(255 days)
The CATSmart System by Fresenius Kabi 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).
The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma. This version of CATSmart is also capable of perioperative separation of blood into PRP and PLS. The CATSmart device operates on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which for decades, have been widely used in blood banks. In a typical CATSmart procedure, 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. In the Plasma Sequestration (PSQ) procedure, the patient's blood is separated into packed red cells (PRCs), plasma (PLS) and platelet rich plasma (PRP). The principle of separation during plasma sequestration is the same as it is for autotransfusion i.e. physical separation of cellular components in the centrifugal field based on the differences in density and particle size. There is no change to system hardware or disposable sets described previously in K160735. The system includes the disposables AT1. AT3. ATS. ATY. ATO. ATR40 and ATR120. ATV-70 and ATV-180, ATF40 and ATF120. An ATV-F140 disposable set has been created (Class I 510(k) exempt). Also, PSQ disposable cleared under K971274 has also been qualified for use with the CATSmart System for the PSQ procedure. An additional wash program has been developed and added to the software to manage the PSO procedure.
The provided text describes the 510(k) summary for the Fresenius Kabi CATSmart Autotransfusion System, but it does not contain a detailed study section with acceptance criteria and device performance information.
Based on the available text, here's what can be inferred and what information is missing:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided text. The text mentions "in vitro blood quality studies in direct comparison to the predicate device C.A.T.S." and that "the validation tests passed for the new PSQ wash program on the CATSmart device with the PSQ set and AT3 tubing set." However, it does not detail the specific acceptance criteria (e.g., target ranges for red cell recovery, platelet removal, etc.) or the quantitative results from these studies.
2. Sample size used for the test set and the data provenance:
This information is not provided. The text only mentions "in vitro blood quality studies."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. Given that this is an autotransfusion device primarily processing blood, the "ground truth" would likely be laboratory measurements of blood component quality, not expert consensus on images or diagnoses.
4. Adjudication method for the test set:
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for qualitative data (e.g., imaging interpretation), which is not the primary focus for validating an autotransfusion device.
5. 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:
This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The CATSmart system is an autotransfusion apparatus, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The CATSmart system itself is a device that processes blood, not an algorithm that performs a standalone diagnostic or interpretive function.
7. The type of ground truth used:
Based on the context of "in vitro blood quality studies," the ground truth likely involved laboratory measurements of various blood parameters (e.g., hematocrit, red cell recovery percentage, plasma volume, platelet count, etc.) obtained through standard analytical techniques.
8. The sample size for the training set:
This information is not provided. The device uses a continuous flow centrifuge principle, and typically such devices are validated through engineering and in vitro performance studies, rather than "training" on a dataset in the way a machine learning algorithm would be. The "new PSQ wash program" implies software, but the document does not specify if it involves machine learning.
9. How the ground truth for the training set was established:
This information is not provided and is likely not applicable in the context of this device as it's not a machine learning-based system that requires a "training set" in the conventional sense. The "ground truth" for evaluating the performance of the wash program would be established through laboratory analysis of the processed blood.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 10, 2018
Fresenius Kabi AG % Anju Kurian Manager, Regulatory Affairs Fresenius Kabi USA Three Corporate Drive Lake Zurich, Illinois 60047
Re: K180831
Trade/Device Name: CATSmart Autotransfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: Class II Product Code: CAC Dated: October 26, 2018 Received: October 29, 2018
Dear Anju Kurian:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Fernando Aguel Fernando Aguel -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K180831
Device Name CATSmart
Indications for Use (Describe)
The CATSmart System by Fresenius Kabi 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).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 C.FR 801 Submart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the Fresenius Kabi logo. The logo consists of three blue wavy lines on the left and the words "FRESENIUS KABI" in blue on the right. Below the words "FRESENIUS KABI" is the phrase "caring for life" in a smaller blue font.
510(K) SUMMARY
Date Prepared: March 29, 2018
I. Submitter
Fresenius Kabi 3 Corporate Drive Lake Zurich, IL 60047
Contact Person: Barry G. Hicks Manager, Regulatory Affairs Phone: 847-550-7981 Fax: 847-550-2690 Email: barry.hicks(@fresenius-kabi.com
II. Device
| Trade Name: | CATSmart |
|---|---|
| Common or Usual Name: | Automated Blood Processing Autotransfusion System |
| Product Code: | CAC |
| Classification Regulation: | 21 CFR § 868.5830 |
| Classification Name: | Apparatus, Autotransfusion |
| Regulation Description: | An autotransfusion apparatus is a device used to collect andreinfuse the blood lost by a patient due to surgery or trauma |
| Review Panel: | Anesthesiology |
| Device Class: | Class II |
III. Predicate Device
Trade Name: Common or Usual Name: 510(k) Number: Date Cleared: Product Code: Device Class:
C.A.T.S. Continuous Autotransfusion System Automated Blood Processing Autotranfusion System K971274 June 13, 1997 CAC Class II
IV. Device Description
The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma. This version of CATSmart is also capable of perioperative separation of blood into PRP and PLS.
Fresenius Kabi USA, LLC
Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us
{4}------------------------------------------------
The CATSmart device operates on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which for decades, have been widely used in blood banks.
In a typical CATSmart procedure, 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.
In the Plasma Sequestration (PSQ) procedure, the patient's blood is separated into packed red cells (PRCs), plasma (PLS) and platelet rich plasma (PRP). The principle of separation during plasma sequestration is the same as it is for autotransfusion i.e. physical separation of cellular components in the centrifugal field based on the differences in density and particle size. There is no change to system hardware or disposable sets described previously in K160735.
The system includes the disposables AT1. AT3. ATS. ATY. ATO. ATR40 and ATR120. ATV-70 and ATV-180, ATF40 and ATF120. An ATV-F140 disposable set has been created (Class I 510(k) exempt). Also, PSQ disposable cleared under K971274 has also been qualified for use with the CATSmart System for the PSQ procedure.
An additional wash program has been developed and added to the software to manage the PSO procedure.
V. Indications for Use
The CATSmart System 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.
Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).
The indications for use of the CATSmart System, subject of this 510(k), is the same as the predicate device C.A.T.S Autotransfusion System cleared under K971274.
VI. Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the CATSmart device used for PSQ procedure remains the same as the predicate C.A.T.S device. The only functional difference of CATSmart compared to C.A.T.S./C.A.T.S?140 is the monitoring of the hematocrit value as an additional technical feature. This feature was evaluated and cleared under K160735.
VII. Performance Data
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.S.MM). The focus of the validation study was the PSQ procedure using CATSmart. Overall it was judged that the validation tests passed for the new PSO wash program on the CATSmart device with the PSO set and AT3 tubing set.
{5}------------------------------------------------
VIII. Conclusions
The performance testing demonstrates that CATSmart is substantially equivalent to the predicate device C.A.T.S Autotransfusion System.
§ 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).