(78 days)
Not Found
No
The summary describes a mechanical bone screw and its associated instruments, with no mention of software, image processing, AI, or ML.
Yes
The device is intended for sacroiliac joint fusion to treat medical conditions, which aligns with the definition of a therapeutic device.
No
Explanation: The device is intended for joint fusion, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states that SICAGE is a fully threaded bone screw and includes implants and instruments for implantation, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrollitis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "fully threaded bone screw" and part of a "System includes implants and instruments for implantation." This is a surgical implant and associated tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
IVD devices are used to diagnose, monitor, or screen for diseases or conditions by testing samples taken from the body. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
SICAGE is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrollitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
SICAGE is a fully threaded bone screw offered in a single diameter and various lengths to accommodate variability in patient anatomy. SICAGE is sold sterile. The SICAGE System includes implants and instruments for implantation.
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)
Mechanical testing of worst case SICAGE System screws included torsion and pullout per ASTM F543 and static and dynamic bending per ASTM F2193. The mechanical test results demonstrated that SICAGE System performance is substantially equivalent to the 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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Sicage LLC % Karen E. Warden, Ph.D. President BackRoads Consulting Inc. P.O. Box 566 Chesterland, Ohio 44026-0566 May 5, 2017
Re: K170475
Trade/Device Name: SICAGETM System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: February 14, 2017 Received: February 16, 2017
Dear Dr. Warden:
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. 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
K170475
Device Name SICAGE™ System
Indications for Use (Describe)
SICAGE is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacrollitis.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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"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."
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510(k) Summary
| Date: | 14 February 2017 |
|---|---|
| Sponsor: | Sicage LLC |
| 6709 S. Minnesota Ave, Suite 206 | |
| Sioux Falls, SD 57108 | |
| Sponsor Contact: | Kristi Vondra, VP of Operations |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | SICAGE™ System |
| Common Name: | Cannulated bone screw |
| Regulatory Class: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Codes: | Smooth or threaded metallic bone fixation fastener, 21 CFR 888.3040, OUR |
| Device Description: | SICAGE is a fully threaded bone screw offered in a single diameter and |
| various lengths to accommodate variability in patient anatomy. SICAGE is | |
| sold sterile. The SICAGE System includes implants and instruments for | |
| implantation. | |
| Indications for Use: | SICAGE is intended for sacroiliac joint fusion for conditions including |
| sacroiliac joint disruptions and degenerative sacroiliitis. | |
| Materials: | The SICAGE bone screws are manufactured from titanium alloy (Ti-6Al-4V |
| ELI per ASTM F136). | |
| Primary Predicate: | Synthes 6.5mm Cannulated Screw (Synthes (USA) – K021932) |
| Additional Predicate: | Silex Sacroiliac Joint Fusion System (X-Spine Systems - K123702) |
| Performance Data: | Mechanical testing of worst case SICAGE System screws included torsion |
| and pullout per ASTM F543 and static and dynamic bending per ASTM | |
| F2193. | |
| The mechanical test results demonstrated that SICAGE System | |
| performance is substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The SICAGE System possesses the same technological characteristics as |
| one or more of the predicate devices. These include: | |
| • intended use (as described above) | |
| • basic design (threaded bone screw), | |
| • material (titanium alloy) and | |
| • sizes (dimensions are comparable to those offered by the predicate systems) | |
| The fundamental scientific technology of the SICAGE System is the same | |
| as previously cleared devices. | |
| Conclusion: | The SICAGE System possesses the same intended use and technological |
| characteristics as the predicate devices. Therefore SICAGE System is | |
| substantially equivalent for its intended use. |