(214 days)
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No
The summary describes a system of physical catheters, guidewires, and a microendoscope for visualization and navigation. There is no mention of AI, ML, image processing, or any software-based analysis that would suggest the use of these technologies. The performance studies focus on physical characteristics like force required for navigation.
No
The device is described as being used for "evaluating proximal tubal occlusion or patency under direct visualization," which indicates a diagnostic rather than a therapeutic purpose.
Yes.
The device is intended to "evaluate proximal tubal occlusion or patency under direct visualization," which are diagnostic activities.
No
The device description explicitly lists multiple hardware components, including catheters, guidewires, and a microendoscope.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "selective catheterization/cannulation of the fallopian tubes in order to evaluate proximal tubal occlusion or patency under direct visualization." This describes a procedure performed on the patient's body to visualize and assess the physical state of the fallopian tubes.
- Device Description: The components listed are instruments used for physical manipulation and visualization within the body (catheters, guidewires, hysteroscope, microendoscope).
- Lack of In Vitro Testing: There is no mention of testing samples (like blood, urine, tissue) outside of the body. IVDs are designed to analyze such samples to provide diagnostic information.
- Input Imaging Modality: Microendoscopy and HSG are imaging techniques performed in vivo (within the living body).
In summary, the Conceptus FTCM System is a medical device used for a diagnostic procedure performed directly on the patient, not for analyzing samples in a laboratory setting, which is the hallmark of an IVD.
N/A
Intended Use / Indications for Use
The Conceptus FTCM System is intended for use in selective catheterization/cannulation of the fallopian tubes in order to evaluate proximal tubal occlusion or patency under direct visualization.
Product codes
Not Found
Device Description
The FTCM System combines well-established procedures of HSG, co-axial catheterization and microendoscopy. The FTCM System is composed of the following components: Soft Seal Cervical Catheter, Soft Torque Uterine Catheter and Accessory Valve, and/or Articulating Tip Hysteroscope, Variable Softness Catheter, guidewires: the Robust Guidewire, the Traveler Guidewire, the Supple Guidewire and the Pirouette Guidewire, and a Microendoscope with Eyepiece. Each component is described below;
Soft Seal Cervical Catheter a.
The Soft Seal Cervical Catheter is a dual lumen device with a latex balloon located at the distal end. The Cervical Catheter is packaged with a malleable Obturator which can be shaped with a gentle curve and will increase column strength of the catheter when inserted completely into the Cervical Catheter. The proximal end of the Cervical Catheter has two ports, one to inflate the balloon and one to access the through-lumen. A two-way stopcock on the balloon port maintains inflation during use. The through-lumen allows injection of dye, contrast medium, or sperm into the uterus and/or serves as a conduit for the Obturator and/or Conceptus Uterine Catheter.
Soft Torque Uterine Catheter, Mandrel and Accessory Valve b.
The Soft Torque Catheter serves as a conduit to the proximal portion of the fallopian tube for the Conceptus Variable Softness Catheter, Guidewire and Microendoscope. The Soft Torque Catheter is a single lumen device with a curved distal tip. The Catheter is packaged with a Mandrel which will straighten the tip curve when inserted completely into the catheter. The hub located at the proximal end of the Catheter has two ports. The side port is used for the attachment of a syringe for injection and is in the same plane and direction as the tip curve. The end port is used for introduction of the Mandrel and / or Variable Softness Catheter and has a valve to prevent reflux during injection. The Soft Torque Catheter can access the utero-tubal ostium through a rigid hysteroscope with direct visualization.
C. Articulating Tip Hysteroscope
The Articulating Tip Hysteroscope is used to permit direct viewing of the cervical canal, the uterine cavity and utero-tubal ostium by a telescopic system introduced into the uterus through the cervix. The scope has a rigid shaft with a flexible articulating tip. The device is equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user's eye or to a video camera.
Variable Softness Catheter d.
The Variable Softness Catheter is an over-the-wire catheter which is intended to access the proximal portion of the fallopian tube. The catheter is used through the Conceptus Soft Torque Uterine Catheter or Articulating Tip Hysteroscope. It is a single lumen 3 French (1 mm) catheter with graded shaft flexibility. The hub located at the proximal end of the catheter has two ports. The side port is used for the attachment of an irrigation tube or a syringe for injection. The is used for introduction of the guidewire and endport microendoscope and has a valve to prevent reflux during injection of dye and/or irrigation fluid. The catheter has a proximal marker which indicates when the Conceptus Variable Softness Catheter is about to exit the Conceptus Soft Torque Catheter.
Guidewire e.
The Conceptus Guidewires are intended for use to increase column strength of the Variable Softness Catheter during positioning within the proximal portion of the fallopian tube. The guidewires have a tapered core wire and a distal coil section for flexibility, and a proximal handle to lock the guidewire into position with the Variable Softness Catheter. The two models differ only with respect to the wire diameter profile and the mid-to-distal coil length. This difference in taper and coil lengths imparts varying degrees of flexibility to the guidewire, and guidewire selection will be based on physician preference.
f. Microendoscope
The Conceptus Microendoscope is an ultra-thin, flexible fiberscope designed for use with the Conceptus Variable Softness Catheter. It is to be used with a Conceptus Eyepiece which is detachable and has adjustable focus. The microendoscope is equipped with a separate image plug and light plug. The light plug has an ACMI-type male The length of the cable provides easy handling when connector. imaging on a television monitor.
Eyepiece g .
The Conceptus detachable Eyepiece is designed to fit onto the image plugs of the Conceptus Microendoscope. The Eyepiece has an adjustable focus and an alignment marker on its tip. The cleaning plug should always be inserted for cleaning and storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fallopian tubes, cervical canal, uterine cavity, utero-tubal ostium
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance testing demonstrated that the Conceptus FTCM System is substantially equivalent to the Conceptus FTC System with respect to force required to navigate the fallopian tube model. Additionally, performance testing and clinical data were provided for the Conceptus FTCM System which further substantiated equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS XVI.
Contact Person
Nancy Naddaff Clinical Research and Regulatory Affairs Specialist Conceptus, Inc. 1021 Howard Avenue San Carlos, CA 94070
Device Description
The FTCM System combines well-established procedures of HSG, co-axial catheterization and microendoscopy. The FTCM System is composed of the following components: Soft Seal Cervical Catheter, Soft Torque Uterine Catheter and Accessory Valve, and/or Articulating Tip Hysteroscope, Variable Softness Catheter, guidewires: the Robust Guidewire, the Traveler Guidewire, the Supple Guidewire and the Pirouette Guidewire, and a Microendoscope with Eyepiece. Each component is described below;
Soft Seal Cervical Catheter a.
The Soft Seal Cervical Catheter is a dual lumen device with a latex balloon located at the distal end. The Cervical Catheter is packaged with a malleable Obturator which can be shaped with a gentle curve and will increase column strength of the catheter when inserted completely into the Cervical Catheter. The proximal end of the Cervical Catheter has two ports, one to inflate the balloon and one to access the through-lumen. A two-way stopcock on the balloon port maintains inflation during use. The through-lumen allows injection of dye, contrast medium, or sperm into the uterus and/or serves as a conduit for the Obturator and/or Conceptus Uterine Catheter.
Soft Torque Uterine Catheter, Mandrel and Accessory Valve b.
The Soft Torque Catheter serves as a conduit to the proximal portion of the fallopian tube for the Conceptus Variable Softness Catheter, Guidewire and Microendoscope. The Soft Torque Catheter is a single lumen device with a curved distal tip. The Catheter is packaged with a Mandrel which will straighten the tip curve when inserted completely into the catheter. The hub located at the proximal end of the Catheter has two ports. The side port is used for the attachment of a syringe for injection and is in the same plane and direction as the tip curve. The end port is used for introduction of the Mandrel and / or Variable Softness Catheter and has a valve to prevent reflux during injection. The Soft Torque Catheter can access the utero-tubal ostium through a rigid hysteroscope with direct visualization.
C. Articulating Tip Hysteroscope
The Articulating Tip Hysteroscope is used to permit direct viewing of the cervical canal, the uterine cavity and utero-tubal ostium by a telescopic system introduced into the uterus through the cervix. The scope has a rigid shaft with a flexible articulating tip. The device is
1
equipped with a separate eyepiece plug and light guide plug. The optical system conveys an image to the user's eye or to a video camera.
Variable Softness Catheter d.
The Variable Softness Catheter is an over-the-wire catheter which is intended to access the proximal portion of the fallopian tube. The catheter is used through the Conceptus Soft Torque Uterine Catheter or Articulating Tip Hysteroscope. It is a single lumen 3 French (1 mm) catheter with graded shaft flexibility. The hub located at the proximal end of the catheter has two ports. The side port is used for the attachment of an irrigation tube or a syringe for injection. The is used for introduction of the guidewire and endport microendoscope and has a valve to prevent reflux during injection of dye and/or irrigation fluid. The catheter has a proximal marker which indicates when the Conceptus Variable Softness Catheter is about to exit the Conceptus Soft Torque Catheter.
Guidewire e.
The Conceptus Guidewires are intended for use to increase column strength of the Variable Softness Catheter during positioning within the proximal portion of the fallopian tube. The guidewires have a tapered core wire and a distal coil section for flexibility, and a proximal handle to lock the guidewire into position with the Variable Softness Catheter. The two models differ only with respect to the wire diameter profile and the mid-to-distal coil length. This difference in taper and coil lengths imparts varying degrees of flexibility to the guidewire, and guidewire selection will be based on physician preference.
f. Microendoscope
The Conceptus Microendoscope is an ultra-thin, flexible fiberscope designed for use with the Conceptus Variable Softness Catheter. It is to be used with a Conceptus Eyepiece which is detachable and has adjustable focus. The microendoscope is equipped with a separate image plug and light plug. The light plug has an ACMI-type male The length of the cable provides easy handling when connector. imaging on a television monitor.
Eyepiece g .
The Conceptus detachable Eyepiece is designed to fit onto the image plugs of the Conceptus Microendoscope. The Eyepiece has an adjustable focus and an alignment marker on its tip. The cleaning plug should always be inserted for cleaning and storage.
Indications for Use
The Conceptus FTCM System is intended for use in selective catheterization/cannulation of the fallopian tubes in order to evaluate proximal tubal occlusion or patency under direct visualization.
2
K962587
P3993
Substantial Equivalence
The Conceptus FTCM System is substantially equivalent to the Conceptus FTC System. Comparative performance testing demonstrated that the Conceptus FTCM System is substantially equivalent to the Conceptus FTC System with respect to force required to navigate the fallopian tube model. Additionally, performance testing and clinical data were provided for the Conceptus FTCM System which further substantiated equivalence.