(57 days)
The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.
The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use 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 of the blades are surgical grade stainless steel.
This document is a 510(k) summary for a medical device (Karl Storz Multidrive Mini Shaver and blades). It describes the device's intended use and design but does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/machine learning devices or software.
This document is from 1997 and pertains to traditional surgical equipment, not AI/ML-driven medical devices. Therefore, the questions regarding acceptance criteria, study design, sample sizes, ground truth, expert consensus, MRMC studies, or standalone performance are not applicable to the information provided in this 510(k) summary.
The summary states that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are established by demonstrating similarity to already legally marketed devices, rather than through a new clinical performance study as would be required for novel AI-based devices.
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Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with a target symbol in place of the letter "O". Below the word "STORZ" is the text "Karl Storz Endoscopy".
Karl Storz Endoscopy America, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Toll Free 800 421 0837 Fax 310 410 5527
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR - 5 1997
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 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: | Renate A. MacLaren, Ph.D. |
| Senior Regulatory Affairs Specialist | |
| Device Identification: | Common Name |
| Shaver for Arthroscopy | |
| Arthroscopic Shaver Blades | |
| Trade Name |
Karl Storz Multidrive Mini Shaver Karl Storz Mini Shaver Blades
Indication: The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.
Device Description: The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use 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 of the blades are surgical grade stainless steel.
Substantial Equivalence: The Karl Storz Multidrive Mini Shaver and blades 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 Karl Storz Multidrive Mini shaver, blades 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:
Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist
§ 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.