(29 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 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. 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 nonerythrocytic 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.
The system includes disposable sets and accessories previously cleared by FDA in respective 510(k)'s.
This document is a 510(k) summary for the Fresenius Kabi CATSmart device, an autotransfusion system. It is a notification of intent to market a device that the manufacturer believes is substantially equivalent to legally marketed predicate devices.
The document does not contain detailed acceptance criteria for a study showing device performance. Instead, it describes general claims of substantial equivalence based on the device's design, materials, specifications, technological characteristics, and function being unchanged from previously cleared devices, and that manufacturing and sterilization methods at a new site remain the same.
Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not available in the provided text.
The document specifically states: "No clinical data was required to support the changes described in this submission." This indicates that a study demonstrating performance against specific criteria was not conducted for this particular submission. The substantial equivalence is based on the device being inherently the same as a previously cleared one.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 11, 2021
Fresenius Kabi AG % Cheryl Roscher Vice President, Regulatory and Clinical Affairs Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047
Re: K210089
Trade/Device Name: CATSmart Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II Product Code: CAC Dated: January 12, 2021 Received: January 13, 2021
Dear Cheryl Roscher:
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
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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
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)
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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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/0 description: The image shows the logo for Fresenius Kabi. The logo consists of three blue, wavy lines on the left side. To the right of the lines, the words "FRESENIUS" and "KABI" are written in blue, with "KABI" on the second line. The logo is simple and modern, and the blue color gives it a sense of trustworthiness.
Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us
510(k) SUMMARY
Date Prepared
11th February 2021
Owner/Operator
Owner/Operator Owner/Operator #: 9027285 Fresenius Kabi AG Bad Homburg, GERMANY 61346
Contact Person (include full address, phone and fax numbers)
| Contact Name: | Deepak Mehta |
|---|---|
| Title: | Sr. Regulatory Specialist |
| Address: | Fresenius KabiThree Corporate Drive, 2nd FloorLake Zurich, IL 60047 USA |
| Telephone: | 847-550-2666 |
| Fax: | 847-550-2960 |
| E-mail: | deepak.mehta@fresenius-kabi.com |
| Official Correspondent: | Cheryl Roscher |
| Title: | Vice President, Regulatory and Clinical Affairs |
| Address: | Fresenius KabiThree Corporate Drive, 2nd FloorLake Zurich, IL 60047 USA |
| Telephone: | 847-550-7909 |
| Fax: | 847-550-2960 |
| E-mail: | cheryl.roscher@fresenius-kabi.com |
Device Trade Name
CATSmart
Common Name/Usual Name:
Automated Blood Processing Autotransfusion System
Classification Name
Class II per 21 CFR 868.5830 Apparatus, Autotransfusion
Product Code
CAC, Anesthesiology
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Image /page/4/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of two parts: a graphic element on the left and the company name on the right. The graphic element is composed of three blue, curved lines arranged vertically, resembling stylized waves or streams. To the right of the graphic, the words "FRESENIUS" and "KABI" are stacked on top of each other, both in a bold, sans-serif typeface and in blue.
Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us
| 510(k) Number | K192368 |
|---|---|
| Device Name | CATSmart |
| Common Name | Automated Blood Processing Autotransfusion System |
| Classification | Class II per 21CFR868.5830 |
| Classification Name | Apparatus, Autotransfusion |
| Product Code | CAC |
| Review Panel | Cardiovascular |
| Manufacturer | Fresenius Kabi AG |
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed
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 nonerythrocytic 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.
The system includes disposable sets and accessories previously cleared by FDA in respective 510(k)'s.
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 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 Comparison as Compared to the Predicate Device
There is no change to CATsmart device design, materials, specifications, technological characteristics and function of the CATSmart disposable sets and accessories.
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Image /page/5/Picture/0 description: The image contains the logo for Fresenius Kabi. The logo consists of three blue, wavy 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.
Fresenius Kabi Three Corporate Drive Lake Zurich, Illinois 60047 T 847-550-2300 T 888-391-6300 www.fresenius-kabi.us
Modification to the Existing Device
There is no design change to the FDA-cleared disposable sets and accessories. Manufacturing process and sterilization methods in the new site remain the same as previously cleared.
Performance Data
As part of the comprehensive sterility assurance program for the validation of this product, bioburden testing, verification of bacterial endotoxin and a performance qualification including biological indicators (BIs), temperature mapping, relative humidity, ethylene oxide concentration and residual testing was performed.
The sterilization validation results demonstrate that the sterilization activities performed do not impact the safety, effectiveness, quality, or fundamental technology of the CATSmart disposable sets and accessories.
Clinical Data
No clinical data was required to support the changes described in this submission.
Conclusion
The fundamental scientific technology, intended use, safety and effectiveness of the CATSmart Continuous Autotransfusion System including disposable sets and accessories remain the same. The validation activities performed in support of the change described in this application provide evidence that the proposed device is substantially equivalent to the predicate device.
§ 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).