(40 days)
The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.
A Standard Volume BRAT® 2 Processing Set consists of a plastic disposable 250 ml centrifuge bowl, a tubing harness to connect the centrifuge bowl with other disposables, a waste bag, and a reinfusion bag. The tubing harness consists of tubing, a pump/valve cartridge, and various connectors.
Modifications to the BRAT® 2 Standard Volume Processing Set covered in this 510(k) consists of a design change to the internal spacer of the Baylor centrifuge bowl. No other material or design feature changes to the Processing Set disposables are required. No hardware or software changes are required to the BRAT® 2 instrument to support this device modification.
This 510(k) summary describes a modification to an existing medical device, the COBE BRAT® 2 Standard Volume Processing Set, rather than a novel device. Therefore, the "acceptance criteria" discussed here relate to demonstrating that the modified device's performance is comparable to or improved over the predicate device, specifically regarding its "Wash Efficiency." The study is designed to show substantial equivalence, not to establish de novo safety and effectiveness benchmarks for a new type of device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Improved Wash Efficiency compared to predicate device | Improved wash efficiency based on reduction in estimated Heparin Load to Patient found in bovine Blood Salvage tests. |
| Heparin Load values meet or exceed values recommended by Yawn' for blood salvage applications (for human blood). | Mayo Clinic test data for Heparin Load values generated per 1 liter of inlet blood volume processed, meet or exceed values recommended by Yawn'. |
| Performance comparable to the predicate device | "In vitro blood testing was done to assure the performance of the modified device was comparable to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical count of individual blood samples or processing runs. The text mentions "In vitro bovine blood testing" and "Human blood testing...in a laboratory setting at the Mayo Clinic." The number of times these tests were performed is not given.
- Data Provenance:
- Bovine Blood Testing: In vitro (laboratory setting).
- Human Blood Testing: In vitro (laboratory setting) at the Mayo Clinic. The country of origin is the USA.
- Retrospective or Prospective: Both bovine and human blood tests appear to be prospective, specifically designed to evaluate the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This submission does not involve expert review or adjudication of the test results in the way one might see for image-based diagnostic AI. The performance metrics (Wash Efficiency, Heparin Load) are objective, quantitative measurements derived from laboratory tests.
The "ground truth" for the performance expectations is based on:
- Comparison to the predicate device's known performance.
- Reference to published medical literature: Yawn's recommendations for "Ensuring Quality Intraoperative Blood Salvage" (LABORATORY MEDICINE, Vol. 25. No. 10, October 1994, p. 629) are cited for acceptable Heparin Load values.
4. Adjudication Method for the Test Set
Not applicable. The tests measured objective performance parameters, rather than requiring subjective interpretation or consensus among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an image-based diagnostic or an AI-assisted device. It's a physical medical device (processing set for blood salvage).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "device" being tested is the modified processing set itself. Its performance was evaluated purely based on its ability to process blood and achieve desired efficiency metrics in a laboratory setting, without the variable performance of human interaction during the test measurement. However, it's not an algorithm in the traditional AI sense.
7. The Type of Ground Truth Used
The ground truth is based on:
- Objective Laboratory Measurements: Quantified values for "Outlet Hct" and "Wash Efficiency," and specifically "estimated Heparin Load to Patient."
- Predicate Device Performance: Used as a baseline for comparison to demonstrate "comparable" performance.
- Published Medical Standards/Recommendations: The reference by Yawn' provides a benchmark for acceptable Heparin Load values.
8. The Sample Size for the Training Set
Not applicable. This device is a physical processing set, not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).