The COBE® BRAT® 2 Autologous Blood Salvage System in indicated for use for the recovery and/or processing of autologous blood. The CRIT-LINE™ Hematocrit Sampling System option is used in conjunction with the COBE® BRAT® 2 Autologous Blood Salvage System to measure the hematocrit of the finished product in the reinfusion bag.

Device Description

The COBE® BRAT® 2 Autologous Blood Salvage System is being modified to add the CRIT-LINE™ Hematocrit Sampling System, which will be used to measure the finished red cell product as it is being emptied into the reinfusion bag. The CRIT-LINE™ Hematocrit Sampling System will be offered as an option for the COBE® BRAT® 2 Autologous Blood Salvage System.

The purpose of the CRIT-LINE™ Hematocrit Sampling System is to give the user a noninvasive, real-time measurement of the hematocrit of the red cell product in the reinfusion bag. It eliminates exposure of the clinician to collection of a blood sample. Because the CR/T-L/NE™ Hematocrit Sampling System measures the hematocrit of the blood ten times per second as it is being collected in the reinfusion bag, the system is able to capture changes in hematocrit as the blood is exiting the centrifuge bowl, and is able to provide a more representative hematocrit result based upon multiple sampling of the blood product, rather than on a single sample.

AI/ML Overview

This 510(k) premarket notification describes a modification to an existing medical device, the COBE® BRAT® 2 Autologous Blood Salvage System. The modification involves adding the CRIT-LINE™ Hematocrit Sampling System as an option. The document focuses on demonstrating that the modified device is substantially equivalent to the predicate device, primarily through testing the added component.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the CRIT-LINE™ Hematocrit Sampling System's performance, nor does it present detailed performance data in a tabular format. The document generally states that "Hematocrit performance testing in accordance with the CRIT-LINE™ product specifications using human blood" was conducted. This implies that there are internal product specifications that define acceptable hematocrit measurement performance, but these are not disclosed in the provided text.

Therefore, a table cannot be fully completed from the given information.

Feature / Metric	Acceptance Criteria (Not Explicitly Stated for Hematocrit Performance)	Reported Device Performance (Implied as meeting specifications)
Hematocrit Measurement Accuracy	(Expected to be defined in CRIT-LINE™ product specifications)	"Hematocrit performance testing... using human blood" (Implies satisfactory performance against internal specifications)
Electrical Safety	EN 60601-1: International Standard for Medical Electrical Equipment, Part 1	Testing done (Implies compliance)
Electromagnetic Immunity	EN60601-1-2: International Standard for Medical Electrical Equipment, Part 1.2	Testing done (Implies compliance)
Electromagnetic Emissions	EN 55011: Limits and Methods of Measurement of Radio Disturbance Characteristics of Industrial, Scientific, and Medical Radio-Frequency Equipment	Testing done (Implies compliance)

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

The document states that "Hematocrit performance testing... using human blood" was performed. However, it does not specify the sample size used for this test set (e.g., number of blood samples or subjects) or the data provenance (e.g., country of origin, retrospective or prospective nature of data collection).

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

This information is not provided in the document. Hematocrit measurement typically uses objective laboratory methods as a reference (ground truth), rather than expert consensus/adjudication.

4. Adjudication Method for the Test Set

As the hematocrit measurement is an objective, quantitative assessment, an adjudication method in the sense of expert review/consensus is not applicable or described. The ground truth for hematocrit is usually established by a validated laboratory method.

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

An MRMC study is not applicable here. The device measures hematocrit, which is a quantitative physiological parameter. MRMC studies are typically used to assess the effectiveness of diagnostic imaging devices that rely on human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The CRIT-LINE™ Hematocrit Sampling System itself appears to operate as a standalone measurement device. Its purpose is to provide a "noninvasive, real-time measurement of the hematocrit." Therefore, the "Hematocrit performance testing" mentioned would inherently be a standalone performance evaluation of the device's measurement accuracy against a reference. The document does not explicitly state "standalone performance study" but the nature of the device suggests this is the type of testing that would have occurred for the hematocrit measurement function.

7. The Type of Ground Truth Used

The ground truth for the hematocrit performance testing would almost certainly be an objective laboratory measurement of hematocrit using a well-established and validated method (e.g., automated hematology analyzer, microhematocrit centrifugation). The document refers to "human blood," implying that the testing was performed on actual biological samples, which would then be compared to a gold standard laboratory method.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This type of device, which measures a physical property (light absorption/scattering for hematocrit), typically relies on established physical principles and calibration, rather than deep learning models that require large training datasets in the conventional sense. If any training was involved in the development of the CRIT-LINE™'s measurement algorithms, this information is not disclosed.

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

As no training set is described or implied in the typical sense of machine learning, this question is not applicable based on the provided information. If calibration was performed, it would involve reference fluids or blood samples with known hematocrit values, established via laboratory methods.

Summary

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a 1999

510(k) Summary

SUBMITTER:	COBE Cardiovascular®, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Lynne LeonardPhone: (303) 467-6586Fax: (303) 467-6429
DATE PREPARED:	June 10, 1999
DEVICE TRADE NAME:	COBE® BRAT® 2 Autologous Blood Salvage System withCRIT-LINE™ Hematocrit Sampling System
COMMON/USUAL NAME:	Autologous Blood Salvage System with Hematocrit Sampling Option
CLASSIFICATION NAME:	Autotransfusion Apparatus
PREDICATE DEVICE:	COBE® BRAT® 2 Autologous Blood Salvage System

DEVICE DESCRIPTION:

INDICATIONS FOR USE

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematoorit Sampling System is substantially equivalent to the currently marketed COBE® BRAT® 2 Autologous Blood Salvage System. The two devices are identical with the exception of the CRIT-LINE™ Hematocrit Sampling System option with its associated hardware, software, and disposables. Otherwise, the intended use,

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specifications, method of operation, accessories, design, and features, of the COBE® BRAT® 2 Autologous Blood Salvage System remain the same.

Testing of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System consisted of:

Electrical safety testing in accordance with EN 60601-1: International Standard for Medical 1. Electrical Equipment, Part 1
Electromagnetic immunity testing in accordance with EN60601-1-2: International Standard for 2. Medical Electrical Equipment, Part 1.2
1. Electromagnetic emmisions testing in accordance with EN 55011: Limits and Methods of Measurement of Radio Distrubance Characteristics of Industrial, Scientific, and Medical Radio-Frequency Equipment
1. Hematocrit performance testing in accordance with the CRIT-LINE™ product specifications using human blood

These data support substantial equivalence of the COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System to the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

SEP 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lynne Leonard Manager, Regulatory Submissions COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, Colorado 80004-3599

Re: K991986

Trade Name: COBE® BRAT® 2 Autologous Blood Salvage System with CRIT-LINE™ Hematocrit Sampling System Option

Regulatory Class: II Product Code: CAC, KOC Dated: June 10, 1999 Received: June 14, 1999

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 legally marketed predicate 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 Regulations, 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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) 594-4588. 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use 1.

510(k) Number (If known):	K991198
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COBE® BRAT® 2 System with CRIT-LINE™ Hematocrit Sampling System Option Device Name:

Indications For Use:

The COBE BRAT 2 is indicated for use for the recovery and/or processing of autologous blood. The CODE BRAT 2 is Indication in add for the roter in conjunction with the BRAT 2 The ONY -EINE Homatoon. Sampling by Stomished product in the reinfusion bag.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Myerson

Division Sign-Off Division of Clinical Laboratory De 510(k) Number

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).