(28 days)
Not Found
No
The device description and intended use focus on mechanical implants for sacroiliac joint fusion, with no mention of AI or ML capabilities.
Yes
The device is intended for sacroiliac fusion for specific medical conditions, which aims to treat or alleviate a disease or injury.
No
The device description, intended use, and performance studies indicate that this system consists of surgical implants (screws) used for fusion and stabilization of the sacroiliac joint, which is a treatment rather than a diagnostic process.
No
The device description explicitly states the system consists of titanium bone screws and an optional serrated washer, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure for fusing the sacroiliac joint to treat specific conditions. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is described as titanium bone screws and an optional washer, which are physical implants used in surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions: • Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. · To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion. · Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The SI-Cure Sacroiliac Joint Fusion System consists of titanium bone screws of Ø7 mm, Ø9.5 mm, Ø10.5 mm, and Ø11 mm diameter and various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw head for load distribution. The screws are made from titanium alloy Ti-6AL-4V ELI per ASTM F136.
The purpose of this submission is to add headless screws with additional screw size options to the previously cleared system.
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
skeletally mature patients
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)
Bench testing was not required in this submission because the addition of the headless screws and length and diameter options do not introduce a new worst case for mechanical performance compared to the cleared implants and do not require performance testing.
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
§ 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
July 28, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Alevio, LLC % Nathan Wright Engineer & Regulatory Specialist Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K231951
Trade/Device Name: SI-Cure Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: June 30, 2023 Received: June 30, 2023
Dear Nathan Wright:
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 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,
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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
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Indications for Use
Submission Number (if known)
Device Name
SI-Cure Sacroiliac Joint Fusion System
Indications for Use (Describe)
The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions:
• Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroillac ioint.
Type of Use (Select one or both, as applicable)
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
510(K) SUMMARY
| Submitter's Name: | Alevio, LLC |
|---|---|
| Submitter's Address: | 200 Cahaba Park Circle |
| Suite 100 | |
| Birmingham, Alabama 35242 | |
| Submitter's Telephone: | 205-783-5778 |
| Contact Person: | Nathan Wright MS, RAC |
| Empirical Technologies | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Technologies Logo | |
| Date Summary was Prepared: | June 30, 2023 |
| Trade or Proprietary Name: | SI-Cure Sacroiliac Fusion Joint System |
| Device Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification & Regulation #: | Class II per 21 CFR §888.3040 |
| Product Code: | OUR |
| Classification Panel: | Orthopedic Devices - Spinal Devices (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The SI-Cure Sacroiliac Joint Fusion System consists of titanium bone screws of Ø7 mm, Ø9.5 mm, Ø10.5 mm, and Ø11 mm diameter and various lengths to accommodate patient anatomy. An optional serrated washer can be placed on the screw head for load distribution. The screws are made from titanium alloy Ti-6AL-4V ELI per ASTM F136.
The purpose of this submission is to add headless screws with additional screw size options to the previously cleared system.
INDICATIONS FOR USE
The SI-Cure Sacroiliac Joint Fusion System is intended for sacroiliac fusion for the following conditions: · Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
· To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
· Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar or the same between the subject and predicates:
- Indications for Use
- Material of Manufacture ●
- . Structural Support Mechanism
- Sizes and Features ●
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- Sterilization ●
- Manufacturing and Biocompatibility
- Mechanical Performance ●
Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K223819 | SI-Cure Sacroiliac Fusion Joint System | Alevio, LLC | Primary |
| K021932 | Synthes 6.5 mm Cannulated Screws | Synthes (USA) | Additional |
PERFORMANCE DATA
Bench testing was not required in this submission because the addition of the headless screws and length and diameter options do not introduce a new worst case for mechanical performance compared to the cleared implants and do not require performance testing.
CONCLUSION
The overall technology characteristics and mechanical performance evaluation lead to the conclusion that subject SI-Cure Sacroiliac Fusion Joint System is substantially equivalent to the predicate device.