(19 days)
Used for submucosal aspiration biopsy of the bronchial tree.
The modified Lung Biopsy Needle is a sterile, disposable device, used for submucosal aspiration biopsy of the bronchial tree through the accessory channel of a bronchoscope. It consists of a 22 gauge needle, 100 cm outer catheter and handle mechanism. The handle mechanism is used to extend and retract the needle with the proximal portion inclusive of the aspiration port.
The provided document is a 510(k) premarket notification for a modification to a medical device, specifically a Wilson-Cook Lung Biopsy Needle. It is not a study assessing the performance of an AI/ML device, but rather a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, much of the requested information regarding AI device performance metrics, study design, and ground truth establishment is not applicable.
However, I can extract the information related to the device's acceptance criteria and how "performance" (in the context of a 510(k) for a non-AI device) was demonstrated.
Here's a breakdown of the relevant information:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device modification, "acceptance criteria" primarily relate to demonstrating that the modified device functions as intended and is as safe and effective as the predicate device. The performance is demonstrated through design verification, ensuring it meets predetermined criteria.
| Characteristic | Acceptance Criteria (Predetermined) | Reported Device Performance |
|---|---|---|
| Intended Use | Submucosal aspiration biopsy of the bronchial tree (aligned with predicate). | Meets the intended use: "Used for submucosal aspiration biopsy of the bronchial tree." This is consistent with the predicate Wang/Mill-Rose Transbronchial Aspiration Needle. |
| Outer Catheter Material | Use of Polyetheretherketone (PEEK) with metal hub at distal tip (changed from Polytetrafluoroethylene). | The device incorporated PEEK with a metal hub at the distal tip. Compatibility and functionality of this material are implicitly accepted through design verification. |
| Needle Gauge | 22 GA stainless steel needle. | The device uses a "22 GA stainless steel needle." This matches the predicate devices. |
| Maximum Needle Extension | 13mm. | The device's maximum needle extension is 13mm. This matches the predicate devices. |
| Outer Catheter Length | 100cm. | The device's outer catheter length is 100cm. This matches the original Wilson-Cook predicate. |
| Sterility | Sterile, Disposable; SAL of 10-6 in accordance with AAMI Standard 11135. | "Validated EO cycle in accordance with AAMI Standard 11135 using an Sterility: SAL of 10-6." Meets the criteria for sterility. |
| Biocompatibility | Reasonable assurance of biocompatibility for patient-contacting materials. | "Reasonable assurance of biocompatibility... established through an extensive history of use in similar patient contacting medical devices and as applicable biocompatibility test results." This implies tests (though not detailed) met internal acceptance criteria for material safety. |
| Design Integrity & Functionality | All results obtained during Design Verification met predetermined acceptance criteria for the product line. | "During Design Verification, visual, dimensional and functional testing... was conducted. All results obtained during our Design Verification met our predetermined acceptance criteria for this product line." (Specific results or acceptance criteria are not detailed in this summary). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The "Design Verification" section mentions "visual, dimensional and functional testing" but does not provide specific sample sizes for these tests. This is typical for a 510(k) for a physical device where testing might involve a limited number of manufactured units to confirm specifications.
- Data Provenance: Not applicable in the context of clinical data for an AI device. The data refers to internal engineering and quality testing performed by Wilson-Cook Medical Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as this is not an AI/ML device that requires expert-established ground truth for a test set. Design verification relies on engineering specifications and physical measurements.
4. Adjudication method for the test set
- Not applicable as this is not an AI/ML device involving expert review adjudication.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used
- For this device, "ground truth" would be the engineering specifications, design requirements, and established standards (e.g., AAMI Standard 11135 for sterility, ISO standards for biocompatibility if referenced internally). The design verification tests against these objective criteria.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML 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.