(77 days)
Not Found
No
The description mentions "proprietary algorithms" for image processing and positioning, but does not explicitly state or imply the use of AI or ML technologies. The focus is on image-guided positioning based on a pre-operative plan.
No
The device is described as assisting surgeons in positioning surgical instruments and guiding tools, not as directly providing therapy or treatment.
No
Explanation: The device is described as an image-guided positioning system used to assist surgeons in accurately positioning surgical tools, and for pre-operative planning and intra-operative guidance. It does not diagnose medical conditions.
No
The device description explicitly states that the SpineAssist device is a "surgical positioning system" that includes an "articulating arm and tool guide" which it positions based on software processing. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the SpineAssist System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The SpineAssist System is a surgical positioning system used during surgery to guide instruments on the patient's body. It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for surgical guidance. The description clearly states its purpose is for "precise positioning of surgical instruments during spinal stabilization surgery" and "spatial positioning and orientation of the surgical tool during intra-operative procedures."
- The device interacts directly with the patient's body. It attaches to the bone and guides surgical tools, which is a direct interaction with the patient, not an analysis of a specimen taken from the patient.
The image processing mentioned is for surgical planning and guidance, not for diagnostic purposes based on analyzing biological samples.
N/A
Intended Use / Indications for Use
The SpineAssist System 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.
The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The SpineAssist device developed by Mazor Surgical Technologies is an accurate imageguided positioning system that extends surgical capability in terms of precision, miniaturization and accessibility. The SpineAssist surgical positioning system assists the surgeon in the operating room to accurately position hand held surgical tools according to a computerized image-based pre-operative plan and to accurately guide surgical tools along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist Device, which positions its articulating arm and tool guide. Using the Hover-T kit, a special bone attachment component, 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.
Mentions image processing
Yes
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
surgeon in the 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)
Not Found
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.
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
SEP - 8 2005
Appendix B:
SECTION 6 - SUMMARY OF SAFETY AND EFFECTIVENESS
K051676 (Premarket Notification [510(k)] Number)
1. 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:
Name: Ahava M. Stein, Consultant Address: A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfår Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534
2. Device Name
| Device Name: | SpineAssist System |
|---|---|
| Device trade or proprietary name: | SpineAssist System |
| Common Name: | Surgical Navigation System / image Guided Surgery |
| Classification Name: | Stereotaxic Instrument, 21 CFR Section 882.4560 |
3. Predicate Devices
The modified SpineAssist device is substantially equivalent to the following device:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| SpineAssist | Mazor Surgical Technologies Ltd. | K033413 |
1
4. Intended Use
The SpineAssist System 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.
The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.
5. Description of the Device
._ : : : =====================================================================================================================================================================
The SpineAssist device developed by Mazor Surgical Technologies is an accurate imageguided positioning system that extends surgical capability in terms of precision, miniaturization and accessibility. The SpineAssist surgical positioning system assists the surgeon in the operating room to accurately position hand held surgical tools according to a computerized image-based pre-operative plan and to accurately guide surgical tools along given trajectories. The system's software processes fluoroscopic and CT images via proprietary algorithms and automatically exports the desired coordinates to the SpineAssist Device, which positions its articulating arm and tool guide. Using the Hover-T kit, a special bone attachment component, 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.
6. Technological Characteristics Compared to Predicate Devier
The technological characteristics of the modified device, 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 device cited above.
このことになると、その他、その他のあるので、その他のあると、その他のあると、その他、この一、ここに、この一、一般のことになるので
. . . . . .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
SEP - 8 2005
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 Israel
Re: K051676
Trade/Device Name: SpineAssist Device Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 18, 2005 Received: August 29, 2005
Dear Ms. Stein:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaon 310(t) per is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 tise stated in the encrosule) to regars actment date of the Medical Device Amendments, or to Commerce provision of May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have occh recultion in avee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The 1 ou may, dierelove, mance as 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 FDA it may be subject to sach additions. Title 21, Parts 800 to 898. In addition, FDA can be found in the Oouverements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled or a badewice complies with other requirements of the Act that I DA has made a decidinations administered by other Federal agencies. You must or any Federal statutes and regulations annualites, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 807), ademig (21 OFF Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 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 Office of Compliance at (240) 276-0115 . 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/industry/support/index.html.
Sincerely yours,
Harbar Rouehud
Mark N. Melkersen Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix A:
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K 051676
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.
The Hover-T Bridge accessory used in conjunction with the SpineAssist device for minimally invasive surgical procedures, is intended for use for lumbar spinal fusion stabilization surgery.
Prescription Use V (Per 21 C.F.R. 801.109) QR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices
510(k) Number_