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1. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.
2. The dual lumen ultrafiltration catheter [A1537] is indicated for use in attaining short-term (less than 30 days) percutaneous vascular access of the central circulatory system for ultrafiltration with the System 100.
3. The catheter extension [A1513] mav also be used to connect commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.
4. The System 100 S-100 console [A1100] may be used when either peripheral or central venous access is employed.
5. The UF 500 circuit [A1500 and A1550] may be used when either peripheral or central venous access is employed.

The System 100 Ultrafiltration Catheters are part of the fluid pathway and intended for blood withdrawal and infusion when repeat venous access over a period of ≤ 30 days is medically desired. Common medical practice is to exchange the catheter every seven days to minimize infection. The CVC catheter is percutaneously introduced into the subclavian vein or the internal jugular vein with the distal tip ending in the mid to lower superior vena cava. The proximal end with the proprietary connectors resides outside the body connecting to the withdrawal and infusion blood lines of the UF500 blood circuits which engages the System 100 pump console for ultrafiltration in patients with fluid overloaded. The catheter extension (A1513) may also be used to connect other commercially available CVC of the appropriate flow rate to the System 100 UF500 blood filter circuits.

The provided text describes the System 100 Ultrafiltration Catheter and System 100 device. However, it is a 510(k) summary for a medical device and not a study report on device performance or an AI/software device. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria for an AI or software product.

Based on the provided document, I can only extract limited information about "acceptance criteria" and "device performance" as it pertains to substantial equivalence for a physical medical device (catheter and ultrafiltration system). The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with detailed study data.

Here's an attempt to answer your request based only on the provided text, highlighting where information is missing due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document mentions "Bench tests," but does not provide details on the number of samples or tests performed.
• Data Provenance: Not specified. It's likely laboratory bench testing.

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

• Number of Experts: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require expert-established ground truth for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This document describes bench testing for a physical device, not an AI or software device that would require an adjudication method for a test set.

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

• MRMC Study: No. This document describes a 510(k) submission for a physical medical device (catheter and ultrafiltration system), not an AI or software device. Therefore, an MRMC comparative effectiveness study is not relevant or mentioned.

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

• Standalone Performance: Not applicable. This document is for a physical medical device. There is no "algorithm only" performance component to evaluate.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "bench tests," the ground truth would be established by the physical measurements and specifications of the device and its compatibility with the System 100. This is based on engineering and manufacturing standards, not expert consensus, pathology, or outcomes data in the context of an AI study.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI or software device, so there is no training set.

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

• Ground Truth for Training Set: Not applicable. This is not an AI or software device, so there is no training set or associated ground truth.

Summary of Device Safety and Performance from the Document:

The safety and performance of the System 100 Ultrafiltration Catheter are primarily established through substantial equivalence to its predicate device (System 100, K013733, K023224, K024124) and other commercially available catheters. The document states:

• The UF catheter and primary predicate device are similar in materials of construction and identical for packaging and sterilization.
• The UF catheter is provided sterile and nonpyrogenic.
• Bench tests demonstrate the UF catheter is compatible with the System 100.
• The use of CVCs (Central Venous Catheters) is expected to be performed in hospital environments where CVC use is common, implying standard medical practice and known risks.

The conclusion is that "Based on the similar intended use, patient population, technology characteristics including well understood CVC medical risks, and performance as access with bench testing the catheter has been shown to be safe and effective for its intended use." This indicates that simple bench testing for compatibility and adherence to material/sterilization similarities to predicate devices were sufficient for demonstrating substantial equivalence for this type of physical medical device.

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For use with the System 100. The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

The UF500 blood circuit with needleless access port allows for aspiration, injection, or gravity flow of fluids using a male luer fitting.

The modified/alternate UF500 circuit incorporates an in-line needleless valve on the circuit withdrawal, infusion or both tubing lines. The in-line needless valve is independently commercially available medical device cleared for commercial distribution since May 15, 1996 (K955585) known as the ULTRASITE® valve. This is a luer activated valve manufactured and distributed by B. Braun Medical. CHF Solutions, Inc. is placing this valve at the end of a short piece of tubing (extension arm) that is permanently joined to the A1500 circuit of the System 100 (K013733) with a tee connector. A sliding clamp is also included on the extension arm and is blue on the withdrawal side and white on the infusion side. The in-line needleless access port allows the health care provided access to the circuit/vasculature without disconnecting the catheter connections or catheter extension (when used) for aspiration, injection, or gravity flow of fluids.

The provided text describes a 510(k) summary for a medical device called "System 100 Modified/Alternate UF500 With In-line Needleless Access Port." However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in a quantitative sense as typically seen in AI/software medical device submissions.

This submission is for a modification of an existing device (UF500 circuit) by adding a commercially available, already cleared, in-line needleless access port. The "study" here is primarily a demonstration of substantial equivalence through bench testing, rather than a clinical trial or performance study with defined statistically-derived acceptance criteria.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of submission described.

Here's an analysis of what information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document implies that the acceptance criteria are met if the modified device remains compatible with the System 100, is sterile, nonpyrogenic, and satisfies the intended use without introducing new safety concerns compared to the predicate devices. The phrase "Bench tests demonstrate the modified/alternative UF500 is remains compatible with the System 100" serves as the primary "acceptance."

Reported Device Performance:

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

• Sample Size: Not specified. The study involved "bench tests," which are typically laboratory tests of the device itself rather than tests on human subjects or clinical data. The quantity of devices tested is not mentioned.
• Data Provenance: The "bench tests" are presumably conducted by the manufacturer, CHF Solutions, Inc., in the United States. They are retrospective in the sense that they were conducted on the modified device before submission.

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

• Not applicable. This is a hardware modification submission, not an AI/software device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. This type of submission does not involve adjudication of clinical data or expert opinions. The evaluation is based on engineering and performance specifications.

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

• No. This is not an AI or software device, and no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Not applicable. This is a physical medical device (circuit with a port), not an algorithm.

7. The Type of Ground Truth Used

• Not applicable in the typical sense for AI/software devices. The "ground truth" here is adherence to engineering specifications for compatibility, sterility, non-pyrogenicity, and mechanical integrity, as demonstrated through bench testing and comparison to predicate device characteristics.

8. The Sample Size for the Training Set

• Not applicable. No training set is mentioned or relevant for this type of device modification.

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

• Not applicable. No training set is mentioned or relevant for this type of device modification.

Summary of the Study (as described in the document):

The study was a series of bench tests conducted by CHF Solutions, Inc. to demonstrate the safety and effectiveness of the modified UF500 circuit. The core of the study aimed to show that integrating an existing, cleared needleless access port into the UF500 circuit did not negatively impact the performance, safety, and compatibility with the System 100. Key aspects verified were:

• Materials, Packaging, and Sterilization: These were confirmed to be identical to the predicate System 100 circuit, leveraging the existing clearance for these aspects.
• Sterility and Nonpyrogenicity: The final modified product was confirmed to be sterile and nonpyrogenic.
• Compatibility: Bench tests specifically demonstrated that the modified/alternative UF500 circuit remains compatible with the System 100, which is crucial as the needleless port is an add-on.

The overall conclusion was that, based on these bench tests and the technological characteristics, the modified device is "safe and effective for its intended use" and "substantially equivalent" to the predicate devices.

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System 100 is indicated for temorary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

System 100 consists of the:
• S-100 console
• UF 500 set
• Venous access catheters
• Catheter extension set
• Needless flushing port
• Catheter insertion kit

The provided text describes the "System 100" device, a high-permeability hemodialysis system, and its FDA 510(k) clearance. However, it does not contain specific acceptance criteria, detailed study designs, or quantitative results that would allow for a complete description of the device's performance against predefined metrics.

The text primarily focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "CHF Solutions, Inc. performed non-clinical testing on System 100 to demonstrate that the device met its functional and performance specification." and "Clinical data confirm that the device is safe and effective for its intended use." However, it does not explicitly define these "functional and performance specifications" as acceptance criteria, nor does it provide quantitative results or metrics against which performance was measured.

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

Explanation: The document mentions "Clinical data confirm that the device is safe and effective." However, it does not provide any details about the sample size of the clinical study, whether it was prospective or retrospective, or the country of origin of the data.

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

Explanation: This type of information is typically relevant for interpretative diagnostic devices where human experts establish ground truth for testing AI algorithms. The System 100 is a medical device for ultrafiltration, not an AI-powered diagnostic tool, so this concept does not directly apply.

4. Adjudication Method for the Test Set

Explanation: As with the previous point, adjudication methods are typically used for establishing ground truth from multiple expert interpretations, which is not relevant for this type of medical device's performance testing.

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

Explanation: An MRMC comparative effectiveness study is specific to evaluating the impact of AI assistance on human reader performance, usually in image-based diagnostics. The System 100 is a physical medical device, not an AI system, so this type of study would not be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Explanation: "Standalone" performance refers to an algorithm's performance without human intervention, again, relevant for AI diagnostic systems. This device is not an AI algorithm.

7. The Type of Ground Truth Used

Explanation: While "Clinical data confirm that the device is safe and effective," the specific type of ground truth (e.g., patient outcomes, physiological measurements, laboratory results) used in these clinical studies to evaluate safety and effectiveness is not detailed. For a device like this, ground truth would likely involve measurements of fluid removal, patient vital signs, and adverse event reporting.

8. The Sample Size for the Training Set

Explanation: The concept of a "training set" is typically associated with machine learning or AI models. The System 100 is a physical medical device, not an AI algorithm, so it does not have a training set in this context.

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

Explanation: As stated above, there is no training set for this type of device.

In summary: The provided 510(k) summary focuses on the regulatory aspects of substantial equivalence. It confirms that non-clinical and clinical data were generated to demonstrate safety and effectiveness but does not provide the granular details requested regarding specific acceptance criteria, study methodologies, or quantitative performance metrics. Such details would typically be found in more comprehensive study reports or validation documentation, which are not part of this 510(k) summary.

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