(147 days)
This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.
The PeriView FLEX Needle is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. The device is supplied sterile and is intended for single patient use.
The device consists of a handle, sheath, needle, and stylet. The sheath and needle (together termed the insertion section) are attached to the handle and needle slider respectively. The removable stylet runs the full length of the device and is located within the lumen of the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well.
The distal end of the insertion portion (sheath and needle) of the PeriView FLEX needle is inserted into the working channel of the bronchoscope and advanced to the target site. The handle is connected to the insertion and has a needle slider component. The needle slider is controlled manually by the user to extend and retract the needle from the sheath at the target site. Once a sample is collected, an air filled syringe or the stylet can be used to expel the sample from the needle.
The PeriView FLEX is available in one model only (NA-403D-2021), with a needle size of 21gauge (21G). The PeriView FLEX Needle can be used with the following optional accessories: vacuum syringe, biopsy valve, and guide sheath. These optional accessories are not included with the Peri View FLEX Needle's packaging and must be obtained separately by the user.
This document is a 510(k) premarket notification for the "PeriView FLEX" aspiration needle. It asserts the substantial equivalence of the new device to a predicate device, the "PeriFLEX" (K162611). Therefore, the study described does not involve a multi-reader, multi-case comparative effectiveness study or a standalone algorithm performance study, as it is a medical device clearance based on equivalence to an already approved device rather than a new AI/software-based diagnostic.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a table format with corresponding performance results in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated through various bench tests designed to show that the new device performs equivalently to the predicate and meets design specifications. The acceptance criteria are implicitly met by successful completion of these tests.
| Test Conducted | Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards (Parts 4, 5, 10, 11) and USP , | All patient contacting surfaces tested in compliance to relevant ISO-10993 requirements. |
| Sterilization | Compliance with ANSI/AAMI/ISO 11607-1:2006 and ANSI/AAMI/ISO 11135-1:2014; maintain sterility for labeled shelf life. | Sterilization (ethylene oxide) validated. Packaging integrity and performance testing support one-year shelf life. |
| Bench Testing: | ||
| - Sheath and Needle Insertion/Withdrawal Force | Meet specified force ranges for smooth operation, comparable to predicate. | Successfully demonstrated performance. |
| - Stylet Insertion and Withdrawal Force | Meet specified force ranges for smooth operation, comparable to predicate. | Successfully demonstrated performance. |
| - Bronchoscope Angulation | Ability to reach upper lobes of the lung, comparable to predicate, accommodating bronchoscope variability. | Demonstrated ability to reach upper lobes of the lung, affirming equivalence. |
| - Activation Force | Meet specified force for user activation, comparable to predicate. | Successfully demonstrated performance. |
| - Plastic Deformation Angle | Maintain structural integrity under stress. | Successfully demonstrated performance. |
| - Puncture Force | Meet force requirements for effective tissue collection, comparable to predicate. | Successfully demonstrated performance. |
| - Transmission Force | Effective transfer of force for needle advancement. | Successfully demonstrated performance. |
| - Handle Assembly Strength/Handle Durability | Withstand reasonable operational stresses for expected lifespan. | Successfully demonstrated performance. |
| - Device Durability | Maintain integrity and functionality over its intended single-use cycle. | Successfully demonstrated performance. |
| - Vacuum Decay Test | Maintain vacuum seal for effective aspiration. | Successfully demonstrated performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical (bench) test. The testing involved physical devices and materials, not patient data.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective) as the submission is based on non-clinical (bench) testing of the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for bench testing is defined by engineering specifications, validated test methods, and compliance with recognized standards. It does not involve expert clinical review or interpretation of results in the way a diagnostic study would.
4. Adjudication Method for the Test Set
Not applicable. Bench tests are objective measurements against predefined specifications, not subjective interpretations requiring 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
No, an MRMC comparative effectiveness study was not done. This device is an aspiration needle (physical medical instrument), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the non-clinical testing is based on engineering design specifications, established performance standards (e.g., ISO, AAMI, USP), and the functional equivalence to the legally marketed predicate device. For example, biocompatibility is assessed against ISO 10993 standards, and mechanical properties are assessed against engineering targets to ensure safe and effective operation comparable to the predicate.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/software device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is a physical medical instrument, not an AI/software device that requires a training set.
§ 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.