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.

AI/ML Overview

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.

Summary

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K973627

NOV - 3 1997

Attachment (5)

(

510(k) Summary

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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:

INDICATIONS FOR USE:

The COBE BRAT® 2 Standard Volume Processing Set is indicated for use for recovery and/or processing of autologous blood.

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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.

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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.

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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

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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)

Over-The-Counter Use

Regulation Number and Section

§ 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).