← Product Code [GCJ](/productcode/GCJ) · K063457 # TRUEHD (1080P) DIGITAL CAMERA SYSTEM (K063457) _Conmed Linvatec · GCJ · Dec 5, 2006 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K063457 ## Device Facts - **Applicant:** Conmed Linvatec - **Product Code:** [GCJ](/productcode/GCJ.md) - **Decision Date:** Dec 5, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The ConMed Linvatec HD Digital Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The ConMed Linvatec HD Digital Camera System will be capable of interfacing with a remote controlled operating system, Linvatec Light Source (K031994) with no impact on normal camera system operation. ## Device Story System consists of camera control unit and camera head; used with endoscope for high-definition visualization during minimally invasive surgery. Operates in OR environment; used by surgeons. Captures optical input via endoscope; processes signal for high-definition display. Enables real-time visualization to assist surgical navigation and decision-making. Interfaces with ConMed I.S. Operating Room Control System and Linvatec Light Source. Camera head and cable require steam sterilization before use. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and technological similarities to the predicate device. ## Technological Characteristics System includes camera control unit and camera head. High-definition visualization capability. Compatible with endoscopes. Sterilization: steam sterilization required for camera head and cable. Connectivity: interfaces with ConMed I.S. Operating Room Control System and Linvatec Light Source. ## Regulatory 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. ## Special Controls *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. In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period. ## Predicate Devices - Linvatec Corporation 3-CCD Digital Camera System ([K031098](/device/K031098.md)) ## Reference Devices - Linvatec Light Source ([K031994](/device/K031994.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ November 9, 2006 DEC - 5 2005 ### 510k Summary In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, ConMed Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the HD Digital Camera System 510(k) Number Kos343 7 5 ### Submitter A. ConMed Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 ### B. Company Contact Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX #### ். Device Name | Trade Name: | TrueHD (1080P) Digital Camera System | |----------------------|---------------------------------------------------------------------| | Common Name: | HD Digital Camera System | | Classification Name: | Laparoscope, General & Plastic Surgery
Endoscope and Accessories | | Proposed Class: | Class II | | Device Product Code: | GCJ | {1}------------------------------------------------ 510k Summary HD Digital Camera System 510(k) # Ko63459 November 9, 2006 ### D. Predicate/Legally Marketed Device Linvatec Corporation 3-CCD Digital Camera System 510(k) K031098 ### ய் Device Description The device description of the modified device is identical to the legally marketed, unmodified device (510(k) K031098) with the exception that the modified device enables high definition visualization. ## Modified Device The ConMed Linvatec HD Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for high definition visualization during minimally invasive surgical procedures. Like the unmodified device, sterilization of the camera head and cable is required before use. Additionally, the camera heads may be sterilized using steam sterilization like the unmodified device. The ConMed Linvatec HD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation. ### Unmodified Device (reference) The ConMed Linvatec Digital Camera System consists of a camera control unit and a camera head that is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head and cable is required before use. The camera heads may be sterilized using steam sterilization. The ConMed Linvatec 3-CCD HD Digital Camera System will be capable of interfacing with the ConMed I.S. Operating Room Control System with no impact on normal camera system operation. Page 4.1 {2}------------------------------------------------ #### F. Intended Use Note: The device description of the modified device is identical to the legally marketed, unmodified device (510(k) K031098). The ConMed Linvatec HD Digital Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The ConMed Linvatec HD Digital Camera System will be capable of interfacing with a remote controlled operating system, Linvatec Light Source (K031994) with no impact on normal camera system operation. #### Substantial Equivalence G. The modifications to the legally marketed device in the HD Digital Camera System do not affect the intended use nor alter the fundamental scientific technology of the device. In addition, the modified device is substantially equivalent in materials, design and sterilization requirements to the unmodified device. The device modifications do not introduce any new issues of safety or efficacy. {3}------------------------------------------------ Public Health Service Image /page/3/Picture/2 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 ConMed Linvatec Corporation % Ms. Elizabeth Paul Manager, Regulatory Affairs 11311 Concept Boulevard Largo, Florida 33773-4908 DEC - 5 2006 Re: K063457 Trade/Device Name: HD Digital Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: November 9, 2006 Received: November 16, 2006 Dear Ms. Paul: 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 cither 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. 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. {4}------------------------------------------------ Page 2 - Ms. Elizabeth Paul 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours, Barbara Buckner Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use November 9, 2006 510(k) Number (if known): Koo 3457 Device Name: HD Digital Camera System Indications For Use: The ConMed Linvatec HD Digital Camera System is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Note: The indications for use of the modified device is identical to the legally marketed, unmodified device (510(k) K031098). 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Raubare Buchur (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 **510(k) Number** K063457 --- **Source:** [https://fda.innolitics.com/device/K063457](https://fda.innolitics.com/device/K063457) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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