(63 days)
Not Found
No
The summary describes image processing and conversion techniques but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is a software that converts 2D fluoroscopic images into 3D volumetric images for better visualization, particularly for orthopedic applications. It does not exert any direct therapeutic action on the patient.
No.
The device processes 2D fluoroscopic images into 3D images for visualization, particularly for orthopedic applications, which is not making a diagnosis but rather aiding in surgical guidance or planning.
Yes
The device description explicitly states "C-InSight is a software based product" and describes its function as converting images. The performance studies focus on software validation and accuracy tests, further supporting its classification as software. While it's an "add-on to commercially available mobile x-ray systems," the device itself is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The C-InSight software processes and converts 2D fluoroscopic images (which are generated in vivo within the patient's body) into 3D images. It does not analyze samples taken from the body.
- Intended Use: The intended use is for generating 3D imaging of high contrast objects for orthopedic applications, which is a diagnostic and visualization tool used during surgical procedures, not for analyzing biological samples.
- Input: The input is 2D fluoroscopic projections, not biological specimens.
Therefore, the C-InSight software falls under the category of medical imaging software used for visualization and potentially diagnosis based on images acquired directly from the patient's body, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
LLZ
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 during the operation especially due to the rise in the scope of minimally invasive procedures.
To answer the need for a reasonably priced, easy 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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D fluoroscopic projections from standard C-Arms
Anatomical Site
Not Specified (implied high contrast objects, particularly for orthopedic applications)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician / Surgical operation rooms
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted on the C-InSight system:
-
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
-
- C-InSight synthetic accuracy test.
-
- C-InSight spine accuracy test.
-
- C-InSight accuracy vs. CT (cadaver tests)
-
- Image Quality test
-
- Radiation Dose Exposure test
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003266, K032280, K040347, K050996, K060344
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
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:
-
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
-
- C-InSight synthetic accuracy test.
-
- C-InSight spine accuracy test.
-
- C-InSight accuracy vs. CT (cadaver tests)
-
- Image Quality test
-
- 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:
-
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
-
- 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 ________________________________________________________________________________________________________________________________________________________________