(28 days)
No
The summary describes image processing and tracking algorithms, but does not mention AI or ML. The modifications focus on hardware, GUI improvements, and a new registration method (CT to C-InSight registration), which are not inherently AI/ML technologies.
No.
The device is indicated for precise positioning of surgical instruments or implants during general spinal surgery, which is a surgical guidance function, not a therapeutic one.
No
The device is used for precise positioning of surgical instruments or implants and for converting 2D fluoroscopic images into 3D volumetric images. While it processes medical images, its primary indicated uses are surgical guidance and imaging, not diagnosis. The system aids in surgical procedures and provides feedback but doesn't explicitly state that it identifies or analyzes diseases, conditions, or injuries for diagnostic purposes.
No
The device description explicitly states that the modifications include a "newly designed workstation (hardware change)" and a "slightly modified SpineAssist Guiding Device (with colored LED lights)," indicating the presence of hardware components beyond just software.
Based on the provided text, the Renaissance System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Renaissance System's Intended Use: The Renaissance System is indicated for "precise positioning of surgical instruments or implants during general spinal surgery." It uses imaging data (CT and fluoroscopy) to guide surgical procedures.
- Lack of Specimen Analysis: The device description and intended use do not mention the analysis of any biological specimens from the patient. Its function is entirely focused on image processing and surgical guidance based on those images.
Therefore, the Renaissance System falls under the category of a surgical guidance system or medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 3D imaging capabilities provide 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.
Product codes
HAW, LLZ
Device Description
The Renaissance system is a device modification of the TenZing system (K102130). which is comprised of the original SpineAssist System and the C-InSight System.
The SpineAssist application enables the surgeon to precisely position surgical instruments or implants during general spinal surgery. This is achieved through preoperation planning and virtual placement of the surgical instrument or implant (e.g., a screw) based on the patients' CT data. During the surgical procedure the pre-planned instrument or implant positions are located and projected on Fluoroscopy images relative to the SpineAssist device position while the SpineAssist arm is then guided to the actual position. The SpineAssist is described in previously cleared 510(k) submissions K033413, K051676, K063607 and K073467.
The C-InSight application is a software based product, which converts a sequence of two-dimensional fluoroscopy images into a 3D volumetric image, intraoperatively. The C-InSight computer is connected to a traditional C-Arm in the operating room and grabs all images from the C-Arm. Using a tracking algorithm, the C-InSight software is able to convert a continuous scan around the region of interest into a 3D image, intra-operatively. The C-InSight is described in the previously cleared 510(k) submission K081672.
The TenZing System cleared in 510(k) submission K102130 is a workstation which contains both the C-InSight and SpineAssist components in one workstation. This allows the physician to perform SpineAssist procedures and C-InSight procedures as independent applications, but using the same workstation console. Furthermore, the TenZing System allows the surgeon to perform SpineAssist procedures and obtain an intra-overative 3D verification image using the C-InSight application. Thus, the surgeon can obtain real time feedback regarding instrument and/or implant positioning.
The modified system is called the Renaissance System. The device modifications include a newly designed workstation (hardware change), a slightly modified SpineAssist Guiding Device (with colored LED lights), and modified software with improved GUI for the original TenZing software (software change) and the ability to perform CT-Fluoroscopy registration using the fluoroscopy images obtained from the C-InSight application (i.e., CT to C-InSight registration).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, CT
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician / operating room
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 performed on the Renaissance System:
- Software validation testing in accordance with the FDA Guidance for the . Premarket Submissions for Software Contained in Medical Devices (January 11, 2002).
- CT to C-InSight Registration Accuracy Testing .
- IEC 60601-1 Electrical and Mechanical Safety Testing
- IEC 60601-1-2 Electromagnetic Compatibility Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K033413, K051676, K063607, K073467, K081672
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS
APR 28 2011
(Premarket Notification [510(k)] Number)
1. Submitter Information
| Manufacturer Name & Address
Mazor Robotics Ltd.
7 HaEshel Str.
P.O.B. 3104
Southern Caesarea Industrial Park, 38900
ISRAEL | Official Correspondent
Ahava Stein
A. Stein - Regulatory Affairs Consulting Ltd.
20 Hata'as St.
Kfar Saba 44425
Israel |
|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 2. Date Prepare: | March 2011 |
| 3. Device Name | |
| Proprietary Name: | Renaissance System |
| Common / Usual
Name: | Combination of:
- Spinal Stereotaxic instrument; and
- 3-D Reconstruction Tool for Mobile X-Ray Devices |
| FDA Classification
Name: | 1. 21 CFR 882.4560; Stereotaxic instrument - 21 CFR 892.2050; System, image Processing, Radiological |
Class II, Product Code HAW and LLZ FDA Classification:
4. Predicate Devices
The Renaissance System is substantially equivalent to the following device:
| Manufacturer | Device | 510(k) | Date Cleared |
|---|---|---|---|
| Mazor Robotics | TenZing | K102130 | 08/26/2010 |
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5. Device Description
The Renaissance system is a device modification of the TenZing system (K102130). which is comprised of the original SpineAssist System and the C-InSight System.
The SpineAssist application enables the surgeon to precisely position surgical instruments or implants during general spinal surgery. This is achieved through preoperation planning and virtual placement of the surgical instrument or implant (e.g., a screw) based on the patients' CT data. During the surgical procedure the pre-planned instrument or implant positions are located and projected on Fluoroscopy images relative to the SpineAssist device position while the SpineAssist arm is then guided to the actual position. The SpineAssist is described in previously cleared 510(k) submissions K033413, K051676, K063607 and K073467.
The C-InSight application is a software based product, which converts a sequence of two-dimensional fluoroscopy images into a 3D volumetric image, intraoperatively. The C-InSight computer is connected to a traditional C-Arm in the operating room and grabs all images from the C-Arm. Using a tracking algorithm, the C-InSight software is able to convert a continuous scan around the region of interest into a 3D image, intra-operatively. The C-InSight is described in the previously cleared 510(k) submission K081672.
The TenZing System cleared in 510(k) submission K102130 is a workstation which contains both the C-InSight and SpineAssist components in one workstation. This allows the physician to perform SpineAssist procedures and C-InSight procedures as independent applications, but using the same workstation console. Furthermore, the TenZing System allows the surgeon to perform SpineAssist procedures and obtain an intra-overative 3D verification image using the C-InSight application. Thus, the surgeon can obtain real time feedback regarding instrument and/or implant positioning.
The modified system is called the Renaissance System. The device modifications include a newly designed workstation (hardware change), a slightly modified SpineAssist Guiding Device (with colored LED lights), and modified software with improved GUI for the original TenZing software (software change) and the ability to perform CT-Fluoroscopy registration using the fluoroscopy images obtained from the C-InSight application (i.e., CT to C-InSight registration).
6. Intended Use / Indications
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 3D imaging capabilities provide 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.
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7. Performance Standards
There are no performance standards under the Federal Food, Drug and Cosmetic Act, for the Renaissance device.
8. Performance Testing
The following Performance tests were performed on the Renaissance System:
- Software validation testing in accordance with the FDA Guidance for the . Premarket Submissions for Software Contained in Medical Devices (January 11, 2002).
- CT to C-InSight Registration Accuracy Testing .
- IEC 60601-1 Electrical and Mechanical Safety Testing �
- IEC 60601-1-2 Electromagnetic Compatibility Testing ●
Technological Characteristics Compared to Predicate Device 9.
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Renaissance device are substantially equivalent to the predicate device cited above.
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દિવ
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mazor Robotics, Ltd. % Ms. Ahava Stein Official Correspondent Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL
APR 2 8 2011
Re: K110911
Trade/Device Name: Renaissance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW and LLZ Dated: March 27, 2011 Received: March 31, 2011
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Enclosure
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SECTION 1 - INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Renaissance System
Intended Use Statement:
The Renaissance System is indicated for precise positioning of surgical instruments or implants during general spinal surgery. It may be used in either open or percutaneous procedures.
Renaissance 3D imaging capabilities provide 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.
Prescription Use V (Per 21 C.F.R. 801 Subpart D) Over-The-Counter Use
(Optional Format Subpart C)
ನ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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OR
Concurrence of CDRH, Office of Device Evaluation (CDDB) ○Д / ○
Minny Stadel
Office of In
510K. K110911