(158 days)
Not Found
No
The description focuses on the mechanical design and materials of the implant and instrument system, with no mention of AI or ML.
Yes.
The device is intended for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis," which are therapeutic applications.
No
The "Intended Use" states that the device is for "sacroiliac joint fusion" and the "Device Description" explains it as an "implantation across the joint space" and a "fusion implantation." These descriptions indicate a therapeutic purpose, not a diagnostic one.
No
The device description clearly states the device is a physical implant made of titanium alloy with a hydroxyapatite coating, and it is used in conjunction with an instrument system for surgical implantation. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Liberty SI Lateral Implant System is a physical implant designed to be surgically inserted into the sacroiliac joint to fuse it. It is a structural device used in vivo (within the body).
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure to stabilize the joint, not to analyze biological samples for diagnostic purposes.
The description clearly indicates a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Liberty SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes
OUR
Device Description
The Liberty SI Lateral Implant System is a minimally invasive sacroliac joint fusion implantation across the joint space (i.e., the implant transfixes the Sl Lateral Implant System is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is partially coated with hydroxyapatite (HA) per ASTM F1185. To accommodate varying patient anatomy, the Liberty Sl Lateral Implants are available in multiple diameters and length offerings. The Liberty Sl Lateral Implants consist of a cannulated central threaded body that has deployable Wings and a Compressive Body. Using the designated instrument system, one or two implants may be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The Liberty SI Lateral Implants are single use devices that are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Non-clinical mechanical tests per ASTM F3574 were performed to support substantial equivalence of the Liberty Sl Lateral Implant System. Custom and cadaver tests were also performed to support the performance of the device.
The following ASTM F3574 tests were performed: ASTM F3574 Static Cantilever Bend Testing ASTM F3574 Static Torsion Testing ASTM F3574 Pullout Strength Testing ASTM F3574 Driving Torque Testing ASTM F3574 Dynamic Cantilever Bend Testing
Clinical performance testing was not performed for this submission.
Spinal Simplicity concludes that the performance testing provided in this 510(k) application demonstrates that the Liberty Sl Lateral lmplant System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 5, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal of the Department of Health & Human Services - USA. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".
Spinal Simplicity LLC Adam Rogers Vice President of Regulatory and Engineering 6363 College Blvd Ste 320 Overland Park, Kansas 66211
Re: K231923
Trade/Device Name: Liberty SI Lateral Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: November 6, 2023 Received: November 6, 2023
Dear Adam Rogers:
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 (the 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" (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).
1
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 OS 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 mediation-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,
Colin
O'neill -S FDA
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
2
Indications for Use
510(k) Number (if known) K231923
Device Name Liberty SI Lateral Implant System
Indications for Use (Describe)
The Liberty SI Lateral Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| K231923 | ||
|---|---|---|
| 510(k) Summary | Page 1 of 2 Prepared on: 2023-12-05 | |
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Spinal Simplicity LLC | |
| Applicant Address | 6363 College Blvd Ste 320 Overland Park KS 66211 United States | |
| Applicant Contact Telephone | 913-451-4414 | |
| Applicant Contact | Mr. Adam Rogers | |
| Applicant Contact Email | arogers@spinalsimplicity.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Liberty SI Lateral Implant System | |
| Common Name | Sacroiliac Joint Fixation | |
| Classification Name | Smooth or threaded metallic bone fixation fastener | |
| Regulation Number | 888.3040 | |
| Product Code | OUR | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K183119 | SI-LOK® Sacroiliac Joint Fixation System | OUR |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The Liberty SI Lateral Implant System is a minimally invasive sacroliac joint fusion implantation across the joint space (i.e., the implant transfixes the Sl Lateral Implant System is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is partially coated with hydroxyapatite (HA) per ASTM F1185. To accommodate varying patient anatomy, the Liberty Sl Lateral Implants are available in multiple diameters and length offerings. The Liberty Sl Lateral Implants consist of a cannulated central threaded body that has deployable Wings and a Compressive Body. Using the designated instrument system, one or two implants may be inserted across the SI Joint to apply a compressive force across the joint and to provide stabilization and fusion. The Liberty SI Lateral Implants are single use devices that are provided sterile.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
Intended Use/Indications for Use
The Liberty SI Lateral Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis.
Indications for Use Comparison
The Liberty SI Lateral Implant System has the same indications for use as the predicate device.
Technological Comparison
The Liberty SI Lateral Implant System is substantially equivalent to the identified predicate device. The Liberty Sl Lateral Implant System has a similar surgical approach, materials, range of sizes, design and principles of operation compared to its predicate device. Any
4
differences in technological characteristics do not raise different questions of safety or effectiveness. Performance testing demonstrates the device has mechanical performance substantially equivalent to that of the predicate.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non-clinical mechanical tests per ASTM F3574 were performed to support substantial equivalence of the Liberty Sl Lateral Implant System. Custom and cadaver tests were also performed to support the performance of the device.
The following ASTM F3574 tests were performed: ASTM F3574 Static Cantilever Bend Testing ASTM F3574 Static Torsion Testing ASTM F3574 Pullout Strength Testing ASTM F3574 Driving Torque Testing ASTM F3574 Dynamic Cantilever Bend Testing
Clinical performance testing was not performed for this submission.
Spinal Simplicity concludes that the performance testing provided in this 510(k) application demonstrates that the Liberty Sl Lateral lmplant System is capable of performing as intended and is substantially equivalent to the legally marketed predicate device.