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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:

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

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. |

2. 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.

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 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.

4. 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.

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 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.

6. 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.

7. 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.

8. 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.

9. 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.

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This device is used endoscopically in the removal and cauterization of sessile polyps and pedunculated polyps from within the gastrointestinal tract.

The subject device consists of a handle section, a sheath section. The snare head section. The snare head section is inserted into the sheath section and is extended and retracted by operating the three-ring handle section.

The sheath section and the snare head section are inserted in the gastrointestinal tract through an endoscope. The snare head is extended from the sheath to resect target polyps. This resection is performed with high-frequency current.

This document is a 510(k) premarket notification for the AcuSnare Polypectomy Snare. It's not a study report that includes typical acceptance criteria and performance data for AI/ML devices. Instead, it demonstrates substantial equivalence to predicate devices for a conventional medical device. Therefore, I cannot extract the information requested as it is not present in the provided text.

Here is why your specific information requests cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance: This document doesn't define acceptance criteria in terms of a study's statistical endpoints (e.g., sensitivity, specificity, AUC) or report quantitative performance metrics like a standalone AI/ML study would. The acceptance criteria for this device are implicitly tied to demonstrating that it performs as intended and is as safe and effective as the predicate devices through non-clinical testing.
2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model for this type of device. The testing described is non-clinical (e.g., tensile strength, shelf life).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned, as this is not an AI/ML diagnostic or prognostic device.
4. Adjudication method: Not applicable for the reasons above.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on comparing the AcuSnare Polypectomy Snare to existing predicate devices based on:

• Intended Use: The device is used endoscopically for the removal and cauterization of sessile and pedunculated polyps from the gastrointestinal tract. This is compared to the predicate devices' stated uses.
• Technological Characteristics: Comparison of physical attributes like configuration, snare material, sheath material, handle material, length, FR size, sterility, sterilization method, reusability, and compatibility with electrosurgical units.
• Non-Clinical Testing: A list of tests performed to demonstrate the device's performance and safety, including:
  • Shelf Life Testing
  • Package Integrity Testing
  • Tensile tests (snare to catheter, catheter to handle, snare head to drive cable joint, snare wire to cannula joint, handle/cannula/drive cable joint, pin to handle joint)
  • IEC 60601-1, IEC 60601-2-2, and IEC 60601-2-18 standards compliance (related to electrical safety for electrosurgical equipment)
  • Biocompatibility testing (ISO 10993-1)

The "study" that proves the device meets acceptance criteria, in this context, refers to the non-clinical testing summarized in {5} and the comparison to predicate devices in {4}. The acceptance criteria are implicitly met if these tests show performance equivalent to or better than the predicate devices, and that the device is safe and effective for its stated intended use. The document concludes that the modifications to the subject device have been adequately addressed through Design Control Processes and do not affect the safety or effectiveness.

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