(90 days)
The AcuSnare Polypectomy Snare - Duckbill (ASDB) device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.
The AcuSnare Polypectomy Snare - Duckbill (ASDB) is a sterile, single use device compatible with the accessory channel of endoscope. This type endoscopic polypectomy device is designed to connect to an electrosurgical unit via an active cord accessory and the drive cable delivers energy through the snare head to cut and/or cauterize tissue as described in the instructions for use. The device consists of a handle, sheath, drive cable and wire loop snare head. The sheath is comprised of polytetrafluoroethylene (PTFE) and is offered in 7 Fr. (2.3 mm) diameter and 240 cm length models. The snare head is available in the shape of a duckbill configuration and offered in a 15 mm or 25 mm width. The stainless-steel drive cable and snare head pass through the sheath and the three ring (polycarbonate) handle allows the user to extend and retract the snare through the distal tip of the sheath.
The provided text describes a 510(k) premarket notification for a medical device called the AcuSnare Polypectomy Snare - Duckbill (ASDB). This is for a device intended for polypectomy (removal of polyps) during endoscopy. The document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study as described in the provided text:
Key Takeaways from the Document:
- This is a Special 510(k) submission, indicating minor modifications to an already cleared device (AcuSnare Polypectomy Snare - K173673).
- The primary change is the addition of a new duckbill shape configuration and associated cannula components.
- The manufacturer claims this change does not alter the method of operation or intended use of the device.
- Performance Data: The document states that a Risk Analysis (DFMECA) was completed, and Design Verification and/or Validation testing was performed to address the impact of modifications. The conclusion is that these tests provide "reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device."
Important Note: The provided text does not contain detailed information about specific acceptance criteria, quantitative performance metrics, or a formal clinical study with a test set, ground truth, or expert review. The focus of this 510(k) is on demonstrating substantial equivalence through design validation and verification of the modifications rather than a de novo extensive performance study.
Given the information, here's an attempt to answer your questions, highlighting where specific details are not provided in the document:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (from text) |
|---|---|
| Safety and Effectiveness: | "Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness and demonstrate that the AcuSnare Polypectomy Snare - Duckbill (ASDB) meets the performance requirements to fulfill the intended use of the device." |
| Functional Equivalence: | "The subject device is substantially equivalent to the predicate device with respect to the intended use, operating mechanism, materials and technological characteristics." |
The modification (duckbill shape) "does not change the method of operation or the intended use of the device." |
| Risk Mitigation: | "The Risk Analysis was completed to access the impact of modifications made to the cleared device using the Design Failure Modes, Effects and Criticality Analysis (DFMECA) method."
"We believe risks associated with the modifications to the subject device have been adequately addressed through our Design Control Processes." |
| Biocompatibility (Inferred): | Not explicitly stated but implied by substantial equivalence and design control. The device components (PTFE sheath, stainless steel drive cable and snare head) are likely the same as the predicate and would have undergone biocompatibility testing in the predicate's clearance. The text mentions "materials" are equivalent. |
| Sterility (Inferred): | Not explicitly stated but common for such devices. The device is described as "sterile, single use." This would have been established with the predicate device and verified for the modified device. |
| Mechanical Performance (e.g., cutting, cauterization efficacy, durability of snare): | Not detailed. The text states "Design verification and/or validation testing was performed." These tests would have covered the physical properties and functional performance of the modified duckbill snare to ensure it effectively cuts and cauterizes polyps as intended, at least equivalently to the predicate. Specific metrics (e.g., force to cut, temperature profile, number of cycles) are not provided. |
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify a sample size for a clinical "test set" in the context of human patients or a specific dataset.
- The "testing" mentioned refers to design verification and validation testing. This typically involves laboratory-based tests on device samples, not patient data.
- Provenance is not applicable as this describes device design testing, not clinical data analysis.
- The submission is a regulatory filing, not a peer-reviewed research paper detailing a study's methodology.
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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 information is not applicable and not provided. As explained above, the submission describes design verification and validation testing of the device itself, not a study involving human interpretation of data where expert ground truth would be established.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. Adjudication methods are relevant for studies where multiple human readers or algorithms interpret medical images or data against a consensus ground truth. This submission focuses on engineering and design testing.
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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 was not done (or at least, not reported in this document).
- This device is a physical medical instrument (polypectomy snare), not an AI or imaging-based diagnostic tool. Therefore, a study on human reader improvement with AI assistance is entirely irrelevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "design verification and validation testing," the "ground truth" would be established against engineering specifications, industry standards, and the performance characteristics of the predicate device. For instance, a test might verify that the snare loop can open to a specified diameter, or that it can effectively cut a tissue phantom without breaking, matching the performance of the predicate. This is functional and safety performance, not clinical ground truth.
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The sample size for the training set
- This information is not applicable and not provided. Training sets are used for machine learning algorithms. This document solely concerns a physical medical device.
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How the ground truth for the training set was established
- This information is not applicable and not provided.
In summary, the provided document is a regulatory submission for a minor device modification. It details the device, its intended use, and states that design verification and validation testing were conducted to confirm that the modifications do not raise new safety or effectiveness concerns and that the device meets performance requirements equivalent to the predicate. It does not provide details on clinical study methodologies or quantitative performance metrics typically found in clinical trials or AI/diagnostic device studies.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).