(115 days)
The ViziShot 2 FLEX has been designed to be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. Do not use this device for any purpose other than its intended use.
The ViziShot 2 FLEX is intended for use with compatible ultrasound endoscopes for Transbronchial Needle Aspiration (TBNA) of submucosal and extramural lesions of the tracheobronchial tree. The device is supplied sterile and intended for single patient use.
The device consists of a handle, sheath, needle, and stylet. The sheath and needle are attached to the handle, and the removable stylet is located within the needle. Note that although, the device has a component called a needle, the device is often referred to as a needle as well.
Prior to a procedure, the flexible catheter portion is inserted into a bronchoscope's working channel (2.2mm) and advanced forward until fully inserted. The handle is then affixed to the channel port of the endoscope via a lever mechanism that locks onto the Adapter Biopsy Valve.
The needle is advanced through the bronchoscope to the sampling site while visualizing both the target and the needle in real time with ultrasound. The handle facilitates advancement of the needle during puncture of the targeted biopsy site. The sample is obtained by penetrating the lesion with the needle while applying suction at the proximal end of the handle. After completing the sampling, the vacuum from the syringe is released to atmosphere, the handle unlocked from the bronchoscope, and the catheter and needle pulled out from the working channel. The removed tissue can then be prepared for cytopathological or microbiological examination and testing.
The ViziShot 2 FLEX is available in one model only (NA-U403SX-4019), with a needle size of 19 gauge (19G). The two required accessories, the Adapter Biopsy Valve and the Merit Syringe with Stopcock, are packaged with the ViziShot 2 FLEX.
The provided text is a 510(k) Summary for the Olympus Surgical Technologies America ViziShot 2 FLEX, a medical device used for fine needle aspiration. It focuses on demonstrating substantial equivalence to a predicate device (ViziShot FLEX) rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a clinical trial report would.
Therefore, the information requested regarding acceptance criteria and performance data for the device's intended clinical function (e.g., diagnostic accuracy, success rate of aspiration, number of adequate samples) is not present in the provided document. The document primarily describes bench tests and non-clinical testing to ensure the device's physical and material properties are comparable to the predicate device.
However, I can extract information related to the non-clinical testing that verifies the device's physical performance, which serves as a form of acceptance criteria for its design changes.
1. Table of Acceptance Criteria and Reported Device Performance (for Non-Clinical Testing):
The document does not provide a formal table of quantitative acceptance criteria and specific reported performance for each test in the way requested. Instead, it states that "Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX."
Below is a representation of the tests conducted, and the implied 'acceptance criteria' is that the ViziShot 2 FLEX performs equivalently or meets the specifications of the predicate device for each category.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from Document) |
|---|---|
| Biocompatibility | Complies with relevant requirements of ISO-10993 for all patient contacting surfaces, including: |
- ISO 10993-4 (Interactions with blood)
- ISO 10993-5 (In vitro cytotoxicity)
- ISO 10993-10 (Irritation and sensitization)
- ISO 10993-11 (Systemic toxicity) |
| Sterilization | Delivered in sterile state, intended for single patient use. - Validated using ANSI/AAMI/ISO 11607-1 (Packaging for terminally sterilized medical devices)
- Validated using ANSI/AAMI/ISO 11135-1 (Sterilization of health-care products - ethylene oxide) |
| Packaging Integrity & Shelf Life | Packaging integrity and performance testing on devices that underwent accelerated aging support a labeled one-year shelf life. |
| Bench Testing (Physical Performance) | "Engineering bench testing confirms that the modified ViziShot 2 FLEX meets its critical product specifications, which are substantially equivalent to those of the predicate ViziShot FLEX." Specific tests conducted for verification include: - Sheath and Needle Insertion and Withdrawal Force
- Stylet Insertion and Withdrawal Force
- Bronchoscope Angulation
- Activation Force
- Plastic Deformation Angle
- Penetration Force
- Transmission Force
- Device Durability/Handle Durability
- Bronchoscope Adapter Sliding Force
- Handle Durability
- Sheath to Handle Joint Strength
- Echogenicity
(The document implies that the ViziShot 2 FLEX performed acceptably in all these areas, equivalent to the predicate ViziShot FLEX .) |
The following information is not available in the provided document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information would typically come from a clinical study. The provided document details non-clinical bench testing and biocompatibility testing, not clinical performance. Thus, there is no "test set" in the context of patient data, nor country of origin or retrospective/prospective nature.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This device is a physical medical instrument (a fine needle aspiration device), not an AI diagnostic algorithm or a system involving human readers in the context of interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For the non-clinical tests, the "ground truth" would be engineering specifications and standards. For biocompatibility, it's compliance with ISO standards.
- The sample size for the training set: Not applicable. No clinical training set is mentioned as this device is not an AI/ML product.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide regarding device evaluation:
The document describes non-clinical testing to support the substantial equivalence claim for the ViziShot 2 FLEX. These tests focus on:
- Biocompatibility: Performed on all patient-contacting surfaces, complying with ISO 10993 standards.
- Sterilization: Validated using ANSI/AAMI/ISO standards to ensure the device is sterile and maintains sterility for a one-year shelf life.
- Bench Testing: A range of physical performance tests (e.g., force, durability, angulation, echogenicity) were conducted to ensure the ViziShot 2 FLEX meets its critical product specifications and is "substantially equivalent" to its predicate device, the ViziShot FLEX. The implication is that the device design changes (primarily ergonomic and manufacturing efficiency improvements) did not negatively impact its physical performance or safety.
The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical data, rather than requiring a full-scale clinical trial to prove efficacy from scratch, especially when the changes are minor and do not alter the fundamental technological characteristics or intended use.
§ 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.