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I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing.

The provided text describes the regulatory clearance of a medical device, the "Volumat Polyethylene I.V. Administration Set," by the FDA. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Baxter Administration Set K203609) rather than establishing novel performance metrics or conducting a clinical study with acceptance criteria.

Therefore, the specific information requested cannot be fully extracted from the provided text. However, I can provide the available information relevant to performance and testing:

Response based on available information:

The document outlines performance testing conducted to support the substantial equivalence determination by showing the device performs as intended and that differences from the predicate device do not raise new questions of safety or effectiveness. It does not explicitly state "acceptance criteria" in a quantitative table with "reported device performance" against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists various standards and tests that were applied, and it states that these tests "demonstrate equivalence" or confirmed that differences "do not impact safety or effectiveness."

For example, regarding the listed technological characteristic differences:

• Operating Mechanism (presence of pumping cassette): "Difference has been verified through performance testing including flow rate accuracy under various environmental conditions (temperature, pressure, humidity) which demonstrate equivalence." (No specific flow rate accuracy acceptance criteria or results are given).
• Length: "Difference tested according to ISO 8536-4 and flow rate accuracy to demonstrate the subject device performance." (No specific length or flow rate acceptance criteria or results are given).
• Priming Volume: "Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness." (No specific priming volume acceptance criteria or results are given).
• Internal/External Tube Diameter: "Difference tested to ISO 8536-8 has demonstrated equivalence." (No specific diameter acceptance criteria or results are given).
• Components (e.g., pump segment): "The differences have been verified in various aspects to demonstrate the subject device's safety and performance including: Biocompatibility testing according to ISO 10993 collateral standards, Microbial Ingress Testing, and Particulate Testing; Performance Testing according to ISO 8536-4, ISO 80369-20, ISO 8536-8 and ISO 8436-14." (No specific acceptance criteria or results for these tests are provided).

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

The document does not detail the sample sizes used for the "performance bench testing" or the specific data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This information is typically relevant for studies involving human interpretation or subjective assessments, such as imaging AI algorithms. The described testing is primarily bench testing of a hardware device.

4. Adjudication Method for the Test Set

Not applicable for the type of bench testing described.

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

No MRMC study was done, as this is a physical medical device (I.V. administration set) and not an interpretive diagnostic tool or AI algorithm requiring human reader comparison. The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

6. Standalone Performance Study (Algorithm Only)

Not applicable, as this is a physical medical device, not an algorithm. The testing described is for the physical device's performance.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards (e.g., ISO 8536-4, ISO 80369-20, ISO 8536-8, ISO 8436-14, ISO 11607-1 & 2, USP). The device's performance was compared against the pass/fail criteria within these standards to "demonstrate equivalence" and that it "performs as intended."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms.

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

Not applicable, as this is a physical medical device.

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IV Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

Transfusion Set for the infusion of blood derivatives from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

The Volumat 100 Line is available for dedicated use with the Volumat MC Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Volumat MC Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613, and the Agilia VP MC Pump was cleared under K210073. The Volumat TM Line components include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, upstream filter, needle free port, rotating male luer lock, luer lock connector, Yconnector, tubing, and burette.

The provided text is a 510(k) summary for the Fresenius Kabi Volumat™ Line, an Intravascular Administration Set. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility testing, rather than a clinical study involving human readers or AI algorithms.

Therefore, many of the requested details, such as MRMC studies, human reader improvement with AI, ground truth establishment for training and test sets, number of experts, and adjudication methods, are not applicable to this device submission as it is a physical medical device (IV administration set) and not an AI/ML-driven diagnostic or therapeutic device.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate the device meets these criteria.

Device: Volumat™ Line (Intravascular Administration Set)
Submission Type: 510(k) Premarket Notification (K220301)
Predicate Device: Baxter Administration Set (K203609)

The acceptance criteria for this type of device are primarily based on established performance standards for IV administration sets, ensuring safety and effectiveness through physical, chemical, and biological compatibility. The "study" proving the device meets these criteria is a series of bench tests and biocompatibility evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of "acceptance criteria" with specific pass/fail values for each test. Instead, it lists the types of tests and applicable ISO standards used to demonstrate that the Volumat™ Line performs as intended and is as safe and effective as the predicate device. The implicit acceptance criterion for each test is successful compliance with the respective standard.

General Acceptance Principles (Implied from the document):

• Functional Equivalence: The device must perform its intended function (infusion of fluids/medications/blood products) safely and accurately.
• Physical Integrity: The device components must withstand operational stresses without leakage, cracking, or separation.
• Biocompatibility: The materials used must be safe for patient contact.
• Sterility: The device must be sterile and maintain sterility until use.
• Compatibility: The device must be compatible with its intended use environment (e.g., infusion pumps, gravity flow).

Reported Device Performance:
The document states that all performance testing and design control activities were "conducted and has confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness." It explicitly states that the device was found to be "at least as safe and effective as the legally marketed predicate device" and "substantially equivalent."

While specific numerical performance results are not provided in this public summary, the successful completion of the listed tests implies that the device met the established acceptance criteria for each standard.

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

The document does not specify the exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant industry standards (e.g., ISO, ASTM) and statistical methods to ensure representativeness and confidence in results.

• Data Provenance: This is bench testing of a physical medical device. The tests were performed to support a 510(k) submission to the FDA. The country of origin for the testing is not specified, but the applicant (Fresenius Kabi) has locations in Germany (address listed) and the USA. The testing would be prospective in the sense that it was conducted specifically to support this regulatory submission for the new device.

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

Not Applicable. This is a physical medical device. The "ground truth" for evaluating its performance is established by validated test methods and international standards (ISO, ASTM, USP), not by human expert opinion (e.g., radiologists interpreting images). The "experts" involved would be engineers, material scientists, and quality assurance professionals performing and reviewing the test results against the specified standards.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" in the sense of multiple human evaluators reviewing outputs. The objective performance is measured against predefined pass/fail criteria from the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for image interpretation) to evaluate the impact of the device on human reader performance. This is a physical IV administration set.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet its functional specifications independently, which was assessed through the various bench tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is derived from established international standards and validated test methods.

• Functional Performance Standards: ISO 8536-8, ISO 80369-20, ISO 8536-4, ISO 8536-14, USP.
• Biocompatibility Standards: ISO 10993 series.
• Sterilization Standards: ISO 11135.
• Packaging Standards: ISO 11607-1, ASTM D4169.

These standards define the expected performance thresholds (e.g., maximum leakage, acceptable tensile strength, no cytotoxicity) against which the device's measured performance is compared.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's design and manufacturing processes are developed based on engineering principles and regulatory requirements.

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

Not Applicable. As there is no "training set" for an AI/ML model, there is no corresponding ground truth establishment process for a training set. The "ground truth" for the device's design and manufacturing are the established engineering principles, material science knowledge, and regulatory standards for medical device safety and efficacy.

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The freetlex@+ Transfer Adapter is indicated for reconstituting a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex®+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.

The freeflex®+ Transfer Adapter is a single use, fluid transfer device that allows for the reconstitution and transfer of powdered or liquid drugs from drug vials into the freeflex + IV Bag (NDA BN070012) through the IV bag medication port. The device consists of a body, male Luer lock and a safety ring. The device is provided as a sterile, non-pyrogenicproduct. The device is intended to be used with standard drug vials with a seal diameter of 20mm. with an elastomeric membrane. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the freeflex®+ Transfer Adapter for the device to meet its intended purpose.

The Fresenius Kabi AG freeflex®+ Transfer Adapter (K212445) is a single-use fluid transfer device intended for reconstituting drugs in a vial with a 20mm closure and transferring them into a freeflex®+ IV Bag prior to administration.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each individual test or the data provenance (e.g., country of origin, retrospective/prospective). It generally mentions "functional performance bench testing was conducted." Without specific numbers, it's impossible to provide these details accurately.

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

Not applicable. This device is a physical medical device, not an AI/ML algorithm requiring expert human interpretation for ground truth establishment. The performance testing is based on objective, quantifiable measurements according to established international and internal standards.

4. Adjudication Method for the Test Set

Not applicable, for the same reason as point 3.

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

Not applicable. This is not an AI/ML device that involves human reader interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on the objective criteria defined by the cited international standards (e.g., ISO 22413, USP , ISO 80369-20, ISO 11607-1) and internal test methods. These standards define measurable thresholds for attributes like leakage, fragmentation, particulate matter, etc. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is a physical device and presumably does not involve a "training set" in the context of an AI/ML algorithm.

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

Not applicable, for the same reason as point 8.

Study Proving Acceptance Criteria are Met:

The study proving the device meets the acceptance criteria is a series of bench testing and biocompatibility testing as detailed in Section 9 of the 510(k) Summary.

• Bench Performance Testing: The device was subjected to various functional tests based on international standards (ISO 22413, USP , ISO 80369-20, ISO 11607-1) and internal test methods. These tests evaluated properties such as freedom from fragmentation, particulate matter, Luer connector leakage, stress cracking resistance, sterile barrier integrity, visual inspection, penetration force, force to remove the safety ring, separation under tensile force, and residual volume.
• Biocompatibility Testing: Following FDA guidance (ISO 10993-1), a comprehensive suite of biocompatibility tests was performed, including hemolysis, cytotoxicity, irritation, skin sensitization, acute systemic toxicity, chemical characterization, material mediated pyrogenicity, and particulate testing.
• Sterilization Validation: Ethylene oxide sterilization was validated to meet DIN EN ISO 11135:2014, achieving an SAL of 10-6.

All these tests were successfully conducted, and their aggregated results are deemed to demonstrate that the freeflex®+ Transfer Adapter performs as intended and supports a substantial equivalence determination to the predicate device (Vial2Bag Advanced™ 20mm Admixture Device, K201415). The conclusion explicitly states: "The freeflex®+ Transfer Adapter, has met all established acceptance criteria for performance testing and design verification testing. Results of functional performance and biocompatibility testing conducted with the freeflex + Transfer Adapter, demonstratethat the subject device supports a substantial equivalence determination to the predicate device."

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The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets.

The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.

It is intended for use by trained healthcare professionals in healthcare facilities.

The Agilia VP Infusion System includes the Agilia VP MC WiFi Volumetric Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with Volumat Line administration sets and optional accessories. The optional accessories are identified as follows:

• Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or 8 pumps at the patient bedside.
• Agilia Duo two-channel accessory designed to power two Agilia infusion pumps.
• Agilia USB Cable - intended to connect the Agilia VP infusion pump to a PC for serial communication.

The provided document is a 510(k) summary for the Fresenius Kabi Agilia VP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device (Agilia Infusion System (K121613)), rather than proving the device meets specific acceptance criteria based on a clinical study evaluating its diagnostic or therapeutic performance (like an AI/CADe device).

Therefore, the requested details specific to a study that proves the device meets acceptance criteria (especially for AI/CADe devices, such as sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context.

This submission relies on non-clinical testing and comparison to a predicate device to establish safety and effectiveness.

Here's an analysis of the document regarding acceptance criteria and the methods used to prove substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with reported numerical performance values in the way one would for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating similarity to a predicate device and showing conformance to industry standards and internal design verification/validation testing.

The "acceptance criteria" are implied by:

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
• Conformance to Standards: Meeting the requirements of relevant electrical safety, EMC, and usability standards (e.g., IEC 60601-1, IEC 62366-1).
• Verification and Validation Testing: This implicitly means the device performs according to its design specifications.
• Reliability Goals: The device met its internal reliability goals.

Implied Acceptance Criteria and Reported Performance (from comparison table and non-clinical testing section):

The following points are N/A for this type of 510(k) submission which is for an infusion pump, not an AI/CADe device.

2. Sample size used for the test set and the data provenance: N/A (No clinical test set for diagnostic performance)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth establishment for diagnostic performance)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A

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: N/A

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth in this context would refer to engineering specifications and performance measurements against those specifications, rather than clinical ground truth for diagnostic accuracy)

8. The sample size for the training set: N/A (Not an AI/ML device in the context of diagnostic algorithms; "training set" would relate to internal engineering development and testing, not a formal clinical data training set for an AI model)

9. How the ground truth for the training set was established: N/A

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The Agilia SP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medication, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous, and intraosseous using dedicated administration sets.

The Agilia SP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood, and blood derivatives through clinically accepted parenteral routes of administration and critical drugs under specific conditions. These routes of administration include intravenous, intraarterial, and subcutaneous using dedicated administration sets.

It is intended for use by trained healthcare professionals in healthcare facilities

The Agilia SP Infusion System includes the Agilia SP MC WiFi Syringe Infusion Pump which is a programmable electronic medical system dedicated to administering a predetermined volume of an infusion product at a programmed rate, in combination with compatible third-party syringes and extension sets along with optional accessories. The optional accessories are identified as follows:

• Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or 8 pumps at the patient bedside.
• Agilia Duo - two-channel accessory designed to power two Agilia infusion pumps.
• Agilia USB Cable - intended to connect the Agilia SP infusion pump to a PC for serial communication.

The provided document describes the FDA 510(k) clearance for the Agilia SP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than a clinical study evaluating the device's performance against specific acceptance criteria for diagnostic or clinical outcomes.

Therefore, many of the requested detailed points regarding acceptance criteria and performance against a test set (especially those related to AI/MRMC studies, ground truth establishment, and expert adjudication) are not applicable directly to this type of device clearance and the information provided in this document.

However, I can extract information related to the acceptance criteria for the non-clinical performance of the infusion pump and the methods used to prove that performance.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating equivalence in technical specifications and safety/performance characteristics. The most direct mention of a performance criterion is for flow rate accuracy.

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Vigilant Master Med is part of a Dose Error Reduction System (DERS) for use with Adults, Pediatrics, and Neonates. It is intended to create, customize, and manage drug library data and device configurations to be uploaded to compatible Fresenius Kabi infusion devices which may reduce the risk of drug administration errors. It enhances safety by preventing infusion errors with the use of Dose Error Reduction System (DERS) in combination with the infusion devices.

Vigilant Master Med is a drug library software that is used by pharmacists to create and identify limits according to policy and procedure of the institution. The infusion devices will notify and clearly indicate to a clinician if the dose for the medication is beyond the limits entered by the pharmacist and provided by Vigilant Master Med in the drug library.

Vigilant Master Med is one component of Vigilant Software Suite (VSS) a multifunction device product. VSS Vigilant Master Med the subject of this submission, is also referred to as Drug Library Software. VSS Vigilant Master Med is drug library software that creates, customizes and manages drug lists, therapies, drug libraries, device configurations, profiles and data sets which are uploaded into compatible infusion pumps.

The provided text describes the 510(k) premarket notification for the "Vigilant Software Suite - Vigilant Master Med" and its comparison to a predicate device, "Vigilant Drug' Lib Agilia." However, the document primarily focuses on demonstrating substantial equivalence based on non-clinical testing and technological comparison. It explicitly states that "Clinical evaluation is not required for this submission to support substantial equivalence." and "no further clinical investigation or testing is needed."

Therefore, I cannot provide details on the acceptance criteria or a study that proves the device meets specific performance criteria in a clinical context, as such data is not included in the provided text. The submission relies on verification and validation of product requirements, human factors engineering testing, interoperability testing, performance testing at maximum capacity, and cybersecurity testing to demonstrate safety and effectiveness, and thus substantial equivalence.

Based on the information provided in the document, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document implicitly defines "acceptance criteria" through the comparison to the predicate device and the findings of non-clinical tests. The "reported device performance" is essentially the determination of "Similar," "Same," or "Different" with supporting statements that these differences do not affect safety or effectiveness, or that verification/testing found no new issues.

2. Sample sizes used for the test set and the data provenance:

• Sample Size: The document does not specify exact "sample sizes" in terms of number of cases or data points for the non-clinical tests (verification, human factors, interoperability, performance, cybersecurity testing). It refers to the sufficiency of these tests to conclude safety and effectiveness.
• Data Provenance: Not specified in terms of country of origin. The data is generated from non-clinical (laboratory/engineering) testing rather than patient data. The studies are prospective in the sense that they are specifically conducted for the regulatory submission to verify and validate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not explicitly stated. The "ground truth" for this device (software for managing infusion pump drug libraries) would primarily be established by:
  • Engineers/Developers: Defining correct software functionality and performance.
  • Quality Assurance personnel: Verifying adherence to requirements.
  • Human Factors Specialists: Assessing usability and safety in simulated clinical tasks.
  • Pharmacists and Clinicians (as users): Participating in human factors evaluations to ensure the software's design supports their workflow and safety goals. The document states "Human Factors studies have been conducted on the subject device demonstrating passing results," implying clinical domain experts were involved in a user capacity.
• Qualifications of Experts: Not explicitly stated for specific roles. However, given the context of medical device regulation, these would be qualified professionals in their respective fields (e.g., software engineers, human factors engineers, clinical experts - likely pharmacists and nurses for an infusion pump system).

4. Adjudication method for the test set:

• Since no multi-reader or multi-expert assessment of clinical "cases" is described (as it's a software substantial equivalence submission based on non-clinical tests), there is no mention of an adjudication method like 2+1 or 3+1. The "adjudication" is implicitly the outcome of the comprehensive verification and validation processes and the safety assurance case.

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:

• No MRMC study was done. This is not an AI-assisted diagnostic device where human reader improvement would be measured. The device is a software for drug library management for infusion pumps, not a medical image analysis or similar AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The software's core function is to create and manage drug libraries, which is "algorithm only" in its processing of data and rules. However, its purpose is to be used with human-in-the-loop (pharmacists inputting data, clinicians interacting with the infusion pump).
• Standalone algorithmic verification: Yes, this is implied by "Verification testing of product requirements," "Performance testing at maximum capacity," and "Cybersecurity penetration testing." These tests assess the software's inherent functionality and robustness independent of user interaction, but within the context of its overall intended use.

7. The type of ground truth used:

• The primary "ground truth" used for this submission is:
  • Pre-defined product requirements and specifications: The software must perform according to these.
  • Safety standards and regulatory guidance: Adherence to these is the "truth" for demonstrating safety and effectiveness.
  • Usability goals derived from human factors analysis: The software's design must support safe and effective use by intended users.
  • Functionality of the predicate device: The new device's functions are compared to the legally marketed predicate.
• It is not based on expert consensus for clinical diagnosis, pathology, or outcomes data, as this is not a diagnostic device.

8. The sample size for the training set:

• Not applicable/Not provided. This is a traditional software engineering development and a 510(k) submission based on substantial equivalence, not a machine learning/AI model that requires a "training set" for its development. The "learning" here is human engineering and design, not algorithmic learning from data.

9. How the ground truth for the training set was established:

• Not applicable. As stated above, there is no "training set" in the machine learning sense.

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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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Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following:

The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702)

The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702)

The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615)

The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615)

The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615)

The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)

The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.

Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:

• Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)(BK960005, BK990009)
• Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol)(single, double or triple units) (BK090065)
• Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039)
• Mononuclear Cells (BK000047)
• Plasma (BK960005, BK120041)
• Fresh Frozen Plasma
• Must be prepared and placed in a freezer at -18° C or colder within eight hours after phlebotomy.
• Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
• Must be stored at 1-6°C within eight hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
• Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24)
• Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
• Source Plasma

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post-platelet count greater than or equal to 100,000 platelets/microliter.

Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double or triple units).

The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to seven days. Additionally, for platelet units stored past five days and through seven days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure."

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a singleuse, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences.

The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alerts.

Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The provided document is a 510(k) Premarket Notification from the FDA for the Fresenius Kabi AMICUS Separator System. This document is a regulatory approval letter and a summary of the device and its modifications, not a study report. As such, it does not contain the detailed performance study data, acceptance criteria, ground truth establishment methods, or sample sizes typically found in a clinical study report or a pre-market approval application for a novel device or a significant new indication.

The document states that the primary changes to the AMICUS device are:

• Replacement of obsolete controller circuit boards and associated redesign of other internal boards.
• Modification to the rear door design to accommodate new USB ports, Ethernet port, serial port, and Wi-Fi antenna.
• An update to the 6.0 software, including a change in the operating system from pSOS to QNX, to run on the proposed device with the new hardware.
• Qualification of a new off-the-shelf USB barcode scanner.

It explicitly states: "The software changes do not involve changes to the core blood component collection or therapeutic procedure functionality." and "The AMICUS disposable apheresis kits remain the same as the currently cleared kits, including design, materials and manufacturing methods."

The conclusion section states: "Software and systems verification testing of impacted requirements were performed with the replacement hardware components and updated 6.0 software. Regression testing was performed including paired testing with the predicate device on key product quality and performance characteristics. Results from the software and systems verification testing indicate that the subject device is as safe and performs as well as the predicate device."

Therefore, based on the provided text, I cannot extract the specific information requested in the prompt regarding acceptance criteria tables, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies, because these types of studies were not conducted or reported in this 510(k) summary for a device modification, where the manufacturer is claiming substantial equivalence to a previously cleared predicate device due to hardware and software updates that do not alter core functionality. The "performance data" section primarily refers to verification testing (software and systems verification, regression testing compared to predicate, and electrical safety/EMC testing) rather than clinical performance studies with human subjects or expert readers that would typically involve the criteria you've listed.

In summary, the document describes a device modification rather than a new device or significant new indication. The approval relies on demonstrating substantial equivalence to existing, cleared devices, primarily through engineering verification and validation testing, and not necessarily new extensive human-based performance studies as would be the case for an AI/ML algorithm with diagnostic capabilities.

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Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following:

The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702)

The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702)

The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615)

The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615)

The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615)

The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)

The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.

Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:

• · Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) (BK960005) (BK990009)
• · Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units) (BK090065)
• · Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039)
• Mononuclear Cells (BK000047)
• · Plasma (BK960005, BK120041)
  • o Fresh Frozen Plasma

· Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy.

• o Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
  • Must be stored at 1-6℃ within 8 hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy.

· Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.

o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24)

• · Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy.

• · Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
  o Source Plasma

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. (BK080018)

Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double, or triple units). (BK090065)

The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure." (BK040059, BK150242)

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences.

The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms.

Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The document provided describes a 510(k) premarket notification for the AMICUS Separator System, focusing on a software update (version 6.0). A 510(k) submission generally claims substantial equivalence to a predicate device, rather than providing extensive de novo clinical studies to establish new acceptance criteria and prove performance against those criteria in a traditional sense.

Therefore, the information requested, which typically relates to clinical studies establishing performance against defined acceptance criteria for a novel device, is not directly available in this type of FDA submission.

However, I can extract the information provided about the verification and validation activities for the software update and explain why some of the requested information is not applicable to a 510(k) for a software modification.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document states that "Software and systems verifications were performed in support of this submission. The results of the testing were acceptable." However, it does not explicitly list specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy for a diagnostic device, or specific performance metrics for a therapeutic device's outcome) and then report quantified performance against those criteria. This type of detailed breakdown is not typically required or provided in a 510(k) for a software enhancement to an already cleared device. The "acceptance criteria" here would be that the software performs its intended functions correctly and safely, as per the design specifications and referenced standards.

The performance is implicitly reported as "acceptable" based on the verification and validation, implying that the software modification did not negatively impact the previously established performance of the AMICUS Separator System, and likely improved the listed enhancements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify a "test set" in the context of clinical data for performance assessment. The "testing" mentioned refers to software and system verification, which would typically involve testing new functionalities, ensuring existing functionalities are preserved, and assessing system stability. The number of test cases run, or the number of simulated or actual apheresis procedures performed during verification, is not disclosed. Data provenance in this context would refer to the details of the testing environment rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. For a software update to an existing apheresis system, "ground truth" as established by medical experts (e.g., radiologists, pathologists) is not relevant in the same way it would be for a diagnostic AI device. Software verification focuses on functional correctness, safety, and adherence to design specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for software verification. Adjudication methods are typically used in clinical studies where multiple experts assess cases and their opinions need to be reconciled to establish a ground truth.

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:

Not applicable. This device is an automated blood cell separator, not a diagnostic AI device that assists human readers. No MRMC study would be performed for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device (AMICUS Separator System) is inherently a "human-in-the-loop" system, as an operator connects and monitors the donor/patient and operates the separator. The software is part of this system. Therefore, the concept of "standalone" algorithm performance as typically applied to AI for diagnosis is not directly relevant here. The software verification assesses the behavior and functionality of the software within the context of the overall system and its intended use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for software verification typically involves the design specifications and expected behavior of the software functions. For example, if a new feature is added to calculate a specific parameter, the "ground truth" is that the calculation is correct according to the mathematical formula and clinical parameters.

8. The sample size for the training set:

Not applicable. This is a software update for a control system, not a machine learning model that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary of what is known from the document regarding meeting acceptance criteria:

The document emphasizes that "Software and systems verifications were performed in support of this submission. The results of the testing were acceptable."

The study (or rather, the verification and validation activities) that proves the device meets (implicitly defined) acceptance criteria is described as compliant with recognized standards and guidance documents:

• IEC 62304 Ed. 1.0, "Medical device software Software life cycle processes": This standard outlines requirements for the software development life cycle of medical device software, ensuring safety and quality.
• ISO 14971:2012 Medical Devices – Applications of Risk Management to Medical Devices: This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
• FDA/CDRH "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." Issued January 11, 2002: This guidance outlines the FDA's current thinking on general principles of software validation for medical devices.
• ES 60601-1:2005/(R)2012 and A1:2012, C1: 2009/(R)2012 and A2:2010/(R)2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance: This standard addresses the basic safety and essential performance requirements for medical electrical equipment.

The conclusion states: "Based on the verification activities performed, the AMICUS Separator System modified with software 6.0 provides a device system that is substantially equivalent to the currently marketed AMICUS Separator System." This indicates that the software enhancements were verified to perform as intended and not introduce new safety or performance concerns, thus maintaining substantial equivalence to the predicate device.

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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

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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