(28 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 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.
The provided text describes updates to an autotransfusion device, the Fresenius Kabi CATSmart, specifically focusing on the addition of two new wash factors. The document, a 510(k) summary, aims to demonstrate substantial equivalence to a previously cleared version of the same device (predicate device K180831).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance of two additional wash factors | Results passed the acceptance criteria (tested in vitro in comparison to existing wash factors). |
| Software changes did not impact other functions | Full system verification testing confirmed the changes did not impact other functional areas of the device. |
2. Sample size used for the test set and the data provenance
The text states that the performance of the two additional wash factors was tested by "in vitro studies." No specific sample size (e.g., number of blood samples, runs) is provided for these in vitro studies. The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document makes no mention of experts being used to establish ground truth for the test set. The evaluation relies on in vitro studies and system verification, which typically involve laboratory measurements against established standards for blood processing performance.
4. Adjudication method for the test set
No adjudication method is mentioned, as the evaluation is based on in vitro measurements and system verification, not on human interpretation or diagnosis requiring expert adjudication.
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
The device described is an autotransfusion apparatus, not an AI-assisted diagnostic imaging device that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an automated system. The "in vitro studies" and "software verification" described are inherently standalone assessments of the device's functionality without human intervention in the processing itself, only in setting up and monitoring the tests.
7. The type of ground truth used
The ground truth for the performance of the wash factors would be based on laboratory measurements of parameters such as the purity of washed red blood cells, removal of plasma and cellular components, and retention of red blood cells. These measurements would be compared against established scientific and regulatory standards for autotransfusion devices. For the software changes, the ground truth would be defined by the expected functional behavior of the device as per its design specifications.
8. The sample size for the training set
The document does not describe a "training set" in the context of an AI or machine learning algorithm. The device is an automated blood processing system, not a learning algorithm. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As there is no training set mentioned for this device, this question is not applicable. The device's functionality is based on its engineering design and validated through performance testing against pre-defined specifications.
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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
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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 #: 9027285Fresenius Kabi AGBad Homburg, GERMANY 61346 |
|---|---|
| Contact Name: | Shane Sawall |
| Title: | Manager, Regulatory Affairs |
| Address: | Fresenius Kabi USAThree Corporate Drive, 2nd FloorLake 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 USAThree Corporate Drive, 2nd FloorLake 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 reinfusethe 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.
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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.
§ 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).