(202 days)
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No
The summary describes a manually operated, reusable flexible fiberscope with a working channel. There is no mention of image processing, AI, ML, or any computational analysis of data.
Yes
The device is described as a 'flexible hysteroscope' used for 'hysteroscopy', which is a medical procedure to examine or treat the uterus, indicating a therapeutic purpose.
No
The device description states it is a "reusable surgical device" and is "intended for hysteroscopy," which implies a procedural or interventional use rather than diagnosing a condition.
No
The device description explicitly states it is a "flexible fiberscope with working channel," indicating it is a physical 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 hysteroscopy," which is a procedure performed directly on the patient's body to visualize the uterus.
- Device Description: The description clearly states it's a "manually operated, reusable surgical device consisting of a flexible fiberscope with working channel." This describes a surgical instrument used for direct visualization and potentially intervention within the body.
- Anatomical Site: The anatomical site is the "uterus," which is an internal organ within the body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. This device is used on the body for direct visualization.
N/A
Intended Use / Indications for Use
The KSEA flexible hysteroscope is intended for hysteroscopy.
Product codes
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Device Description
The KSEA 10.5 Fr. flexible hysteroscope is a manually operated, reusable surgical device consisting of a flexible fiberscope with working channel The instrument is long enough to gain access to the uterus.
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
uterus
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.
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Image /page/0/Picture/0 description: The image appears to be a black and white abstract pattern. The pattern is composed of small, irregular black shapes scattered across a white background. The density of the black shapes varies across the image, with some areas having a higher concentration than others. The overall effect is a textured, grainy appearance.
Image /page/0/Picture/1 description: The image shows a date stamp that reads "NOV 13 1986". The text is in a bold, sans-serif font and is printed in black ink. The date is likely stamped on a document or photograph. The image quality is poor, with some blurring and distortion.
Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
oll Free 800 421 0837 Fax 310 410 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR. 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Manager, Regulatory Affairs
Betty M. Johnson
Device Identification:
Common Name Hysteroscope, Flexible Fiber Optic Endoscope. Flexible Fiberscope, Flexible Hysterofiberscope Trade Name Karl Storz 10.5 Fr. Flexible Hysteroscope
Indication: The KSEA flexible hysteroscope is intended for hysteroscopy.
Device Description: The KSEA 10.5 Fr. flexible hysteroscope is a manually operated, reusable surgical device consisting of a flexible fiberscope with working channel The instrument is long enough to gain access to the uterus.
Substantial Equivalence: The KSEA 10.5 Fr. flexible hysteroscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA 10.5 Fr. flexible hysteroscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
Betty M. Johnson
Betty M. Johnson
anager, Regulatory Affairs
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