(129 days)
Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.
The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.
They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli.
Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures.
These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours.
The Vanguard Blood Cardioplegia Systems are the modified version of the disposables currently marketed in the SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763) and the NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847).
The provided document is an FDA 510(k) approval letter for the VANGUARD Blood Cardioplegia Systems. It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies.
Therefore, many of the requested sections regarding acceptance criteria, new study design, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable to this type of regulatory submission and are not present in the document.
The document emphasizes a non-clinical performance evaluation to demonstrate equivalence, primarily focusing on material changes and updated technical specifications, without conducting new clinical trials.
Here's an analysis based on the provided text, indicating where information is not present or not applicable:
Acceptance Criteria and Device Performance
Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, there are no explicit "acceptance criteria" defined as performance metrics that the device must meet in a novel clinical trial. Instead, the "acceptance" is based on demonstrating that the modified devices perform equivalently to the existing, cleared predicate devices through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs cardioplegia fluid delivery, regulates temperature, and traps air emboli equivalently to predicate. | Confirmed: "The Vanguard Blood Cardioplegia Systems have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices." (Page 7) |
| Material Biocompatibility/Safety: New materials (PVC without DEHP, new PP, new Versapor) are safe and do not negatively impact device performance. | Confirmed: "The tubing and connectors of the Vanguard devices made of PVC materials were changed within the modified Vanguard Blood Cardioplegia Systems in order to remove the diethylhexyl phthalate (DEHP)...the rigid connectors...were changed...to remove the DOTE...PP Purell material...was replaced with another PP material (Bormed); and the mesh Versapor material...was replaced with another kind of Versapor material." (Page 7) "No other design changes have been made to the devices." (Page 7) |
| Compliance with Standards: Device complies with applicable voluntary standards. | Confirmed: "The Vanguard Blood Cardioplegia Systems comply with all the applicable voluntary standards related to cardiovascular systems. The devices passed all the testing in accordance with national and international standards." (Page 7) |
| No New Safety/Effectiveness Questions: Changes do not raise new questions regarding safety and effectiveness compared to predicates. | Confirmed: "The Vanguard Blood Cardioplegia Systems, as designed and manufactured, do not raise new questions regarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices listed above." (Page 7) |
| Duration of Use: Device maintains performance for 6 hours or less. | Confirmed: "These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours." (Page 6) And "The devices are intended to be used for 6 hours or less." (Page 4 & 6) |
2. Sample size used for the test set and the data provenance:
- The document explicitly states: "No clinical testing was conducted in support of the Vanguard Blood Cardioplegia Systems..." (Page 7).
- The "test set" for performance evaluation was based on non-clinical verification and validation testing. The specific sample sizes for these tests (e.g., number of devices tested for material compatibility, flow rates, temperature regulation, etc.) are not detailed in this summary document.
- Data provenance is also not specified regarding country of origin or whether it was retrospective/prospective, as it pertains to internal lab testing for device verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Since no clinical testing was performed, there was no need for experts (e.g., radiologists) to establish a clinical "ground truth" for a test set. The validation was based on engineering and performance criteria against standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.
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:
- Not applicable. This device is a hardware system (cardioplegia set), not an AI/software device. No MRMC study was done, and the concept of "human readers improving with AI assistance" is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is not an algorithm or software. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance data, the "ground truth" (or reference) would be engineering specifications, regulatory standards, and the established performance characteristics of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this device.
Summary regarding the Study:
The "study" that proves the device meets the (implied) acceptance criteria is a non-clinical verification and validation testing program. This means the manufacturer conducted a series of tests in their labs to ensure the modified device functions as intended, meets design specifications, is biocompatible with the new materials, and performs equivalently to the predicate devices, all in accordance with relevant national and international standards. This type of evidence is common for 510(k) submissions, particularly when changes are made to materials or manufacturing processes of existing device types where substantial equivalence can be demonstrated without new clinical data.
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).