The C.A.T.S (Continuous Autotransfusion Svstem) by Frescruus is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

Device Description

The Fresenius C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e.; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components: Reusable Autotransfusion Device (electromechanical microprocessor controlled device) and Disposable AT1 Autotransfusion Set.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fresenius C.A.T.S Autotransfusion System Plasma Sequestration-Direct Draw Program and PSQ Set (Direct Draw).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full clinical study report designed to prove novel efficacy or safety with predefined criteria and detailed performance metrics. As such, some of the requested information (like specific effect sizes for MRMC studies, number of training set samples, or direct performance statistics for clinical outcomes) is not explicitly present.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not presented in a quantitative, pass/fail table as might be seen for a new device claiming specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new components (PSQ Set (DD) and the direct draw software module) meet established standards and operate equivalently to predicate devices and the existing C.A.T.S system.

Acceptance Criterion (Implied)	Reported Device Performance (Summary)
Biocompatibility: Materials in contact with blood are safe.	All blood/fluid contacting materials of the PSQ Set (DD) subjected to biocompatibility testing consistent with FDA's modified ISO standards for biological evaluation of medical devices. Fresenius has demonstrated the materials are suitable for intended use.
Structural Integrity: PSQ Set (DD) can withstand intended use.	The PSQ Set (DD) satisfies requirements of the AAMI/ANSI standards for autotransfusion devices with respect to structural integrity. Shelf-life validation studies determined structural integrity will be maintained for the labeled shelf-life.
Shelf-life Validation: Maintains performance over time.	Shelf-life validation studies pertinent to the PSQ Set (Direct Draw) have determined that biocompatibility, structural integrity, packaging integrity, and sterility will be maintained for the labeled shelf-life.
Software Performance: Direct draw program module functions correctly.	The plasma sequestration direct draw program module of the C.A.T.S system software has undergone testing to assure that system software requirements are met. Through system software testing, it has been established that the program module will meet the requirements as set forth in the Software Requirements Specification.
Substantial Equivalence: To predicate devices and existing C.A.T.S system.	The direct draw plasma sequestration program and disposable PSQ Set (DD) of the Fresenius C.A.T.S autotransfusion device is substantially equivalent to the currently marketed plasma sequestration program and PSQ Set, and to the direct draw programs and accessories of the Sequestra 1000 and Cell Saver 5 autotransfusion systems. (This is the overarching conclusion rather than a direct performance metric).

Study Details

Based on the provided K973378 510(k) Summary, here's what can be inferred about the "study" (which consists of multiple tests to support substantial equivalence):

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient numbers or blood samples. The testing appears to be primarily in vitro or bench testing on the device itself and its components (biocompatibility, structural integrity, software testing).
- Data Provenance: Not specified. Given the nature of the tests (biocompatibility, structural integrity, software), it would likely be laboratory or bench test data, not necessarily country-specific clinical data. It is a retrospective compilation of test results.
Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- Number of Experts: Not applicable or not specified. This document describes testing against engineering standards (AAMI/ANSI) and internal software requirements, and biocompatibility standards (FDA/ISO). Ground truth, in the sense of clinical expert consensus for diagnosis or interpretation, is not relevant here as the device processes blood, it doesn't make clinical diagnoses.
- Qualifications of Experts: The experts involved would be those performing the biocompatibility, materials, structural, and software engineering tests. Their specific titles or experience are not detailed.
Adjudication Method for the Test Set:
- Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or data against a consensus ground truth. Here, the "test set" involves measurable physical and software performance against defined standards.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is not an AI/imaging device and an MRMC study is not relevant to its purpose. The device is an autotransfusion system, not an interpretive diagnostic tool.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The "standalone" performance here refers to the device's operational capabilities without direct human intervention once started. The software testing confirms the automated functions of the plasma sequestration direct draw program module meet requirements without human-in-the-loop comparison for efficacy. However, the device itself is an automated system for blood processing, so "standalone" performance in the AI context isn't directly applicable.
The Type of Ground Truth Used:
- Ground Truth: The "ground truth" for the tests described are:
  - Biocompatibility: Compliance with FDA's modified ISO standards for biological evaluation of medical devices.
  - Structural Integrity: Compliance with AAMI/ANSI standards for autotransfusion devices.
  - Software Functionality: Meeting the requirements as set forth in the internal "Software Requirements Specification."
  - Shelf-life: Maintenance of biocompatibility, structural integrity, packaging integrity, and sterility over time, as tested according to internal protocols often based on industry standards.
The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. The "development" and "validation" would refer to engineering design, manufacturing, and testing processes.
How the Ground Truth for the Training Set Was Established:
- Training Set Ground Truth: Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's engineering and performance validation comes from established engineering standards, material science principles, and software development best practices.

Summary

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KA73378

X. 510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR §807.3 (Federal Register, Vol. 59, No. 239, Dec. 14, 1994, pg. 64295).

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510(k) Summary for the Fresenius C.A.T.S Autotransfusion System Plasma Sequestration-Direct Draw Program and PSQ Set (Direct Draw)

Submitter's Name and Address:	Fresenius USA, Critical Care Division2637 Shadelands DriveWalnut Creek, CA 94598
Phone Number:	(510) 295-0200
Telefax Number:	(510) 988-1932
Contact Person:	Virginia Singer
Date Summary Prepared:	August 27, 1997
Device Trade Name:	C.A.T.S Autotransfusion System
Common name:	Automated Blood ProcessingAutotransfusion System
Classification Name:	Autotransfusion Apparatus per 21 CFR868.5830
Legally Marketed Device to whichsubstantial equivalence is claimed:	Medtronic Sequestra 1000 andHaemonetics's CellSaver 5 AutotransfusionSystems

Intended Use:

1993

The Fresenius C.A.T.S Autotransfusion System is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of whole blood into packed red cells (PRC), plasma (PLS) and platelet rich plasma (PRP).

Device Features:

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The C.A.T.S device is comprised of two major components:

ﻟﺘﻨﻈﻴﻢ

Reusable Autotransfusion Device: The C.A.T.S machine is an electromechanical a) microprocessor controlled device which incorporate the following major system components: the user display and function keys, centrifuge housing, centrifuge rotors; blood, packed red cell (PRC) and saline roller pumps; blood, saline and PRC sensors; leakage detector, and power supply unit. Additionally, the system includes the electronic components and system software which control and monitor the blood processing procedure.
Disposable AT1 Autotransfusion Set: This disposable set incorporates the continuous b) washing chamber, adapters for mounting the set into the C.A.T.S device, blood inlet line with stepped adapter, pump tubing, fluid lines; and the waste and reinfusion bags.

There have been no modifications made to the existing C.A.T.S system hardware to allow for the plasma sequestration direct draw program. Furthermore, the plasma sequestration processing procedure is performed using the same AT1 Autotransfusion Set that were subject of previous premarket notifications reviewed and concurred by the Agency. In order to perform plasma sequestration using the direct draw method, an additional disposable set, the PSQ Set (Direct Draw-DD) is necessary. The PSQ Set (DD) includes all components currently included in the standard PSQ set; e.g., bags required for collection of concentrated red blood cells, plasma and platelet rich plasma; and lines for connection between the PSQ Set (DD) and AT1 Autotransfusion Set. Additionally, a blood drawing line/anticoagulant burette assembly required for blood collection and anticoagulation is included in the package. The burette drip chamber allows for manual metering of the anticoagulant during blood withdrawal.

Technological Characteristics of the Subject Device Compared with Predicate Devices

The 510(k) "Substantial Equivalence Decision Making Process (Detailed)" decision tree (ODE Guidance Memo #K86-3) was used to make a determination of substantial equivalence (reference Exhibit IV-1 included in this section). The answers to questions identified on this decision tree lead to a determination of substantial equivalence.

1.0 Does the New Device Have the Same Indication Statements?

Yes. The C.A.T.S device, Sequestra 1000 and Cell Saver 5 autotransfusion systems are indicated for the processing of autologous shed blood, collected during a variety of surgical procedures, to obtain washed packed red blood cells for reinfusion. Furthermore, all three systems allow for plasma sequestration of blood collected either in a standard anticoagulated blood bag or by direct patient connection.

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Does New Device Have Same Technological Characteristics (e.g., design, 2.0 materials etc.)?

Yes. There are differences in technology and operation between the C.A.T.S device and the predicate devices. However, with the exception of the blood collection and anticoagulation method, the technological characteristics of the C.A.T.S Plasma Sequestration Direct Draw procedure are the same as that of the standard plasma sequestration procedure. Both the disposable components and the processing procedure employed for sequestration are identical.

The technological characteristics of the patient drawing and anticoagulant line of the C.A.T.S and Medtronic Sequestra are the same. The C.A.T.S and Medtronic blood withdrawal/anticoagulation subassemblies are manufactured using similar components and they are used in the same manner. Both sets must be connected to an anticoagulant source and are directly connected to the patient's venous access site. Anticoagulant is stored in the burette chamber and is manually metered to maintain a suitable anticoagulant:whole blood ratio. As stated previously, the C.A.T.S and Sequestra devices are designed to prevent fluid from being pumped back into the patient during the blood withdrawal process.

3.0 Are the Descriptive Characteristics Precise Enough to Ensure Equivalence?

No. Although, the disposable assemblies of the C.A.T.S and Sequestra 1000 are very similar, there may be differences in the materials used to manufacture the assemblies and in the manufacturing methods employed to build the assemblies. These differences could impact the biocompatibility, structural integrity and shelf-life of the PSQ Set (DD). Furthermore, the C.A.T.S system software has been modified to include a new software program module for the direct draw plasma sequestration procedure. The program module requires validation to ensure proper performance.

4.0 Are Performance Data Available to Assess Equivalence?

Yes. All blood/fluid contacting materials of the PSQ Set (DD) have been subjected to biocompatibility testing consistent with FDA's modified ISO standards for biological evaluation of medical devices. Information pertinent to the structural integrity of the PSQ set and shelf-life validation has been provided. Furthermore, the plasma sequestration direct draw program module of the C.A.T.S system software has undergone testing to assure that system software requirements are met.

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Does Performance Data Demonstrate Equivalence? 5.0

Based on the results of the testing cited above, Fresenius has demonstrated that: Yes.

The PSQ Set satisfies requirements of the AAMI/ANSI standards for . autotransfusion devices with respect to structural integrity and the materials used to manufacture the disposable set are suitable for the intended use of the device,
Shelf-life validation studies pertinent to the PSQ Set (Direct Draw) have . determined that the biocompatibility, structural integrity, packaging integrity and sterility of the PSO Set (Direct Draw) will be maintained for the labeled shelf-life,
Through system software testing, it has been established that the plasma . sequestration direct draw program module incorporated into the C.A.T.S's system software will meet the requirements as set forth in the Software Requirements Specification,

CONCLUSION: Based on the information and test results provided in this premarket notification, the direct draw plasma sequestration program and disposable PSQ Set (DD) of the Fresenius C.A.T.S autotransfusion device is substantially equivalent to the currently marketed plasma sequestration program and PSQ Set. Additionally, the C.A.T.S direct draw plasma sequestration program and PSQ Set (DD) are substantially equivalent to the direct draw programs and accessories of the Sequestra 1000 and Cell Saver 5 autotransfusion systems.

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three abstract shapes resembling birds in flight, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV = 5 397

Ms. Virginia Singer Manager, Regulatory Affairs Critical Care Division Fresenius USA, Inc. 2637 Shadelands Drive Walnut Creek, California 94598

Re : K973378 Fresenius C.A.T.S. (Continuous Autortansfusion System) Requlatory Class: II (Two) Product Code: CAC Dated: September 5, 1997 Received: September 8, 1997

Dear Ms. Singer:

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 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 requlations.

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Page 2 - Ms. Virginia Singer

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. Callahan

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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Indications for Use Statement

Page I of I

510(k) Number ( if known): K 973378

C.A.T.S Continuous Autotransfusion System Device Name:

The C.A.T.S (Continuous Autotransfusion Svstem) by Frescruus is an autotransfusion Indications for Use: device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bess le Rempelle

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

510(k) Number K 973378

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).