(109 days)
Not Found
No
The summary describes a mechanical implant (screws) and its material properties and mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as a 'Sacroiliac Screw System' intended for 'sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis', which indicates it is used to treat or alleviate a disease or condition.
No
The device is a sacroiliac screw system used for joint fusion, which is an interventional treatment. It is not described as being used to diagnose conditions.
No
The device description explicitly states it consists of "cannulated, fully threaded screws" fabricated from "medical grade titanium alloy." This indicates a physical, implantable hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (screws and washers) made of titanium alloy, designed to be surgically inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis.
The Blue Topaz Sacroiliac Screw System is a surgical implant used for orthopedic purposes.
N/A
Intended Use / Indications for Use
The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
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
Prescription Use
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)
The Blue Topaz Sacroiliac Screw System has been tested in the following test modes:
- Static and Dynamic Cantilever Bending per ASTM F2193
- Driving Torque per ASTM F543
- Static Torsion per ASTM F543
- Pullout per ASTM F543
The results of this non-clinical testing show that the strength of the Blue Topaz Sacroiliac Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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
March 1, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osseus Fusion Systems, LLC % Mr. Nathan Wright Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K213590
Trade/Device Name: Blue Topaz Sacroiliac Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 28, 2022 Received: January 31, 2022
Dear Mr. 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,
for
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
| ------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------- |
|---|
Indications for Use
| 510(k) Number ( if known ) | K213590 |
|---|---|
| Device Name | |
| Blue Topaz Sacroiliac Screw System | |
| Indications for Use ( Describe ) | |
| The Blue Topaz Sacroiliac Screw 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) | |
| ✓ 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." |
FORM FDA 3881 (7/17)
3
| Submitter's Name: | Osseus Fusion Systems, LLC |
|---|---|
| Submitter's Address: | 1931 Greenville Ave, Suite 200 |
| Dallas, Texas 75206 | |
| Submitter's Telephone: | 888-330-5960 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Testing Corp. Logo | |
| Date Summary was Prepared: | November 11, 2021 |
| Trade or Proprietary Name: | Blue Topaz Sacroiliac Screw System |
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | OUR |
| Classification Panel: | Orthopedic Devices – Spinal Devices (DHT6B) |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Blue Topaz Sacroiliac Screw System consists of cannulated, fully threaded screws intended to facilitate fusion of the sacroiliac joint. The Blue Topaz Sacroiliac Screw System is fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Blue Topaz System implants come in various sizes and lengths to accommodate patient anatomy. Optional washers are included for each screw diameter to aid in conforming to patient anatomy.
INDICATIONS FOR USE
The Blue Topaz Sacroiliac Screw System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
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 identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture .
- Structural support mechanism ●
- Size ●
4
Predicate Devices
| 510k # | Trade or Proprietary or Model Name | Manufacturer | Product Code | Type |
|---|---|---|---|---|
| K152237 | Entasis™ Dual-Lead Sacroiliac Implant | CoreLink, LLC | OUR | Primary |
| K181881 | Outlet Sacroiliac Joint Fusion System | SIJ Surgical | OUR | Additional |
| K121148 | SAMBA™ Screw System | Medical Designs LLC | HWC, OUR | Additional |
Performance Data
The Blue Topaz Sacroiliac Screw System has been tested in the following test modes:
- Static and Dynamic Cantilever Bending per ASTM F2193 ●
- Driving Torque per ASTM F543 .
- Static Torsion per ASTM F543 ●
- Pullout per ASTM F543 .
The results of this non-clinical testing show that the strength of the Blue Topaz Sacroiliac Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Blue Topaz Sacroiliac Screw System is substantially equivalent to the predicate device.