(143 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 PeriFLEX 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 intended for single patient use.
The main components of the device are a handle, a sheath, a needle, and a stylet. The sheath and needle (together termed the insertion portion) are attached to the handle. The removable stylet runs the full length of the device and fits inside the lumen of the handle and the needle.
The needle is housed within the sheath. These components, i.e., the insertion portion, are inserted into the working channel of the endoscope 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, the stylet may be used to assist with removing the sample from the needle.
The PeriFLEX Needle is available in one model only (PERIFLEX-21G), with a needle size of 21 gauge (21G). The PeriFLEX Needle can be used with the following accessories: vacuum syringe (to assist with sample collection), biopsy valve (to assist with creating a vacuum), and guide sheath (to extend the working length). However, these accessories are not included with the PeriFLEX Needle's packaging and must be obtained separately by the user.
The provided text describes the PeriFLEX Needle, an aspiration needle for collecting tissue from intrapulmonary regions through a bronchoscope. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted. While specific quantitative acceptance criteria are not explicitly stated for each test in a table format, the narrative indicates that the device "met the pre-determined acceptance criteria as outlined in the test protocols."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Sheath and Needle Insertion and Withdrawal Force | Met pre-determined acceptance criteria |
| Stylet Insertion and Withdrawal Force | Met pre-determined acceptance criteria |
| Bronchoscope Angulation | Met pre-determined acceptance criteria |
| Handle Activation Force | Met pre-determined acceptance criteria |
| Plastic Deformation Angle | Met pre-determined acceptance criteria |
| Transmission Force | Met pre-determined acceptance criteria |
| Handle Assembly Strength | Met pre-determined acceptance criteria |
| Handle Durability | Met pre-determined acceptance criteria |
| Durability | Met pre-determined acceptance criteria |
| Vacuum Leak Test | Met pre-determined acceptance criteria |
| Sheath to Handle Joint Strength | Met pre-determined acceptance criteria |
| Biopsy Sample Size (Ex Vivo) | Met pre-determined acceptance criteria; direct comparison to reference device (Olympus NA-1C Needle) also conducted |
| Sterilization & Biocompatibility | |
| Sterilization Validation | Met pre-determined acceptance criteria |
| Product Adoption | Met pre-determined acceptance criteria |
| Comparative Resistance | Met pre-determined acceptance criteria |
| Packaging and Shelf Life | Met pre-determined acceptance criteria |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Toxicity, Pyrogenicity) | Met pre-determined acceptance criteria; the results demonstrate that the performance and technological characteristics meet defined design requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated with a specific number for each test. The document refers to "in vitro (bench) and ex vivo testing" and "simulated use - ex vivo (bovine lung) bench testing" for biopsy sample size.
- Data Provenance: The testing was conducted as "in vitro (bench)" and "ex vivo (bovine lung) bench testing." This suggests laboratory-based testing rather than human subject data. The country of origin is not specified but is presumably where Spiration, Inc. conducts its R&D, likely the USA given the Redmond, Washington address. The testing is considered prospective as it was performed specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily engineering and material performance assessments (e.g., force, strength, leak tests, biocompatibility) rather than diagnostic accuracy assessments requiring expert interpretation of results.
- For the "Biopsy Sample Size" test, it involved ex vivo bovine lung, which implies objective measurement of tissue obtained rather than expert consensus on its characteristics.
4. Adjudication Method for the Test Set
- No adjudication method is mentioned or relevant as the testing described is not clinical or diagnostic in nature requiring expert review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or reported. The device is an aspiration needle, not an imaging or diagnostic AI device that would typically undergo such a study. The focus is on the physical and mechanical performance of the tool itself.
6. Standalone (Algorithm Only) Performance
- This is not applicable as the PeriFLEX Needle is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used
- The "ground truth" for the performance tests was based on engineering specifications, material science standards, and objective measurements derived from the in vitro and ex vivo tests. For example, force measurements, leak detection, and observed physical integrity against pre-determined thresholds. For biopsy sample size, it would be the objective measurement of the collected tissue from the ex vivo bovine lung.
8. Sample Size for the Training Set
- Not applicable. There is no algorithm or AI model being developed or trained for this device.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set mentioned or implied.
In summary, the information provided focuses on the physical, mechanical, and biological performance of the PeriFLEX Needle against engineering and safety specifications, rather than clinical efficacy or diagnostic accuracy that would typically involve a "test set" and "ground truth" derived from human clinical data or expert consensus. The study described is a series of pre-clinical bench and ex vivo tests demonstrating the device's conformance to its design requirements and equivalence to predicate devices.
§ 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.