The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

Device Description

The KSEA Spinoscope is a fiber optic endoscope with a remote eyepiece. The body contact portions of the KSEA Spinoscope 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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Karl Storz Spinoscope." A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of submission. The provided text does not contain any information regarding clinical studies, performance metrics, or acceptance criteria in the manner typically associated with device performance evaluations.

The core of this submission is the statement of substantial equivalence:

"The Karl Storz Spinoscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Spinoscope 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."

In summary, none of the requested information can be extracted from the provided text because it is a 510(k) summary for an arthroscope, which focuses on substantial equivalence rather than performance against pre-defined acceptance criteria through a study.

Summary

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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 is accurate and complete to the best of KSEA's knowledge.

Applicant:	Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100
Contact:	James A. Lee, Ph.D.Senior Regulatory Affairs Specialist
Device Identification:	Common Name:ArthroscopeTrade Name: (optional)

Karl Storz Spinoscope

Indication: The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

Device Description: The KSEA Spinoscope is a fiber optic endoscope with a remote eyepiece. The body contact portions of the KSEA Spinoscope 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 Spinoscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Spinoscope 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:

Murklee

James A. Lee, Ph.D. Senior Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Karl Storz Endoscopy James A. Lee, Ph.D. Senior Regulatory Affairs Specialist 600 Corporate Pointe Drive Culver City, California 90230-7600

Re: K023187

Trade/Device Name: Karl Storz Spinoscope Regulation Number: 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: September 23, 2002 Received: September 24, 2002

Dear Dr. Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Dr. James A. Lee

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K023187

Device Name: Spinoscope

Indications for Use: The Spinoscope is intended for use to view and facilitate treatment of disc herniations in the lumbar region of the spine (including disc prolapses and foramen stenoses).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.109)
OR Over-The-Counter Use:
(Optional Format 1-2-96)

Miriam C. Provost
(Division Sign-Off)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023187

Regulation Number and Section

§ 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.