(104 days)
This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).
The EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is an endoscopic ultrasound needle used for fine needle aspiration (FNA). The device is used in conjunction with an endobronchial ultrasound (EBUS) endoscope to gain access to the target site. The needle is dimpled for ultrasonic visualization. The needle is advanced into the target site for aspiration. The device allows for the adjustment of the sheath length and the needle length to enable the user to adiust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet which is removed for aspiration. The device is supplied with an adaptor which allows the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to be connected to the endoscope's accessory channel. The device is also supplied with a syringe that is used to aspirate the specimen.
Based on the provided text, the Cook EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is a Fine Needle Aspiration (FNA) device. The information provided focuses on its substantial equivalence to predicate devices and its indications for use, rather than a clinical study establishing specific performance metrics against defined acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not explicitly present in the given text. The document is a 510(k) summary for premarket notification, which typically focuses on demonstrating substantial equivalence through non-clinical testing and comparison with legally marketed predicate devices, rather than detailed performance studies with clinical endpoints and statistical significance.
Here's a breakdown of what can be extracted and what is not available from the provided input:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document implies general safety and effectiveness.
- Reported Device Performance: The primary "performance data" mentioned is that "Non-clinical testing was carried out on the device to determine the equivalence of the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to the predicate devices to provide assurance of safety and effectiveness." Specific numerical results of this non-clinical testing are not provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided. The text only mentions "Non-clinical testing."
- Data Provenance: Not provided, as this was non-clinical testing likely conducted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Since the document only mentions "Non-clinical testing" for equivalence and does not describe clinical studies requiring expert ground truth, this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication is described.
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. This is not an AI-assisted device and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a physical medical device (an aspiration needle), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As the performance data is based on "non-clinical testing" to demonstrate "equivalence" to predicate devices, there's no mention of clinical ground truth like pathology or outcomes. It likely involved comparisons of physical characteristics, materials, and functional aspects in a laboratory setting against the predicate devices.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.