(447 days)
This device is used in obtaining biopsy samples in the bronchi or lungs. This device is indicated for adult use only.
The Captura® Disposable Bronchoscope Biopsy Forceps (subject device) represents modifications made to the Disposable Bronchoscope Biopsy Forceps (predicate device) currently cleared to market via 510K K923847 by Wilson-Cook Medical, Inc. The Captura® Disposable Bronchoscope Biopsy Forceps consist of a spool handle, coated coilspring catheter, drive cable, forceps cups and forceps housing.
The bronchoscope biopsy forceps is used by passing the device through a prepositioned endoscope to the targeted location. The forceps cups are attached on one end of the coilspring sheath with the spool handle attached to the opposite end. The handle is actuated by moving the spool forward to open the forceps cups and backward to close. The Captura® Bronchoscope Biopsy Forceps have a surgical rim edge around the circumference of the cups and the cups are fenestrated. The cups are opened and pressed against the biopsy site. When the cups are closed, they are pulled away from the biopsy site, pinching off the top surface, obtaining a tissue biopsy.
This document is a 510(k) premarket notification for the Captura® Bronchoscope Biopsy Forceps, a medical device. It does not describe a study involving machine learning, AI, or software, but rather a traditional medical device equivalency assessment. Therefore, most of the questions about acceptance criteria, AI performance, ground truth, and training sets are not applicable.
Here's the information that can be extracted from the provided text, aligning with the spirit of your request where possible:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a physical medical device, there isn't a direct "performance metric" like accuracy or precision as would be found in an AI/ML study. Instead, the "performance" relates to demonstrating the device functions comparably to a predicate device and adheres to safety and functional standards.
| Acceptance Criteria (Demonstrated Through Testing) | Reported Device Performance (as stated in submission) |
|---|---|
| Functionality (Shelf Life Testing) | Subject device performs as intended |
| Durability / Mechanical Integrity (Flex and Fracture Design Verification) | Subject device performs as intended |
| Biopsy Efficacy (Force to Biopsy) | Subject device performs comparably to the predicate device |
| Packaging Integrity (Burst Testing, Dye Leak Testing) | Packaging maintains integrity and device sterility |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Toxicity, Material-mediated Pyrogenicity) | Biocompatibility performed in accordance with FDA Guidance (ISO 10993-1) |
| Substantial Equivalence to Predicate Device | Maintained intended use, key operating mechanics, and technological characteristics. |
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 general "sample sizes" in terms of patient data or clinical images, as this is not an AI/ML study. Instead, testing involves physical exemplars of the device. The text states:
- Sample Size: Not specified for individual tests. Testing would typically involve multiple units of the device for each test (e.g., several devices for flex and fracture, multiple packaged units for burst/dye leak tests).
- Data Provenance: The testing was conducted by Wilson-Cook Medical, Inc. / Cook Endoscopy. This is a medical device manufacturer based in Winston-Salem, North Carolina, USA. The data is from in-house design verification and validation testing, which is prospective for the purpose of demonstrating substantial equivalence.
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)
Not applicable. This is a submission for a physical medical device. "Ground truth" in this context refers to engineering specifications, validated test methods, and compliance with standards, not expert medical opinion on diagnostic images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a submission for a physical medical device. Adjudication methods like 2+1 are typically used for interpreting ambiguous cases or establishing ground truth in clinical or imaging studies involving human readers, which is not relevant here.
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 a 510(k) submission for a physical medical device, not an AI/ML-driven diagnostic tool. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component to this physical biopsy forceps device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance is established by:
- Engineering Specifications: The design and manufacturing specifications of the device.
- Validated Test Methods: Adherence to established scientific and engineering principles for testing functionality, durability, and safety.
- Regulatory Standards: Compliance with FDA guidance documents and international standards (e.g., ISO 10993-1 for biocompatibility).
- Predicate Device Performance: The cleared performance of the previously marketed predicate device (Disposable Bronchoscope Biopsy Forceps, K923847) serves as a benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical medical device.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.