(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.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).