(90 days)
The KSEA C-Mount Arthroscope is intended for large joint arthroscopic procedures.
These instruments are manually operated surgical devices intended for arthroscopic procedures of the shoulder and knee.
The Karl Storz C-Mount Arthroscope are manually operated surgical devices. The KSEA C-Mount Arthroscope are 30° and 70° view Telescopes. The body contact portions of the KSEA C-Mount Arthroscope 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.
The provided document is a 510(k) summary for the Karl Storz C-Mount Arthroscope, which is a manually operated surgical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as described in your request.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from clinical or standalone studies. Therefore, I cannot extract the requested information from this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in large, bold letters, and below it is the text "Karl Storz Endoscopy" in a smaller font.
DEC Pres 10008
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) 558-1500 |
|---|---|
| ------------ | --------------------------------------------------------------------------------------------------------------- |
Contact: Kevin Kennan Regulatory Affairs Specialist
Device Identification: Common Name: Arthroscope
Trade Name: (optional) Karl Storz C-Mount Arthroscope
Indication: The KSEA C-Mount Arthroscope is intended for large joint arthroscopic procedures.
The Karl Storz C-Mount Arthroscope are manually operated surgical Device Description: devices. The KSEA C-Mount Arthroscope are 30° and 70° view Telescopes. The body contact portions of the KSEA C-Mount Arthroscope 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 C-Mount Arthroscope is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz C-Mount Arthroscope 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:
ed:
Kevin Kennan Senior Regulatory Affairs Specialist
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1998 DEC
Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver Ĉity, California 90230-7600
Re: K983142 Trade Name: KSEA C-Mount Arthroscope Regulatory Class: II Product Code: HRX Dated: September 2, 1998 Received: September 8, 1998
Dear Mr.Kennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{2}------------------------------------------------
Page 2 - Mr. Kevin A. Kennan
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo features the word "STORZ" in a bold, sans-serif font, with a circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, sans-serif font. The background of the image is black, and the text is white.
510(k) Number (if known): K q 8> | 42-
Device Name: KSEA C-Mount Arthroscopes
Indications for Use: These instruments are manually operated surgical devices intended for arthroscopic procedures of the shoulder and knee.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 2983142 |
| Prescription Use: (Per 21 CFR 801.109) | X | OR Over-The-Counter Use: | |
|---|---|---|---|
| ---------------------------------------- | --- | -------------------------- | -- |
(Optional Format 1-2-96)
Image /page/3/Picture/6 description: The image shows a series of numbers, specifically the number 0 repeated several times, followed by the number 3. The zeros are drawn in a way that they appear to be linked together, resembling a chain. The number 3 is drawn in a larger font size and is more bolded than the zeros.
§ 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.