(167 days)
The LungPoint Tools are endoscopic tools intended to be used with LungPoint Software guided bronchoscopes. The LungPoint Sheath is intended to be used as a working channel through which endoscopic tools may be introduced to targeted tissue. The LungPoint Dilation Balloon is intended to dilate tissue of the bronchial tree and may be inserted through the LungPoint Sheath or directly through the working channel of the bronchoscope. Not for pediatric use.
The LungPoint Tools are endoscopic tools used during bronchoscopy procedures. The LungPoint Sheath is designed to be used with a bronchoscope to provide a working channel through which endoscopic tools, such as needles, dilation balloons, or other endoscopic devices may be introduced to the targeted lung tissue within the respiratory organs. The LungPoint Dilation Balloon is used to dilate tissue of the bronchial tree and may be inserted through the sheath or directly through the working channel of the bronchoscope. The bronchoscope is advanced to a predefined target following guidance of the LungPoint Software (previously cleared under 510(k) #K 12051 to guide endoscopic tools or catheters in the lungs or to enable marker placement in soft lung tissue).
The materials used in the LungPoint Tools are commonly used medical grade materials and include platinum iridium markers.
This document describes the validation of the LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon). It's important to note that this is a 510(k) summary for a medical device (tools), not an AI/ML device, so many of the requested fields related to AI/ML device validation (e.g., effect size with AI assistance, training set details) are not applicable (N/A). The summary focuses on demonstrating substantial equivalence to predicate devices through physical and functional performance testing.
Acceptance Criteria and Device Performance
The acceptance criteria for the LungPoint Tools were based on meeting pre-determined specifications for functional and performance tests. The specific numerical acceptance criteria are not detailed in the provided text but are stated to have been met.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional testing | Met pre-determined criteria |
| Joint/tensile test | Met pre-determined criteria |
| Simulated use | Met pre-determined criteria |
| Balloon fatigue/burst pressure | Met pre-determined criteria (e.g., LungPoint Dilation Balloon rated burst pressure 20 atm) |
| Balloon deflation time | Met pre-determined criteria |
| Radiopacity | Met pre-determined criteria |
Study Details
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated in terms of number of devices tested, but the performance data refers to a series of physical and functional tests performed on the devices themselves.
- Data provenance: The tests were conducted internally by the manufacturer (Broncus Medical, Inc.) to verify the design and safety of the devices. The context suggests these were laboratory-based engineering and performance tests relevant to the physical characteristics and function of the tools.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This device is a physical medical tool, and its "ground truth" is established by its physical specifications and functional performance under laboratory conditions, not by expert interpretation of data or images. Performance was verified against pre-determined engineering and safety specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically relevant for interpretive tasks involving human experts, which is not the case for this type of device performance testing.
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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:
- N/A. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for these physical tools is their engineering specifications, material properties, and functional performance benchmarks as established during the design and manufacturing process. The goal was to demonstrate that the devices met these pre-determined acceptance criteria and performed comparably to predicate devices.
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The sample size for the training set:
- N/A. This is not an AI/ML device.
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How the ground truth for the training set was established:
- N/A. 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.