(71 days)
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No
The device description explicitly states it is "manually operated" and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is used for visualization, diagnosis, and removal of loose bodies during arthroscopic procedures, which are diagnostic and surgical interventions, not therapeutic in themselves.
Yes
The "Intended Use / Indications for Use" section states: "is also for the illumination and visualization of the hip joint to diagnose disease". Diagnosing disease makes it a diagnostic device.
No
The device description explicitly lists physical components made of surgical grade stainless steel, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The KSEA Large Joint Arthroscopy Set is described as a set of manually operated surgical devices used for arthroscopic procedures and visualization of joints. These are procedures performed inside the body.
- Intended Use: The intended use is for surgical procedures (arthroscopy) and direct visualization of joints to diagnose disease and remove loose bodies. This is a direct intervention and observation within the body, not a test on a sample outside the body.
The device is a surgical instrument used for direct examination and intervention within the body, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The KSEA Large Joint Arthroscopy Set is intended for arthroscopic procedures of the shoulder, knee and is also for the 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 Karl Storz Large Joint Arthroscopy Set are manually operated surgical devices. The KSEA Large Joint Arthroscopy Set is composed of Forward-Oblique 30° enlarged view Telescopes, Lateral 70° enlarged view Telescopes, Arthroscope Sheath with sharp and blunt obturators, Grasping and Biopsy Forceps, Trocar, and Inflow Cannula. The body contact portions of the KSEA Large Joint Arthroscopy Set are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has 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
shoulder, knee, hip joint
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
STORZ
Karl Storz Endoscopy
K9635-24
510(k) SUMMARY OF SAFETY AND EFFECTIVENES
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 is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 | NOV 1 4 1996 |
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Contact:
Kevin Kennan Regulatory Affairs Specialist
Device Identification:
Arthroscope
Common Name:
Trade Name: (optional) Karl Storz Large Joint Arthroscopy Set
Indication: The KSEA Large Joint Arthroscopy Set is intended for arthroscopic procedures of the shoulder, knee and is also for the illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint.
Device Description: The Karl Storz Large Joint Arthroscopy Set are manually operated surgical devices. The KSEA Large Joint Arthroscopy Set is composed of Forward-Oblique 30° enlarged view Telescopes, Lateral 70° enlarged view Telescopes, Arthroscope Sheath with sharp and blunt obturators, Grasping and Biopsy Forceps, Trocar, and Inflow Cannula. The body contact portions of the KSEA Large Joint Arthroscopy Set are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Substantial Equivalence: The Karl Storz Large Joint Arthroscopy Set is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Large Joint Arthroscopy Set and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
ed:
Kevin Kennan
Kevin Kennan Regulatory Affairs Specialist