(114 days)
The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMI), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.
The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory 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 (K963029, Karl Storz Slotted Whisker Arthroscopic Blade). It is a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical study with performance metrics against pre-defined acceptance criteria in the way a clinical trial or algorithm validation study would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in the provided text.
The document states: "The KSEA Slotted Whisker Arthroscopic Blade is 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 Slotted Whisker Arthroscopic Blade 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."
This indicates that the "study" proving the device meets criteria is primarily a comparison against existing legally marketed predicate devices to show that it is equally safe and effective, rather than a new performance study with quantitative acceptance metrics.
Since the provided text does not contain the information needed to fill out the table or answer the specific questions, I cannot generate the requested output.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and the background is black. The logo is stylized and modern.
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
NOV 2 7 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
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 PointeCulver City, CA 90230(310) 558-1500 |
|---|---|
| Contact: | Betty M. JohnsonManager, Regulatory Affairs |
| Device Identification: | Common NameSurgical Arthroscopic Blade |
Trade Name Karl Storz Slotted Whisker Arthroscopic Blade
The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled Indication: shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMI), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff.
Device Description: The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.
Substantial Equivalence: The KSEA Slotted Whisker Arthroscopic Blade is 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 Slotted Whisker Arthroscopic Blade 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:
: Marika Anderson
Marika Anderson
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.