(172 days)
In procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass. For use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for volume replacement.
The Medtronic MAXIMA FORTÉ™ Hardshell Venous Reservoir is a single use, disposable, sterile and nonpyrogenic fluid path device. Venous blood is collected and defoamed while cardiotomy blood is collected, defoamed and filtered prior to mixing with the venous blood. The Medtronic MAXIMA FORTE™ Hardshell Venous Reservoir consists of a polycarbonate housing which incorporates a filter/defoamer assembly. The filter/defoamer assembly, which consists of polyurethane defoamers, a 20 micron (nominal) polyester filter and a styrene frame, is designed to defoam and filter cardiotomy blood and defoam venous blood. The maximum capacity of the MAXIMA FORTE™ Hardshell Venous Reservoir is approximately 4,000 ml. The reservoir housing tapers toward the blood outlet port. The hardshell venous reservoir operates at venous blood flow rates from 1 to 7 liters per minute and cardiotomy blood flow rates from 1 to 5 liters per minute. Following intraoperative use, these reservoirs are used for the collection and autotransfusion of shed blood.
The Medtronic MAXIMA FORTÉ™ Hardshell Venous Reservoir (FT-HSVR) is a medical device intended for use in extracorporeal circulation during cardiopulmonary bypass procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria or a comprehensive study report for standalone performance.
Therefore, many of the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and AI-related studies are not available in this document. The document primarily highlights comparative testing against a predicate device to affirm similar safety and effectiveness.
Here's the information that can be extracted or reasonably inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "the in-vitro testing demonstrated that when compared to a predicate device the MAXIMA FORTÉ™ Hardshell Venous Reservoirs do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed hardshell venous reservoirs." This implies the performance of the MAXIMA FORTÉ™ was comparable to or within acceptable variations of the predicate device.
| Test Category | Reported Device Performance (Compared to Predicate Device) |
|---|---|
| Breakthrough Volume Testing | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Blood Trauma Testing | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Static Hold-Up Volume Testing | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Pressurization Testing | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Filtration Efficiency Testing | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Dynamic Hold-Up Volume Testing | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Cleanliness | Did not significantly affect safety and effectiveness; substantially equivalent. |
| Key Performance Characteristics (Nominal Specifications) | MAXIMA FORTÉ™ Hardshell Venous Reservoir |
| Duration of Use (Maximum) | 6 hours |
| Blood Flow Rate (Maximum) | Venous: 7 lpm, Cardiotomy: 5 lpm |
| Cardiotomy Filter | 20 micron depth filter |
| System Volume Capacity | 4000 ml |
| Minimum Operating Level | 500 ml |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the in-vitro tests (Breakthrough Volume, Blood Trauma, etc.). It only mentions that "in-vitro testing" was performed.
- Sample Size (Test Set): Not specified.
- Data Provenance: The tests were "in-vitro testing," suggesting laboratory-based studies. The country of origin of the data is not specified, but the company is Medtronic, based in the USA. The data is likely retrospective in the context of the submission, but the tests themselves would have been prospective experiments designed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This device is a physical medical component, not an AI or diagnostic system that relies on expert interpretation for ground truth. The "ground truth" for its performance would be established through physical and chemical measurements during in-vitro testing.
4. Adjudication Method for the Test Set
Not Applicable. As mentioned above, this device's performance is assessed through objective in-vitro measurements, not through subjective expert opinions requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. This is a physical medical device, not a diagnostic tool or AI system that involves human readers interpreting cases. Therefore, a MRMC comparative effectiveness study is irrelevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in the sense of a physical device. The "in-vitro testing" described is essentially the standalone performance evaluation of the device itself, without human intervention affecting its inherent filtration, defoaming, or blood-handling characteristics. It's not an "algorithm" in the computational sense, but the device's functional performance was assessed independently.
7. Type of Ground Truth Used
For the in-vitro tests, the "ground truth" would be established by:
- Direct Physical Measurements: For parameters like volume capacity, flow rates, and hold-up volumes.
- Laboratory Assays: For blood trauma (e.g., hemolysis markers), filtration efficiency (e.g., particle count after filtration), and cleanliness (e.g., particulate analysis).
- Engineered Test Conditions: For breakthrough volume and pressurization testing.
8. Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As no training set is relevant for this type of device, ground truth establishment for a training set is not applicable.
§ 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.