The CATSmart (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively to obtain washed packed red blood cells for reinfusion.

Device Description

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intraand/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifyge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks. The shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and non-erythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

AI/ML Overview

This document describes the CATSmart (Continuous Autotransfusion System) device and its substantial equivalence to its predicate device, C.A.T.S., as per the FDA 510(k) submission. Below is the requested information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All three wash programs (emergency wash program, low volume wash, smart wash) were tested. Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set. A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood."

Based on this, the implied acceptance criteria are the successful execution and performance of the device's core functions (blood washing programs) to a similar or acceptable level as the predicate device, particularly concerning the removal of plasma, non-erythrocytic cellular components, activated coagulation factors, fibrinolysis products, cell trauma products, anticoagulant, fat, and heparin, all leading to washed packed red blood cells suitable for reinfusion.

Acceptance Criteria (Implied)	Reported Device Performance
Successful processing of autologous shed blood	"Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set." The device processes anticoagulated shed blood in a continuous washing process to obtain washed packed red blood cells for reinfusion.
Effective removal of plasmatic and non-erythrocytic components	"During this process all plasmatic and non-erythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed." This statement implies successful removal of these components, meeting a performance standard judged to be acceptable.
Effective removal of fat and heparin	"A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood." This explicitly states the successful removal of these specific impurities.
Electrical safety compliance	"The electrical safety of the CATSmart device was tested according to the general requirements for basic safety and essential performance directive of IEC 60601-1-2:2007." The successful completion of this testing implies compliance with these safety standards.
Durability and resistance to vibration/shock	"Furthermore, vibration and shock resistance was tested as well as the durability." The successful completion of these tests implies the device meets internal durability and resistance standards.
Performance comparable to predicate device	"The performance of the CATSmart device was tested by in vitro blood quality studies in direct comparison to the predicate device C.A.T.S." The context suggests that the CATSmart performed comparably to the predicate, leading to the conclusion of substantial equivalence. The main functions of CATSmart and the underlying methodology remained unchanged compared to its predecessors. The only functional difference is the monitoring of the hematocrit value for informational purposes, not diagnostic. Electrical safety, vibration, shock, and durability also tested.

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

The document does not explicitly state the specific sample size (e.g., number of blood samples or test runs) used for the in-vitro performance testing. It only mentions "in vitro blood quality studies."

There is no information about data provenance in terms of country of origin or whether it was retrospective or prospective. Given it was "in vitro blood quality studies," it would inherently be a prospective experimental setup.

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

This information is not provided in the document. The document states "Overall it was judged that all validation tests were passed," implying internal assessment. There is no mention of external experts or their qualifications for establishing ground truth for the in-vitro studies.

4. Adjudication Method

The document does not specify an adjudication method. The statement "Overall it was judged that all validation tests were passed" suggests an internal evaluation without detailing a formal adjudication process involving multiple parties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. The CATSmart device is an autotransfusion apparatus, not an image-reading or diagnostic device that would involve human readers. Its primary function is blood processing, and the "hematocrit monitoring function" is specifically noted as "only used to monitor the wash process for informational purposes and is not intended for diagnostic or quality control purpose." Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The performance testing described is for the device as a whole, including its operational algorithms embedded in the software. The study focuses on the device's ability to process blood and remove impurities. While the document mentions a software update that includes the hematocrit function and touch screen control, it doesn't separate the "algorithm only" performance from the integrated system performance. However, since it's an automated system, its performance inherently represents an "algorithm only" or "device only" performance in its operational context. There is no human-in-the-loop interaction for the core blood processing function itself.

7. Type of Ground Truth Used

The ground truth for the device's performance (i.e., effective blood washing, removal of impurities) would have been established through analytical testing of the processed blood samples. This would likely involve laboratory measurements of various blood components, contaminants (e.g., plasma proteins, anticoagulants, fat, heparin), and red blood cell recovery, probably using established clinical laboratory standards and methods. The document mentions "in vitro blood quality studies," which supports this interpretation.

8. Sample Size for the Training Set

The document does not mention any "training set" or machine learning model development in the context of device performance testing. The main functional difference, the hematocrit monitoring, is an "additional technical feature" and its values are explicitly stated as "not a substitute for the hematocrit check on the product before it is reinfused... The sensors are not calibrated measuring instruments." This suggests that any algorithms related to hematocrit monitoring are rather simple estimations for informational display and are not based on complex machine learning requiring a "training set" in the typical sense. The device's core blood washing function is based on a continuous flow centrifuge, a well-established physical principle, rather than a learned algorithm needing an extensive training set.

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

As no training set is mentioned or implied for the core functions or the hematocrit monitoring (which is for informational purposes only), the establishment of ground truth for a training set is not applicable to the information provided.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2016

Fresenius Kabi USA, LLC % Barry Hicks Manager, Regulatory Affairs Three Corporate Drive Lake Zurich, Illinois 60047

Re: K160735

Trade/Device Name: CATSmart Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: September 14, 2016 Received: September 16, 2016

Dear Barry Hicks:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Willhemen

for

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160735

Device Name CATSmart

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image shows the logo for Fresenius Kabi. The logo consists of three blue, curved lines on the left, followed by the text "FRESENIUS" in blue, and "KABI" in blue below that. The logo is simple and modern, and the blue color gives it a sense of trustworthiness.

Section 5: 510(k) Summary

1. Submitter

This 510(k) summary was created on 14 March 2016.

The 510(k) owner and contact person for this application is:
Name:	Barry G. Hicks
Position:	Manager, Regulatory Affairs
Company:	Fresenius Kabi USA, LLC.
Address	Three Corporate DriveLake Zurich, IL60047 USA
Phone:	847-550-7981
Fax:	847-550-2960
Email:	barry.hicks@fresenius-kabi.com
Establishment registration number:	3004548776

2. Device Name and Classification

Proprietary / Trade Name:	CATSmart
Common Name:	Automated Blood Processing Autotransfusion System
Classification Name:	Apparatus, Autotransfusion
Classification:	Class II per 21 CFR § 868.5830
Product Code:	CAC
Panel:	Anesthesiology

3. Predicate Device

This application is intended to demonstrate that the CATSmart Autotransfusion System, including its associated disposables, is substantially equivalent to the following predicate device:

510(k) number:	K960006
Proprietary / Trade Name:	C.A.T.S. Continuous Autotransfusion System
Common Name:	Automated Blood Processing Autotranfusion System
Classification Name:	Apparatus, Autotransfusion
Classification:	Class II per 21 CFR § 868.5830
Product Code:	CAC
Panel:	Cardiovascular
Manufacturer:	Fresenius AG, Frankfurter Str. 6-8, 66606 St. WendelGermany

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CATSmart

Image /page/4/Picture/2 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue vertical lines that are curved at the top. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "FRESENIUS" on top of "KABI". The logo is simple and modern.

The C.A.T.S. Autotransfusion System was modified with the addition of the following accessories under K984233 and K984586:

510(k) number:	K984233
Proprietary / Trade Name:	C.A.T.S AUTOTRANSFUSION ACCESSORIES,MODELS ATS SUCTION LINE, ATY Y-ADAPTER,AND ATO OXYGENATOR LINE
Common Name:	Automated Blood Processing Autotranfusion System
Classification Name:	Apparatus, Autotransfusion
Classification:	Class II per 21 CFR § 868.5830
Product Code:	CAC
Panel:	Cardiovascular
Manufacturer:	Fresenius AG, Frankfurter Str. 6-8, 66606 St. Wendel,Germany
510(k) number:	K984586
Proprietary / Trade Name:	FRESENIUS ATR40 AND ATR120AUTOTRANSFUSION RESERVOIRS
Common Name:	Cardiovascular Surgical Devices
Classification Name:	Reservoir, Blood, Cardiopulmonary Bypass
Classification:	Class II per 21 CFR § 870.4400
Product Code:	DTN
Panel:	Cardiovascular
Manufacturer:	Fresenius AG, Frankfurter Str. 6-8, 66606 St. Wendel,Germany

4. Description

The product described in this document is the CATSmart (Continuous Autotransfusion System) including the disposables AT1, AT3, ATS, ATY, ATO, ATR40 and ATR120, ATV-70 and ATV-180, ATF40 and ATF120.

The shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and non-erythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

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Image /page/5/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, curved lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are stacked on top of each other, also in blue. The logo is simple and modern in design.

CATSmart is based on the predecessor products C.A.T.S. and C.A.T.SP."", which have been in clinical use for almost 20 years. CATS was originally cleared in 1996. Following minor modifications it has been marketed as C.A.T.Smits since 2005. CATSmart has as an additional technical feature: monitoring of the hematocrit value.

5. Intended Use

The CATSmart (Continuous Autotransfusion System) device by Fresenius Kabi is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion.

6. Substantial Equivalence

Fresenius CATSmart is substantially equivalent to the predicate device system, with the following components.

a) The reusable autotransfusion device:

CATSmart is based on the predecessor products C.A.T.S. and C.A.T.SP.446, which have been in clinical use for almost 20 years. The main functions of CATSmart and the underlying methodology remained unchanged. In fact, the only functional difference of CATSmart compared to C.A.T.S./C.A.T.S./C.A.T.S./C.A.T.S. of the hematocrit value as an additional technical feature. Moreover, the main controller software was updated. The update includes the hematocrit function as a new item and usage of a touchscreen control instead of a keyboard. The software structure and the requirements remain unchanged compared to the C.A.T.S./C.A.T.Splus software.

b) Disposables:

The predicate device C.A.T.S./C.A.T.SPl46 system also includes the disposable blood processing chamber with all necessary tubing (called AT1) as described in the 510(k) submission K960006. The new disposable for the proposed device CATSmart is AT3. The only difference between AT3 and AT1 is the integration of a cuvette into the tubing for the hematocrit measurement. The AT1 disposable may also be used with CATSmart, but no hematocrit information will be displayed.

The following disposables have received prior 510(k) clearance, do not change in their usage with CATSmart, and are not further mentioned in this 510(k):

ATS suction line (cleared under K984233), -
ATY Y-Adapter (cleared under K984233). -
-ATO Oxygenator Line (cleared under K984233).
ATR40 Autotransfusion Reservoir (cleared under K984586), -
ATR120 Autotransfusion Reservoir (cleared under K984586) -

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Image /page/6/Picture/1 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, curved lines on the left side. To the right of the lines, the text "FRESENIUS KABI" is written in blue, with "FRESENIUS" on top of "KABI".

The following additional disposables are exempted from 510(k) submission, do not change with their usage with CATSmart, and are not further mentioned in this 510(k):

-ATV-70 and ATV-180 vacuum lines. These devices are classified as cardiopulmonary bypass accessory equipment and exempted according to 21 CFR & 870.4200.

Discussion of differences between CATSmart and the predicate device.

The only functional difference of CATSmart compared to C.A.T.S./C.A.T.Sn/W is the monitoring of the hematocrit value as an additional feature. The hematocrit monitoring function of CATSmart is only used to monitor the wash process for informational purposes and is not intended for diagnostic or quality control purpose. As stated in the Operator's Manual, the hematocrit values given by the device are not a substitute for the hematocrit check on the product before it is reinfused in the patient. The sensors are not calibrated measuring instruments.

Conclusion:

Based on the identified characteristics it is claimed that the device is substantially equivalent to the predicate devices.

7. Performance testing

The performance of the CATSmart device was tested by in vitro blood quality studies in direct comparison to the predicate device C.A.T.S. (currently marketed as C.A.T.Sº™). All three wash programs (emergency wash program, low volume wash, smart wash) were tested. Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set. A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood. The electrical safety of the CATSmart device was tested according to the general requirements for basic safety and essential performance directive of IEC 60601-1-2:2007. Furthermore, vibration and shock resistance was tested as well as the durability.

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).