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K Number
K022546
Device Name
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
Manufacturer
HORIZONS INTL. CORP.
Date Cleared
2002-08-12

(11 days)

Product Code
EOQ,EOO
Regulation Number
874.4680
Type
Traditional
Panel
Ear Nose & Throat
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Horizons ANSO Transbronchial Aspiration Needle is intended to be used in the flexible endescope for submucosal aspiration biopsy of the bronchial tree.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Horizons International Corp. regarding their ANSO Transbronchial Aspiration Needle. This document determines substantial equivalence to a predicate device, allowing the manufacturer to market the device.

However, the provided document does not contain any information about acceptance criteria for the device's performance, nor does it describe any studies that prove the device meets such criteria.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness against specific performance criteria in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from the provided text. The document does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes for test sets, data provenance, or study types (retrospective/prospective).
  3. Number or qualifications of experts for ground truth.
  4. Adjudication methods.
  5. Information about MRMC comparative effectiveness studies or effect sizes.
  6. Results of standalone algorithm performance studies.
  7. The type of ground truth used.
  8. Sample size for training sets.
  9. How ground truth for training sets was established.

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.