(41 days)
The Captivator and Captiflex Polypectomy Snares are used endoscopically in the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.
The Captivator and Captiflex Single-Use Polypectomy Snares consist of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.
This document describes a 510(k) premarket notification for Captivator and Captiflex Single-Use Polypectomy Snares. The submission focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests but does not explicitly define acceptance criteria as numerical thresholds for all tests. It generally states that the modified snares "met all pre-defined specifications." For cutting force, comparative data is provided, implying that the modified devices should perform comparably to or better than the predicate.
| Test Description | Undefined Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Loop Extension Functionality | "met all pre-defined specifications" | All snare configurations were tested and met specifications in a simulated-use tortuous path. |
| Loop Retraction Functionality | "met all pre-defined specifications" | All snare configurations were tested and met specifications in a simulated-use tortuous path. |
| Snare Actuation Force | "met all pre-defined specifications" | The largest snare (M00561290) was tested as a worst-case and met specifications in a simulated-use tortuous path. |
| Maximum Cutting Force | Implied: Comparable or superior to predicate device performance | Predicate Device Means (lbf): Captiflex Medium Oval (5.4), Captivator Large Oval Thin (4.4), Captivator Large Oval (5.0), Captivator II Extra Large Rounded (5.7), Sensation Large Oval (12.0) Modified Device Means (lbf): Captiflex Medium Oval (6.4), Captivator Large Oval Thin (6.2), Captivator Large Oval (6.7), Captivator II Extra Large Rounded (7.1), Captivator Medium Oval Stiff (7.4), Captivator Medium Hexagonal Stiff (6.2), Captivator Medium Crescent (6.8). The modified devices generally show higher mean cutting force compared to the specific predicate versions measured. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (n) for each test. It mentions "All snare configurations were tested" for loop extension and retraction, and "the largest snare (M00561290) was tested to represent all snares" for actuation force. For maximum cutting force, multiple UPNs for both predicate and modified devices are listed, with mean and standard deviation provided, suggesting multiple measurements were taken for each UPN, but the exact number of units/measurements per UPN is not specified.
- Data Provenance: The data is generated from bench testing conducted by Boston Scientific Corporation. This is a controlled, in-vitro environment, not human or animal data. There is no mention of country of origin of the data beyond Boston Scientific's location being Marlborough, MA. The study is effectively a prospective evaluation of the modified devices against internal specifications and comparative data from existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is not applicable to this submission. The "ground truth" here is defined by engineering specifications and objective physical measurements (e.g., force, functionality), not subjective expert assessment as would be the case for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
This is not applicable. As the testing involves objective bench measurements against specifications, there is no need for adjudication by experts.
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
This is not applicable. This submission is for physical medical devices (polypectomy snares), not an AI-assisted diagnostic or therapeutic system that would involve human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance demonstration is based on engineering specifications and objective physical measurements obtained through bench testing. This includes:
- Functionality (extension, retraction)
- Force measurements (actuation force, maximum cutting force)
These are established through internal design validation processes to ensure the devices meet their intended technical performance.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not a machine learning or AI device. The development process would involve iterative design and testing, but not a formally defined "training set" in the context of AI.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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).