(280 days)
The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours.
The MEDOS HILITE MVC 4030 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 4030 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/2' venous inlet at the center top section of the lid. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 7 lpm. The maximum cardiotomy flow rate is 4 lpm.
The provided text describes a medical device submission (K083131) for the Medos Hilite MVC 4030 Hardshell Venous Reservoir. This is a conventional 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of AI/software devices. The submission focuses on device characteristics, intended use, and performance tests related to its manufacturing quality and functional requirements.
Therefore, many of the requested points, especially those related to AI/algorithm performance (e.g., sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, training set details), are not applicable to this type of traditional medical device submission.
Here's the information that can be extracted and inferred from the provided text, addressing the applicable points:
1. Acceptance Criteria and Reported Device Performance
The submission states that the device was "subjected to extensive safety, performance, and validations prior to release." It also mentions "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" and "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
While specific quantitative acceptance criteria are not detailed in the summary, the general areas of performance and safety are highlighted. The reported "performance" is that the device meets these functional requirements and specifications.
| Acceptance Criteria Area | Reported Device Performance |
|---|---|
| Functional Requirements | The device meets all of its functional requirements and performance specifications, including: |
- Collection, storage, and filtration of blood during cardiopulmonary bypass.
- Filtering and defoaming intrathoracic suctioned blood.
- Operation at venous flow rates of 1.0 to 7.0 liters per minute.
- Operation at cardiotomy flow rates of up to 4.0 liters per minute.
- Use for periods up to 6.0 hours. |
| Safety Standards Compliance | The device complies with applicable industry and safety standards. Implicitly, this includes being sterile, non-pyrogenic, and single-use, as stated in the description. |
| Equivalence to Predicate | The device is considered equivalent in safety and effectiveness to the predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) based on being able to perform the same indications for use and having similar technological characteristics. The FDA's substantial equivalence determination implies it meets sufficient standards comparable to the predicate. |
2. Sample size used for the test set and the data provenance
This is not applicable as this is not a study evaluating an algorithm on a "test set" of data in the AI sense. Performance testing would have involved physical units of the device. The text does not provide details on the number of physical units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth in this context refers to established functional parameters and safety standards for the device's physical operation. It does not involve expert review or consensus of interpretable data like medical images.
4. Adjudication method for the test set
This is not applicable. Regular engineering testing and validation procedures would have been followed, not adjudication in the context of expert review.
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
This is not applicable. This device is a hardware component for cardiopulmonary bypass and does not involve AI or human-in-the-loop performance for image reading or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be derived from:
- Engineering specifications and design requirements: These define what the device should do (e.g., flow rates, filtration efficiency).
- Established industry standards: Pertaining to biocompatibility, sterilization, materials, and mechanical integrity for blood-contacting devices.
- Comparability to the predicate device: The predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) serves as a benchmark for performance and safety.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable. No training set exists for this type of 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.