(201 days)
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No
The description focuses on hardware and software modifications for functional improvements and safety features, with no mention of AI or ML algorithms for data analysis or decision-making.
Yes.
The device is used for the recovery and/or processing of autologous blood, which is a medical intervention aimed at improving a patient's health by returning their own blood.
No
Explanation: The COBE BRAT 2 is indicated for the recovery and processing of autologous blood, which is a therapeutic rather than a diagnostic function. The description focuses on changes to its blood processing capabilities, not on obtaining information about a patient's health status.
No
The device description explicitly mentions "Hardware and software modifications" and "Development of a disposables set," indicating it is not solely software.
Based on the provided text, the COBE BRAT 2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "recovery and/or processing of autologous blood." This describes a process performed on blood outside the body, but the purpose is to prepare it for reinfusion into the same patient. This is a blood processing system, not a diagnostic test.
- Device Description: The description details a system for processing blood, including features related to volume delivery, manual operation, pump control, and blood collection. These are all consistent with a blood salvage and processing system.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It doesn't analyze blood to provide information about a patient's health status.
- Performance Studies: The performance studies focus on the processing capabilities of the device (plasma volume, hemoglobin, cell recovery, hematocrit, platelet aggregation, pH) rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC.
In summary, the COBE BRAT 2 is a device used to process a patient's own blood for reinfusion, which falls under the category of a blood processing or blood salvage system, not an IVD.
N/A
Intended Use / Indications for Use
The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
NONCLINICAL TEST RESULTS:
The COBE BRAT 2 with Modified PRP was tested to assure that it met its functional specifications. In vitro blood testing was done to assure the performance of the modified system was comparable to the predicate BRAT 2 PRP system. In vitro testing consisted of plasma volume per liter of blood processed, plasma free hemoglobin generated per liter of blood processed, percent platelets harvested, percent white blood cells recovered, percent platelets recovered, percent red cells recovered, hematocrit in reinfused blood and hematocrit in collected plasma. In addition, human blood testing was performed with the direct draw set to measure platelet aggregation and pH following storage for 6 hours.
CLINICAL TEST RESULTS:
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Plasma Recovery Program (PRP) for the COBE® BRAT® 2 Autologous Blood Salvage System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Electromedics AT 500 System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KA62689
JAN 28 1997
510(k) SUMMARY
| SUBMITTER: | COBE Cardiovascular, Inc. ®
14401 W. 65th Way
Arvada, CO 80004 |
|-----------------------------------|----------------------------------------------------------------------------------------|
| CONTACT PERSON:
Phone:
Fax: | Mary L. Armstrong
(303) 467-6521
(303) 467-6525 |
| DATE PREPARED: | July 8, 1996 |
| DEVICE TRADE NAME: | Plasma Sequestration Option for the COBE® BRAT® 2 Autologous
Blood Salvage System |
| COMMON NAME: | Plasma sequestration option for autologous blood salvage system |
| CLASSIFICATION NAME: | Autotransfusion Apparatus |
| PREDICATE DEVICES: | Plasma Recovery Program (PRP) for the COBE® BRAT® 2
Autologous Blood Salvage System |
DEVICE DESCRIPTION:
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 ●
COBE . BRAT . and COBE Cardiovascular, Inc. are registered trademarks for COBE Laboratories, Inc.
1
INDICATIONS FOR USE:
The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.
TECHNOLOGICAL CHARACTERISTICS:
The COBE BRAT 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP) is a modification of its predicate, the Plasma Recovery Program (PRP) for the COBE® BRAT® 2 Autologous Blood Salvage System.
Through software modifications, the process pump has the capability to run at a wider range of fill speeds for plasma sequestration purposes. Redundant hardware has been added for detection and prevention of pump direction reversal and hardware has been added to prevent clockwise pump rotation with the fill valve open which would result in fluid flow towards the patient if directly connected in a PRP mode of operation. Software modifications have also been made to create a manual mode of operation for plasma sequestration.
A disposable set for the COBE BRAT 2 with Modified PRP permits the collection, anticoagulation, and delivery of blood directly from the patient to the BRAT 2 instrument for plasma sequestration purposes, as is done in the predicate Electromedics AT 500 System.
NONCLINICAL TEST RESULTS:
The COBE BRAT 2 with Modified PRP was tested to assure that it met its functional specifications. In vitro blood testing was done to assure the performance of the modified system was comparable to the predicate BRAT 2 PRP system. In vitro testing consisted of plasma volume per liter of blood processed, plasma free hemoglobin generated per liter of blood processed, percent platelets harvested, percent white blood cells recovered, percent platelets recovered, percent red cells recovered, hematocrit in reinfused blood and hematocrit in collected plasma. In addition, human blood testing was performed with the direct draw set to measure platelet aggregation and pH following storage for 6 hours.
CLINICAL TEST RESULTS:
No clinical testing was performed.
CONCLUSIONS:
,一
The COBE BRAT 2 Autologous Blood Salvage System with Modified Plasma Recovery Program (PRP), through hardware and software modifications and disposables design, is substantially equivalent to the Plasma Recovery Program (PRP) for the COBE BRAT 2 Autologous Blood Salvage System and the Electromedics Autotransfusion Machine AT 500.