(88 days)
This device is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
The EchoTip Procore® HD Ultrasound Biopsy Needle is used in conjunction with an ultrasound endoscope and is available with needle gauge sizes of 19, 20, 22 and 25 ga. The device comprises of a needle assembly and a syringe. The needle assembly consists of the needle cannula, stylet, sheath and handle. 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 a notch. The purpose of the needle cannula is for puncturing/biopsy of the target site. The preloaded nitinol stylet is withdrawn from the needle for biopsy. Some variants have a stylet that coils when not in the needle. The sheath covers the needle when it's not in use. The device handle allows for needle and sheath length adjustment. The syringe can aid in tissue aspiration. The device is supplied sterile and is intended for single use. The device is for Rx used only.
This document is a 510(k) premarket notification for a medical device called the EchoTip Procore® HD Ultrasound Biopsy Needle. It is not an academic study or research paper, but rather a regulatory submission to the FDA. Therefore, it does not contain the detailed information typically found in study reports regarding acceptance criteria and performance data for an AI/ML device.
Specifically, the document pertains to a physical medical device (a biopsy needle), not a diagnostic algorithm or AI/ML-driven device. As such, the typical metrics for evaluating AI performance (such as sensitivity, specificity, AUC, MRMC studies, standalone performance, etc.) are irrelevant to this submission.
Here's a breakdown of why the requested information cannot be provided from this document:
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Acceptance criteria and reported device performance (for AI/ML): This document deals with a physical biopsy needle. Its performance is evaluated through metrics like biocompatibility, visual inspection, dimensional inspection, simulated use, stylet removal force, and joint strength. These are mechanical and material property tests to ensure the physical device functions as intended and is safe for use, not metrics for algorithm accuracy.
- Table of acceptance criteria and reported device performance: Not applicable for AI/ML. The document states "Performance testing such as visual inspection, dimensional inspection, simulated use, stylet removal force testing and joint strength testing were performed as per Cook Ireland's design control system." Specific numerical acceptance criteria or performance results for these physical tests are not provided in this summary.
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Sample size for test set and data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The 'tests' performed are on the physical device itself (e.g., individual needles).
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Number of experts used to establish ground truth & qualifications: Not applicable. There is no ground truth, as understood in AI/ML validation, for a physical biopsy needle. Its performance is based on physical and biological characteristics.
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Adjudication method: Not applicable.
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MRMC comparative effectiveness study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.
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Standalone performance (algorithm only): Not applicable. There is no algorithm.
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Type of ground truth used: Not applicable.
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Sample size for training set: Not applicable. There is no AI model requiring a training set.
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How ground truth for training set was established: Not applicable.
Summary relevant to the provided document for a physical device:
- Acceptance Criteria: The document mentions that performance testing was conducted "as per Cook Ireland's design control system" and refers to ISO 10993-1:2009 for biocompatibility and FDA's G95-1 guidance. This implies internal, pre-defined acceptance criteria for physical, mechanical, and biological properties, but the specific numerical criteria are not detailed in this public summary.
- Reported Device Performance: The summary only states that "Non-clinical testing carried out on the device supports the substantial equivalence... and provides a reasonable assurance of safety and effectiveness." No specific performance data (e.g., exact force values, dimensional tolerances met, cytotoxicity scores) are provided.
- Study Types:
- Biocompatibility evaluation: Conducted according to ISO 10993-1:2009 and FDA's G95-1 guidance. Tests performed were Cytotoxicity, Sensitization, and Intracutaneous reactivity.
- Performance testing (physical/mechanical): Visual inspection, dimensional inspection, simulated use, stylet removal force testing, and joint strength testing.
- Purpose of the "study": To demonstrate substantial equivalence to predicate devices (Cook Endoscopic Ultrasound Needle, K083330, and Biopsy Sciences, LLC Maxi-Cell Biopsy Needle, K021847) for regulatory clearance, not to evaluate an AI algorithm.
§ 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.