(189 days)
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No
The summary describes a standard hysteroscope with a telescopic system for direct viewing, and there is no mention of AI, ML, or image processing capabilities.
No
The device is used for direct viewing and image acquisition within the body for diagnostic and operative procedures, but its description does not indicate it delivers any form of therapy on its own.
Yes
The "Intended Use / Indications for Use" states that the hysteroscope is used for "both diagnostic and operative procedures," indicating its role in diagnosis.
No
The device description clearly outlines a physical, rigid shaft with an articulating tip, eyepiece, and light guide, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct viewing of the cervical canal and uterine cavity for diagnostic and operative procedures. This involves visualizing internal structures within the body.
- Device Description: The device is a hysteroscope, which is a medical instrument used for direct visualization of the uterus. It uses a telescopic system and light.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device is used inside the body for direct observation.
Therefore, the Conceptus hysteroscope is a medical device used for internal visualization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Conceptus hysteroscope 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical canal and the uterine cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
MAR 12 1996
Image /page/0/Picture/1 description: The image shows the word "Conceptus" in a stylized, outlined font. Each letter is formed by two parallel lines, creating a hollow effect. The word is presented in a horizontal arrangement, with the letters evenly spaced and of uniform size.
Conceptus Hysteroscope Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The Conceptus hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix for both diagnostic and operative procedures.
The Conceptus hysteroscope 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.
The intended use, optics, design, materials, specifications and mode of operation of the Conceptus Hysteroscope were found to be substantially equivalent to several predicate hysteroscopes,
Ka54164
Conceptus, Inc.• 1021 Howard Avenue, San Carlos, CA 94070 Phone:415/802-7240 Fax:415/802-7272
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