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K Number
K973128
Device Name
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1997-11-18

(89 days)

Product Code
FOG
Regulation Number
868.5700
Type
Traditional
Panel
AN
Reference & Predicate Devices
K904667
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).

Device Description

Olympus NA-10J-1 Aspiration Needle

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Olympus NA-10J-1 Aspiration Needle) and does not contain information about acceptance criteria or a study proving device performance in the context of AI/algorithm-based diagnostic devices.

The provided document is a regulatory submission for a physical medical device (an aspiration needle) and focuses on establishing substantial equivalence to a predicate device for market clearance. It primarily covers:

  • Device Name and Intended Use: Specifies the Olympus NA-10J-1 Aspiration Needle for ultrasonically guided fine needle aspiration (FNA) of lesions.
  • Regulatory Classification: Identifies the classification name (Gastroenterology-Urology Biopsy Instruments) and product code (78 FOG).
  • Predicate Device: States the Olympus NA-1C Aspiration Needle (K904667) as the predicate.
  • FDA Clearance Letter: Confirms the FDA's review and determination of substantial equivalence, allowing the device to be marketed.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/algorithm-based device is not present in this document. This document describes a traditional medical device, not an AI/ML diagnostic system.

§ 868.5700 Nonpowered oxygen tent.

(a)
Identification. A nonpowered oxygen tent is a device that encloses a patient's head and upper body to contain oxygen delivered to the patient for breathing. This generic type of device includes infant oxygen hoods.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.