(34 days)
This instrument is indicated for providing endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.
The KSEA ENDOSPINE Operating Tube and Telescope Bridge consists of an operating tube, an obturator for use with the operating tube, and a telescope bridge for use with the operating tube. The telescope bridge contains a working channel, an irrigation channel, and a channel for an endoscope. The body contact portions of the KSEA ENDOSPINE Operating Tube and Telescope Bridge 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 text describes a 510(k) summary for the Karl Storz ENDOSPINE Operating Tube and Telescope Bridge, which is a surgical instrument. It does not include information about acceptance criteria, device performance metrics, or study details typically associated with AI/ML-powered medical devices.
Therefore, I cannot provide the requested information in the format you specified. The document is about a mechanical surgical device and primarily focuses on its substantial equivalence to predicate devices, rather than performance studies with defined acceptance criteria.
Here's why I cannot fulfill your request based on the provided text:
- No AI/ML Component: The device described is an "Arthroscope" (specifically an "Operating Tube and Telescope Bridge") made of surgical grade stainless steel. It is a mechanical instrument for providing endoscopic access and retracting tissues during surgery. There is no mention of any software, algorithm, or AI/ML component.
- No Performance Data: The document states that "minor differences between the KSEA ENDOSPINE Operating Tube and Telescope Bridge and the predicate device raises no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This indicates a substantial equivalence pathway, which typically does not require extensive performance studies with acceptance criteria and ground truth as would be needed for novel AI solutions.
- No Study Details: There are no details about any studies conducted, such as sample sizes, data provenance, expert reviews, or MRMC studies. The content focuses on regulatory compliance and equivalence to existing devices.
In essence, the information you're asking for is specific to the evaluation of AI/ML or diagnostic devices, which is not what this 510(k) summary pertains to.
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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 circle in the middle of the "O". Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller, simpler font. The logo is in white against a black background.
No. 22 83 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS K49354D
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 KennanRegulatory Affairs Specialist |
| Device Identification: | Common Name:Arthroscope |
| Trade Name: (optional)Karl Storz ENDOSPINE Operating Tube and Telescope Bridge |
Indication: The KSEA ENDOSPINE Operating Tube and Telescope Bridge is designed to be used by qualified surgeons and physicians for providing endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.
Device Description: The KSEA ENDOSPINE Operating Tube and Telescope Bridge consists of an operating tube, an obturator for use with the operating tube, and a telescope bridge for use with the operating tube. The telescope bridge contains a working channel, an irrigation channel, and a channel for an endoscope. The body contact portions of the KSEA ENDOSPINE Operating Tube and Telescope Bridge 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 KSEA ENDOSPINE Operating Tube and Telescope Bridge is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA ENDOSPINE Operating Tube and Telescope Bridge and the predicate device raises no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
Kevin Kennan
Senior Regulatory Affairs Specialist
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
NOV 22 1999
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230
Re: K993540
Trade Name: ENDOSPINE Operating Tube and Telescope Bridge Regulatory Class: II Product Code: HRX Dated: October 11, 1999 Received: October 19, 1999
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.
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Page 2 – Mr. Kevin 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 vours.
Stipt Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K99354D 510(k) Number (if known):
Device Name: ENDOSPINE Operating Tube and Telescope Bridge
Indications for Use: This instrument is indicated for providing endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.
(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 | K993540 |
| Prescription Use: | X | OR Over-The-Counter Use: | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
§ 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.