(30 days)
INSPIRE 6F M is intended for use in 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 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 8F M is intended for use in 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.
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.
The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE model 6F M also has an integrated arterial filter. The INSPIRE 6F M 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 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. The device is a modified version of the currently marketed INSPIRE 6F M products.
The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE 6M 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 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 device is a modified version of the currently marketed INSPIRE 6M products.
The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE model 8F M also has an integrated arterial filter. The INSPIRE 8F M 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 arterial filter provides additional protection against air and solid emboli. The device is a modified version of the currently marketed INSPIRE 8F M products.
The device consists of an oxygenator with an integrated heat exchanger. The INSPIRE 8M 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 device is a modified version of the currently marketed INSPIRE 8M products.
The provided document is a 510(k) premarket notification for several models of the INSPIRE Hollow Fiber Oxygenator. This type of submission is for demonstrating substantial equivalence to a predicate device, not necessarily for proving novel clinical effectiveness or "AI" performance.
Based on the information provided in the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Moisture handling | Successfully met all acceptance criteria for moisture handling. |
2. Sample size used for the test set and the data provenance
The document mentions "Testing was performed to compare devices with the modified and predicate gas outlet port." It states this was "in vitro test results" and conducted on "sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling."
- Sample size for the test set: Not explicitly stated. The document refers to "devices" in the plural, but the exact number is not provided.
- Data provenance: In vitro testing, which means it's laboratory-based data, not human patient data. It is prospective testing designed to evaluate the modified device. The country of origin for the data is not specified, but the submitter is Sorin Group Italia S.r.l. in Mirandola (MO) ITALY.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was in vitro performance testing of a medical device, not a human reader study requiring expert opinion for ground truth.
4. Adjudication method for the test set
Not applicable. This was in vitro performance testing of a medical device against predefined engineering/performance criteria, not a study requiring adjudication of expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. This document describes in vitro testing of a device's physical and functional properties, not a reader study. There is no mention of human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is not an AI/algorithm-based device. It's a cardiopulmonary bypass oxygenator. The testing described is for the device itself.
7. The type of ground truth used
The "ground truth" for this in vitro performance testing would be the predefined engineering specifications and performance standards for moisture handling for oxygenator devices. The document states "successfully met all acceptance criteria for moisture handling," implying these criteria were established prior to the testing.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.”