(40 days)
No
The summary describes a disposable processing set for an autologous blood salvage system, focusing on mechanical design changes to a centrifuge bowl. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is indicated for "recovery and/or processing of autologous blood," which is a therapeutic intervention aimed at improving a patient's health by returning their own blood to them.
No
The device is indicated for the recovery and/or processing of autologous blood, which is a therapeutic rather than diagnostic function. It is used to process blood after it has been collected, not to perform a diagnosis.
No
The device description explicitly states it consists of physical components like a centrifuge bowl, tubing harness, waste bag, and reinfusion bag, and the modification is a design change to the internal spacer of the centrifuge bowl. It also mentions "No hardware or software changes are required to the BRAT® 2 instrument to support this device modification," indicating the device itself is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 the blood for reinfusion into the same patient. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The components (centrifuge bowl, tubing harness, bags) are designed for processing blood, not for analyzing it to diagnose a condition.
- Performance Studies: The performance studies focus on metrics like "Wash Efficiency" and "Heparin Load," which are related to the effectiveness of the blood processing procedure, not the accuracy of a diagnostic test.
- No Mention of Diagnostic Purpose: There is no mention of the device being used to detect, identify, or measure substances in the blood for the purpose of diagnosing a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's purpose is to process blood for reinfusion, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.
Product codes
CAC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Test Results: The Modified BRAT® 2 Standard Volume Processing Set was tested to assure that it met its functional specifications. In vitro blood testing was done to assure the performance of the modified device was comparable to the predicate device. In vitro bovine blood testing consisted of Blood Salvage test protocols and Plasma Sequestration test protocols. Human blood testing was also performed on the modified device in a laboratory setting at the Mayo Clinic, using Blood Salvage protocols. The results find improved wash efficiency for the modified device based on reduction in estimated Heparin Load to Patient found in bovine Blood Salvage tests. Mayo Clinic test data for Heparin Load values generated per 1 liter of inlet blood volume processed, meet or exceed values recommended by Yawn' for blood salvage applications.
Clinical Test Results: No clinical testing was performed.
Key Metrics
Not Found
Predicate Device(s)
Currently Marketed Standard Volume Processing Set for the COBE BRAT ® 2 Autologous Blood Salvage System
Reference Device(s)
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
NOV - 3 1997
Attachment (5)
(
(
510(k) Summary
1
510(k) Summary
| SUBMITTER: | COBE Cardiovascular, Inc. |
|---|---|
| 14401 W. 65th Way | |
| Arvada, CO 80004 | |
| CONTACT PERSON: | Lynne Leonard |
| Phone: | (303)-467-6586 |
| FAX: | (303)-467-6429 |
| DATE PREPARED: | September 22, 1997 |
| DEVICE TRADE NAME: | Standard Volume Processing Set for the COBE BRAT ® 2 |
| Autologous Blood Salvage System | |
| COMMON NAME: | Standard Volume Processing Set for |
| Autologous Blood Salvage System | |
| PREDICATE DEVICE: | Currently Marketed Standard Volume Processing Set for the |
| COBE BRAT ® 2 Autologous Blood Salvage System |
DEVICE DESCRIPTION:
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.
INDICATIONS FOR USE:
The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.
2
TECHNOLOGICAL CHARACTERISTICS:
The Modified BRAT® 2 Standard Volume Processing Set is a modification of its predicate device, (510(k) # K933625, K933625, K962689) the Current BRAT® 2 Standard Volume Processing Set. Through a change in part design, a fin feature located at the base of the internal spacer of the centrifuge bowl was added. This change is intended to modify the profile of the internal fluid pathway of the centrifuge bowl. Cellular Performance Characteristics, (i.e. Outlet Hct, Wash Efficiency), which are dependent on fluid pathway design are changed. The intent of this modification is to improve the Wash Efficiency of the device.
NONCLINICAL TEST RESULTS:
The Modified BRAT® 2 Standard Volume Processing Set was tested to assure that it met its functional specifications. In vitro blood testing was done to assure the performance of the modified device was comparable to the predicate device. In vitro bovine blood testing consisted of Blood Salvage test protocols and Plasma Sequestration test protocols. Human blood testing was also performed on the modified device in a laboratory setting at the Mayo Clinic, using Blood Salvage protocols.
The results find improved wash efficiency for the modified device based on reduction in estimated Heparin Load to Patient found in bovine Blood Salvage tests. Mayo Clinic test data for Heparin Load values generated per 1 liter of inlet blood volume processed, meet or exceed values recommended by Yawn' for blood salvage applications.
CLINICAL TEST RESULTS:
No clinical testing was performed.
CONCLUSION:
The Modified BRAT® 2 Standard Volume Processing Set is substantially equivalent to its predicate device, the Current BRAT 2 Standard Volume Processing Set.
Y Yawn, DH, Ensuring Quality Intraoperative Blood Salvage, LABORATORY MEDICINE, Vol. 25. No. 10, October 1994, p. 629.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three human profiles visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way 80004-3599 Arvada, Colorado
NOV - 3 19
Re: K973627 COBE® BRAT® 2 System with Modified Standard Volume Processing Set Regulatory Class: II (Two) Product Code: CAC Dated: September 22, 1997 Received: September 24, 1997
Dear Ms. Leonard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Lynne Leonard
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
- 5830- CAC II - Auto transfusion Apparatus
Pg.7148
Indications For Use 2.
K973627 510(k) Number (If known):
Device Name: COBE BRAT® 2 System with Modified Standard Volume Processing Set
Indications For Use:
The COBE BRAT 2 is indicated for use for recovery and/or processing of autologous blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bette L. Loemker
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K973627
Prescription Use _> (Per 21 CFR 801.109)
OR
Over-The-Counter Use