(36 days)
These devices are indicated for use in endoscopic carpal ligament release.
The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
The provided text describes a 510(k) summary for Karl Storz Endoscopy instruments, focusing on their substantial equivalence to predicate devices for endoscopic carpal ligament release.
However, the document does not contain any information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or AI-related effectiveness studies (MRMC or standalone).
Therefore, I cannot extract the requested information. The text primarily addresses regulatory aspects of substantial equivalence based on design and intended use, rather than detailed performance study outcomes.
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Image /page/0/Picture/0 description: The image shows the Karl Storz Endoscopy logo. The logo is white and has a stylized font. The background is a grainy black and white texture.
scopy An erica, Inc.
600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500
Tcll Free 800 421 0837 Fax 310 410 5527
96/244
510(K) SUMMARY OF SAFETY AND EFFECTIVE
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 CRF 807.92. All data included in this documents 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: | Betty M. Johnson Manager, Regulatory Affairs |
| Device Identification: | Common Name arthroscopes knives dilators sheaths obturators retractor with guiding tube |
Indication: These devices are indicated for use in endoscopic carpal ligament release.
Device Description: The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
Substantial Equivalence: The KSEA instruments for endoscopic carpal ligament release are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the KSEA instruments for the endoscopic treatment of carpal tunnel syndrome 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 the devices.
Signed:
Betty M. Johnson
Betty M. Johnson
Manager, Regulatory Affairs
00011
§ 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.