(384 days)
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No
The summary describes a purely mechanical and optical device (fiberoptic endoscope and accessories) with no mention of software, image processing, or any terms related to AI/ML.
No
The device is used for viewing and accessing a surgical site, which is diagnostic/interventional, not therapeutic. The accessories are also for surgical procedures (forceps, scissors, probes, trocars, cannulae, and needles) indicating interventional use rather than therapeutic.
No
Explanation: The device is designed for viewing and accessing a surgical site during endoscopic procedures, which is an interventional/surgical function, not a diagnostic one.
No
The device description clearly states it is a straight-shafted, fiberoptic endoscope with physical accessories like forceps and scissors, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures." This describes a device used in vivo (within the body) for direct visualization and surgical manipulation.
- Device Description: The description of "straight-shafted, fiberoptic endoscopes" and accessories like forceps and scissors further supports its use as a surgical instrument for direct intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, for diagnostic purposes. IVDs are typically used to perform tests on these samples to provide information about a patient's health status.
Therefore, the Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are surgical endoscopes used for direct visualization and intervention during procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures.
Product codes
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Device Description
Karl Storz Semi-Rigid Micro-Endoscopes are straight-shafted, fiberoptic endoscopes. Accessories are available for use with the Micro-Endoscopes, including forceps, scissors, probes, trocars, cannulae, and needles. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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
Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '9', '5', '1', '3', '4', and '3'. The numbers are written in a simple, slightly irregular style, typical of handwriting.
APR 1 1 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺮﺍﺟﻊ
1
Image /page/1/Picture/0 description: The image shows a logo with the letters "ORZ" stacked on top of the word "Endoscopy". Above the letters is a circle with a smaller circle inside of it. Below the logo is the number "K951343" written in a handwritten style.
har > tr) Endr scopy America. Inc
600 Corporate Pointe Culver City, California 90236-7600 Phone 310 558 1500
Toll Free 800 12 0837 Fax 310 410 55:2
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 CRF 807.92. All data included in this documents 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: | Betty M. Johnson |
| Manager, Regulatory Affairs | |
| Device Identification: | Common Name: |
| fiberoptic endoscopes and accessories |
Trade Name (optional): Karl Storz Semi-Rigid Micro-Endoscopes and Accessories
Indication: The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures.
Device Description: Karl Storz Semi-Rigid Micro-Endoscopes are straight-shafted, fiberoptic endoscopes. Accessories are available for use with the Micro-Endoscopes, including forceps, scissors, probes, trocars, cannulae, and needles. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
Substantial Equivalence: The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for endoscopic gynecological surgery are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Endoscopic Gynecological Surgery 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 the devices.
Signed:
Beth M. Johnson
Betty M. Johnson Manager, Regulatory Affairs