(159 days)
The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.
The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.
The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.
The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.
The provided text is a 510(k) premarket notification letter from the FDA for the TAO ASPIRATOR™ and PLASTIC FINGER™. This document confirms the substantial equivalence of the devices to legally marketed predicates and outlines their indications for use.
Crucially, the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.
The 510(k) clearance process focuses on substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. While a manufacturer would typically have internal testing and validation data to support their 510(k) submission, this specific FDA letter does not describe or summarize those studies or their acceptance criteria.
Therefore, I cannot provide the requested information based on the given input. The categories in your request (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are all relevant to study design and results, which are not present in this regulatory correspondence.
§ 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.