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510(k) Data Aggregation
(224 days)
The STRATA™ Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool. The tamper resistant design helps ensure that the valve's performance level is not inadvertently changed.
The STRATA™ Valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. This combination enables the valve to maintain intraventricular pressure (IVP) within a normal physiological range, regardless of a patient's CSF flow requirements or body position. Similar to the Hakim Programmable Valve and the Sophysa Pressure Adjustable Valve, the STRATA™ Valve incorporates the following features: (1) valve mechanism (spring biased ball in cone/seat), (2) 316L Stainless Steel spring coils for pressure flow regulation, (3) internal magnet, (4) valve element (ruby), (5) outer jacket (silicone elastomer). Additionally, the STRATA™ Valve incorporates a tamper-resistant internal dis-adjustment mechanism to prevent extreme changes in pressure (i.e., from the highest to the lowest settings) and a strong return spring to stabilize the rotor. The STRATA Valve is available with the BioGlide surface modification, identical to that reviewed under K951258. The product is also provided as part of a shunt configuration equivalent to that reviewed under K900676 and K951258. The shunt consists of the valve and a proximal and distal catheter, equivalent to those reviewed under K792007 and K792005.
The provided text describes a medical device, the Medtronic PS Medical STRATA Valves, and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a "SAFETY AND EFFECTIVENESS SUMMARY" for a 510(k) premarket notification. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a study with acceptance criteria for the new device's performance.
Therefore, I cannot provide the requested information from the given text. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance study results.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
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(90 days)
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(74 days)
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(65 days)
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(502 days)
The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.
The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).
A Ventricular Catheter manufactured of Polyurethane tubing. A Flow Control Valve manufactured of a Polypropylene base and a silicone elastomer housing which incorporates a Tecoflex elastomer resin, polyurethane coating. A Cardiac/Peritoneal Catheter manufactured of Polyurethane tubina.
This document is a 510(k) summary for a medical device (Medtronic PS Medical Polyurethane Shunt) and a clearance letter from the FDA. It does not contain any information about acceptance criteria, study details, or performance metrics that would typically be found in a clinical study report or a detailed device performance study.
Therefore, I cannot provide the requested information. The provided text primarily focuses on:
- Device Description: What the device is made of and its components.
- Intended Use: The purpose of the device (shunting CSF).
- Technological Comparison: Statement of substantial equivalence to predicate devices based on materials, intended uses, performance characteristics, and design specifications. This implies that the device is similar to existing devices known to be safe and effective, rather than presenting new performance data.
- FDA Clearance: The letter confirming FDA's determination of substantial equivalence, allowing the device to be marketed.
In summary, the provided text does not contain the information necessary to describe acceptance criteria or the study that proves the device meets those criteria.
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(84 days)
The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.
The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.
The provided document is a 510(k) premarket notification for a medical device called the "Medtronic PS Medical Endoscope Introducer." This type of document focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.
Therefore, many of the requested details about performance, sample sizes, ground truth establishment, and comparative effectiveness studies are not available in this document. The document's purpose is to show that the new device is as safe and effective as existing ones, based on similar design and intended use.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of acceptance criteria or specific performance metrics that the Medtronic PS Medical Endoscope Introducer was tested against in a formal study.
Instead, the document asserts technological comparison and substantial equivalence to predicate devices (Navigational F Sheath and Codman Peel Away Sheath) based on:
- Device configuration/contents: Peel Away Sheath, Obturator
- Sterility Method: EtO (Ethylene Oxide)
- Sterile: Sterile single-use device
- Intended Use: To make a channel through the brain into the ventricular system.
The "reported device performance" is implicitly that it performs like the predicate devices, enabling the creation of a channel through the brain for ventricular access. No quantitative performance data is provided.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. As a 510(k) submission based on substantial equivalence, it relies on the established safety and effectiveness of the predicate devices. There is no mention of a specific test set or data derived from testing the Medtronic PS Medical Endoscope Introducer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. Ground truth establishment for a test set is typically part of a dedicated performance study, which is not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done (or at least, not reported in this document). The 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on a human-in-the-loop study with AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This device is a physical medical instrument, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only)" performance is not applicable to this product.
7. The Type of Ground Truth Used
The "ground truth" here is not clinical outcome data or expert consensus on performance of the new device. Instead, the "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate devices (Navigational F Sheath (K931973) and Codman Peel Away Sheath (K883607)), which allow for the "creation of a channel through the brain into the ventricular system." The new device is deemed substantially equivalent in its design, materials, and intended use.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
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(90 days)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to reduce intracranial pressure (ICP), e.g. preintra- or postoperative; monitor CSF chemistry, cytology and physiology; provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts. The monitoring of the intracranial pressure (ICP) is indicated in selected patients with severe head injury; subarachnoid hemormage graded III, IV or V preoperatively; Reyes syndrome or similar encephalopathies; hydrocephalus; intracranial hemorrhage or miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.
The Medtronic PS Medical Becker EDMS is indicated for the draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space. The Becker EDMS is substantially equivalent in indications, materials of fabrication, performance characteristics and design specifications as compared with the predicate device, Codman External Drainage System II.
The materials utilized in the Becker EDMS are not substantially different to those used in currently marketed products. The Becker EDMS is comprised of a nondistensible blue striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, three non-latex iniection sites, and a removable drainage bag with approximate volumetric graduations and microbial filter. A graduated 50 cc flow chamber with drip former and conical bottom and locking bracket is included on the main system section.
Here's an analysis of the provided text regarding the Medtronic PS Medical Becker External Drainage and Monitoring System (EDMS), focusing on acceptance criteria and the study proving its compliance.
It's important to note that the provided text is a 510(k) premarket notification summary from the FDA. This type of submission primarily focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than presenting a full clinical trial establishing novel safety and effectiveness. Therefore, many of your requested criteria (like sample sizes for training/test sets, expert qualifications, MRMC studies, standalone performance details) are typically not explicitly detailed in a 510(k) submission focused on substantial equivalence. The "study" here is essentially the comparison to the predicate device and the assertion of equivalent performance and indications.
Analysis of Acceptance Criteria and Device Performance for Medtronic PS Medical Becker EDMS
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|---|
| Indications for Use | Equivalent to Codman External Drainage System II (K902257, K920938) | The Becker EDMS has expanded indications but is considered equivalent to the predicate's purpose of draining and monitoring CSF to reduce ICP. New indications include monitoring CSF chemistry/cytology/physiology, temporary drainage for infected shunts, specific conditions (severe head injury, subarachnoid hemorrhage, Reyes syndrome, hydrocephalus, intracranial hemorrhage), and evaluation for space-occupying lesions. The FDA deemed these acceptable within the scope of substantial equivalence based on the predicate. |
| Material Composition | Not substantially different from predicate device. | Materials utilized are "not substantially different to those used in currently marketed products" (including the predicate). |
| Performance Characteristics | Equivalent to Codman External Drainage System II | Asserted to be substantially equivalent. Functionality (draining, monitoring CSF flow from ventricles/lumbar subarachnoid space) is equivalent. |
| Design Specifications | Equivalent to Codman External Drainage System II | Asserted to be substantially equivalent. Closed system design, specific components (nondistensible patient line, stopcock, mounting panel, injection sites, drainage bag with microbial filter, flow chamber with drip former and locking bracket) are presented without specific quantifiable performance targets, but as equivalent in function and design to the predicate. |
| Safety | Equivalent to predicate device. | Asserted to be safe, indicated by its substantial equivalence claim, and compliance with general controls (annual registration, GMP, labeling, etc.). |
| Effectiveness | Equivalent to predicate device. | Asserted to be effective, indicated by its substantial equivalence claim. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable/Not specified. This is a 510(k) submission based on substantial equivalence, not a clinical study with a distinct "test set" of patients in the typical sense. Performance is inferred from comparison to a predicate device and existing knowledge about the technology.
- Data Provenance: The "data" primarily comes from "predicate device product labeling" and the general understanding of ICP monitoring devices that have been "in widespread use" since 1973. There is no mention of specific patient data (retrospective or prospective) used to test the Becker EDMS directly against human outcomes within this document. The "provenance" is largely regulatory and comparative.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/Not specified. Since there isn't a "test set" in the context of a new clinical performance study, there's no mention of experts establishing ground truth for such a set.
- Qualifications of Experts: The document mentions "input from neurosurgeons" in the development of the device design. These neurosurgeons would be qualified clinical users of such devices, but they were involved in design input, not typically in establishing "ground truth" for a discrete test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No formal adjudication method involving a test set of cases is described. The FDA's review process itself serves as a form of "adjudication" of the substantial equivalence claim.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This is not a type of study typically performed or required for a 510(k) submission for a device like this. It is a physical device for drainage and monitoring, not an AI or imaging diagnostic tool where reader performance is a primary outcome.
- Effect Size of AI vs. Without AI Assistance: Not applicable. The device does not involve AI.
6. Standalone Performance Study
- Standalone Performance Study: No explicit standalone clinical study is described. The core of the submission is demonstrating equivalence to a predicate device already on the market. While the device itself is "standalone" in its function, its performance is "proven" by comparison and assertion of similar physical and functional characteristics to a known, established device. Performance validation would typically involve bench testing for sterility, fluid dynamics, material compatibility, etc., but not a clinical standalone study against human outcomes as would be seen for a novel therapeutic or diagnostic.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device (Codman External Drainage System II), as well as the long-standing understanding of ICP monitoring and CSF drainage as described in literature since 1973. The Becker EDMS's performance is asserted to be equivalent to this established standard, rather than being independently validated against pathology or patient outcomes data in this specific filing.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not specified. This is not an AI/machine learning device. No "training set" in that sense is mentioned.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set mentioned, this question does not apply.
Summary of the "Study" Proving Acceptance:
The "study" proving the device meets acceptance criteria is primarily an argument for substantial equivalence based on:
- Direct comparison of the Medtronic PS Medical Becker EDMS device's design, materials, and intended use with the predicate Codman External Drainage System II. Tables 1 and 2 (though not provided in the excerpt) would detail these comparisons.
- Assertion of equivalent performance characteristics based on the similarities in design and materials.
- Reference to the accepted safety and effectiveness of the predicate device as demonstrated in its own product labeling and commercial distribution history.
- The historical context that ICP monitoring devices have been in "widespread use" since 1973, suggesting established clinical benefit and technological understanding.
- Input from neurosurgeons during the device's development phase.
The FDA's review and ultimate 510(k) clearance (K984053) signifies their agreement that Medtronic PS Medical successfully demonstrated this substantial equivalence, allowing the device to be marketed. This process does not typically involve the type of detailed clinical study data often associated with new technology or drugs.
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(90 days)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
- Monitor CSF chemistry, cytology and physiology;
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with - Severe head injury;
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
- Reves syndrome or similar encephalopathies;
- Hydrocephalus;
- Intracranial hemorrhage
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.
The reusable portion of the system is comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro.
The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.
The Medtronic PS Medical Niveau Drainage System is deemed substantially equivalent to predicate devices, but the provided text does not contain detailed acceptance criteria, device performance data from specific studies, or any information regarding AI components.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria or report detailed device performance metrics from a study (e.g., accuracy, precision, sensitivity, specificity, flow rates, ICP measurement accuracy, etc.). The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological comparison of features, and materials.
The table below outlines the comparison of features, which is presented as evidence of substantial equivalence rather than a direct performance against acceptance criteria.
| Feature Comparison | Medtronic PS Medical Niveau Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System II |
|---|---|---|---|
| Device Configuration/Contents | |||
| Locking bracket | Integral with mounting panel | Pole mount bracket assembly, braided cord and cord lock | Doubled 24 in. string w/Cord-loc® locking mechanism |
| Mounting panel | Main system section with pressure scale in mmHg and cmH2O | System Panel with instruction label | 27 cm measuring backboard |
| Drip Chamber | 50 cc Conical sliding graduated flow chamber with locking bracket and vent system | 100 ml graduated chamber with filter vent | 75 ml drip chamber with anti-reflux valve and atmospheric vent |
| Patient line | Nondistensible blue striped patient connection line | Nondistensible green striped patient connection line | 157 cm patient line with two slide clamps |
| Stopcocks | Two four-way stopcocks | Two four-way stopcocks | Two four-way stopcocks with female luer port |
| Injection/Sampling Sites | One non-latex injection/sampling site | Two injection sites | Two latex injection/sampling sites |
| Drainage Bag | 500 - 800 ml drainage bag (removable) with volumetric graduations, microbial filter, and drain port | 500ml drainage bag with valve and drain port | 700 ml capacity graduated vinyl collection bag |
| Drainage Bag connection line | Present | Not specified | Not specified |
| Leveling device | Laser leveling device | Line level | Not specified |
| Sterility Method | EtO | EtO | Not specified |
| Sterile | Sterile device with reusable mounting panel section and disposable fluid contact section | Sterile device with reusable mounting panel section and disposable fluid contact section | Sterile single use device |
2. Sample size used for the test set and the data provenance:
The provided document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective study) for evaluating the device's performance. The submission relies on a comparison to predicate devices rather than independent clinical testing data of the Niveau Drainage System against specific performance criteria.
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 as the document does not describe a study involving a test set that required expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document does not describe a study involving a test set that required 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:
This information is not applicable. The provided document is for a medical device (drainage system) and makes no mention of Artificial Intelligence (AI) or any MRMC studies involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a physical medical drainage system, not an algorithm, and the document makes no mention of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as the document does not describe a study that required the establishment of a ground truth for evaluating the device's performance. The basis for approval is substantial equivalence to existing predicate devices.
8. The sample size for the training set:
This information is not applicable, as there is no mention of an algorithm or a training set in the document.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no mention of an algorithm or a training set in the document.
In summary, the provided document is a 510(k) premarket notification for a medical device (intracranial pressure monitoring and CSF drainage system) that primarily demonstrates substantial equivalence to existing predicate devices. It does not contain information about clinical studies with specific performance metrics, acceptance criteria for those metrics, or any methodologies related to AI or ground truth establishment.
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