← Product Code [HKI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI) · K101861 # TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM (K101861) _Truevision Systems, Incorporated · HKI · Dec 22, 2010 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K101861 ## Device Facts - **Applicant:** Truevision Systems, Incorporated - **Product Code:** [HKI](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI.md) - **Decision Date:** Dec 22, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.1120 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for Use The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates. ## Device Story The TrueVision 3D Visualization and Guidance System is a stereoscopic high-definition digital video camera and workstation. It functions as an adjunct to surgical microscopes during cataract surgery and slit lamp microscopes for pre/post-operative imaging. The system captures video and displays real-time 3D images on a flat-panel high-definition monitor for the surgeon and OR staff. Using TrueWare software, the system overlays surgeon-driven, on-screen graphical templates and guides onto the live video feed. These templates assist with limbal relaxing incisions, capsulorhexis sizing, and toric IOL rotational alignment. The surgeon controls the system via a remote keyboard and touchpad mouse, providing confirmation at each step of the planning and positioning process. This visual guidance aims to improve surgical precision and alignment, potentially benefiting patients through optimized IOL placement and incision accuracy. ## Clinical Evidence Performance verification and validation testing included software verification and a non-significant risk clinical study. All criteria were met, demonstrating the device meets performance specifications. ## Technological Characteristics Stereoscopic high-definition digital video camera, workstation, and flat-panel 3D display. Includes TrueWare software for graphical overlay and guidance. Controlled via remote keyboard and touchpad mouse. Operates as an adjunct to surgical and slit lamp microscopes. ## Regulatory Identification An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area. ## Special Controls *Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Predicate Devices - TrueVision® Visualization System for Microsurgery (Class 1 Device) - Optronics EPIC Color Television Camera System ([K963333](/device/K963333.md)) - OphthaVision Imaging System ([K980295](/device/K980295.md)) - IMAGEnet Professional PC Software ([K082364](/device/K082364.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}------------------------------------------------ 510(k): k101961 TrueVision 3D Visualization and Guidance System 7/14/2010 DEC 2 2 2010 # II: 510(k) Summary Image /page/0/Picture/5 description: The image shows the logo for TrueVision Systems, Inc. The logo consists of a globe-like graphic on the left, followed by the word "TrueVision" in a bold, sans-serif font. Below "TrueVision" are the words "SYSTEMS, INC" in a smaller, sans-serif font. The logo is black and white. ## TrueVision® 3D Visualization and Guidance System Submitter: TrueVision Systems Inc. 114 E. Haley Suite L Santa Barbara, CA 93101 Tel: (805) 963-9700 Fax: (805) 963-9719 #### Official Correspondent: A. Burton Tripathi, Ph.D. Vice President of Product Development 114 E. Haley St., Suite L Santa Barbara, CA 93101 Tel: 805-963-9700 Email: btripathi@truevisionsys.com Date: June 30, 2010 | Device Trade Name | Classification Name | Common Name | |-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | TrueVision® 3D Visualization
and Guidance System | Microscope, Surgical
Class I per 21 CFR
878.4700

Camera, Ophthalmic
Class II, per 21 CFR
886.1120

Picture archiving and
communications System
Class II, Per 21 CFR
892.2050 | Visualization and
Guidance System | Product Codes: HKI, NFJ {1}------------------------------------------------ #### Substantial Equivalence: The TrueVision® 3D Visualization and Guidance System is substantially equivalent to the following devices: - TrueVision® Visualization System for Microsurgery, Class 1 Device 1) TrueVision Systems, Inc. Surgical Microscope/21CFR878.4700, EPT - Optronics EPIC Color Television Camera System 2) Karl Storz Imaging Ophthalmic camera/21CFR 886.1850 K963333, HKI - 3) OphthaVision Imaging System MRP Group, Inc. Ophthalmic camera/21CFR 886.1850 K980295. HKI - IMAGEnet Professional PC Software, Digital Image Management 4) Software Topcon Corporation Picture archiving and communications system/21 CFR 892.2050 K082364, NFJ #### Description of the Device Subject to Premarket Notification: The TrueVision® 3D Visualization and Guidance System is a stereoscopic highdefinition digital video camera and workstation, which operates as an adjunct to the surgical microscope during cataract surgery and the slit lamp microscope during pre-operative and post-operative image capture. The visualization system displays real-time images during eve surgery on a flat-panel, high-definition digital 3D display device positioned for live video image viewing by the surgeon and surgical personnel in the operating room. The Cataract and Refractive Toolset system combines the TrueVision FDAregistered Class 1 Device (TrueVision® 3D Visualization System for Microsurgery) with proprietary TrueWare™ software (controlled via remote keyboard with included touchpad mouse) to provide enhanced visualization and surgical quidance assistance to the surgeon during specific procedures such as Limbal Relaxing Incision, Capsulorhexis, and toric IOL positioning. Using standard pre-operative clinical data, together with surgeon-driven, onscreen templates and guides, the Refractive Cataract Toolset provides graphical assistance to the surgeon as desired during the surgery. Guidance {2}------------------------------------------------ applications include incision templates to optimize the position of limbal relaxing incisions, sizing and positioning of capsulorhexis tears, and rotational alignment of toric intraocular lenses (toric IOL). #### Indications for Use: The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen quidance with alignment, orientation, and sizing for eve surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and quidance provided during anterior seqment ophthalmic surgical procedures, including limbal relaxing incisions. capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of quidance templates. ## Performance Standards: None. There are no mandatory performance standards for this type of device. ## Basis for Determination of Substantial Equivalence: The TrueVision® 3D Visualization and Guidance System described in this submission is substantially equivalent to the predicate device(s) listed above. All of the devices are used in ophthalmic imaging applications, provide means for capture, storage, and manipulation of said images, and provide practitioners with tools to provide visualization or surgical guidance assistance. All of the devices contain similar system components (camera, processor, and display), and all are used on the same anatomical location. The minor differences between the TrueVision 3D Visualization and Guidance System and the listed predicate devices do not raise any new questions of safety or of effectiveness in comparison to the predicate devices. #### Performance Data: Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the TrueVision® 3D Visualization and Guidance System. This was accomplished by software verification testing and a nonsignificant risk clinical study. All criteria for this testing were met and results demonstrate that the TrueVision® 3D Visualization and Guidance System meets all performance specifications and requirements. #### Conclusions: As described in this 510(k) Summary, all testing deemed necessary was conducted on the TrueVision® 3D Visualization and Guidance System to ensure that the device is safe and effective for its intended use and is substantially {3}------------------------------------------------ equivalent to legally marketed devices. · {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 TrueVision Systems, Inc. c/o Dr. A. Burton Tripathi Vice President. Product Development 114 East Haley Street, Suite L Santa Barbara, CA 93101 DFC 2 2 2010 Re: K101861 Trade/Device Name: TrueVision 3D Visualization and Guidance System Regulation Number: 21 CFR 886.1120 Regulation Name: Ophthalmic Camera Regulatory Class: II Product Code: HKI, NFJ, EPT Dated: Not Dated Received: October 14, 2010 Dear Dr. Tripathi: 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. Iisting 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 (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 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 {5}------------------------------------------------ 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, Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): Original Premarket Notification Device Name: TrueVision® 3D Visualization and Guidance System ## Indications for Use: DEC 2 2 2010 K101861 The TrueVision® 3D Visualization and Guidance System is an adjunct imaging tool that provides onscreen guidance with alignment, orientation, and sizing for eye surgery. The system is intended for use as a preoperative and postoperative image capture tool with visualization and guidance provided during anterior segment ophthalmic surgical procedures, including limbal relaxing incisions, capsulorhexis and toric intraocular lens (toric IOL) positioning. The system utilizes surgeon confirmation at each step for planning and positioning of guidance templates. Prescription Use X (Part 21 CFR 801 Subpart D) Signature (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K101861 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K101861](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKI/K101861) **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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