(49 days)
Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Olympus EBUS scopes: This device is used to sample targeted submucal lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).
Echotip® Ultra Endobronchial High Definition Ultrasound Needle for use with Pentax EBUS scopes: This device is used to sample targeted submucal lesions within or adjacent to the tracheobronchial tree through the accessory channel of an ultrasound endoscope for Fine Needle Aspiration (FNA).
Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Olympus EBUS scopes: This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract.
Echotip Procore® Endobronchial High Definition Ultrasound Biopsy Needle for use with Pentax EBUS scopes: This device is used with an ultrasound endoscope for fine needle biopsy. (FNB), of submucosal and extramural lesions within or adjacent to the tracheobronchial tree.
The Echotip Ultra/ Procore Endobronchial High Definition Ultrasound Needle is used in conjunction with an endobronchial ultrasound endoscope and is available with needle gauge sizes of 22 and 25 Ga. The device is composed of a needle assembly and a syringe. An adapter can also be supplied for use with endobronchial ultrasound endoscopes with metal non-Luer hubs. The stainless steel needle cannula has a dimpling pattern on the distal end to allow visualization of the needle tip under endoscopic ultrasound. The needle cannula has a bevelled tip design and comes either with or without an additional cutting surface on the distal end of the needle cannula. The purpose of the needle cannula is for puncturing/ sampling of the target site. The needle is provided with a preloaded stylet which remains in place during advancement of the needle. The sheath covers the needle when the needle is retracted and not in use. The device handle allows for needle and sheath length adjustment. The stylet/ syringe can aid in specimen retrieval. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.
The provided document is a 510(k) Pre-Market Notification for a medical device (Echotip Ultra and Echotip Procore Endobronchial High Definition Ultrasound Needles). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data to prove new acceptance criteria and device performance.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical trial report would. Instead, it focuses on non-clinical performance data supporting the device's safety and substantial equivalence to existing devices.
Here's a breakdown of what can and cannot be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity targets) or reported performance metrics that would typically be found in a clinical study report for diagnostic or prognostic devices. The performance data mentioned is non-clinical (e.g., dimensional, visual, force testing, simulated use).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "performance testing" but does not detail the sample size for a test set in the context of clinical performance (e.g., number of patients or cases). The provenance and study type (retrospective/prospective) are not mentioned as this is a non-clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Cannot be provided. Since this is a non-clinical submission for a biopsy needle, there is no "ground truth" derived from expert review of images or diagnoses. The ground truth for such devices is typically related to the physical characteristics of the tissue sample obtained and the device's mechanical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is mentioned as there's no clinical test set requiring expert consensus or a similar process.
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 a biopsy needle, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical instrument (biopsy needle), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance data mentioned, the "ground truth" would be established by various engineering and laboratory testing standards and measurements (e.g., precise measurements for dimensions, force gauges for stylet removal, direct observation of aspiration, leak testing, joint strength testing). The document states "Performance testing such as dimensional and visual inspections, stylet removal force testing, simulated use testing, device aspiration testing, endoscope evaluation and leak testing, and joint strength testing were performed as per Cook's design control system."
8. The sample size for the training set
- Not applicable. This document describes a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is relevant for this type of device.
Summary of what is present:
The document primarily focuses on demonstrating substantial equivalence to predicate devices. It lists the following non-clinical performance data that supports this claim:
- Biocompatibility evaluation: Conducted in accordance with ISO 10993-1:2009 and FDA's G95-1 guidance.
- Device-specific guidance document consultation: "Guidance for the Content of Premarket Notifications for Biopsy Devices Used in Gastroenterology and Urology."
- Performance testing:
- Dimensional and visual inspections
- Stylet removal force testing
- Simulated use testing
- Device aspiration testing
- Endoscope evaluation and leak testing
- Joint strength testing
These tests are performed as per Cook's design control system to ensure the device performs as intended and is safe, but they do not involve clinical performance metrics or expert reviews as requested in your prompt for diagnostic (e.g., imaging) devices.
§ 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.