(268 days)
The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.
The Image1 GI CCU consists of two components: the camera control unit and a keyboard. The Image1 GI CCU is used in conjunction of a videoscope and a light source, which transmit the video signals to camera control unit (image processor) to provide optical visualization via a video monitor.
The provided 510(k) summary for the KARL STORZ Endoscopy America, Inc. Image1 GI CCU does not contain the detailed information requested regarding acceptance criteria and study results.
This summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than providing detailed performance data against specific acceptance criteria. Substantial equivalence generally means proving that the new device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).
Here's why the requested information is not present in the provided text:
- Acceptance Criteria and Reported Device Performance: The document states, "Internal safety and performance testing are performed to ensure the safety and efficacy of the device." However, it does not outline specific acceptance criteria (e.g., image resolution, color accuracy, latency thresholds) nor does it report the quantitative results of these tests.
- Sample Size and Data Provenance: No information is provided about the sample sizes of any test sets or the origin of the data (e.g., country, retrospective/prospective).
- Number and Qualifications of Experts for Ground Truth: There is no mention of experts or ground truth establishment for any test data.
- Adjudication Method: Not applicable as no expert review of test data is described.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This type of study is not mentioned. The device is a camera control unit, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be relevant in this context.
- Standalone Performance: The concept of "standalone performance" (algorithm only) is not applicable here as the device is a hardware component (camera control unit) for endoscopy, not a standalone algorithm.
- Type of Ground Truth: Not applicable as no ground truth data is discussed.
- Training Set Sample Size and Ground Truth Establishment for Training Set: Not applicable as this is not an AI/machine learning device that requires a training set.
In summary, the provided document serves as a 510(k) premarket notification emphasizing substantial equivalence, not a detailed technical report demonstrating device performance against quantitative acceptance criteria through clinical or technical studies with data and expert involvement.
To get the type of information requested, one would typically look for a more detailed Technical File, Design History File, or specific performance testing reports, which are usually proprietary and not publicly disclosed in the 510(k) summary.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR - 6 2012
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. 2151 E. Grand Ave El Segundo, CA 90245 (424) 218-8379
Contact:
Winkie Wong Associate Regulatory Affairs Specialist
Date of Preparation:
July 11, 2011
Device Identification:
Gastroscopes and Accessories, Flexible/Rigid Common Name:
Trade Name: (optional) Image1 GI CCU
Indications: The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.
Device Description: The Image1 GI CCU consists of two components: the camera control unit and a keyboard. The Image1 GI CCU is used in conjunction of a videoscope and a light source, which transmit the video signals to camera control unit (image processor) to provide optical visualization via a video monitor.
Substantial Equivalence: The Image1 GI CCU is a modification of the already cleared Image1 Video Imaging System, previously known as KSI's New Camera Architecture (NCA) Video Imaging System (K003325). The underlying fundamental technology and intended use remains unchanged. All the changes were made to enhance image quality specifically for GI indication and to allow to print an image via the USB printer or store an image to a USB storage device for documentation purpose. Internal safety and performance testing are performed to ensure the safety and efficacy of the device.
The Image1 GI CCU is also substantially equivalent to Fujinon EPX-4400HD Video Processor and Light Source (K102466). Both devices consist of a video processor (CCU) and a keyboard. They also share the same indications for use and fundamental technologies, which offers external image storage capability and
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similar features such as: Brightness Control, Enhancement Control, Light Source Control, White Balance, Zoom and HD Capability. The differences between the subject and predicate devices are the subject device incorporates the KARL STORZ Communication Bus (SCB) system for ease of use.
Conclusion: The Image1 GI CCU is substantially equivalent to the identified predicate devices and the differences between the subject and the predicate devices do not raise any new issues of safety and efficacy.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
PR -6 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Winkie Wong Associate Regulatory Affairs Specialist KARL STORZ Endoscopy America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245
Re: K111997
Trade/Device Name: Image1 GI CCU Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: March 13, 2012 Received: March 14, 2012
Dear Ms. Wong:
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 for association 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 r ou mayy are su 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 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 i lease of advisod that I Dri a labor that your device complies with other requirements of the Act that i DA hade a dotenminentistic is as administered by other Federal agencies. You must of any I cocraf statures and regulements, including, but not limited to: registration and listing Confight and and the Prev Store Part 801); medical device reporting (reporting of medical
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher, Ph.D.
Beniamin 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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Indication for Use
510(k) Number (if known): Not yet assigned
Device Name: Image1 GI CCU
Indication for use: The Image1 GI CCU is to be used in conjunction with a light source and endoscope by physician/endoscopist to provide optical visualization via a video monitor for endoscopic observation and image recording during diagnostic and therapeutic procedures of the upper/lower digestive tract.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Helent Lunn
Division' Sign-Off) sion of Reproductive, Gastro-Renal, and ological Device k) Numbe
§ 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.