← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K081672 # C-INSIGHT (K081672) _Mazor Surgical Technologies , Ltd. · LLZ · Aug 15, 2008 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K081672 ## Device Facts - **Applicant:** Mazor Surgical Technologies , Ltd. - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Aug 15, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications. ## Device Story C-InSight is a software-based add-on for standard mobile C-Arm X-ray systems used in operating rooms. It converts 2D fluoroscopic projections into 3D volumetric images intraoperatively. The system requires a 'C-InSight Reference Belt' placed on the patient's anatomical area of interest. The clinician scans the patient and the belt for 20 seconds; the data is sent to a processing unit. The system uses target recognition algorithms to calculate relative projection and location coordinates. The output is a 3D volume viewable in AP, LT, and AX projections. Surgeons use this real-time assessment to verify implant placement, potentially improving surgical accuracy in minimally invasive procedures. ## Clinical Evidence No clinical data. Performance was established via non-clinical bench testing: software validation (IEC 60601-1-4), synthetic accuracy tests, spine accuracy tests, accuracy vs. CT (cadaver tests), image quality tests, and radiation dose exposure tests. ## Technological Characteristics Software-based 3D reconstruction tool. Components: workstation, reference belt, image adaptor, sterile sheath. Connectivity: add-on to mobile C-Arms. Standards: IEC 60601-1/2, IEC 60601-1-4. Algorithm: target recognition for coordinate calculation. ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - Siremobil Iso-C 3D software ([K003266](/device/K003266.md), [K032280](/device/K032280.md), [K040347](/device/K040347.md)) - O-Arm Imaging System software ([K050996](/device/K050996.md), [K060344](/device/K060344.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}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters that appear to be alphanumeric. The sequence reads as 'K081672'. The characters are written in a simple, somewhat crude style, with varying stroke thicknesses. # Allic 1 5 2008 #### 510(K) SUMMARY OF SAFETY & EFFECTIVENESS SECTION 5 - ### DISCASSIST™ SYSTEM ### 510(k) Number K_ ### Applicant's Name: | Company name: | Mazor Surgical Technologies Ltd. | |---------------|------------------------------------------------------------------------------------| | Address: | 7 HaEshel Str.
P.O.B. 3104
Southern Caesarea Industrial Park 38900
ISRAEL | | Tel.: | +972-4-6270171 | | Fax: | +972-4-6377234 | | e-mail: | armin@mazorst.com | ### Contact Person: | Official Correspondent: | Ahava Stein | |-------------------------|-------------------------------------------------------------------------------------| | Company name: | A. Stein - Regulatory Affairs Consulting | | Address: | Beit Hapaamon (Suite 213)
20 Hata'as Str. (Box 124)
Kfar Saba 44425
ISRAEL | | Tel: | + 972-9-7670002 | | Fax: | +972-9-7668534 | | e-mail: | ahava@asteinrac.com | ### Name of the device: C-InSight System ### Trade or proprietary name, if applicable: C-InSight System ### Common or usual name: 3-D Reconstruction Tool for Mobile X-ray Devices. {1}------------------------------------------------ #### Establishment Registration No .: 3005075696 #### Classification Name: System, Image Processing, Radiological #### Classification: FDA has classified Radiological Image Processing systems as a Class II medical device, with product code LLZ and 21 CFR classification code 892.2050. Review by the Radiology Panel. #### Predicate Device: The C-InSight™ system is substantially equivalent to the Siremobil Iso-C 3D software (manufactured by Siemens Medical Systems, Inc. and subject of 510(k) document no. K003266, K032280, K040347) and O-Arm Imaging System software (manufactured by Breakaway Imaging and subject of 510(k) document no. K050996 and K060344). A comparison table and detailed discussion are presented in Section 12 of this application. #### Device Description: C-InSight is a software based product, which converts a sequence of Two-dimensional fluoroscopy images into a 3D volume, intraoperatively. The C-InSight is an add-on to commercially available mobile x-ray systems. Two-dimensional imaging is available nowadays in every operating room in the form of a mobile C-Arm. However, there is often a need for a three-dimensional imaging {2}------------------------------------------------ during the operation especially duc to the rise in the scope of minimally invasive procedures. To answer the need for a reasonably priced, casy to use and highly mobile intraoperative 3D imaging, the C-InSight was developed. C-InSight is a software-based product, which gives the solution for 3D imaging intraoperatively, using a standard 2D Mobile C-Arm. Coupling the 3D capabilities of the C-InSight using existing C-Arms in the operating rooms, can give surgeons a real-time assessment of implant placement. The clinician who uses the C-InSight should identify the anatomical area which is scanned, and cover it with the C-InSight Reference Belt. The user scans the body and the C-InSight Reference Belt for 20 seconds. The scanned data is sent to the C-InSight processing unit, which converts this data into three-dimensional volume. The clinician is then able to view the scanned data in different anatomical projections: AP, LT, AX and 3D volume. The main components of the C-Insight system include: - A. Workstation - B. Accessories, including C-InSight Reference Belt and Image Adaptor - C. Disposable kit, including C-InSight Sterile Sheath ### Intended Use / Indication for Use: The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications. ### Comparison of Technological Characteristics with the predicate device: {3}------------------------------------------------ The C-InSight system is similar to the predicate device regarding intended use and regarding technological characteristics. All are intended to be used when the clinician and patient benefit from generated 3D imaging of high contrast objects. They all include software which provides conversion of 2D fluoroscopic projections from C-Arms into a volumetric 3D image. The C-InSight system uses a reference belt and target recognition algorithms to calculate the relative projection and location coordinates of each image, while the predicate devices use built-in sensors to receive these coordinates. ### Non-Clinical Performance Data The following performance tests were conducted on the C-InSight system: - 1. Software Validation (IEC 60601-1-4 & FDA Guidelines) - 2. C-InSight synthetic accuracy test. - 3. C-InSight spine accuracy test. - 4. C-InSight accuracy vs. CT (cadaver tests) - 5. Image Quality test - 6. Radiation Dose Exposure test ## Clinical Performance Data Not Applicable {4}------------------------------------------------ ## Conclusions Drawn from Non-Clinical and Clinical Tests: The performance tests demonstrate that C-InSight system may be safely and effectively used in surgical operation rooms, as an 3D visualization software, particularly for orthopedic applications. The software validation and accuracy performance tests demonstrate that the C-InSight system meets its design and performance specifications and is substantially equivalent to the previously cleared systems. #### Substantial Equivalence: In summary, the intended use of the C-Insight system is substantially equivalent to a combination of the Siremobil Iso-C 3D system and the O-Arm Imaging System. Furthermore, the basic technological characteristics of the C-InSight system are identical to the predicate devices. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the C-InSight system is substantially equivalent to the Siremobil Iso-C 3D system and the O-Arm Imaging System device. #### Performance Standards: The C-InSight™ system complies with the voluntary recognized standards: - 1. Software Validation (IEC 60601-1-4 & FDA Guidelines) - 2. Medical Electrical Equipment (IEC 60601-1 / 2) {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # AUG 1 5 2008 Mazor Surgical Technologies Ltd. % Ms. Ahava Stein/ Ofer Hornick Consultant A. Stein -- Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL Re: K081672 Trade/Device Name: C-Insight System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 11, 2008 Received: June 13, 2008 #### Dear Ms. Stein: 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 either 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. {6}------------------------------------------------ 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 requivements 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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Crance of Compliance of one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.btml Sincerely vours. Nancy Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health enclosure {7}------------------------------------------------ ### INDICATIONS FOR USE 510(k) Number (if known): Device Name: C-InSight System ### Intended Use Statement: The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications Prescription Use _ V (Per 21 C.F.R. 801 Subpart D) C) OR Over-The-Counter Use (Optional Format Subpart (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Concurrence of CDRH, Office of Device Evaluation (ODE) Helene Reimer ivision Sign-Off) ivision of Reproductive, Abdominal and ്adiological Devices K081672 J10(k) Number ________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K081672](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K081672) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com