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K Number
K012358
Device Name
CHIBA NEEDLE
Manufacturer
ISPG, INC.
Date Cleared
2001-10-15

(82 days)

Product Code
FCG
Regulation Number
876.1075
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
Predicate For
K052435
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Chiba needles are used in a variety of procedures including biopsy, nerve block, pericardiocentesis, transhepatic cholorangiography as well as other applications where injection and/or aspiration of fluids are required.

Device Description

Chiba Needle

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Chiba Needle." This letter confirms the device's substantial equivalence to legally marketed predicate devices and permits its marketing.

However, this document does not contain the information required to answer your questions about acceptance criteria, device performance, study details, ground truth, or sample sizes.

The letter is a regulatory approval document and does not include the results of performance studies, details about test sets, expert qualifications, or ground truth establishment. It merely states that the device is substantially equivalent for the stated indications for use.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer any of the specific questions (1-9) based on the input text.

§ 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.