(87 days)
The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) video processor and the KSI Telecam SL with IPM (Image Processing Module) video processor.
The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. An optional adapter allows DCC camera head attachment to non-DCC rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor.
The KSI DCC incorporates two programmable function buttons (to select an accessory port(s) and to control the port output) and two focus buttons. The light cable is connected directly to the back of the camera head. The camera is designed to allow the user to directionally rotate the camera head to maintain proper image orientation on the monitor.
The provided document is a 510(k) summary for the Karl Storz Imaging Direct Coupled Camera Head, submitted in 1997. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment.
Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, experts, or ground truth based on this document. The document essentially states that the new device is substantially equivalent to existing ones because it integrates features already present in their earlier models, implying that extensive new performance studies were not deemed necessary for this submission.
Summary of what cannot be provided from the document:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is a camera head, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a camera, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not mentioned.
- The sample size for the training set: Not applicable as this is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
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K973252
Nov.24,1997
510(k) Summary of Safety and Effectiveness
This summary of premarket notification safety and effectiveness information is being submitted in CEP This Sunninal y or premarker notheaton safety and offees Act (SMDA) of 1990 and 21 CFR 807.92.
| Application: | Karl Storz Imaging, Incorporated175 Cremona DriveGoleta, California 93117 |
|---|---|
| Contact: | Mr. Terry Fernandez |
| Registration: | 2027009 |
| Device Name: | Proprietary Name -- Karl Storz Imaging Direct Coupled Camera HeadCommon Name -- Color Television Camera HeadClassification Name -- Camera, Television, Endoscopic |
| Intended Use: | The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is acolor, television camera head designed for attachment to a Karl Storz Tuttlingen(KST) DCC endoscopic visioning system. The KSI DCC camera head iscompatible with the currently marketed KSI Telecam SL (Super Luxury) videoprocessor and the KSI Telecam SL with IPM (Image Processing Module) videoprocessor. |
| The camera head is suitable for attachment to any KST DCC rigid or flexibleendoscope, including, but not limited to sinoscopes, colonoscopes,sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes,ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled tothe endoscope by directly pressing the endoscope onto the front of the DCCcamera head until it locks into place. An optional adapter allows DCC camerahead attachment to non-DCC rigid and flexible endoscopes. The endoscopicimage can be displayed on any standard operating room video monitor. | |
| Device Description: | The KSI DCC incorporates two programmable function buttons (to select anaccessory port(s) and to control the port output) and two focus buttons.The light cable is connected directly to the back of the camera head. The camerais designed to allow the user to directionally rotate the camera head to maintainproper image orientation on the monitor. |
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Substantial Equivalence:
KSI believes that its proposed new device, the Direct Coupled Camera Head, is substantially equivalent to several other camera heads currently in commercial distribution including the camera head in the KŠI Tricam Color Endoscopic Television Camera System (K950862) and the camera head in the KSI Telecam Color Endoscopic Television Camera System (K883943). The proposed new KSI camera head is unique only in that it incorporates into one camera head variations of several features found in similar, earlier camera head models.
Signed: Terry Fernandez
Date: 08/27/97
Image /page/1/Picture/6 description: The image shows a close-up of a signature. The signature is illegible and appears to be a series of overlapping loops and lines. The lines are dark and thick, and the overall impression is one of a quick, stylized mark.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1997
Terry Fernandez Director, Regulatory and Standards Compliance Karl Storz Imaging, Inc. 175 Cremona Drive Goleta, California 93117
Re: K973252 Karl Stortz Direct Coupled Camera Head Dated: August 27, 1997 Received: August 29, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78KOG and GCJ
Dear Mr. Fernandez:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.
This letter will allow you to begin marketing 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) 594-4613. 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.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: KSI DIRECT COUPLED CAMERA SYSTEM
Indication for Use:
The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head The Kall Storz maging (Kor) Diroce Couptlingen (KST) DCC endoscopic visioning system. The KST
designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visionin designed for attachinent to a hear its the currently marketed KSI Telecam SL (Super Luxury) and the KSI Telecam SL with IPM (Image Processing Module) video processors.
The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but I no valiford to sinoscopes, colonoscopes, sigmoidoscopes, gastroscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. 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)
ﮯ ﺑ
510(k) Number _
L Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_________
Pobut D (Division Sign-Off)
and Radiological Devices
Division of Reproductive, Abdominal, ENT,
510(k) Number_1973252
(Optional Format 1-2-96)
§ 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.