro tests, adhering to the protocols of ISO standards and FDA guidance. Their expertise would be in biomaterials, mechanical engineering, fluid dynamics, and quality assurance for medical devices.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation where adjudication for discrepancies would be needed. The tests are objective measurements (e.g., structural integrity, gas transfer, filtration efficiency). The "adjudication" would be achieved by comparing the measured performance against the pre-defined acceptance criteria (performance of predicate devices and standard requirements).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the premarket notification for a physical medical device (oxygenator/reservoir system), not an AI or software device that interprets data for human readers. Therefore, an MRMC comparative effectiveness study is not relevant or included.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not an algorithm-based device. The "standalone performance" is essentially what is described in the "IN VITRO TEST RESULTS" section, where the device's physical and functional capabilities are tested in a controlled laboratory environment.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Established engineering specifications and performance benchmarks: Derived from relevant ISO standards (e.g., ISO 15675, ISO 15674, ISO 7199) and FDA guidance documents.
- Performance of predicate devices: The D903 AVANT 2 Ph.I.S.I.O. Adult Hollow Fiber Oxygenator and the Micro 40 Ph.I.S.I.O. Adult Arterial Filter serve as the primary references for substantial equivalence. The INSPIRE 8F is considered to meet acceptance criteria if its performance is "substantially equivalent" to these predicates.
8. Sample Size for the Training Set
Not applicable. This is a conventional medical device, not an AI or machine learning model that requires a training set. The device itself is designed and engineered based on established principles and tested as described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an AI model, there's no ground truth needing to be established for it. The "ground truth" in the context of this traditional device development is the established scientific and engineering principles of cardiopulmonary bypass, and the performance characteristics of previously approved similar devices.
§ 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.”