(147 days)
Baxter Healthcare Corp. LE PTA Catheter, Conceptus Fallopian Tube Catheterization System, OvaMed GyneSys Dx Uterine Ostial Access Catheter, OvaMed Saratoga Modular Miniature Endoscope System, Optimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes
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No
The summary does not mention any AI or ML terms, image processing, or descriptions of training/test sets typically associated with AI/ML development. The device description focuses on physical components and access/evaluation functions.
No
The device is indicated for "evaluation of occlusions" in the fallopian tube, which describes a diagnostic purpose rather than a therapeutic one.
Yes
The device is indicated for "evaluation of occlusions in the fallopian tube," which is a diagnostic purpose.
No
The device description explicitly lists hardware components: "Linear Everting (LE) Fallopian Tube Access Catheter" and "Falloposcope".
Based on the provided information, the Imagyn Falloposcopy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intratubal catheterization for evaluation of occlusions in the fallopian tube." This describes a procedure performed within the body (in vivo) to visualize and assess the fallopian tubes.
- Device Description: The components are a catheter and a falloposcope, which are instruments used for direct visualization and access within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body (in vitro) to provide information about a person's health. The description of the Imagyn Falloposcopy System does not involve the analysis of any biological samples.
Therefore, the Imagyn Falloposcopy System is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube.
Product codes
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Device Description
The Imagyn Falloposcopy System consists of the following components: Linear Everting (LE) Fallopian Tube Access Catheter, Falloposcope
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fallopian tube
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use.
Key Metrics
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Predicate Device(s)
Baxter Healthcare Corp. LE PTA Catheter, Conceptus Fallopian Tube Catheterization System, OvaMed GyneSys Dx Uterine Ostial Access Catheter, OvaMed Saratoga Modular Miniature Endoscope System, Optimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only
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§ 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.
0
FEB
510(k) Summary
| Submitted By: | Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677-3917
(714) 362-2500
Contact: Debra A. Rinderer |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | September 5, 1996 |
| Device: | Imagyn Falloposcopy System |
| Predicate Devices: | Baxter Healthcare Corp. LE PTA Catheter
Conceptus Fallopian Tube Catheterization System
OvaMed GyneSys Dx Uterine Ostial Access Catheter
OvaMed Saratoga Modular Miniature Endoscope System
Optimed Technologies, Inc. Flexible Fiber Optic Hysteroscopes |
| Device Description: | The Imagyn Falloposcopy System consists of the following components:
Linear Everting (LE) Fallopian Tube Access CatheterFalloposcope |
| Intended Use of Device: | The Imagyn Falloposcopy System is indicated for intratubal catheterization for evaluation of occlusions in the fallopian tube. |
| Technological Comparisons: | The device has equivalent technological characteristics to the predicate devices to achieve intratubal catheterization for evaluation of occlusions in the fallopian tube. |
| Performance Summary: | Clinical and non-clinical tests were performed to demonstrate that the device performed according to its description and intended use. |
Imagyn Medical, Inc. 27651 La Paz Road
Laguna Niguel, CA 92677 Tel: (714) 362-2500
Fax: (714) 362-2520
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