(211 days)
The GenCut core biopsy system is utilized through a flexible endoscope or with the superDimension™ navigation system by physicians who are trained in endoscopic techniques for retrieving specimens from patients with endobronchial lesions, peripheral lung nodules, or lung masses.
The GenCut™ core biopsy system (GenCut system) is an endobronchial biopsy system that consists of a core biopsy tool, extension tube, locking syringe, and a tissue removal brush. The GenCut system is intended to retrieve tissue specimens from lungs during an endobronchial lung biopsy procedure. The product is used either through a flexible endoscope or in conjunction with the superDimension™ navigation system (cleared under 510(k) K092365).
The core biopsy tool is comprised of a polymeric shaft with steel braid reinforcement and a stainless steel side-cutting tip. The extension tube connects to the proximal end of the core biopsy tool shaft via a connection hub. The extension tube fittings allow the user to provide suction to the shaft via the supplied syringe. Upon completion of sampling, the tissue removal brush can be inserted through the length of the shaft to collect any remaining tissue not expelled through aspiration.
The product is packaged in a Tyvek pouch and sterilized with ethylene oxide. The product package contains the core biopsy tool and the following associated accessories:
- Extension tube .
- Locking syringe .
- Tissue removal brush ●
Here's an analysis of the acceptance criteria and the study proving the GenCut™ Core Biopsy System meets them, based on the provided text:
Acceptance Criteria and Device Performance for GenCut™ Core Biopsy System
The document states, "All acceptance criteria were met" for the preclinical study. However, the specific quantitative acceptance criteria or performance metrics are not explicitly defined in the provided text. The document only broadly states that the device was evaluated for its ability to retrieve specimens from lung tissues.
Therefore, the table below reflects what can be inferred rather than explicitly stated quantitative criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to successfully retrieve tissue specimens | All acceptance criteria were met. Device design meets intended use. |
| Functionality in an endobronchial lung biopsy procedure | All acceptance criteria were met. Device design meets intended use. |
| Safe operation within intended use | No adverse events or safety concerns mentioned; biocompatibility testing passed. |
| Compatibility with flexible endoscope/superDimension system | Functionality confirmed during simulated use and animal study. |
| Biocompatibility | Passed Cytotoxicity, Sensitization, Intracutaneous Study. |
| Structural Integrity (Tensile, Shelf Life, Packaging, Dimensional) | Passed Tensile Testing, Shelf Life Testing, Packaging and Distribution Testing, Dimensional Testing. |
2. Sample Size and Data Provenance
- Test Set Sample Size: A "preclinical study was conducted in a porcine model." The exact number of porcine subjects is not specified.
- Data Provenance: Prospective (animal study mimicking clinical use). Country of origin is not specified.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Three physicians.
- Qualifications of Experts: Two pulmonologists and one thoracic surgeon. Years of experience are not specified.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated. It says "All acceptance criteria were met. Therefore, the design of the GenCut system meets the intended use." This implies a consensus or agreement among the experts regarding the successful performance, but the specific process (e.g., 2+1, 3+1) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The study described is a preclinical animal study evaluating the device's performance, not comparing human readers' performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical core biopsy system, not an AI algorithm. Therefore, a standalone (algorithm-only) performance evaluation is not relevant.
7. Type of Ground Truth Used
The ground truth for the animal study was based on the direct observation and assessment of the three expert physicians (two pulmonologists and one thoracic surgeon) during the biopsy procedures in the porcine model. This would likely involve:
- Successful specimen retrieval.
- Quality of the retrieved specimens (though not explicitly detailed).
- Ease of use and functionality of the device.
- Absence of complications related to the device.
8. Sample Size for the Training Set
Not applicable. This device is a physical core biopsy system, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth associated with it in that context. The "ground truth" for its performance evaluation (animal study) was established by direct expert observation and assessment.
§ 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.