Search Results

Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

1. Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
2. Monitor CSF chemistry, cytology, and physiology;
3. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
   Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
4. Severe head injury
5. Subarachnoid hemorrhage graded III, IV. or V preoperatively
6. Reyes syndrome or similar encephalopathies
7. Hydrocephalus
8. Intracranial hemorrhage
9. 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 Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:

1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
   The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
   The main system section located on the mounting panel includes:
3. Mounting bracket for height adjustment of system
4. Optional self-adjusting cord with lock for adjustment of system height
5. Main system stopcock with optional transducer attachment location
6. Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
7. Two drainage line slide clamps for flow monitoring and sampling
8. Drainage bag connection line
9. Needleless Injection Site (Interlink or Smartsite)
10. Instructions for Use
    The system does not contain any latex components.

Here's an analysis of the acceptance criteria and supporting study for the Becker External Drainage and Monitoring System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

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 sample size for each specific bench test. However, the testing was conducted as part of the design verification process for a modified component (the disposable drainage bag) within the Becker EDMS. The data provenance is from bench testing, which is a controlled laboratory environment, not derived from human patients or specific geographical regions.

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

This information is not applicable as the studies were bench tests evaluating physical properties and functional performance against engineering specifications, not clinical outcomes requiring expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were bench tests against predetermined engineering specifications, not studies involving subjective interpretation of data that would require an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device, not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

This information is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests was based on engineering specifications and design requirements for the physical properties and functional performance of the modified drainage bag.

8. The Sample Size for the Training Set

This information is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."

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

This information is not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device is the "Becker External Drainage and Monitoring System" (Becker EDMS), with specific modifications to its disposable drainage bag component. The study proving the device meets acceptance criteria was a series of "Performance Data - Bench" tests.

The modifications to the disposable bag primarily involved changes in its design (approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port, and a hydrophobic/anti-microbial vent).

The performance testing was conducted in accordance with a risk assessment of these changes, which determined that dimensional verification and design verification testing of the bag were necessary. The specific tests performed included:

• Visual and Dimensional Inspection: To ensure the printed graduations met volumetric capacity.
• Leakage of Drainage Bag: To confirm the bag could withstand inversion without leaking.
• Flow Initiation Pressure: To record the pressure at which fluid flow begins.
• Drainage Bag Seal Weld: To ensure the bag's seals were intact and leak-free.
• Tensile Strength of Drainage Bag Inlet Port: To evaluate the durability of the connection point.

The results of all these bench tests showed that the Becker EDMS device met the specified acceptance criteria for each test. Based on these successful results, the manufacturer concluded that the changes introduced by the modified disposable bag do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence to the predicate device (Medtronic PS Medical Becker External Drainage and Monitoring System, K984053).

No animal or clinical testing was deemed necessary for these specific modifications, as the determination of substantial equivalence was based solely on the design verification bench testing.

Ask a specific question about this device

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

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:

1. 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.
2. Assertion of equivalent performance characteristics based on the similarities in design and materials.
3. Reference to the accepted safety and effectiveness of the predicate device as demonstrated in its own product labeling and commercial distribution history.
4. The historical context that ICP monitoring devices have been in "widespread use" since 1973, suggesting established clinical benefit and technological understanding.
5. 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.

Ask a specific question about this device