(219 days)
The Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological analysis.
The Windy Hill Technology Fuii Catheter is a dual lumen device with a flexible shaft. The hub located at the proximal end of the Fuii Catheter has two branches which each correspond with a single port. The entry port is used for saline or contrast infusion and is marked with an arrow pointing in the distal direction of the catheter. The corresponding entry lumen is located at the distal end of the catheter, adjacent to the 1 cm marker. The exit port is used for fluid collection and for quidewire introduction and is marked with an arrow pointing in the proximal direction of the catheter. The corresponding exit lumen is located at the distal tip of the catheter. The device is provided sterile and is intended for single use only.
This document describes a medical device, the Windy Hill Technology Fuji Catheter, submitted for 510(k) clearance, which is a premarket submission made to FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). Therefore, the provided text does not contain information about acceptance criteria or a study designed to prove a device meets specific performance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.
Based on the provided text, here’s a breakdown of the information that is available, and what is not:
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A table of acceptance criteria and the reported device performance: Not applicable. This document is for a 510(k) submission for a manual surgical instrument, not a device with quantifiable performance metrics like sensitivity/specificity that would require acceptance criteria in this format. The submission relies on demonstrating substantial equivalence to predicate devices through laboratory, preclinical, and clinical testing in terms of safety and effectiveness for its intended use.
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "clinical testing was conducted to evaluate human use of the device in pre-mastectomized or lumpectomized breasts," but the number of subjects is not provided.
- Data Provenance: The preclinical testing used a "human cadaver model." The clinical testing was on "pre-mastectomized or lumpectomized breasts" (implying human subjects, and likely prospective data collection for the study). Country of origin is not specified, but the applicant (Windy Hill Technology, Inc.) is based in Menlo Park, California, USA, suggesting the studies likely occurred in the USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. For a manual surgical instrument, "ground truth" in the context of diagnostic accuracy (like for an imaging AI) is not the relevant paradigm. The "clinical testing" would likely focus on ease of use, safety, and ability to perform the intended function (e.g., successful contrast delivery, successful fluid collection), which would be observed and assessed by medical professionals during the procedure, rather than establishing a diagnostic ground truth against which the device's output is compared.
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Adjudication method for the test set: Not applicable/not provided. Since this is not a diagnostic reader study, an adjudication method for reconciling expert opinions on diagnostic outcomes is not relevant here.
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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 "manual surgical instrument," not an AI or imaging device designed to be read by human readers. Therefore, an MRMC study and AI assistance are not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical instrument, not an algorithm.
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The type of ground truth used: For the clinical testing, the "ground truth" would be related to the successful performance of the device's intended functions (contrast enhanced radiography of breast milk ducts, collection of cells/fluid for cytological evaluation) and safety observations, rather than a diagnostic 'ground truth' in the sense of a disease state. Pathology or cytological evaluation of collected samples would be considered the ground truth for the use of the device in collecting samples, but not for the device's intrinsic function itself.
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set. The "testing" mentioned refers to traditional engineering, preclinical, and clinical evaluations.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 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.