(282 days)
The EndoRotor device is indicated to resect and remove necrotic tissue in symptomatic Walled off pancreatic necrosis /Walled off necrosis (WOPN/WON) after having undergone endoscopic ultrasound (EUS) guided drainage.
The EndoRotor ® is a powered resection tool intended to morcellate necrotic pancreatic tissue through the instrument biopsy channel of an endoscope. The device is to be used after a patient has undergone a procedure to drain any fluid accumulated in the pancreas due to pancreatitis.
This document describes the EndoRotor, an endoscopic pancreatic debridement device. The information provided outlines its regulatory classification, indications for use, device description, and summarizes nonclinical and clinical studies conducted to support its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance
The primary acceptance criteria for the EndoRotor device are related to its effectiveness in reducing the volume of Walled-off Pancreatic Necrosis (WOPN) and its safety profile. A direct set of quantitative acceptance criteria for the device's performance is not explicitly stated in the provided text as 'acceptance criteria,' but rather as effectiveness endpoints evaluated in the IDE study. For the purpose of this response, I will interpret the key effectiveness endpoints from the IDE study as the de facto acceptance criteria used for approval.
| Acceptance Criteria (Effectiveness Endpoint from IDE Study) | Reported Device Performance (IDE Study, Per Protocol Population) |
|---|---|
| Successful debridement resulting in a significant reduction in WOPN volume. | Median percent reduction of WON size: (b) (4)% (reported as "more than 98% volume reduction"). |
| Mean percent reduction of WON size: (b) (4)% (reported as "82%"). | |
| 18 out of 22 (82%) subjects achieved at least a (b) (4)% (reported as "70%") reduction in WON size. | |
| Number of procedures required to achieve clearance of necrosis. | Average of 2.1 treatments per subject (for 30 subjects, 63 procedures). |
| Device-related Serious Adverse Events (SAEs) | 0 device-related SAEs. |
| Procedure-related Serious Adverse Events (SAEs) | 3 SAEs (2 gastrointestinal bleeds, 1 pneumoperitoneum) occurred in 30 subjects, 10% complication rate. |
Note on (b) (4): The document contains redacted information indicated by "(b) (4)". Where percentages or specific values are given in descriptive text alongside these redactions, I've used the descriptive values (e.g., "more than 98% volume reduction", "82%") if they clearly correspond to the redacted field.
2. Sample Sizes and Data Provenance
Test Set (IDE Study, G180127):
- Sample Size: 30 subjects were treated with the device (Intent-to-Treat, ITT). 22 subjects were included in the Per Protocol (PP) analysis. Multiple procedures were performed, totaling 63 procedures.
- Data Provenance: Multicenter and multinational trial, with ten centers. 23 out of 30 (77%) subjects were treated in U.S. centers. This was a prospective study.
Erasmus Investigator Study (Supporting Data):
- Sample Size: 12 subjects were treated (8 with Version 1, 4 with Version 2 of the device).
- Data Provenance: Conducted in the Netherlands, a prospectively-defined cohort.
Real World Data (Supporting Data):
- Sample Size: Data were collected for 134 EndoRotor DEN/ETN procedures in 108 subjects. For effectiveness analysis with baseline and follow-up imaging, 29 subjects with a known number of procedures were analyzed.
- Data Provenance: Obtained from institutions outside the US. The data were not collected as part of a formally designed retrospective clinical study.
Literature Review (Supporting Data):
- Search Yield: Initially 2,527 articles (after duplicate elimination). Narrowed down to 28, then 5 articles were utilized by FDA for qualitative comparison.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience").
However, it implicitly relies on:
- Treating Physicians/Investigators: For clinical assessments, symptomatology, and determination of additional treatments.
- Radiologists/Clinicians: For CECT interpretations at baseline and follow-up to measure WOPN volume. The protocol required investigators to use the Atlanta Classification for necrotic collections on CECT, suggesting a standardized diagnostic approach interpreted by medical professionals.
- Pathology: To confirm infection through positive culture obtained by fine needle aspiration (FNA) for inclusion criteria.
4. Adjudication Method for the Test Set
The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the test set results. The primary effectiveness endpoint (percent volume reduction) was measured by contrast-enhanced CT, comparing baseline and follow-up scans. While the Atlanta Classification was used for determining necrotic collections, there is no mention of independent readers or an adjudication process for these measurements or other endpoints. Decisions on additional treatments were based on the treating clinician's judgment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The EndoRotor is a physical medical device for tissue debridement, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable, as the EndoRotor is a physical device, not a standalone algorithm. Its performance is tied to its use by a human operator.
7. Type of Ground Truth Used
The ground truth for the effectiveness endpoints primarily relied on:
- Imaging Data: High-resolution, contrast-enhanced CT (CECT) scans at baseline and 21 (± 7) -day follow-up. This was used to quantitatively measure the volume of WOPN/WON and its reduction.
- Clinical Assessment: Symptomatology, physical examination, adverse events.
- Pathology/Laboratory: Positive culture obtained by fine needle aspiration (FNA) to confirm infection.
- Clinical Judgement: For decisions regarding additional procedures and assessment of adequacy of debridement (though FDA did not rely on subjective endoscopic assessment for effectiveness).
8. Sample Size for the Training Set
The document does not describe a separate "training set" in the context of device development or algorithm training. The clinical studies (IDE, Erasmus, RWD) serve as validation for the device's performance in human subjects.
9. How the Ground Truth for the Training Set was Established
As there is no distinct "training set" described for an algorithm, this question is not fully applicable. However, if interpreted as "how device design and operational parameters were refined," it would involve non-clinical (bench) and animal testing for Version 1 and 2, which informed the device's specifications and performance prior to human trials. Bench testing involved evaluating critical functions and design verification, and animal testing focused on resecting and removing tissue. The "ground truth" for these phases would be engineered performance targets and histological/visual assessment of tissue removal in experimental models.
§ 876.4330 Endoscopic pancreatic debridement device.
(a)
Identification. An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including evaluation of debridement of walled off pancreatic necrosis and all adverse events.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.
(5) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
(6) 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) Testing of rotational speeds and vacuum pressure;
(ii) Functional testing including testing with all device components and the ability to torque the device; and
(iii) Functional testing in a relevant tissue model to demonstrate the ability to resect and remove tissue.
(7) Performance data must demonstrate the electromagnetic compatibility (EMC) and electrical safety of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Training must be provided so that upon completion of the training program, the user can resect and remove tissue of interest while preserving non-target tissue.
(10) Labeling must include the following:
(i) A summary of the clinical performance testing conducted with the device;
(ii) Instructions for use, including the creation of a conduit for passage of endoscope and device into a walled off pancreatic necrotic cavity;
(iii) Unless clinical performance data demonstrates that it can be removed or modified, a boxed warning stating that the device should not be used in patients with known or suspected pancreatic cancer;
(iv) The recommended training for safe use of the device; and
(v) A shelf life for any sterile components.