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510(k) Data Aggregation
(27 days)
The ReFlow® System Mini and the ReFlow® Mini Flusher, used as components of a shunt system, are for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Mini Flusher may be used by a qualified clinician as a tool to facilitate a nominvasive retrograde fluid flush of the shunt ventricular catheter to unblock inlet holes to restore, increase, or maintain CSF flow. When used with the ReFlow Ventricular Catheter, the flush can also open the ReFlow Ventricular Catheter's relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini components are not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction, and instruction of the treating physician, the ReFlow Mini Flusher may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.
The ReFlow® System Mini (RSM) consists of the ReFlow® Mini Flusher and ReFlow® Ventricular Catheter, both implantable components of a cerebrospinal fluid (CSF) shunt system used in the treatment of patients with hydrocephalus and other CSF disorders when draining of CSF is medically indicated. The ReFlow Mini Flusher is also sold separately. A ventricular catheter is surgically implanted in the ventricle of the brain and connected distally to the ReFlow Mini Flusher. The ventricular catheter may be the ReFlow Ventricular Catheter or a commercially available ventricular catheter (only the ReFlow Ventricular Catheter is provided as part of the ReFlow System Mini). The ReFlow Mini Flusher is then connected to a commercially available flow/pressure regulating valve (not provided as part of the ReFlow System Mini).
The flusher contains a fluid reservoir and, when implanted as part of a shunt system, may be used at the treating physician's discretion as a tool to non-invasively facilitate a one-way retrograde pulse of fluid through the ventricular catheter to potentially restore, increase, or maintain CSF flow in the shunt system by potentially unblocking the proximal catheter. The flusher is noninvasively actuated by depressing the flusher dome, which is palpable underneath the patient's scalp, to send a controlled and limited pulse of a consistent volume of fluid (patient's CSF or sterile saline introduced from the priming procedure before implant) within the closed system. The fluid flush generated by the flusher is intended to potentially unblock shunt ventricular catheter inlet holes. In cases when the ReFlow Mini Flusher is used with the ReFlow Ventricular Catheter, the flush will open the ReFlow Ventricular Catheter emergency relief membrane to provide a secondary fluid pathway to restore or increase CSF flow in the shunt system if inlet holes are not able to be unblocked by the flush actuation. Once this relief membrane is open, subsequent flushes with the flusher may not be sufficient to unblock the secondary fluid pathway, which may become occluded in a manner similar to that of the proximal catheter inlet holes.
After flushing the ReFlow Mini Flusher, palpation to confirm the dome has returned to its original shape may be used to determine that the reservoir has refilled prior to flushing a second time. Refilling of the flusher reservoir can be confirmed by palpation of the dome, indicating that CSF from the ventricles is able to flow through the ventricular catheter to the ReFlow Mini Flusher. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the ReFlow System Mini.
The ReFlow System Mini and the ReFlow Mini Flusher do not regulate the flow/pressure of the shunt system. A flow regulating shunt valve is not provided with the ReFlow System Mini or ReFlow Mini Flusher. During passive flow, fluid from the ventricular catheter flows freely through the ReFlow Mini Flusher to the flow requlating valve. The ReFlow System Mini and the ReFlow Mini Flusher are designed to be compatible with most commercially available flow/pressure regulative valves with standard inlet connectors. Additionally, the Reflow Mini Flusher component utilizes a common barbed connector designed to be compatible with most commercially available ventricular catheters in addition to the ReFlow Ventricular Catheter.
The ReFlow System Mini components are provided in two packaging configurations as follows: ReFlow® System Mini
- Package Contents: ReFlow Ventricular Catheter and ReFlow Mini Flusher System .
- Ventricular Catheter (Qty: 1) o
- Flusher (Qty: 1) o
- o Stylet (Qty: 1)
ReFlow® Mini Flusher
- Package Contents: ReFlow Mini Flusher only .
- o Flusher (Qty: 1)
ReFlow® Ventricular Catheter Description
The ReFlow® Ventricular Catheter is made from silicone elastomer and barium sulfate, with an inner diameter of 1.27 mm and an outer diameter of 2.54 mm. The Ventricular Catheter is 150 mm in length and is supplied with 20 inlet holes (4 rows of 5 holes at the proximal end). There is a thin silicone relief membrane at the proximal end of the catheter distal to the inlet holes. The relief membrane is designed to open via manual depression of the Mini Flusher dome to provide a noninvasive and consistent method to restore or increase flow in a suspected non-flowing or slow-flowing shunt system. The relief membrane has only been tested as a one-time use feature. This Ventricular Catheter is MR safe and not made with natural rubber latex.
A stainless-steel stylet is provided with the ReFlow Ventricular Catheter for insertion of the catheter into the ventricle. This stylet is MR Unsafe and not made with natural rubber latex.
ReFlow® Mini Flusher Description
The ReFlow® Mini Flusher contains a fluid reservoir encased in a flexible silicone housing. The device utilizes a common barbed connector that allows direct connection to the ventricular catheter. The device has a flush dome (reservoir). The ReFlow System Mini offers a noninvasive means to facilitate a retrograde flush of the ventricular catheter to either unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. Retrograde flushing of the ventricular catheter is performed by depression of the flusher dome. When actuated as per the treating physician's guidance and instruction, the flusher sends a controlled and limited retrograde pulse of fluid (CSF or sterile saline from the priming procedure before implant) towards the ventricular catheter to either maintain or resume flow by opening the suspected blocked inlet holes or open the relief membrane of the ReFlow Ventricular Catheter to restore flow in the shunt system.
The ReFlow Mini Flusher does not regulate the flow of the shunt system or inhibit the function of the flow regulating valve. During passive flow, fluid from the ventricular catheter flows freely through the Mini Flusher. A flow regulating shunt valve is not provided with the ReFlow System Mini. The ReFlow Mini Flusher is compatible with shunt valves with standard barbed connections.
The Mini Flusher is MR safe and is not made with natural rubber latex.
The provided text describes a 510(k) premarket notification for the "ReFlow® System Mini and ReFlow® Mini Flusher" and declares it substantially equivalent to a predicate device (K221918). However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study proving the device meets these criteria in the context of an AI/human-in-the-loop performance study.
The document focuses on the mechanical and functional aspects of a medical device (a CSF shunt system component) rather than an AI-powered diagnostic or assistive tool. Therefore, terms like "multi-reader multi-case (MRMC) comparative effectiveness study," "human readers improve with AI vs without AI assistance," "standalone (algorithm only) performance," "ground truth establishment for training set," and "number of experts for ground truth" are not applicable or detailed in this submission.
The document does mention "human factors evaluations in a simulated clinical use model," but provides no details on how many participants, their qualifications, or how performance was measured in a quantitative manner that would relate to comparative effectiveness of human performance with and without an AI.
Despite the limitations of the provided text for an AI-focused study, I can extract the following information based on the typical content of a 510(k) submission for a physical medical device:
Acceptance Criteria and Device Performance (Based on the provided text, heavily interpreted for a physical device, NOT an AI study)
The document primarily refers to bench testing and compliance with recognized standards for medical device performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical/Functional Performance | Pressure 1m Water Column Leak Test | "All results met acceptance criteria and demonstrate the RSM is suitable for its intended use..." |
| Occlusion Studies | "All results met acceptance criteria and demonstrate the RSM is suitable for its intended use..." | |
| Pressure Flow Characterization | "All results met acceptance criteria and demonstrate the RSM is suitable for its intended use..." | |
| Material Compatibility | (Implied by compliance with standards like ISO 7197) | "The ReFlow System Mini performs as intended and is substantially equivalent to its predicate." (Implies material and design compatibility) |
| Sterility | Terminally sterilized for 10-6 SAL per ANSI/AAMI/ISO 11137-2 | "Terminally sterilized for 10-6 SAL with no damage to system components." |
| Packaging Integrity | Packaging maintains sterility and protects device | "Packaging maintains sterility and protects device." |
| Biocompatibility | (Not explicitly detailed, but usually a requirement for implanted devices and would fall under design requirements met via ISO standards) | (Not explicitly stated, but assumed to be proven by meeting design requirements and substantial equivalence.) |
| Human Factors | Simulated clinical use model | "conducted ... human factors evaluations in a simulated clinical use model per the available guidance." (No specific quantitative performance metrics provided in the document.) |
| Interoperability/Compatibility | Compatibility with current shunt systems and accessories | "Compatible with current shunt systems and accessories." |
| Overall Performance | Adherence to design specifications and performance requirements for intended use | "These test results confirm that RSM complies with the recognized standards, meets the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate." |
Based on the provided text, the following points cannot be fully answered as they are typically relevant to AI/Software as a Medical Device (SaMD) performance studies, not the mechanical device described:
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for the bench tests. For human factors, no sample size is mentioned.
- Data Provenance: The "data" comes from bench testing of the physical device components. There's no mention of patient data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of mechanical bench testing. "Ground truth" for this device would be established by physical measurements and engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is relevant for subjective expert review, not objective bench testing.
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 done. This is a physical device, not an AI assisting human readers. The human factors evaluation mentioned is typically about usability and safety, not diagnostic performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical component of a shunt system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on engineering specifications and compliance with recognized industry standards (e.g., ISO 7197:2006, ASTM F647:94), measured through bench testing.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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(90 days)
The ReFlow System Mini, used as components of a shunt system, is for use in the treatment of patients with hydrocephalus or conditions where draining of cerebrospinal fluid (CSF) is medically indicated. The miniaturized ReFlow Flusher may be used by a qualified clinician as a tool to facilitate a noninvasive retrograde fluid flush of the ReFlow Ventricular Catheter to unblock inlet holes or open its relief membrane to restore, increase, or maintain CSF flow. The ReFlow System Mini is not intended to change the diagnosis, treatment, or follow-up of patients with proximal catheter occlusions. Under the care, direction of the treating physician, the ReFlow System Mini may be used as directed for noninvasive flushing by a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment.
The ReFlow System Mini (RSM), consists of the ReFlow Mini Flusher and ReFlow Ventricular Catheter, both implantable components of a cerebrospinal fluid (CSF) shunt system used in the treatment of patients with hydrocephalus and other CSF disorders when draining of CSF is medically indicated. The catheter is surgically implanted in the ventricle of the brain and connected distally to the Mini Flusher. The Mini Flusher is then connected to a commercially available flow/pressure regulating valve (not provided as part of the ReFlow System Mini).
The flusher contains a fluid reservoir and when implanted as part of a shunt system, may be used at the treating physician's discretion as a tool to non-invasively facilitate a one-way retrograde pulse of fluid through the ventricular catheter to potentially restore or maintain flow in the shunt system by unblocking the proximal catheter. The flusher is noninvasively actuated by depressing the flusher dome, which is palpable underneath the patient's scalp, to send a controlled and limited pulse of a consistent volume of fluid (patient's CSF or sterile saline introduced from the priming procedure before implant) within the closed system. In cases where inlet holes are not able to be unblocked by a flush actuation, the flush will open the ReFlow Ventricular Catheter emergency relief membrane to provide a secondary fluid pathway to restore or increase CSF flow in the shunt system.
After flushing the device, palpation to confirm the dome has returned to its original shape may be used to determine that the reservoir has refilled prior to flushing a second time. Refilling of the flusher reservoir can be confirmed by palpation of the dome, indicating that CSF from the ventricles is able to flow through the ventricular catheter to the ReFlow Mini Flusher. The clinician must use his/her medical judgment and standard practice at his/her institution to care for the patient pre, during, and post utilization of the ReFlow System Mini.
The ReFlow System Mini does not regulate the flow/pressure of the shunt system. A flow regulating shunt valve is not provided with the ReFlow System Mini. During passive flow, fluid from the ventricular catheter flows freely through the Mini Flusher to the regulating valve. The ReFlow System Mini is designed to be compatible with most commercially available flow/pressure requlative valves with standard inlet connectors. Additionally, the Reflow Mini Flusher component utilizes a common barbed connector designed to be compatible with most commercially available ventricular catheters in addition to the ReFlow Ventricular Catheter.
This document describes the ReFlow System Mini, a device used in the treatment of hydrocephalus. The device consists of a miniaturized flusher and a ventricular catheter, designed to facilitate non-invasive retrograde fluid flushing to restore or maintain CSF flow. The submission (K221918) seeks to demonstrate substantial equivalence to a predicate device (ReFlow Ventricular Catheter and Flusher System, K172006).
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes performance data rather than providing a detailed table of acceptance criteria and specific numerical performance metrics. However, based on the provided text, the acceptance criteria are generally "met specifications for intended use" and "substantially equivalent to the predicate device."
| Test Category | Test Method Summary | Reported Device Performance and Conclusion |
|---|---|---|
| Particulate Testing | Units undergo particulate testing to evaluate that the number of particulates generated from both exterior and interior lumen of the ReFlow Mini Flusher, under simulated use conditions, does not pose any safety risks. | All results met acceptance criteria and demonstrate that the RSM performance is suitable for its intended use and is substantially equivalent to the predicate device. |
| Design Verification Bench Testing | Conducted testing and reported results in accordance with ISO 7197:2006 (E), Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components and ASTM F647: 94(2014), Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. | All results met acceptance criteria and demonstrate the RSM is suitable for its intended use and is substantially equivalent to the predicate device. |
| Reliability and System Level Functional Test | Testing was conducted to verify the reliability of the ReFlow System Mini to function during its expected useful life and meet requirements of ISO 7197:2006 (E), Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components and ASTM F647: 94(2014), Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. | All results met acceptance criteria and demonstrate the RSM is suitable for its intended use and is substantially equivalent to the predicate device. |
| Usability and Human Factors Testing | Human Factors and Usability evaluations for critical tasks according to ReFlow Mini labeling were conducted in accordance with ANSI/AAMI HE 75, Human Factors Engineering Design of Medical Devices, IEC 62366:2007, Medical Devices - Application of Usability Engineering to Medical Devices, and FDA Guidance (Jun 22, 2011) Human Factors Draft Guidance. | RSM is deemed to meet its specifications for its intended use and is substantially equivalent to the predicate device. In all cases, the acceptance criteria were met, and the device performed as expected according to its specifications and in compliance with applicable recognized standards. In all instances, the RSM functioned as intended and were as expected. These test results confirm that RSM complies with the recognized standards, the design specifications and performance requirements for the intended use, and is substantially equivalent to the predicate. |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document mentions that usability and human factors testing demonstrated that flushing can be performed by "a trained healthcare provider (other than the treating physician), a caregiver, or adult patient" without special skills or education. However, it does not specify the sample size for this human factors test set, nor the country of origin of the data, or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document states that human factors and usability performance testing demonstrated that the device could be used by "a trained healthcare professional in-clinic or by a trained caregiver or adult patient in a non-clinical environment" under the direction of the treating physician. However, it does not specify the number of experts used to establish a 'ground truth' for the test set or their qualifications, as the testing seems focused on user performance rather than expert assessment of outcomes in a clinical trial.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set. The performance data focuses on technical and functional compliance rather than diagnostic or clinical effectiveness that would typically require such adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focuses on the safety and performance of the device itself, and its equivalence to a predicate device, rather than comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device described is a physical medical device (shunt system components) and not an algorithm or AI-powered system. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here. The device's function involves human interaction for actuation (flushing).
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on engineering and performance standards (ISO 7197:2006, ASTM F647: 94(2014), ANSI/AAMI HE 75, IEC 62366:2007, and FDA Guidance for Human Factors) and whether the device operates as designed to restore or maintain CSF flow, without posing safety risks. The "ground truth" here is the successful demonstration that the device's functional and safety characteristics meet these established engineering and usability requirements.
8. The Sample Size for the Training Set:
This information is not provided in the document, as the device is a physical medical device, not a machine learning model that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not a machine learning model, and therefore, there is no "training set" or ground truth for such a set in the context of this submission.
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