(70 days)
No
The description mentions a "Microprocessor controlled automatic exposure" which is a standard image processing technique, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, or any related concepts.
No.
The device is a camera system designed to capture and display endoscopic images, which is diagnostic rather than therapeutic.
No
The device is a camera system designed to display endoscopic images on a monitor. Its primary function is image acquisition and display for viewing during endoscopic procedures, rather than providing a diagnosis based on analysis of the images.
No
The device description clearly outlines physical hardware components including a camera head, video processor, cable, and optical adapters, along with their weights and dimensions. While it mentions microprocessor-controlled image processing, the core of the device is hardware.
Based on the provided information, the Karl Storz Imaging (KSI) Endovision XL System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "color, television camera head designed for use with any flexible or rigid endoscope." It is used to capture and display images from inside the body during endoscopic procedures.
- Device Description: The description focuses on the camera's technical specifications, how it attaches to endoscopes, and its image processing capabilities (automatic exposure).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or treat disease. IVDs are typically used in laboratories or point-of-care settings for analyzing biological samples.
The Endovision XL System is an endoscopic imaging device used for visualization during surgical or diagnostic procedures performed in vivo (within the living body). This is distinct from the function of an IVD.
N/A
Intended Use / Indications for Use
The Karl Storz Imaging (KSI) Endovision XL System is a color, television camera head designed for use with any flexible or rigid endoscope.
The camera head may be attached to any rigid or flexible endoscope, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes.
The camera is connected to the video processor via a ten foot cable. The endoscopic image can be displayed on any standard operating room video monitor.
or
The Karl Storz Imaging (KSI) Endovision XL Camera System is a color, celevision camera system designed for attachment to endoscopic visioning systems.
The camera head is suitable for attachment to any rigid or flexible endoscope, including, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope with a V-mount adapter. The camera is connected to the video processor via cable. The endoscopic image can be displayed on any standard operating room video monitor.
Product codes
GCJ
Device Description
The Endovision XL is a state-of-the-art endoscopic camera. The head of the camera is equipped with a V-mount thread, allowing the head to couple to Karl Storz V-mount optical adapters. Three adapters, 15 mm, 20 mm and 25 mm, are available with the system. These couplers allow easy attachment of the XL head to any standard endoscope. Microprocessor controlled automatic exposure adjusts image brightness. The image sensor is a 1/4" CCD-chip. The processor weighs 1.77 pounds and the camera .6 pounds. Dimensions of the processor and camera in width, height and depth are: 8.29 x 2.16 x 6.07 inches and 1.96 x 2.4 x 3.9 inches respectively.
Mentions image processing
Microprocessor controlled automatic exposure adjusts image brightness.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary of Safety and Effectiveness
This summary of premarket notification 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.
| Application: | Karl Storz Imaging, Incorporated
175 Cremona Drive
Goleta, California 93117 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Terry Fernandez |
| Registration: | 2027009 |
| Device Name: | Proprietary Name -- Karl Storz Imaging Endovision XL Endoscopic Camera
System
Common Name -- Color Television Camera System
Classification Name -- Camera, Television, Endoscopic |
| Intended Use: | The Karl Storz Imaging (KSI) Endovision XL System is a color, television
camera head designed for use with any flexible or rigid endoscope.
The camera head may be attached to any rigid or flexible endoscope, such as
sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes,
laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes.
The camera is connected to the video processor via a ten foot cable. The
endoscopic image can be displayed on any standard operating room video
monitor. |
| Device Description: | The Endovision XL is a state-of-the-art endoscopic camera. The head of the
camera is equipped with a V-mount thread, allowing the head to couple to Karl
Storz V-mount optical adapters. Three adapters, 15 mm, 20 mm and 25 mm,
are available with the system. These couplers allow easy attachment of the XL
head to any standard endoscope. Microprocessor controlled automatic exposure
adjusts image brightness. The image sensor is a 1/4" CCD-chip.
The processor weighs 1.77 pounds and the camera .6 pounds. Dimensions of
the processor and camera in width, height and depth are: 8.29 x 2.16 x 6.07
inches and 1.96 x 2.4 x 3.9 inches respectively. |
1
Substantial Equivalence:
KSI believes that its proposed new device, the Endovision XL endoscopic camera system, is substantially equivalent to several other systems currently on the market including the KSI Tricam Color Endoscopic Television System
(K950862) and the KSI Telecam Color Endoscopic Television System (K883943). The proposed new KSI Endovision XL is unique only in that it is a smaller, lighter, more portable camera system.
Signed: Terry Fernandez
Date: 1/26/98
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Mr. Terry Fernandez Director Regulatory & Standards Compliance Karl Storz Imaging, Incorporated 175 Cremona Drive Goleta. California 93117
Re: K974391
Trade Name: Karl Storz Endovision XL Endoscopic Camera System Regulatory Class: II Product Code: GCJ Dated: November 20, 1997 Received: November 21, 1997 ...
Dear Mr. Fernandez:
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 requirements , as set forth in the Quality System Regulation (OS) 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
3
Page 2 - Mr. Fernandez
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 vour 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
4
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: KSI ENDOVISION XL CAMERA SYSTEM
Indication for Use:
The Karl Storz Imaging (KSI) Endovision XL Camera System is a color, celevision camera system designed for attachment to endoscopic visioning systems.
The camera head is suitable for attachment to any rigid or flexible endoscope, including, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope with a V-mount adapter. The camera is connected to the video processor via cable. The endoscopic image can be displayed on any standard operating room video monitor.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| 510(k) Number | K974391 |
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use |
(Optional Format 1-2-96)