(109 days)
INSPIRE 6F M: Hollow Fiber Oxygenator
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 6F is consisting of an oxygenator, integrated with an arterial filter and a heat exchanger (INSPIRE 6F 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 6F 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 6 liters per minute (I/min).
The hollow fiber membrane oxygenator provides oxygenation and carbon dioxide removal from venous 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.
Here's a breakdown of the acceptance criteria and study information for the INSPIRE 6F device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| TEST # | TEST CLASSIFICATION | TEST TITLE | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | Physical/Mechanical | Structural Integrity | Not explicitly stated in the provided text. Implied to meet specifications for safe operation. | Passed |
| 2 | Physical/Mechanical | Blood, water, gas pathway integrity | Not explicitly stated in the provided text. Implied to meet specifications for preventing leaks and cross-contamination. | Passed |
| 3 | Physical/Mechanical | Blood pathway integrity | Not explicitly stated in the provided text. Implied to meet specifications for preventing leaks and maintaining blood circuit integrity. | Passed |
| 4 | Functional/Performance | Blood volume capacity | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for intended use. | Passed |
| 5 | Functional/Performance | Blood rest volume | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for intended use. | Passed |
| 6 | Functional/Performance | Gas transfer performance/blood side pressure drop | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D905 EOS) and meet requirements for oxygenation and CO2 removal with acceptable blood side pressure drop. | Passed |
| 7 | Functional/Performance | Heat exchange performance/water side pressure drop | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D905 EOS) and meet requirements for temperature control with acceptable water side pressure drop. | Passed |
| 8 | Functional/Performance | Air handling capability | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D733) and meet requirements for air removal. | Passed |
| 9 | Functional/Performance | Air handling | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D733) and meet requirements for air removal. | Passed |
| 10 | Functional/Performance | Break-through time and volume | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for preventing breakthrough of air or foam. | Passed |
| 11 | Functional/Performance | Defoaming efficiency | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D905 EOS) and meet requirements for effective defoaming of blood. | Passed |
| 12 | Functional/Performance | Dynamic priming volume / Hold-up | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and acceptable for intended use. | Passed |
| 13 | Functional/Performance | Filtration Efficiency | Not explicitly stated in the provided text. Implied to be comparable to predicate devices (D733) and meet requirements for filtering emboli. | Passed |
| 14 | Functional/Performance | Filtration Efficiency - venous section | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and meet requirements for filtering emboli in the venous section. | Passed |
| 15 | Functional/Performance | Filtration Efficiency - cardiotomy section | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and meet requirements for filtering emboli in the cardiotomy section. | Passed |
| 16 | Functional/Performance | Flow rate capacity | Not explicitly stated in the provided text. The device can be operated at flow rates up to 6 liters per minute (l/min). This is a performance specification rather than a formal AC, but it's a key operating parameter. | Passed (The device is stated to operate at flow rates up to 6 liters per minute, which is consistent with the general requirement for this type of device.) |
| 17 | Functional/Performance | Pressure drop | Not explicitly stated in the provided text. Implied to be comparable to predicate devices and within acceptable limits for clinical use. | Passed |
| 18 | Functional/Performance | Hemolysis | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards (e.g., ISO 10993) and comparable to predicate devices. | Passed |
| 19 | Functional/Performance | Reservoir Hemolysis | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards (e.g., ISO 10993) and comparable to predicate devices. | Passed |
| 20 | Functional/Performance | Blood compatibility | Not explicitly stated in the provided text. Implied to meet biocompatibility requirements as defined by relevant standards (ISO 10993-1) and comparable to predicate devices. | Passed |
| 21 | Functional/Performance | Reservoir Blood compatibility | Not explicitly stated in the provided text. Implied to meet biocompatibility requirements as defined by relevant standards (ISO 10993-1) and comparable to predicate devices. | Passed |
| 22 | Functional/Performance | Leaching of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 23 | Functional/Performance | Reservoir Leaching of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 24 | Functional/Performance | Flaking of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 25 | Functional/Performance | Reservoir Flaking of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
| 26 | Functional/Performance | Uniformity of coating | Not explicitly stated in the provided text. Implied to be within acceptable limits as defined by relevant standards and comparable to predicate devices. | Passed |
Study Proving Device Meets Acceptance Criteria:
The study described is a non-clinical in vitro testing program designed to demonstrate substantial equivalence to predicate devices and compliance with safety and effectiveness requirements.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact number of units or replicates used for each in vitro test. It generally states that "In vitro testing was carried out" and "The INSPIRE 6F passed each test mentioned in the table below."
- Data Provenance: The study was conducted as in vitro testing. The country of origin of the data is implied to be within the company's testing facilities (Sorin Group Italia S.r.I. is located in Italy), but this is not explicitly stated for the testing location itself. The nature of the testing is non-clinical (laboratory-based), making "retrospective or prospective" labels less applicable in the typical sense; it's a prospective testing program for device validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not applicable to this type of study. The ground truth for in vitro performance tests is established by objective measurements against predefined specifications and recognized standards (e.g., ISO standards, FDA Guidance documents) rather than expert consensus on diagnostic imaging or clinical outcomes.
4. Adjudication Method for the Test Set:
- This information is not applicable to this type of study. Adjudication methods like "2+1" are typically used in clinical or diagnostic studies involving human interpretation. Here, tests yield objective quantitative or qualitative results (e.g., pressure drop values, filtration efficiency percentages, pass/fail for integrity).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance, often in diagnostic imaging, and is not relevant for an in vitro performance evaluation of a cardiopulmonary bypass device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This concept is not applicable here. The INSPIRE 6F is a medical device (oxygenator with integrated filter and reservoir), not an algorithm or AI system. Its performance is inherent to its physical design and function tests, not algorithmic output.
7. The Type of Ground Truth Used:
- The ground truth for the in vitro tests was established by:
- Reference Standards: International and national standards (e.g., ISO 10993-1, ISO 15675, ISO 15674)
- Regulatory Guidance Documents: FDA guidances ("Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions," "Guidance for Extracorporeal Blood Circuit Defoamer 510(k) Submissions," "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions")
- Predicate Device Performance: Performance data from the D905 EOS and D733 devices served as a benchmark for demonstrating substantial equivalence.
- Internal Specifications: Implied by the statement "demonstrate compliance with performance specifications."
8. The Sample Size for the Training Set:
- Not applicable. This study does not involve a training set as it is not a machine learning or AI algorithm development study.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.”