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) consist of addition of a one-year expiration date to the Modified Standard Volume processing set covered in 510(k) K973627 and a design change to the internal spacer of the Baylor centrifuge bowl.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the COBE® BRAT® 2 System with Modified Standard Volume Processing Set (K974897):

Given the nature of the device (a processing set for autologous blood salvage), the "performance" discussed here relates to its functional specifications and its ability to process blood effectively, rather than diagnostic accuracy metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Functional Specifications	The Modified BRAT® 2 Standard Volume Processing Set must meet its functional specifications.	"The Modified BRAT® 2 Standard Volume Processing Set was tested to assure that it met its functional specifications." (The specific functional specifications are not detailed in the provided text, but the statement confirms they were met.)
Blood Processing Performance	Performance of the modified device in blood processing (e.g., Blood Salvage, Plasma Sequestration) must be 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." Specifically, "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." This indicates not just comparability, but an improvement in a key performance metric.
Expiration Date Validation	The device must maintain its performance characteristics after simulated aging to support a one-year expiration date.	"Devices tested in this 510(k) were exposed to an accelerated aging process which produces a one year expiration date." The successful outcome of this testing is implied by the clearance with a one-year expiration date.
Substantial Equivalence	The modified device must demonstrate substantial equivalence to its predicate device, the Current BRAT® 2 Standard Volume Processing Set.	"The Modified BRAT® 2 Standard Volume Processing Set is substantially equivalent to its predicate device, the Current BRAT 2 Standard Volume Processing Set." The FDA concurred with this finding.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for the in vitro blood testing (number of processing sets or blood samples tested).
Data Provenance: The testing was in vitro using bovine blood. This indicates the data is from a laboratory setting, not human subjects. It does not state the country of origin, but given the submitter is in Arvada, CO, USA, it's highly likely the testing was conducted in the US. The study was prospective in the sense that the testing was specifically designed and performed to evaluate the modified device for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is a medical device for blood processing, not an AI or diagnostic imaging device that typically requires expert consensus for "ground truth." Therefore, the concept of "experts used to establish ground truth" in the traditional sense (e.g., radiologists interpreting images) does not apply here.
The ground truth for performance relied on established laboratory protocols and quantitative measurements derived from the in vitro blood tests (e.g., measurement of heparin load, which would be an objective chemical or biological measurement using standard lab techniques/equipment). The expertise involved would be in medical device engineering, laboratory science, and potentially hematology, but not in visual interpretation or clinical diagnosis by multiple expert readers.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of device and testing performed. Adjudication methods like "2+1" or "3+1" are used in studies where human readers provide subjective interpretations (e.g., image diagnosis) that need to be reconciled to form a ground truth. The testing here involved objective, quantitative measurements from in vitro blood processing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done.
MRMC studies are typically performed for diagnostic devices, especially those involving human interpretation of imaging or other complex data, to assess the impact of a device (like AI assistance) on reader performance. This submission is for a physical medical device (blood processing set) and its functional performance, not a diagnostic aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is also generally not applicable to this type of device. The device is a "processing set," which is a consumable component of a larger system (COBE BRAT® 2 Autologous Blood Salvage System). Its "performance" is inherently tied to its function within that system, and there isn't an "algorithm only" component in the way one would consider it for an AI diagnostic tool. The performance evaluated was the standalone physical device's characteristics and its functional performance in processing blood in vitro.

7. The Type of Ground Truth Used

The ground truth in this context was based on objective, quantitative measurements obtained from established in vitro laboratory protocols using bovine blood. Specifically, it included:
- Functional specifications: Verification of the device's physical and operational attributes against engineering requirements.
- Biochemical/physiological measurements: Data such as "reduction in estimated Heparin Load to Patient" are objective measurements.

8. The Sample Size for the Training Set

This information is not provided in the document.
The concept of a "training set" as understood in machine learning/AI is typically not directly applicable to the development and testing of a physical medical device like a blood processing set. Device modifications are often based on engineering design principles, material science, and prior predicate device performance, rather than iterative "training" with a dataset. Any "training" or optimization during the development phase would involve engineering iterations and testing, but not in the sense of a machine learning training set with ground truth labels.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the concept of a "training set" in the AI sense does not apply here. Therefore, the establishment of its "ground truth" is also not an applicable concept. Any design verification and validation during the device's development would rely on engineering specifications, material testing standards, and established laboratory methods.

Summary

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K974897

MAR 3 1 1998

510(k) Summary

SUBMITTER:	COBE Cardiovascular, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Lynne Leonard
Phone:	(303)-467-6586
FAX:	(303)-467-6429
DATE PREPARED:	December 28, 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 and was cleared for marketing per 510(k) K973627. This 510(k) covers the addition of a one-year expiration date to the product.

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. Devices tested in this 510(k) were exposed to an accelerated aging process which produces a one year expiration date.

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.

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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that suggest a profile. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

MAR 3 1 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 144Q1 W. 65th Way Arvada, CO 80004-3599

Re: K974897

COBE® BRAT® 2 System with Modified Standard Volume Processing Set Requlatory Class: II (Two) Product Code: CAC Dated: December 30, 1997 Received: December 31, 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 requlations 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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. Callahon

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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CAC-

Pg.7143

2. Indications For Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K97 4897

COBE® BRAT® 2 System with Modified Standard Volume Processing Set Device Name:

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)

Ago 2000

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

K 97489 510(k) Number

Prescription Use X (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).