(307 days)
This instrument has been designed to be used with ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree.
The Single Use Aspiration Needle NA-U401SX-4025N (aka ViziShot 2) is used in conjunction with Olympus ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA). The subject devices consist of a handle section and insertion. The handle section is connected to the endoscope's instrument channel port via the single use adapter biopsy valve (MAJ-1414). The insertion section is composed of the sheath, needle and stylet. The needle tube is stored in the sheath and extended from the sheath to puncture the target tissue to collect specimen by moving the needle slider on the handle. A syringe is attached to the aspiration port on the handle section to aspirate the specimen. The needle is dimpled for echo enhancement. The subject devices will be sold with or without the medallion syringe manufactured by Merit Medical, which consists of the VACLOK Syringe and Stopcock.
This submission (K190239) is for a medical device (Single Use Aspiration Needle NA-U401SX-4025N, also known as ViziShot 2), not an AI/ML device. Therefore, the questions related to AI/ML specific criteria like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for training/test sets, and adjudication methods are not applicable to the provided document.
The document describes the device, its intended use, and substantial equivalence to a predicate device based on non-clinical testing.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization/Shelf-life | Device remains sterile and functional for its intended shelf-life. | - Sterilization/shelf-life testing conducted per FDA's "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." |
- Accelerated aging test conducted per ASTM F1980-16 for sterile barrier systems.
- Real-time aging test for three years will be performed to
demonstrate longer stability and support accelerated aging test results. |
| Biocompatibility | Device materials are biocompatible and do not pose unacceptable biological risks. | - Biocompatibility testing conducted per FDA's "Use of International Standard ISO 10993-1:2009, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'." - Specific tests completed: Cytotoxicity, Intracutaneous Study, Sensitization, Systemic Toxicity, Pyrogen Study. |
| Performance - Bench | Device functions as intended and meets design specifications for aspiration, piercing, visibility, etc. | - Bench testing conducted to ensure devices perform as intended and meet design specifications. - Specific tests performed: Piercing, Ultrasound visibility, Needle extraction and retraction, Aspiration, Endoscope compatibility, Handle function, Joint Pull Strength, Breakage Strength.
- "Bench testing confirms that the NA-U401SX-4025N meets its essential performances, which are technologically equivalent to those of the reference device." |
| Risk Analysis | Identified risks are mitigated adequately and meet established in-house acceptance criteria based on ISO 14971:2007. | - Risk analysis conducted in accordance with ISO 14971:2007. - Design verification tests and their acceptance criteria were identified and performed based on this assessment. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the document. The document refers to "bench testing," "accelerated aging test," and "biocompatibility testing," which inherently involve testing a certain number of devices or samples.
- Data Provenance: The tests were conducted internally by Olympus ("established in-house acceptance criteria"). The country of origin of the data is not explicitly stated, but the submitter is Olympus Medical Systems Corp. in Tokyo, Japan. The tests are non-clinical (bench, lab-based), so retrospective or prospective doesn't directly apply in the same way it would for clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not an AI/ML device dealing with "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance tests would be the established engineering and biological standards and specifications the device is designed to meet.
4. Adjudication method for the test set
- Not applicable. This is not an AI/ML device involving human interpretation and 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. This device is not an AI product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI product.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on engineering specifications, established medical device performance standards (e.g., sterilization, biocompatibility, mechanical strength), and a risk analysis based on ISO 14971:2007. It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable. This device does not use 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.