(78 days)
The Karl Storz Image 1® Video Imaging System with optional insufflators control allows remote control of Karl Storz insufflators by Image 1® camera head control buttons. The Karl Storz Image 1® Video Imaging System is a color video camera system which can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head is directly coupled to the endoscope. Any compatible Image 1® camera head may be used with the Image 1® Karl Storz Camera Control units (CCU). The endoscopic image can be displayed on any standard operating room video monitor and all standard endoscopic light sources may be used with the Image 1® camera head.
The Image 1® Video Imaging System with modification for insufflators control is a digital video imaging system used by qualified personnel in the operating room to view endoscopic images and to interface with Karl Storz devices such as selected insufflators through the Karl Storz Communication Bus (SCB). Karl Storz SCB technology, based on a modular design concept, provides centralized remote control over compatible medical equipment and peripheral system via touch screen or camera head buttons in the sterile environment. The modification for insufflators control is a software change only to the Image 1® Video Imaging System to allow the camera to exert control over Karl Storz insufflators functions through Karl Storz SCB
This document is a 510(k) summary for the Karl Storz Image 1® Video Imaging System with optional insufflators controls. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study that defines and proves acceptance criteria for a new AI/CADe device. Therefore, a direct response to your detailed request about acceptance criteria and study design for an AI/CADe system is not possible based on the provided text.
The document discusses a software change only to allow the camera to control insufflators, focusing on general safety and effectiveness in comparison to a predicate device. It does not provide information about performance metrics such as sensitivity, specificity, or any clinical trial data that would be relevant for an AI/CADe system’s acceptance criteria.
Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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 applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to the device and its submission:
- Trade/Device Name: Image 1® Video Imaging System with Optional Insufflators Controls
- Regulation Number: 21 CFR 876.1500
- Regulation Name: Endoscope and accessories
- Regulatory Class: II
- Product Code: FET
- Indications for Use: The system allows remote control of Karl Storz insufflators by Image 1® camera head control buttons. It is a color video camera system that can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head couples to the endoscope, and the image can be displayed on standard operating room video monitors, using standard endoscopic light sources.
- Device Description: A digital video imaging system for qualified personnel to view endoscopic images and interface with Karl Storz devices (like selected insufflators) via the Karl Storz Communication Bus (SCB). The modification for insufflator control is "a software change only" to allow the camera to control insufflator functions via SCB.
- Substantial Equivalence Claim: The device is substantially equivalent to legally marketed predicate devices, with similar basic technology, design, and intended usage. The differences are minor and do not raise new issues of safety and effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Karl Storz, Endoscopy-America, Inc. Regulatory Affairs Department Mr. Paul Lee Senior Regulatory Affairs Specialist 600 Corporate Pointe, 5th Floor Culver City, CA 90230-7600
JUL 27 2015
Re: K070716
Trade/Device Name: Image 10 Video Imaging System with Optional Insufflators Controls Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated (Date on orig SE ltr): May 21, 2007 Received (Date on orig SE ltr): May 22, 2007
Dear Mr. Lee
This letter corrects our substantially equivalent letter of May 31, 2007.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
076716
Device Name: Image 1® Video Imaging System with Optional Insufflators Controls
Indications for Use:
The Karl Storz Image 1® Video Imaging System with optional insufflators control The Karl Storz Image 1 - Video Intaging by Image 1 camera head control buttons.
allows remote control of Karl Storz insufflators by Image website which allows remove control of Nan Olenz wing System is a color video camera system which The Kan Storz Image | "Video Infoging Oycenhile a solos filexible endoscopes." The camera
can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera can be dseal as an endoscople accossoory with mage 1 " camera head may
head is directly coupled to the endoscope. Any complex of the endoscopic
be used with the image 1 " Ka be used with the infage 1 " Ran Storz Outliner Contra Control (e o on video monitor and all standard
image can be displayed on any standard operating room video monitor and a image can be displayed on any standard operating room video manist.
endoscopic light sources may be used with the Image 10 camera head.
Prescription Use:
(Per 21 CFR 801.Subpart D)
Over-The-Counter Use: OR (21 CFR 801 Subpart C)
(Please Do Not WRITE BELOW THIS LINE - Continue on Another Page IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devig 510(k) Number
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K070716
Page 1 of 2
MAY 3 1 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510{k) safety and effectiveness information is being submitted in accerdance rins summaly of 310(N) Salety and encolvents in (SMDA) of 1990 and 21 CFR 807.92. All
with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.
| Applicant: | Karl Storz Endoscopy - America, Inc.600 Corporate Pointe DriveCulver City, CA 90230(310) 338-8100 |
|---|---|
| Contact: | Paul S. LeeSenior Regulatory Affairs SpecialistTelephone +1-310-410-2769Telecopier +1-310-410-5519E-mail: plee@ksea.com |
| Device Identification: | Common Name: Video Imaging SystemTrade Name: Image 1® Video Imaging System with optionalinsufflators controls |
| Indication: | The Karl Storz Image 1® Video Imaging System with optionalinsufflators control allows remote control of Karl Storz insufflators byImage 1® camera head control buttons. The Karl Storz Image 1®Video Imaging System is a color video camera system which can beused as an endoscopic accessory with rigid or flexible endoscopes.The camera head is directly coupled to the endoscope. Anycompatible Image 1® camera head may be used with the Image 1®Karl Storz Camera Control units (CCU). The endoscopic image canbe displayed on any standard operating room video monitor and allstandard endoscopic light sources may be used with the Image 1®camera head. |
| Device Description: | The Image 1® Video Imaging System with modification forinsufflators control is a digital video imaging system used by qualifiedpersonnel in the operating room to view endoscopic images and tointerface with Karl Storz devices such as selected insufflatorsthrough the Karl Storz Communication Bus (SCB). Karl Storz SCBtechnology, based on a modular design concept, providescentralized remote control over compatible medical equipment andperipheral system via touch screen or camera head buttons in thesterile environment. The modification for insufflators control is asoftware change only to the Image 1® Video Imaging System to allowthe camera to exert control over Karl Storz insufflators functionsthrough Karl Storz SCB |
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K070716
Page 2 of 2
Substantial Equivalence: The Karl Storz Image 1° Video Imaging System is substantially THE Kar Storz miage i vices since the basic technology and design are similar. The intended usage is similar to predicate design are simmal. The intended safety and effectiveness. The devices and Talses fro new Issues of ouloty and Innoon System and minor differences between the may the performance, function or intended use of the devices.
Signature:
Paul Lee Senior Regulatory Affairs Specialist
§ 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.