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K Number
K963580
Device Name
IMAGYN FALLOPOSCOPY SYSTEM
Manufacturer
IMAGYN MEDICAL, INC.
Date Cleared
1997-01-31

(147 days)

Product Code
MKO
Regulation Number
884.1690
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.

Device Description

The Imagyn Falloposcopy System consists of the following components:
Linear Everting (LE) Fallopian Tube Access Catheter
Falloposcope

AI/ML Overview

I am sorry, but the provided text does not contain sufficient information to describe the acceptance criteria and the study that proves the device meets those criteria in the structured format you requested.

The document is a 510(k) summary for the Imagyn Falloposcopy System and primarily focuses on:

  • Identification of the device and manufacturer.
  • Identification of predicate devices.
  • Description of the device and its intended use.
  • Technological comparisons to predicate devices.
  • A general statement that "Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use."

However, it does not provide details on:

  • Specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
  • Any performance metrics achieved by the device.
  • Sample sizes for test sets or training sets.
  • Data provenance.
  • The number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Whether MRMC studies were performed.
  • Whether standalone algorithm performance was assessed (the device described is a physical medical device, not an AI algorithm).
  • The type of ground truth used (beyond the general statement of "clinical tests").
  • How ground truth for the training set was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study design with the given input.

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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 § 884.9.