(55 days)
No
The summary describes a surgical fixation system and navigation instruments that work with a pre-existing navigation system (Medtronic StealthStation System S8). While navigation systems can sometimes incorporate AI/ML, this summary does not mention any AI/ML components within the Xenix Medical device itself or its interaction with the navigation system. The performance studies focus on mechanical testing and accuracy testing with the navigation system, not on AI/ML performance metrics.
Yes
The device is indicated for sacroiliac joint fusion and fracture fixation, aiming to treat medical conditions and restore function.
No
The device is a sacroiliac fixation system, an implant and surgical instrumentation designed for joint fusion and fracture fixation. While it uses navigation instruments that assist in precisely locating anatomical structures during surgery using imaging modalities, the system itself is not designed to diagnose a condition, but rather to treat it.
No
The device description explicitly states that the system consists of 3D printed medical grade Titanium Alloy Implants and surgical instrumentation, which are hardware components. While there are navigation instruments that interact with a navigation system, the core device includes physical implants and instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Xenix Medical Sacroiliac Fixation System is a surgical implant and instrumentation system used for physically fixing and stabilizing the sacroiliac joint. It is used during surgery to treat anatomical issues.
- Intended Use: The intended use clearly describes a surgical procedure involving implantation and navigation, not the analysis of biological samples.
- Device Description: The device consists of implants and surgical instruments, not reagents, test kits, or analytical equipment used for in vitro testing.
- Performance Studies: The performance studies described focus on mechanical testing of the implants, sterilization validation, and accuracy testing of the navigation instruments – all related to the physical and functional aspects of a surgical device, not diagnostic performance.
In summary, the Xenix Medical Sacroiliac Fixation System is a surgical device used for treatment and stabilization, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:
- · Sacroiliac joint dysfunction including degenerative sacroiliac joint disruptions
· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, and nontraumatic fractures involving the sacroiliac joint.
The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OUR, OLO, HWC
Device Description
The Xenix Medical Sacroiliac Fixation System consists of 3D printed medical grade Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI based model, fluoroscopy images
Anatomical Site
sacroiliac joint, pelvis or vertebra
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon in either open or minimally invasive procedures
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)
Mechanical testing, including static and dynamic cantilever bending and axial pull-out, were conducted in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence of the subject Xenix Medical Sacroiliac Fixation System Implants to the predicate devices. Sterilization validation of the subject implants was performed in accordance with ISO 11137-1 and ISO 11137-2. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72.
Accuracy testing was performed on the Xenix Medical Sacroiliac Fixation System Navigation instruments to confirm that the instruments register and function properly with the Medtronic StealthStation S8 Navigation System. Dimensional analysis of the Xenix Medical Sacroiliac Fixation System Navigation instruments was performed against the predicate instruments.
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.
K222605, K161210, K150017, K021932
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.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
August 15, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HT Medical d.b.a. Xenix Medical % Justin Eggleton Vice President, Regulatory Affairs Mcra LLC 803 7th Street NW, 3rd Floor Washington, District of Columbia 20001
Re: K231829
Trade/Device Name: Xenix Medical Sacroiliac Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR, OLO, HWC Dated: June 21, 2023 Received: June 21, 2023
Dear Justin Eggleton:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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/6 description: The image contains the name "Colin O'neill -S" in black font on the left side of the image. On the right side of the image is the letters "FDA" in a light blue color. The letters "FDA" are much larger than the name on the left side of the image. The background of the image is white.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231829
Device Name
Xenix Medical Sacroiliac Fixation System
Indications for Use (Describe)
The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:
- · Sacroiliac joint dysfunction including degenerative sacroiliac joint disruptions
· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, and nontraumatic fractures involving the sacroiliac joint.
The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Device Trade Name: | Xenix Medical Sacroiliac Fixation System |
|---|---|
| Manufacturer: | HT Medical d.b.a. Xenix Medical |
| 111 W Jefferson St., Suite 100 | |
| Orlando, FL 32801 | |
| Contact: | Teresa Cherry |
| Vice President of Quality Assurance and Regulatory Affairs | |
| Xenix Medical | |
| Phone: 888.594.8633 | |
| Prepared by: | Mr. Justin Eggleton |
| Vice President, Regulatory Affairs | |
| MCRA, LLC | |
| 803 7th Street NW, 3rd Floor | |
| Washington, DC 20001 | |
| jeggleton@mcra.com | |
| Phone: 202-552-5804 | |
| Date Prepared: | August 15, 2023 |
| Classifications: | 21 CFR §888.3040; Smooth or threaded metallic bone fixation |
| fastener | |
| 21 CFR §882.4560; Stereotaxic Instruments | |
| Class: | II |
| Product Codes: | OUR, OLO, HWC |
| Device Common | |
| Name: | Sacroiliac Joint Screw, Orthopedic Stereotaxic Instrument |
4
Indications for Use:
The Xenix Medical Sacroiliac Fixation System is indicated for sacroiliac joint fusion for:
- Sacroiliac joint dysfunction including degenerative sacroiliitis and sacroiliac joint ● disruptions
- Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature ● patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion
The Xenix Medical Sacroiliac Fixation System is also indicated for fracture fixation of acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The Xenix Medical Sacroiliac Fixation System Navigation Instruments are intended to be used with the Xenix Medical Sacroiliac Fixation System during surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System S8, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Description:
The Xenix Medical Sacroiliac Fixation System consists of 3D printed medical grade Titanium Alloy Implants (Ti-6Al-4V ELI per ASTM F-3001) and surgical instrumentation for implantation. Implants are provided sterile in various lengths and diameters. The reusable instrumentation is provided non-sterile in a steam sterilization instrument tray.
Predicate Devices:
| Device Name(s) | Manufacturer | K-Number |
|---|---|---|
| Primary Predicate Device | ||
| iFuse TORQ Implant System | SI-Bone | K222605 |
| Additional Predicate Devices | ||
| Rialto™ SI Fusion System | Medtronic | K161210 |
| Sacrix Sacroiliac Fixation | ||
| (SacroFuse/SIJFuse) | SpineFrontier (Sacrix) | K150017 |
| Synthes 6.5mm Cannulated Screw | Synthes | K021932 |
| Reference Device | ||
| Quantum Anterior Cervical Plate (for manufacturing reference) | Nvision Biomedical Technologies, Inc | K210424 |
5
Performance Testing Summary:
Mechanical testing, including static and dynamic cantilever bending and axial pull-out, were conducted in accordance with ASTM F2193 and ASTM F543 to demonstrate substantial equivalence of the subject Xenix Medical Sacroiliac Fixation System Implants to the predicate devices. Sterilization validation of the subject implants was performed in accordance with ISO 11137-1 and ISO 11137-2. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72.
Accuracy testing was performed on the Xenix Medical Sacroiliac Fixation System Navigation instruments to confirm that the instruments register and function properly with the Medtronic StealthStation S8 Navigation System. Dimensional analysis of the Xenix Medical Sacroiliac Fixation System Navigation instruments was performed against the predicate instruments.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, materials, function, manufacturing, and performance.
Conclusion:
The Xenix Medical Sacroiliac Fixation System is substantially equivalent to the cited predicate devices with respect to intended use, indications for use, design, function, materials, and performance. The differences in the technological characteristics between the subject device and the predicate devices do not raise new or different questions of safety and effectiveness.