(475 days)
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No
The summary describes a rigid telescope for viewing during surgical procedures, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is used for "viewing of the site during laparoscopic and hysteroscopic surgical procedures," indicating a diagnostic or procedural assistance role, not a direct therapeutic intervention.
No
The device is described as "designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures." It is a tool for visualization during surgery, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "straight-shafted, rod lens-type rigid telescope," which is a hardware component.
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 the site during laparoscopic and hysteroscopic surgical procedures." This describes a device used in vivo (within the body) for direct visualization during surgery.
- Device Description: The description of a "straight-shafted, rod lens-type rigid telescope" aligns with a surgical endoscope, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for clinical purposes. This device is used for direct visualization during surgery.
N/A
Intended Use / Indications for Use
The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Karl Storz devices are straight-shafted, rod lens-type rigid telescopes. All body contact materials are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility 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 (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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§ 884.1720 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.
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Image /page/0/Picture/0 description: The image shows a grainy, black and white photo of a document. The document has some dark smudges and spots scattered across the top half. In the bottom right corner, the text "K950" is visible in a bold, sans-serif font.
600 Corp
Karl Storz Endoscopy America, Inc.
600 Corporate Culver City, California 90230-760() Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
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MAY 1 6 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
The Karl Storz Rigid Telescopes for Obstetrics and Gynecology and their predicate devices are designed to allow viewing of the site during laparoscopic and hysteroscopic surgical procedures. The Karl Storz devices are straight-shafted, rod lens-type rigid telescopes. All body contact materials are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use.
The Karl Storz Rigid Telescopes for Ob/Gyn 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 Rigid Telescopes for Ob/Gyn 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.