(620 days)
The remOVE System consists of the DC Impulse and the DC Cutter Set.
The remOVE DC Impulse is a medical electrical device for fragmentation of OTSC® (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD® (endoscopic device for full-thickness resection of colorectal wall lesions) clips made by Ovesco Endoscopy AG for the digestive tract.
The remOVE DC Cutter Set is a set of instruments for use in flexible endoscopy. It consists of a bipolar DC instrument for the fragmentation of OTSC (endoscopic device for effective treatment of hemorrhage and acute or chronic wall defects in the GI tract) and FTRD (endoscopic device for full-thickness resection of colorectal wall lesion) clips from Ovesco Endoscopy AG, a pair of forceps and a cap for removal of these fragmented clips,
The remOVE System is comprised of the DC Impulse generator and the DC Cutter Set for the fragmentation and removal of OTSC ("over the scope clip" cleared under K101428) and FTRD ("full thickness resection device" cleared under K153550) clips from the digestive tract.
DC Impulse:
The DC Impulse is an electrical generator that produces pulsed, direct current (DC) to cut OTSC and FTRD clips. The DC Impulse generator is equipped with internal energy storage, allowing the device to generate pulsed DC without additional load on the power supply. The internal energy storage is charged before delivering the pulsed DC. DC Impulse is designed specifically for use with the DC Cutter and cannot be used with other instruments. Components required for operating the DC Impulse generator are a foot switch, a DC cord for connection to the DC Cutter instrument, and a power cord. The DC Impulse and accessories are reusable.
DC Cutter Set:
The DC Cutter Set includes three components: DC Cutter instrument, SecureCap retrieval cap, and Grasper. The DC Cutter is a bipolar, direct current instrument for flexible endoscopy and is meant for use only with the DC Impulse generator and flexible endoscopes with a working channel diameter of 2.8 mm. It is connected to the DC Impulse generator via the DC cord. The Grasper is used to retrieve the clip fragments. The dimensions of the Grasper are 2200 mm in length and 2.3 mm in diameter. The set is provided sterile and intended for single use only.
The provided text does not contain information about acceptance criteria and a study that proves the device meets them in the format typically used for AI/ML device evaluations (e.g., performance metrics like sensitivity, specificity, AUC). Instead, it describes regulatory information, device details, non-clinical/bench studies, animal studies, and limited clinical information (compassionate use cases) for a medical device called the "remOVE System," an endoscopic electrosurgical clip cutting system.
The "acceptance criteria" in this context are implicitly the fulfillment of various safety and effectiveness requirements demonstrated through the described studies. The "study that proves the device meets the acceptance criteria" refers to the entire body of evidence presented in the document, which supports the De Novo request.
However, I can extract the relevant information from the provided text and present it in a modified format as best as possible, aligning with the spirit of your request.
Acceptance Criteria and Study for the remOVE System
The provided document describes the regulatory approval process for the remOVE System, an endoscopic electrosurgical clip cutting system, via a De Novo request. The "acceptance criteria" are implicitly defined by the regulatory requirements and "Special Controls" outlined in the document, which focus on safety, effectiveness, biocompatibility, sterility, shelf-life, and usability. The "study that proves the device meets the acceptance criteria" refers to a combination of non-clinical bench testing, animal studies, and limited compassionate use clinical experience.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Special Controls & Risks) | Reported Device Performance (Summary from studies) |
|---|---|
| Functional Performance: |
- Usability (operability, field of view, comprehensibility of labeling)
- Stress (device integrity over lifespan)
- Compatibility (with specified instruments)
- Reliability | Usability: Passed IEC 62366 testing; evaluated functional/operational aspects supporting safe/effective use. Key elements (operability, field of view, labeling comprehensibility) evaluated.
Stress: DC Impulse generator passed all test cycles (165 A max, 75 ms pulse) over its lifespan; no deterioration.
Compatibility: DC Cutter designed specifically for DC Impulse, cannot be used with other instruments.
Reliability: Implied by successful stress testing and animal/clinical outcomes. |
| Electrical and Thermal Safety (e.g., unintended tissue damage, burns, perforations) | Compliant with IEC 60601-1; thermal safety evaluated via risk management; electrophysiological safety tests showed current/density below adverse effect thresholds. Animal studies evaluated thermal collateral tissue damage. |
| Electromagnetic Compatibility (EMC) (e.g., interference, electrical shock) | Compliant with IEC 60601-1-2. |
| Biocompatibility (for patient-contacting components, e.g., adverse tissue reaction) | DC Cutter Set (external communicating, limited contact) tested per ISO 10993-1; all results demonstrated acceptable biocompatibility profile. |
| Sterility (for components provided sterile, e.g., infection) | Ethylene Oxide (EO) sterilization validated per ISO 11135-1 (SAL of 10-6) for DC Cutter Set. |
| Shelf Life (continued sterility, package integrity, device functionality) | Labeled for 1 year based on accelerated aging (ASTM F1980-07); post-aging, devices passed integrity (seal strength, visual, dye penetration) and functional bench testing. |
| Tissue Damage Evaluation (in vivo, including thermal effects, and clip removal effectiveness) | Animal Studies: In vivo/ex vivo testing in esophagus, gastric wall, duodenum, colon. Evaluated safety and effectiveness of clip removal, thermal collateral tissue damage. Grasper and SecureCap functionality tested. "Results support safe and effective use." |
| Clinical Effectiveness & Safety (successful clip removal, absence of serious complications) | Compassionate Use (Europe): 11 patients: Complete retrieval in 10. One firmly ingrown piece left, no further consequences. All bleeding treatable. No changes in heart rhythm.
Retrospective Study (74 patients incl. above): Clip removal successful in 72. Two not possible (epithelialized). 9 had fragment remain (deeply incorporated). No serious complications. Two minor bleedings treated. One superficial mucosal tear closed. 63 (of 74) had complete clip removal. "Overall, the information on the 74 cases support the safety and effectiveness."
Compassionate Use (US): Approved requests, follow-up reports indicated successful procedures with no serious complications. |
| Labeling (instructions, shelf life, warnings, precautions) | Complies with 21 CFR 801 and special controls. Includes IFU, brochure, package labels. DC Cutter Set labeling includes shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The text primarily describes non-clinical and animal studies, along with limited human experience.
-
Human Data (Clinical Experience):
- Sample Size: 11 patients (European compassionate use) + 63 additional patients for a total of 74 patients (retrospective study in Europe, including the initial 11). Additionally, unspecified "several compassionate use requests" in the United States.
- Data Provenance: Europe (initial 11 and the retrospective 74 patients), United States (additional compassionate use cases).
- Retrospective or Prospective: The 74-patient study is explicitly called a "retrospective study on the compassionate use." The initial 11 patients were part of "compassionate use" experience. US compassionate use cases are also described retrospectively.
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Animal Studies:
- Sample Size: Not specified (e.g., number of animals or procedures).
- Data Provenance: Not specified, assumed controlled laboratory setting.
- Retrospective or Prospective: Not specified, generally considered prospective for controlled studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The "clinical information" is from compassionate use cases and a retrospective study, where outcomes were likely assessed by the treating clinicians rather than a panel of independent experts establishing a "ground truth" for a predefined test set in a typical AI/ML validation context.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the clinical data (compassionate use and retrospective review), a formal adjudication method by a panel of experts is highly unlikely to have been employed in the manner typical for AI/ML validation studies.
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
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. The remOVE System is a mechanical/electrical device, not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The concept of "standalone performance" for an algorithm is not applicable here, as the remOVE System is a physical medical device (an electrosurgical clip cutting system) that requires human operation. It is not an AI algorithm. Its "standalone performance" would equate to its bench and animal study performance, which was indeed evaluated without human intervention in the decision-making process.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the human clinical data (compassionate use and retrospective study), the "ground truth" for success/failure of clip removal and complication assessment was based on clinical outcomes data as observed and documented by the treating physicians during and after the procedures. For animal studies, the "ground truth" for safety and effectiveness was based on direct observation of tissue damage, thermal effects, and device functionality. For bench testing, the ground truth was based on pre-defined performance specifications and measurement outcomes.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here. The remOVE System is a hardware device; it does not employ an AI/ML algorithm that requires a training set of data. Its design and development would have involved various engineering tests and iterations, but not data-driven "training" in the AI/ML sense.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no AI/ML algorithm or training set for the remOVE System.
§ 876.4310 Endoscopic electrosurgical clip cutting system.
(a)
Identification. An endoscopic electrosurgical clip cutting system is a prescription device that applies electrical energy to fragment metallic clips, which are devices placed in the digestive tract to close gastrointestinal perforations, hemorrhages, or perform resection. The system includes instruments that are then used to remove the fragmented clips from the digestive tract.(b)
Classification. Class II (special controls). The special controls for this device are:(1) 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) Performance bench testing to evaluate the functionality (including stress, compatibility, usability, and reliability) of the device during use;
(ii) Electrical and thermal safety testing; and
(iii) Electromagnetic compatibility testing.
(2) Animal testing must evaluate tissue damage, including thermal effects, during the clip removal procedure. This testing must also evaluate usability and effectiveness of the device.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
(5) Performance data must support shelf life by demonstrating continued sterility of the device (or the sterile components), package integrity, and device functionality over the labeled shelf life.
(6) Labeling of the device must include:
(i) Instructions for use, and
(ii) A shelf life for single use components.