(195 days)
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No
The summary describes a manually operated, reusable surgical device (arthroscope) with adjustable magnification. There is no mention of image processing, AI, ML, or any data-driven components.
No.
The device is described as a magnifying arthroscope used for visualization and diagnosis, not for providing a therapeutic effect or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "illumination and visualization of the hip joint to diagnose disease."
No
The device description explicitly states it is a "manually operated, reusable surgical device consisting of a rigid arthroscope with a ring for adjusting the magnification of the image" and mentions "surgical grade stainless steel" as body contact materials. This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device description: The KSEA magnifying arthroscopes are described as surgical devices used during arthroscopic procedures. They are used to visualize the inside of joints directly, not to analyze specimens taken from the body.
- Intended Use: The intended use clearly states they are for use by surgeons during arthroscopic procedures to diagnose disease and remove loose bodies. This is a surgical intervention and visualization tool, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the KSEA magnifying arthroscopes are surgical instruments, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint".
Product codes
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Device Description
The KSEA magnifying arthroscopes are manually operated, reusable surgical devices consisting of a rigid arthroscope with a ring for adjusting the magnification of the image The arthroscopes are long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
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
small and large joints, shoulder, knee, elbow, ankle, wrist, jaw, hip joint
Indicated Patient Age Range
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Intended User / Care Setting
qualified surgeons
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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§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.
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Karl Storz Endoscopy-America. Inc 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Free 800 421 0837 Fax 310 410 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENE
This summary of 510(k) safety and effectiveness information is being submitted in accordan 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
OCT 1 0 1996
Contact:
Marika Anderson Senior Regulatory Affairs Specialist
Device Identification:
Common Name Arthroscope Trade Name Karl Storz Magnifying Arthroscope
Indication: The KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint".
Device Description: The KSEA magnifying arthroscopes are manually operated, reusable surgical devices consisting of a rigid arthroscope with a ring for adjusting the magnification of the image The arthroscopes are long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA magnifying arthroscopes and accessories are 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 magnifying arthroscopes 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: Maika Anderson
Marika Anderson Senior Regulatory Affairs Specialist