FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

1. Patients undergoing open descending thoracic aortic aneurysm (open TAA) or open descending thoraco-abdominal aortic aneurysm (open TAAA) repair surgery.
1. Patients post TAA/TAAA repair that become symptomatic with neurological deficit such as paraplegia.

Device Description

The Medtronic DUET™ External Drainage and Monitoring System (EDMS) that is the subject of this De Novo request is designed to drain and monitor cerebrospinal fluid (CSF) from the lumbar subarachnoid space.
The DUET™ EDMS consists of the following: a green-striped patient connection line (pressure tubing) with an inner diameter of 0.075 ± 0.005 inches, an outer diameter of 0.124 ± 0.003 inches, and a total length of 60 inches (9), a patient line stopcock (10), a main system stopcock (8) that may be attached at two locations on the main panel, a drip chamber (4) with a drip chamber stopcock (5), a rotatable pressure scale (3), three latex-free needleless injection/CSF sampling sites (Figure 1b (IS-5), (IS-10) and (IS-11)) and a removable drainage bag (7) with approximate volumetric graduations and a hydrophobic microbial barrier air vent. There is a pole mount clamp (6) and a cord (12) with a cord lock (13) to enable independent suspension of the system, or to provide additional security when using the pole clamp as identified in Figure 1 below. It should be noted that the numbers in parentheses correspond with the numbers in Figure 1.
The DUET™ EDMS are not long-term implants but are intended for limited external drainage of CSF. The drainage flow of CSF into the DUETTM EDMS is uni-directional and gravity-driven; there is no recirculation of the CSF. During use, an external lumbar catheter inserted into the lumbar subarachnoid space is connected to the DUET™ EDMS patient connection line. The CSF drains through the catheter, into the patient connection line and into the graduated drip chamber. CSF collects in the drip chamber, exits the bottom of the chamber via another connection line and is collected in a drainage bag. In the event that the patient may require administration of fluid directly into the lumbar subarachnoid space or CSF sampling is required, the DUET™ EDMS features injection/CSF sampling ports integrated into the patient connection line. The DUET™ EDMS is completely disposable. The DUET™ EDMS is recommended for use with the Clear-Site™ Laser Level (cleared under K984053) that is provided separately.

AI/ML Overview

The provided document describes the Medtronic Neurosurgery DUET™ External Drainage and Monitoring System (EDMS), a device intended for temporary draining and monitoring of cerebrospinal fluid (CSF) flow. The document does not describe an AI/ML powered device, and therefore does not contain information on acceptance criteria for AI performance metrics (like sensitivity, specificity, AUC), nor does it have a study comparing human readers with and without AI assistance (MRMC study).

Instead, the document focuses on the safety and performance of a medical device through biocompatibility, shelf-life, and performance bench testing, along with a review of existing clinical literature to support its intended use.

Here's a breakdown of the requested information based on the provided text, adapted to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document provides extensive tables for biocompatibility and shelf-life testing, and a list of performance testing - bench. Since there are many individual tests within these categories, I will present a summary table derived from them. Each of these tests had specific acceptance criteria and the document explicitly states that the device "passed" or "meets requirements" for all of them.

Category	Acceptance Criteria (Summary)	Reported Device Performance (Summary)
Biocompatibility	- Cytotoxicity: Meets ISO 10993-1 requirements (Non-Cytotoxic).

Sensitization: Meets ISO 10993-1 requirements (Non-Sensitizer).
Intracutaneous Reactivity: Meets ISO 10993-1 requirements (Non-Irritant).
Acute Systemic Toxicity: Meets ISO 10993-1 requirements (No Acute Systemic Toxicity, Biocompatible Materials). | All tests passed: Non-Cytotoxic, Non-Sensitizer, Non-Irritant, No Acute Systemic Toxicity, Biocompatible Materials. |
| Shelf-Life/Sterility| - Functional and Package Integrity Testing: Maintain secure connections (e.g., MSS assembly, clamp, drip chamber, junctions) under specified torque/load.
Vent Integrity: Withstand 150 mm Hg fluid pressure; allow fluid withdrawal without compromising mechanical integrity; allow drainage of blood/Ringer's solution; provide CSF flow with minimal resistance.
Leakage: Bonds to withstand 200 mmHg air with ; non-pyrogenic.
Packaging: Secure, undamaged, and meet specifications after simulated shipping. | All shelf-life testing, including functional and package integrity, passed acceptance criteria after 3 years and one month of real-time aging and EO sterilization. Device achieved SAL of 10⁻⁶, met endotoxin limits, and was non-pyrogenic. Packaging integrity was maintained. |
| Performance Testing | - Dimensional measurements within specifications.
Mechanical Strength: MSS assembly, clamp, cord, drip chamber attachment, junctions, bottom cap bond to withstand specified forces/torques.
Vent Functionality: Ensure proper fluid pressure withstand, blood solution drainage, and minimal CSF flow resistance.
Leakage: UV-cure bonds and drainage bag to show no leakage under specified conditions.
Flow Initiation Pressure within limits.
Drip Chamber: Verify fluid weight and proper volume.
Hydrophobic Microbial Barrier Vent: Demonstrate 99.9% Bacterial Filtration Efficiency (BFE). | All "Performance Testing - Bench" 항목 had specific test methods and the document states the DUET™ EDMS "was tested and passed" all of them. Specific quantitative results are not provided for each test in the summary. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Bench Testing (Biocompatibility, Shelf-Life, Performance): The sample sizes for each specific test (e.g., number of devices, number of material samples) are not explicitly stated in the provided text. The data provenance is internal testing conducted by Medtronic (the manufacturer).
Clinical Literature:
- "Coselli et al." (2002): 145 subjects. Prospective, randomized study.
- "Estrera et al." (2001): 148 subjects. Retrospective study.
- "Estrera et al." (2005): 238 subjects in adjunct group, 62 subjects in "other" groups (12 CSF drainage alone, 34 DAP alone, 16 neither). Retrospective study.
- "Safi et al." (2003): 1004 subjects (741 in adjunct group, 263 in non-adjunct group). Retrospective study.
- "Svensson et al." (1998): 17 subjects in treatment group, 16 subjects in control group. Randomized, prospective study.
The countries of origin for these clinical studies are not explicitly stated, but are likely in countries with advanced surgical capabilities (e.g., USA, Europe), based on the typical publication venues for such medical research.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this device and study. The "ground truth" for the bench testing is established by engineering standards and measurement accuracy, not by human expert assessment. For the clinical literature review, the "ground truth" refers to patient outcomes and diagnoses reported by medical professionals in those studies, determined by standard clinical practice in those contexts. The number and qualifications of experts involved in establishing those clinical outcomes are not detailed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The bench tests are objective measurements against defined standards, not subjective assessments requiring adjudication. The clinical studies cited were clinical trials or retrospective reviews, not studies involving adjudication of a test set for this specific device.

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 applicable. This is not an AI/ML device, and no MRMC study was performed or is relevant to its evaluation.

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

Not applicable. This is not an AI/ML device. The device's performance is standalone in the sense that it functions mechanically and physically as designed, but it always requires a human in the loop for its operation, monitoring, and interpretation of its output (e.g., CSF pressure readings).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Bench Testing (Biocompatibility, Shelf-Life, Performance): The "ground truth" is based on pre-defined engineering specifications, international/national standards (e.g., ISO, ASTM, USP), and objective measurements (e.g., torque, load, pressure, leakage volume, dimensional measurements).
Clinical Literature: The "ground truth" for the effectiveness section is patient outcomes data (e.g., incidence of spinal cord injury, neurological deficit rates) collected in the cited clinical studies, as diagnosed and managed by the clinical teams in those studies.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

Regulation Number and Section

§ 882.5560 Cerebrospinal fluid shunt system.

(a)
Identification. A cerebrospinal fluid shunt system is a prescription device used to monitor and 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 preventing spinal cord ischemia or injury during procedures that require reduction in central nervous system pressure. A cerebrospinal fluid shunt system may include catheters, valved catheters, valves, connectors, and pressure monitors intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device description must include a detailed summary of the device technical parameters, including design configuration, dimensions, engineering drawings, and a list of all components with identification of their materials of construction.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Simulated use testing must be conducted to characterize fluid flow and resistance to leakage; and
(ii) Mechanical integrity testing of all connections must be conducted.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf life.
(5) Performance data must demonstrate the sterility and pyrogenicity of patient-contacting components of the device.
(6) The labeling must include:
(i) Contraindications with respect to patients who should not receive a lumbar drain;
(ii) A warning that the device should have 24-hour-a-day availability of trained personnel to supervise monitoring and drainage;
(iii) Instructions on proper device setup, positioning, and monitoring;
(iv) Warnings and precautions to inform the user of serious hazards and special care associated with the use of the device;
(v) A statement that the device is not to be reused, reprocessed, or resterilized when open but unused; and
(vi) Cleaning instructions for the injection sites.