(167 days)
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No
The device description and performance studies focus on the optical and mechanical characteristics of a rigid fiberoptic hysteroscope, with no mention of AI, ML, or image processing capabilities.
No
This device is for "viewing" and performing "diagnostic and surgical procedures," which points to a diagnostic and procedural role, not primarily therapeutic. While surgical procedures can be therapeutic, the device itself is a viewing tool.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the purpose of performing diagnostic and surgical procedures."
No
The device description clearly outlines physical components such as a stainless steel shaft, fiberoptic bundles, lenses, and an eyepiece, indicating it is a hardware device.
Based on the provided information, the MicroSpan Hysteroscope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." This describes a device used for direct visualization and intervention within the body, not for testing samples in vitro (outside the body).
- Device Description: The description details a rigid, fiberoptic hysteroscope with components for illumination and imaging. This aligns with a surgical/diagnostic instrument used for internal examination.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MicroSpan Hysteroscope is a tool for direct visualization and procedural intervention.
N/A
Intended Use / Indications for Use
The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
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Device Description
The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the 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
Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its thermal characteristics and biocompatibility.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its thermal characteristics and biocompatibility.
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.
Imagyn Hysteroscope, Imagyn MicroLap Laparoscope, Karl Storz Miniscope Straight Forward Telescope, Optimed Technologies Rigid Fiber Optic Hysteroscope
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.
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| OCT 1 5 1996 | 510(k) Summary | K9616 88 |
|---|---|---|
| Submitter: | Imagyn Medical, Inc. | |
| 27651 La Paz Road | ||
| Laguna Niguel, CA 92656-3917 | ||
| (714) 362-2500 | ||
| Contact: Debra A. Rinderer | ||
| Summary Preparation: | April 30, 1996 | |
| Device: | MicroSpan Hysteroscope | |
| Predicate Devices: | Imagyn Hysteroscope | |
| Imagyn MicroLap Laparoscope | ||
| Karl Storz Miniscope Straight Forward Telescope | ||
| Optimed Technologies Rigid Fiber Optic Hysteroscope | ||
| Device Description: | The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptic | |
| hysteroscope without through lumens. The device consists of an outer | ||
| stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At | ||
| one end of the imaging bundle is the distal lens and at the other is the rotatable | ||
| eyepiece. An endoscopic light source is connected to the light post of the | ||
| hysteroscope through compatible light cables. If desired, the eyepiece can be | ||
| connected through a focusing optical coupler to a camera head which carries | ||
| the image by cable to the camera. | ||
| Intended Use of Device: | The MicroSpan Hysteroscope is used to permit viewing of the cervical canal | |
| and the uterine cavity for the purpose of performing diagnostic and surgical | ||
| procedures. | ||
| Technological Comparisons: | Light from a high intensity light source (e.g. xenon) is transmitted through | |
| illumination fibers to the distal end of the hysteroscope in order to illuminate | ||
| the target object. The distal lens system focuses the image of the object onto | ||
| image fibers, which then transmits the image to the proximal lens system. The | ||
| proximal lens system magnifies and focuses the image onto an eyepiece at the | ||
| proximal end of the hysteroscope for viewing and/or directly to standard | ||
| video cameras, monitors and recording equipment. The MicroSpan | ||
| Hysteroscope and the predicate devices all have equivalent technological | ||
| characteristics. | ||
| Performance Summary | Non-clinical tests were performed to demonstrate that the device performed | |
| according to its description. Testing included evaluation of optical and | ||
| mechanical characteristics of the device and the effect of simulated reuses on | ||
| these characteristics. The device was also evaluated for its thermal | ||
| characteristics and biocompatibility. |
..............................................................................................................................................................................
Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677
Laguna Niguel, CA 92677
Tel: (714) 362-2500 Fax:(714) 362-2520