(201 days)
The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.
The COBE BRAT 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP) consists of a number of changes from the original Plasma Recovery Program for the COBE BRAT 2 approved per 510(k) number K933960. These changes include: Expanded volume delivery range of 25 to 200 ml/min for the fill cycle of PRP . . Addition of a manual mode of operation for PRP Hardware and software modifications for detection and prevention of pump reversal ● Development of a disposables set to permit direct connection to the patient for blood . collection Other minor changes to the software to improve usability of the BRAT 2 instrument ●
This submission (K962689) is for a modification to an existing medical device, the COBE BRAT 2 Autologous Blood Salvage System. As such, the "acceptance criteria" and "device performance" discussed in the documentation refer to demonstrating that the modified device performs comparably to its predicate device for the specific changes introduced. This is common for 510(k) submissions focusing on modifications.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values in the way one might expect for a de novo device. Instead, the acceptance is based on demonstrating comparability to the predicate device. The "acceptance criteria" are implied by the performance metrics measured for the predicate device.
For the modified device, the "reported device performance" is framed as being comparable to the predicate.
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Plasma volume per liter of blood processed | Comparable to predicate BRAT 2 PRP | Comparable |
| Plasma free hemoglobin generated per liter of blood processed | Comparable to predicate BRAT 2 PRP | Comparable |
| Percent platelets harvested | Comparable to predicate BRAT 2 PRP | Comparable |
| Percent white blood cells recovered | Comparable to predicate BRAT 2 PRP | Comparable |
| Percent platelets recovered | Comparable to predicate BRAT 2 PRP | Comparable |
| Percent red cells recovered | Comparable to predicate BRAT 2 PRP | Comparable |
| Hematocrit in reinfused blood | Comparable to predicate BRAT 2 PRP | Comparable |
| Hematocrit in collected plasma | Comparable to predicate BRAT 2 PRP | Comparable |
| Platelet aggregation (with direct draw set) | Acceptable levels expected for direct draw, comparable to Electromedics AT 500 (implied) | Measured following storage for 6 hours |
| pH (with direct draw set) | Acceptable levels expected for direct draw, comparable to Electromedics AT 500 (implied) | Measured following storage for 6 hours |
| Expanded volume delivery range | Achieves 25 to 200 ml/min for PRP fill cycle | Achieved |
| Manual mode of operation | Functional | Functional |
| Pump reversal detection/prevention | Functional | Functional |
| Prevention of clockwise pump rotation with fill valve open | Functional | Functional |
| Direct connection to patient for blood collection | Functional with new disposable set | Functional with new disposable set |
Note: The document implicitly states "comparable" for the in vitro blood testing parameters without providing specific numeric values. For the new functionalities (like expanded fill range or manual mode), the acceptance criteria are simply that they function as intended.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify a numerical sample size for the in vitro blood testing. It mentions "In vitro blood testing was done" and "human blood testing was performed." Without a number, we cannot determine the specific sample size.
- Data Provenance: The text does not provide information on the country of origin of the data. The testing appears to be prospective laboratory testing (in vitro blood testing and human blood testing), rather than retrospective patient data analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a blood salvage system, not an AI/imaging device where expert interpretation establishes ground truth. The "ground truth" for its performance is determined by direct measurement of physical and biological properties of processed blood, compared against the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is not an interpretive device requiring expert adjudication.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not a standalone algorithm. Its performance is measured directly through its operation and output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established through direct measurement of physical and biological properties (e.g., plasma volume, hemoglobin, cell recovery percentages, hematocrit) using standardized laboratory methods, compared against the established performance of its predicate device. For the new functionalities, the ground truth is simply whether the function performs as designed.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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).