(66 days)
The Tru-Core™ I Reusable Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
Our company is presently authorized by the Food and Drug Administration to manufacture a reusable handle gun K962969 that utilizes the same disposable soft tissue biopsy needles as the disposable version of this gun, K982960. This new device has the same operation and firing cycle as the disposable gun, but is intended to be reusable, as in the gun submitted under K962969. This new device will also utilize the same disposable soft tissue biopsy needles.
The biopsy needle is guided into position utilizing external guidance (Ultrasound, Mammography, etc.). The device consists of a spring powered, reusable handle, and a disposable needle set. To operate, the needle set is loaded into the reusable handle, the device is "cocked", then "fired" into the appropriate site, and tissue (specimen) is retrieved from the needle set for laboratory evaluation and diagnosis. Specifically, when "fired", the inner part of the needle set (stylet) moves forward first, penetrating the biopsy site. Tissue fills a "slot" at the tip of the stylet. Then the outer part of the needle set (cutting cannula) advances forward slicing off the tissue in the slot and enclosing it during removal from the patient. The tissue specimen is removed from the stylet slot after placing the device in the sample retrieval position. The procedure is repeated for additional biopsies, if dictated by the physician
The provided text is a 510(k) summary for the MD Tech Tru-Core™ I Reusable Biopsy Instrument. It does not contain information about acceptance criteria, a specific study proving the device meets criteria, sample sizes for test sets or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.
Instead, the document focuses on:
- Device Description: Explaining the operation and components of the reusable biopsy instrument.
- Substantial Equivalence: Comparing the new device to previously cleared devices (K962969 and K982960) by the same company. The core claim is that it has the "same operation and firing cycle" as the disposable gun and is "intended to be reusable, as in the gun submitted under K962969."
- Indications for Use: Defining for what medical purposes the device is intended (obtaining multiple core samples from soft tissue like liver, kidney, prostate, breast, and various soft tissue lesions, but not bone).
- FDA Clearance: An FDA letter confirming the review of the 510(k) notification and a determination of substantial equivalence to legally marketed predicate devices.
Therefore, I cannot provide the requested information as it is not present in the given text. The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific performance metrics and acceptance criteria in the manner requested.
§ 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.