(78 days)
Use of the Subdural Evacuating Port System Cranial Access Kit is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The Subdural Evacuating Port System Cranial Access Kit is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.
The Subdural Evacuating Port System Cranial Access Kit is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The Subdural Evacuating Port System Cranial Access Kit consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the Subdural Evacuating Port System Cranial Access Kit's "SEPS Components" are designed to promote gradual brain reexpansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir. The completeness of the Subdural Evacuating Port System Cranial Access Kit saves time and eliminates the need to gather supplies; this convenience can be critical in an emergency situation.
The Subdural Evacuating Port System Cranial Access Kit is available in three (3) kit configurations:
- SEPS-CA, Catalog # 11-0401-CA (Standard Kit)
- SEPS-CAL, Catalog # 11-0401-CAL (Standard Kit with Lidocaine w/epinephrine)
- SEPS-CAND, Catalog # 11-0401-CAND (Standard Kit without Lidocaine, ChloraPrep® One-Step, or PVP (Povidone-Iodine) ointment -- no drugs).
The provided text describes a 510(k) submission for the Subdural Evacuating Port System Cranial Access Kit (SEPS Cranial Access Kit). This is a medical device, not an AI/ML algorithm or software that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested categories in the prompt are not applicable to this type of traditional medical device submission. The 510(k) process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a study with clearly defined statistical endpoints for sensitivity/specificity.
Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present or relevant to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | The device is substantially equivalent to predefined predicate devices (Subdural Evacuating Port System Kit, Ventriculostomy Kits, Cranial Access Kit) in terms of intended use, materials, biocompatibility, design, performance, function, and operating characteristics, and does not raise new safety or effectiveness issues. This was based on successful performance testing and clinical data presented and accepted for the predicate device (K002970). |
| No New Safety/Effectiveness Issues: | The device was found to introduce no new issues relating to the safety or effectiveness of its intended use compared to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for the current device. The submission refers to "successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)." This implies that the data relied upon was from studies previously conducted for the predicate device.
- Data Provenance (country of origin, retrospective/prospective): Not provided in this summary. The data provenance would relate to the predicate device's studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable/Not provided. The 510(k) submission for this device type does not involve establishing ground truth through expert reads of images for performance evaluation in the way an AI diagnostic device would. Performance is demonstrated through substantial equivalence to existing devices.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not provided. Adjudication is typically used in studies involving human readers or AI output where discrepancies need resolution, which is not the primary assessment method described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is specifically designed for evaluating the impact of AI assistance on human reader performance, which is not relevant for this physical medical device.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done: No. This device is a physical surgical kit, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable/Not provided in the context of typical AI performance evaluation. For this device, the "ground truth" for demonstrating safety and effectiveness is primarily established through the regulatory approval of the predicate device(s) and their associated clinical performance data. The current submission relies on the established safety and performance of the predicate.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical medical kit and does not involve AI model training.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of Performance Testing (as per document):
The manufacturer (Medical Designs, LLC) states that the Subdural Evacuating Port System Cranial Access Kit is "substantially equivalent to the Subdural Evacuating Port System Kit (Predicate Device #1) based on the successful performance testing and clinical data presented and accepted for the predicate device (510(k) # K002970)."
This means that the current device's safety and effectiveness were demonstrated by showing that it is essentially the same as a device already approved by the FDA, which had its own performance testing and clinical data submitted previously. No new specific clinical trials or performance studies unique to the "SEPS Cranial Access Kit" itself (as described in the 510(k) summary) were conducted beyond demonstrating its equivalence to the predicate. Biocompatibility was also confirmed by noting that components are FDA approved or substantially equivalent to approved components.
§ 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).