(72 days)
Not Found
No
The description mentions "proprietary algorithms" for image processing and "computer controlled" guidance, but there is no explicit mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic performance. The focus is on image-guided surgery and precise positioning based on pre-operative plans and image processing, which can be achieved with traditional algorithms.
No
The device is indicated for precise positioning and guidance of surgical instruments during spinal fusion surgery, not for treating a disease or condition itself.
No
The device is an image-guided surgery system designed to assist surgeons in precisely positioning surgical tools during spinal fusion surgery, not to diagnose a condition. It processes images for planning and guidance, not for diagnostic interpretation.
No
The device description explicitly lists hardware components (Planning System, Workstation, Miniature Surgical Guidance System MSG) and describes a physical articulating arm and tool guide, indicating it is not software-only.
Based on the provided information, the SpineAssist device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "precise positioning of surgical instruments during spinal fusion stabilization surgery." This is an in vivo procedure, meaning it is performed on a living organism (the patient).
- Device Description: The device is described as a "computer controlled miniature medical image-guided surgery (IGS) system" that "assists surgeons in precisely guiding handheld surgical tools." This clearly indicates a surgical assistance device used during a procedure on the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The SpineAssist does not perform any such analysis of biological specimens. It uses imaging data to guide surgical tools on the patient.
Therefore, the SpineAssist falls under the category of a surgical guidance or navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SpineAssist is indicated for precise positioning of surgical instruments during spinal stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The SpineAssist device is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based preoperative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the MSG, which positions its articulating arm and tool guide. Through the bone-attaching procedure, the SpineAssist device attaches to the bone on which the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan.
The main components of the SpineAssist device include:
- A. Planning System;
- B. Workstation; and
- C. Miniature Surgical Guidance System MSG
Mentions image processing
The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the MSG, which positions its articulating arm and tool guide.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic and CT images
Anatomical Site
spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / Not Found
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)
Testing was carried out to assure compliance with recognized electrical safety standards. Mazor Surgical Technologies has certified compliance with the EN 60601-1 standard for electrical safety and compliance with the EN 60601-1-2 standard for electromagnetic compatibility. Tests were also carried out to satisfy the requirements of the IEC 60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices. Additional device performance tests were performed to validate the accuracy and repeatability of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963256, K991081, K010968, K021306, K981315, K031156
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
SECTION 7 - SUMMARY OF SAFETY AND EFFECTIVENESS
Applicant:
Mazor Surgical Technologies Ltd. 7 HaEshel Str. P.O.B. 3104 Southern Caesarea Industrial Park 38900 ISRAEL Tel: +972-4-6270171 Fax: +972-4-6377234
Corresponding Official:
Ahava Stein, Consultant Name: Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Ticl: +972-9-767 0002 Fax: +972-9-766 8534
| Device Name: | SpineAssist Device |
|---|---|
| Device trade or proprietary name: | SpineAssist Device |
| Common Name: | Surgical Navigation System / Image Guided Surgery |
| Classification Name: | Stereotaxic Instrument, 21 CFR Section 882.4560 |
Description of the Device:
The SpineAssist device is a computer controlled miniature medical image-guided surgery (IGS) system which serves as a technological platform for solutions that provide unprecedented levels of accuracy, precision and accessibility in performing orthopedic procedures. The SpineAssist is designed to assist surgeons in precisely guiding handheld surgical tools in line with a computerized, image-based preoperative plan along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the MSG, which positions its articulating arm and tool guide. Through the bone-attaching procedure, the SpineAssist device attaches to the bone on which
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1
the procedure is being performed and assists surgeons in precisely guiding handheld surgical tools in line with the computerized, image-based, pre-operative plan.
The main components of the SpineAssist device include:
- A. Planning System;
- B. Workstation; and
- C. Miniature Surgical Guidance System MSG
Intended Use:
The SpineAssist is indicated for precise positioning of surgical instruments during spinal stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.
Performance Data:
Testing was carried out to assure compliance with recognized electrical safety standards. Mazor Surgical Technologies has certified compliance with the EN 60601-1 standard for electrical safety and compliance with the EN 60601-1-2 standard for electromagnetic compatibility. Tests were also carried out to satisfy the requirements of the IEC 60601-1-4 standard and the FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices. Additional device performance tests were performed to validate the accuracy and repeatability of the device.
Predicate Device:
The SpineAssist device is substantially equivalent to a combination of the following devices. Device names, manufacturers and 510(k) numbers are designated in the following table.
| Device | Manufacturer | Type of Device | 510(k) Number |
|---|---|---|---|
| Neuromate | Brainlab AG | Stereotaxic Instrument | K963256, K991081 |
| Vector Vision | Integrated Surgical | ||
| Systems Inc. | Stereotaxic Instrument | K010968, K021306 | |
| Navitrack | OrthoSoft Inc. | Stereotaxic Instrument | K981315, K031156 |
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C033413
Technological Characteristics Compared to Predicate Device
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the SpineAssist device are substantially equivalent to the predicate devices cited above. The differences that exist between the devices, relative to the technical specifications do not raise new issues of safety or effectiveness regarding the SpineAssist device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mazor Surgical Technologies Ltd. c/o Ms. Ahava Stein Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. (Room 213) 44425 Kfar Saba
Re: K033413
Israel
Trade/Device Name: SpineAssist Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: October 22, 2003 Received: November 4, 2003
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.
JAN - 7 2004
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.
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 CHR 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 elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Ahava Stein
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 predicated 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K033413
Device Name:
SpineAssist Device
Indications For Use:
The SpineAssist is indicated for precise positioning of surgical instruments during spinal fusion stabilization surgery. The device enables pre-operative planning of the surgical procedure and subsequent spatial positioning and orientation of the surgical tool during intra-operative procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-Page 1 of
Muriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K033413