(202 days)
The KSEA flexible hysteroscope is intended for hysteroscopy.
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.
The provided document is a 510(k) summary for a Karl Storz 10.5 Fr. Flexible Hysteroscope. This document does not contain any information about acceptance criteria or a study proving device performance against such criteria.
The document primarily focuses on:
- Device Identification: Common and trade names, indication, and a brief description.
- Substantial Equivalence Claim: Stating that the device is substantially equivalent to predicate devices and that minor differences do not raise new safety or effectiveness issues.
There is no mention of an algorithm, AI, or any performance metrics that would require a study with sample sizes, ground truth establishment, or expert adjudication. Therefore, I cannot generate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement.
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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
000084
§ 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.