VACUUM ASSISTED CORE BIOPSY DEVICE

• K Number: K034021
• Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer: SUROS SURGICAL SYSTEMS, INC.
• Date Cleared: 2004-09-08 ( 259 days)
• Product Code: KNW
• Regulation Number: 876.1075
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and callors on such organs as also earlier, of breast biopsy, the product is for diagnosis only.

Device Description

Vacuum Assisted Spring Loaded Core Biopsy Device

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) letter dated September 8, 2004, for the "Vacuum Assisted Spring Loaded Core Biopsy Device" (K034021) does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

This letter is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device. It briefly mentions the indications for use but does not delve into the underlying studies or data that would typically be included in a scientific publication or a more detailed regulatory submission summary.

Therefore, I cannot fulfill your request for the specific details about the acceptance criteria and the study that proves the device meets them based on the provided input.

Regulation Number and Section

§ 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.