(49 days)
The Circulatory Technology Inc. V-BAG™ with GBS® Coating is a disposable soft shell venous reservoir that accepts venous and cardiotomy blood and facilitates the removal of air bubbles during surgical procedures requiring extracorporeal support for up to six hours. When used with a vacuum source, it is suitable for Vacuum Assisted Venous Drainage (VAVD).
The V-BAG™ with GBS® Coating is an expandable blood chamber having a polyester screen with a pore size of 105u separating the inlet from the outlet of the blood chamber. The inlet with a pore the blood chamber at its top and extends to the bottom of the screen. Blood flows table oncert the became the screen, and to the outlet port. The screen, once wet, allows mom the mid liguid but rejects most air bubbles float up and are removed through the purge line. Channels formed along the outside diameter of the tubes placed vertically, running parge inforcement of the inlet section to the top of the blood chamber, provide pathways for hrom the to move upward to the purge port. The inlet, outlet and gas purge tubes are threaded through, bonded to, and sealed within a rigid top-plate.
The V-Bag™, is made by welding two polyvinyl chloride films to form an expandable blood chamber with a front and back wall. A polyester screen with a pore size of 105µ is sealed between the two walls along their vertical sides as well as along the front wall at the bottom thereby forming a pouch between the screen and the front wall. The inlet tube enters the blood chamber at its top and extends diagonally to the bottom of the pouch. Blood flows from across the screen to the outlet port. The screen, once wet, allows passage of liquid but rejects most air bubbles. Bubbles in the pouch float up and are removed through the purge line.
The provided document is a 510(k) summary for the Circulatory Technology Inc. V-BAG™ with GBS® Coating, a soft venous reservoir used during cardiopulmonary bypass. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial might.
Therefore, much of the requested information regarding detailed acceptance criteria, specific sample sizes for test/training sets, expert consensus, MRMC studies, and ground truth establishment, is not available in this summary as it's not typically required for a 510(k) submission that relies on predicate device equivalence.
However, I can extract the available relevant information and explain why other parts are missing based on the nature of this submission.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not present a formal table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it makes a general statement about the device meeting functional requirements and performance specifications.
| Acceptance Criteria Category | Specific Metric/Requirement | Acceptance Threshold | Reported Device Performance |
|---|---|---|---|
| Safety and Performance | Overall Safety and Performance | Equivalent to predicate devices | "Subjected to extensive safety, performance, and validations prior to release." "Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." |
| Functional Equivalence | Device Design and Materials | Same as predicate devices | "The Circulatory Technology Inc. V-BAG™ with GBS® Coating has the same device design and materials as its predicate devices, K001822 and K024065." |
| Efficacy | Clinical Efficacy | Equivalent to predicate devices | "Equivalent in safety and efficacy to its predicated devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "various performance tests" and "extensive safety, performance, and validations," but no specific sample sizes for these tests are mentioned.
- Data Provenance: Not specified. The tests were conducted internally by the manufacturer ("Circulatory Technology Inc. V-BAG™ with GBS® Coating has been subjected to extensive safety, performance, and validations prior to release."). No information regarding the country of origin or whether data was retrospective or prospective is provided. Given the nature of a 510(k) for a device like a blood reservoir, this would likely involve bench testing and possibly animal studies, rather than human clinical trials for primary data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For a device like a blood reservoir, ground truth wouldn't typically be established by expert consensus in the same way it would for an AI diagnostic algorithm. Performance would be measured against engineering specifications and established standards for medical device function (e.g., flow rates, air removal efficiency, biocompatibility).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Performance testing for this type of device would likely involve objective measurements rather than subjective expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, and is not applicable to a physical medical device like a blood reservoir.
- Effect Size of AI assistance: Not applicable, as this is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Standalone Study: Not applicable. This is not an algorithm or AI device. The testing described refers to the performance of the physical device itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a medical device like a blood reservoir, ground truth would be established through:
- Engineering Specifications: Performance metrics (e.g., blood flow capacity, air removal efficiency, pressure drop) defined by the manufacturer and validated through bench testing.
- Biocompatibility Standards: Testing (e.g., ISO 10993 series) to ensure the materials used are safe for contact with blood.
- Sterility and Packaging Integrity: Validation of sterilization processes and packaging to maintain sterility.
- Predicate Device Performance: The primary "ground truth" or benchmark for this 510(k) submission is the performance established by the legally marketed predicate devices (Circulatory Technology Inc. V-BAG™, K001822 and Gish Soft Venous Reservoir SVR with GBS™ Coating, K024065). The new device aims to be substantially equivalent to these devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. "Training set" is a concept used in machine learning or AI development. This document describes a physical medical device, not a software algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for a physical 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.