(142 days)
Not Found
No
The summary describes a navigation system that uses acquired imaging and image data based models for anatomical reference during surgical procedures. While this involves image processing and potentially complex algorithms for registration and accuracy, there is no explicit mention of AI, ML, deep learning, or any related concepts in the provided text. The performance studies focus on registration, accuracy, rigidity, and compatibility, which are standard evaluations for surgical navigation systems and do not inherently indicate the use of AI/ML.
No
The device, Genesys Spine Sacroiliac Joint Fusion System with Navigation, is described as assistive technology for surgeons to precisely locate anatomical structures during SI joint fusion procedures and consists of implants. It is a surgical aid and an implant, not a therapeutic device that directly treats a condition through its own mechanism of action beyond stabilization.
No
The device is a surgical navigation system that assists the surgeon in locating anatomical structures and is used in conjunction with a fusion system, not diagnose conditions.
No
The device description explicitly states that the system consists of "instruments compatible with the Medtronic O-arm® Imaging System and StealthStation™ Navigation System" and also includes "implants designed to secure the sacroiliac joint". This indicates the presence of physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: The Genesys Spine Sacroiliac Joint Fusion System with Navigation is a surgical system used to assist surgeons in precisely locating anatomical structures during sacroiliac joint fusion procedures. It involves instruments, implants, and navigation technology that interacts directly with the patient's body during surgery.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens from the patient. The system relies on imaging data and anatomical references, not laboratory tests on bodily fluids or tissues.
Therefore, the device falls under the category of a surgical device with navigation capabilities, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Genesys Spine Sacroiliac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in SIros and SIros O procedures, in which the use of stereotactic surgery may be appropriate, and where reference to anatomical structures, such as the pelvis or vertebra, can be identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Genesys Spine Sacrolliac Joint Fusion with Navigation consist of instruments compatible with the Medtronic O-arm® Imaging System and StealthStation™ Navigation System to assist the surqeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medtronic O-arm® Imaging System and StealthStation™ Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.
The Genesys Spine Sacrolliac Joint Fusion System consists of implants designed to secure the sacroiliac joint and minimize micromotion to enable bony fusion. All Implants are cannulated and self-tapping; they are offered with different diameters and lengths to accommodate variations in patient anatomy and surgeon preference. The Slros OTM Sacrolliac Joint Fusion System implants are manufactured from implant grade titanium (Ti-6AL-4V ELI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Sacroiliac Joint, pelvis or vertebra, spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / 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 completed to ensure the functionality and compatibility with the Medtronic o-arm and StealthStation Systems.
- Registration - Registration testing was performed to ensure that the instruments can be registered to the StealthStation®.
- Accuracy - Accuracy testing was completed for comparison to the reference instruments.
- Rigidity - Rigidity testing evaluated the connection between the Medtronic NavLock and the subject instruments.
- Compatibility with Genesys Spine Sacroiliac Fusion System Implants - Compatibility with the Implant System has been evaluated to ensure that the isubject instruments are compatible with the Implant System.
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.
K172268, K191748, K161210, K150216
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
Image /page/0/Picture/0 description: The image shows the date March 29, 2024. The text is in a simple, sans-serif font. The date is written out in full, with the month, day, and year clearly visible. The text is horizontally aligned and evenly spaced.
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a staff entwined with a serpent, which is a common symbol for medicine and healthcare. The text on the right is written in a clear, sans-serif font, with "FDA" in a blue square.
Genesys Spine Derek Southard Chief Technical Officer 1250 S. Capital of Texas Highway Building 3, Suite 600 Austin, Texas 78746
Re: K233595
Trade/Device Name: Genesys Spine Sacroiliac Joint Fusion System with Navigation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 28, 2024 Received: February 28, 2024
Dear Derek Southard:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
K233595 - Derek Southard
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image contains the name "Shumaya Ali-S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and clearly legible.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Genesys Spine Sacroiliac Joint Fusion System with Navigation
Indications for Use (Describe)
The Genesys Spine Sacroillac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in SIros and SIros O procedures, in which the use of stereotactic surgery may be appropriate, and where reference to anatomical structures, such as the pelvis or vertebra, can be identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
| 510(k) Summary | Prepared |
|---|---|
| 21 CFR |
Contact Details
R 807.92(a)(1)
T
| Applicant Name | Genesys Spine | ||||
|---|---|---|---|---|---|
| Applicant Address | 1250 S. Capital of Texas Highway Building 3, Suite 600 Austin TX 78746 | ||||
| United States | |||||
| Applicant Contact Telephone | 512-381-7080 | ||||
| Applicant Contact | Mr. Southard Derek | ||||
| Applicant Contact Email | derek.southard@genesysspine.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Genesys Spine Sacroiliac Joint Fusion System with Navigation | ||||
| Common Name | Stereotaxic instrument | ||||
| Classification Name | Orthopedic Stereotaxic Instrument | ||||
| Regulation Number | 882.4560 | ||||
| Product Code | OLO | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K172268 | iFuse Implant System - iFuse Navigation | OLO | |||
| K191748 | Genesys Spine Sacroiliac Joint Fusion System | OUR | |||
| K161210 | Medtronic Navigated Manual Reusable Instruments for use with th | OLO | |||
| K150216 | Medtronic Navigated StealthStation System with Synergy Cranial | HAW | |||
| Device Description Summary | |||||
| 21 CFR 807.92(a)(4) |
4
GENERAL OVERVIEW
The Genesys Spine Sacrolliac Joint Fusion with Navigation consist of instruments compatible with the Medtronic O-arm® Imaging System and StealthStation™ Navigation System to assist the surqeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medtronic O-arm® Imaging System and StealthStation™ Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.
The Genesys Spine Sacrolliac Joint Fusion System consists of implants designed to secure the sacroiliac joint and minimize micromotion to enable bony fusion. All Implants are cannulated and self-tapping; they are offered with different diameters and lengths to accommodate variations in patient anatomy and surgeon preference. The Slros OTM Sacrolliac Joint Fusion System implants are manufactured from implant grade titanium (Ti-6AL-4V ELI).
PRODUCT SPECIFICATIONS AND DIMENSIONS
Product and engineering specifications, and engineering drawings for all system specific instruments are provided as attached.
SURGICAL TECHNIQUE
A detailed surgical technique is available as attached. The surgical technique for instrumentation use, anatomical location of use, various user interfaces, how the devices and how the devices interact with the patient.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Genesys Spine Sacrolliac Joint Fusion System with Navigation is intended to be used with the Genesys Spine Sacroiliac Joint Fusion System to assist the surgeon in precisely locating anatomical structures in which the use of stereotactic surqery may be appropriate, and where reference to anatomical structures, such as the identified relative to acquired imaging (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or image data based models of the anatomy. Navigation instruments are intended to be used with the Medtronic O-arm® Imaging System and StealthStation® Navigation System.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The Genesys Spine Sacrolliac Joint Fusion System with Navigation instruments are intended to be used with the Genesys Spine Sacrollac Joint Fusion System (implants and existing instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of Genesys Spine SJ Joint Fusion implants These inilar designs as the predicate instruments and incorporate the additional design features based on the predicate and reference devices to enable navigation and use with the SteathStation Navl ock trackers.
The Navigation instrument set is intended to be used with the Medtronic StealthStation using the Medtronic O-arm imaging system. The instrument modification detailed in this submission the technological characteristics of either the existing Genesys Spine Sacroiliac Joint Fusion Implants, instruments, or the Medtronic O-arm® and StealthStation® systems.
5
The primary predicate device for this 510(k) is the iFuse Navigation (K172268). The Genesys Spine Sacrolliar Joint Fusion System with Navigation is similar to the cited predicate in regard to instrument design, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, manufacturing, etc.) and performance testing.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Testing was completed to ensure the functionality and compatibility with the Medtronic o-arm and StealthStation Systems. The performance testing completed:
-
Registration - Registration testing was performed to ensure that the instruments can be registered to the StealthStation®.
-
Accuracy - Accuracy testing was completed for comparison to the reference instruments.
-
Rigidity - Rigidity testing evaluated the connection between the Medtronic NavLock and the subject instruments.
-
Compatibility with Genesys Spine Sacroiliac Fusion System Implants - Compatibility with the Implant System has been evaluated to ensure that the isubject instruments are compatible with the Implant System.
Not Applicable
The intended use of the subject Genesys Spine Sacroiliac Fusion System with Navigation instruments, as part of the Genesys Spine Sacroiliac Fusion Implant System, is substantially equivalent to the predicate instruments. The verification and validation results support substantial equivalence of the subject instruments compared to the predicate devices.