(29 days)
Not Found
Not Found
No
The description focuses on manually operated surgical instruments and does not mention any AI/ML components or functionalities.
Yes.
The device is designed to "treat vertebral disc herniations", indicating a therapeutic purpose.
No.
The device is described as an instrument set for treating vertebral disc herniations, designed for visualization and treatment, not for diagnosing a condition.
No
The device description explicitly states it is a set of manually operated, reusable surgical instruments made of physical materials like stainless steel and brass, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure to visualize and treat vertebral disc herniations in the body. IVDs are designed to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The description lists surgical instruments used for direct intervention on the patient's spine. These are not devices used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components or uses of IVDs.
This device is a surgical instrument set used for a therapeutic procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The KSEA instrument set for arthroscopic percutaneous discectomy is designed to visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control.
Product codes
Not Found
Device Description
The KSEA instrument set for arthroscopic percutaneous discectomy are manually operated, reusable surgical devices consisting of arthroscopes, forceps, cannulae, sheaths, dilation sheaths, trephines, puncture needles and curettes. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials are surgical grade stainless steel or chrome plated brass.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
fluoroscopic control
Anatomical Site
lumbar region of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image is a black and white abstract design. The left side of the image is mostly black, with a white circle in the lower left corner. The right side of the image is a mix of black and white, with a pattern of vertical lines and speckles. The overall effect is one of texture and contrast.
Karl Rice? End socie
600 Corporate - conti Culver City. Canforma 0230-7600 Phone 310 558 1' Cs
T == 300 421 0837 - x : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
K9617/3
MAY 3 1 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1 hr 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 cocument are accurate and complete to the best of KSEA's knowledge.
/\pr licant:
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 Arthroscope, Arthroscopic forceps, cannulae, sheaths, dilation rods, dilation sheaths, Trephine, Spinal Needles, Curettes
Trade Name
Karl Storz Arthroscopes, Karl Storz Arthroscopic forceps, Karl Storz cannulae and sheaths, Karl Storz dilation rods and dilation sheaths, Karl Storz puncture needles, Karl Storz trephines, Karl Storz curettes
Indication: The KSEA instrument set for arthroscopic percutaneous discectomy is designed to visualize and treat vertebral disc herniations in the lumbar region of the spine using a posterolateral approach and fluoroscopic control.
Device Description: The KSEA instrument set for arthroscopic percutaneous discectomy are manually operated, reusable surgical devices consisting of arthroscopes, forceps, cannulae, sheaths, dilation sheaths, trephines, puncture needles and curettes. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials are surgical grade stainless steel or chrome plated brass.
Substantial Equivalence: The KSEA instrument set for arthroscopic percutaneous discectorny procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA instruments 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
Manager, Regulatory Affairs