(78 days)
The KSEA Xenon-100 SCB Light Source is intended for use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.
The Karl Xenon-100 SCB is a Light Source unit for Karl Storz video gastro-endoscopes.
The provided text describes a 510(k) summary for the Karl Storz Xenon-100 SCB Light Source. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Substantial equivalence is a regulatory pathway in the US that avoids the need for extensive clinical trials by showing a new device is as safe and effective as a legally marketed predicate device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a clinical performance study with AI (like multi-reader multi-case studies, standalone performance, ground truth, sample sizes, etc.) is not present in the provided document.
Here's why and what information is available:
- No acceptance criteria or study results for device performance are listed. The document states: "The minor differences between the Karl Storz Xenon-100 SCB Light Source and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices." This implies that extensive comparative performance testing (as would be done for a novel AI device) was not required for this 510(k) submission.
- The focus is on "Substantial Equivalence." The entire submission hinges on demonstrating that the new device is functionally similar to an already approved device.
- The device is a "Light Source unit," not an AI-powered diagnostic or therapeutic device. The nature of the device (a light source for endoscopes) does not typically require the types of performance studies involving human readers, ground truth establishment, or AI algorithms as outlined in your request.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, deep learning studies, multi-reader multi-case studies, and ground truth in the way you've requested, as this information is not part of this 510(k) submission document.
However, based on the document, I can provide the following relevant details about the submission process:
- Device Name: Xenon-100 SCB Light Source
- Intended Use: For use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons. It features remote control, central operation, central display, automatic initial setting, and interlocking operation to the Karl Storz SCB Control Computer.
- Regulatory Pathway: 510(k) Premarket Notification, demonstrating Substantial Equivalence to a predicate device.
- Predicate Device: A legally marketed device with similar basic features and intended uses, but not explicitly named in the provided text.
- Date Submitted: September 30, 2008
- Date Received by FDA: October 1, 2008
- FDA Clearance Date: December 18, 2008
To reiterate, the provided document does not contain the specific information you've asked for regarding acceptance criteria, study design, datasets, or AI performance because it's a 510(k) for a light source, not an AI-enabled device requiring such validation studies.
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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 font. The logo is in white against a black background.
Ko 8 2925
DEC 1 8 2008
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.
Karl Storz Endoscopy - America, Inc. Applicant: 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500
Monika Campbell Contact: Senior Regulatory Affairs Specialist
Common Name: Device Identification: Light Source
Trade Name: (optional) Xenon-100 SCB Light Source
The KSEA Xenon-100 SCB Light Source is intended for use in Indications for Use: Storz video-endoscopes for gastro-enterology or with Karl Storz combination with Karl endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.
Device Description: The Karl Xenon-100 SCB is a Light Source unit for Karl Storz video gastro-endoscopes.
Substantial Equivalence: The Karl Storz Xenon-100 SCB Light Source is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz Xenon-100 SCB Light Source and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.
Signed: Monika Campbell
Monika Campbell Senior Regulatory Affairs Specialist
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2008
Ms. Monika Campbell Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor CULVER CITY CA 90230-7600
Re: K082925
Trade/Device Name: Xenon-100 SCB Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCT Dated: September 30, 2008 Received: October 1, 2008
Dear Ms. Campbell:
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.
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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.
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
voque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082925
Device Name: Xenon-100 SCB Light Source
The KSEA Xenon-100 SCB Light Source is intended for use in Indications for Use: combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helen Reiner
Page X
(Posted November 13, 2003)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
G04
C
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.