(258 days)
INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less.
INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood and suction blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less.
The Sorin INSPIRE SVR 1200 (hereinafter referred to as INSPIRE SVR 1200) is a flexible PVC soft shell venous reservoir bag. This reservoir may be attached to the INSPIRE 6F C and INSPIRE 8F C oxygenator systems using a molded fitting connected to the gas exchange module. The blood contacting surfaces of this device are coated with a phosphorylcholine-based (Ph.I.S.I.O.) coating that provides a uniform surface. The device is provided with a 1/2" venous inlet connector and a 3/8" blood outlet connector. The venous inlet has an integral cardiotomy reservoir connector to allow receipt of blood from both venous cannulation and from a cardiotomy reservoir.
The INSPIRE SVR 1200 can be operated at flow rates up to 8 liters per minute (I/min) and has a maximum reservoir volume of 1325 mL.
The INSPIRE SVR 1200 soft shell venous reservoir is similar to the predicate devices as it consists of a soft PVC material and is used to collect blood during cardiopulmonary bypass procedures lasting up to 6 hours. The intended use and principles of operation are consistent with the predicate devices. It differs from the predicate devices in volume and dimensions, length of purge lines, and it includes a mounting backplate.
The device is ethylene oxide sterilized, has a non-pyrogenic fluid path and is for single use only.
The provided text describes the 510(k) premarket notification for a medical device called INSPIRE SVR 1200, a flexible PVC soft shell venous reservoir bag used during cardiopulmonary bypass procedures. The document focuses on demonstrating the substantial equivalence of this new device to previously marketed predicate devices.
However, the information required to answer your specific questions about acceptance criteria, study details, and ground truth establishment (especially for AI/ML device testing) is not present in the provided text. The document describes a traditional medical device submission, where "acceptance criteria" primarily refer to meeting specific performance and safety standards through non-clinical laboratory testing, rather than a study involving a test set, expert readers, or AI/ML performance metrics.
The document lists various non-clinical tests performed on the device (e.g., biocompatibility, blood trauma, flow rate capacity, structural integrity) and states that the device "successfully met all acceptance criteria for each of the following tests." These acceptance criteria are implicitly the performance specifications for these physical and functional tests, designed to show the device's substantial equivalence to predicates.
Therefore, I cannot provide details on:
- A table of acceptance criteria and reported device performance (in the context of AI/ML performance metrics like sensitivity, specificity, etc.): The document lists types of tests but not specific quantitative acceptance criteria or their corresponding numerical results for each test.
- Sample size used for the test set and data provenance: The tests are likely bench tests or in-vitro tests on mechanical properties and blood interaction, not a "test set" of patient data in the AI/ML sense.
- Number of experts used to establish ground truth and qualifications: This is not relevant to the type of testing described (physical and chemical properties of a medical device).
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI assistance: This device is a physical component used in a surgical procedure, not an AI diagnostic or assistance tool.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in this context would be laboratory measurements and established biological safety standards, not case-level diagnostic ground truth.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that undergoes training.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes the regulatory approval process for a physical medical device (a blood reservoir) based on its functional, material, and safety properties, demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not contain information relevant to the testing and validation of an AI/ML-based medical device.
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.