(28 days)
Not Found
No
The description focuses on the physical principles of centrifugation and separation, and there is no mention of AI or ML terms or concepts.
No.
The device is an autotransfusion system designed for processing shed blood to obtain washed red blood cells for reinfusion, and for separating blood into packed red cells, plasma, and platelet-rich plasma. It is a blood processing device, not a therapeutic device meant to treat a disease or condition.
No
The device is described as an "autotransfusion device" and an "intraoperative autotransfusion system" that processes blood to obtain washed red blood cells for reinfusion, or separates blood into packed red cells, plasma, and platelet-rich plasma. Its purpose is to prepare blood components for reinfusion or separation, not to perform diagnosis.
No
The device description clearly outlines a physical system involving a continuous flow centrifuge, disposable sets, and accessories for processing blood. While software is mentioned for controlling wash factors, the core functionality relies on hardware components.
Based on the provided text, the CATSmart System by Fresenius Kabi is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health, diagnose conditions, or monitor treatment.
- CATSmart Function: The CATSmart System processes blood collected from a patient during or after surgery and then reinfuses it back into the same patient. Its primary function is to prepare blood components for reinfusion, not to analyze the blood for diagnostic purposes.
- Intended Use: The intended use clearly states "processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion" and "perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP)." These are therapeutic and processing functions, not diagnostic ones.
- Device Description: The description emphasizes the processing of blood for reinfusion and separation of components, not analysis for diagnostic information.
While the device handles blood, its purpose is to prepare it for reintroduction into the patient, which falls outside the scope of an IVD.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
CAC
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.
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.
The system includes disposable sets and accessories previously cleared by FDA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the two additional wash factors was tested by in vitro studies in comparison to the Smart Wash and Emergency Wash factors available in the predicate device. Results passed the acceptance criteria.
Software changes to add the other wash factors were verified with testing. Full system verification testing confirmed the changes did not impact other functional areas of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 27, 2019
Fresenius Kabi AG % Shane Sawall Manager, Regulatory Affairs Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047
Re: K192368
Trade/Device Name: CATSmart Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: August 29, 2019 Received: August 30, 2019
Dear Shane Sawall:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192368
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 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 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Fresenius Kabi USA
Three Corporate Drive
Lake Zurich, Illinois 60047
T 847-550-2300
T 888-391-6300 www.fresenius-kabi.us
510(k) SUMMARY
Date Prepared
August 29, 2019
Owner/Operator and Contact Person
| Owner/Operator | Owner/Operator #: 9027285
Fresenius Kabi AG
Bad Homburg, GERMANY 61346 |
|-------------------------|-------------------------------------------------------------------------------------|
| Contact Name: | Shane Sawall |
| Title: | Manager, Regulatory Affairs |
| Address: | Fresenius Kabi USA
Three Corporate Drive, 2nd Floor
Lake Zurich, IL 60047 USA |
| Telephone: | 847-550-0702 |
| Fax: | 847-550-2960 |
| E-mail: | shane.sawall@fresenius-kabi.com |
| Official Correspondent: | Cheryl Roscher |
| Title: | Vice President, Regulatory Affairs |
| Address: | Fresenius Kabi USA
Three Corporate Drive, 2nd Floor
Lake Zurich, IL 60047 USA |
| Telephone: | 847-550-7909 |
| Fax: | 847-550-2960 |
| E-mail: | cheryl.roscher@fresenius-kabi.com |
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Modified 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 and reinfuse |
| the blood lost by a patient due to surgery or trauma. | |
| Review Panel: | |
| Device Class: | Class II |
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed
| Trade Name: | CATSmart |
|---|---|
| Common or Usual Name: | Automated Blood Processing Autotransfusion System |
| Product Code: | CAC |
| 510(k) Number: | K180831 |
| Date Cleared: | December 10, 2018 |
| Device Class: | Class II |
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.
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.
The system includes disposable sets and accessories previously cleared by FDA.
5
Indications for Use
The CATSmart System by Fresenus 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).
Technological Characteristics as Compared to the Predicate Device
The technological characteristics of the modified CATSmart device stay the same as the predicate CATSmart device. The only functional difference of the modified CATSmart device is that two additional wash factors have been included.
Performance Data
The performance of the two additional wash factors was tested by in vitro studies in comparison to the Smart Wash and Emergency Wash factors available in the predicate device. Results passed the acceptance criteria.
Software changes to add the other wash factors were verified with testing. Full system verification testing confirmed the changes did not impact other functional areas of the device.
Conclusion
The in vitro studies and the software verification demonstrate that the modified CATSmart device is substantially equivalent to the predicate device.