(466 days)
Not Found
No
The summary describes a mechanical implant for sacroiliac joint fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for sacroiliac joint fusion, which is a procedure to treat medical conditions like sacroiliac joint disruptions and degenerative sacroiliitis, indicating its use in managing a disease or condition.
No
The device is a fusion device designed to provide stabilization, not to diagnose a condition.
No
The device description clearly states the device is manufactured from medical grade titanium alloy and is offered in various sizes and designs, indicating it is a physical implant, 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 for conditions including sacroiliac joint disruptions and degenerative sacroillitis." This describes a surgical procedure performed in vivo (within the body) to stabilize a joint.
- Device Description: The device is a physical implant made of titanium alloy, designed to be surgically placed in the sacroiliac joint.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The device described is a surgical implant used for musculoskeletal fixation.
N/A
Intended Use / Indications for Use
The MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Product codes
OUR
Device Description
The MSB Sacroiliac Joint Fusion Device is designed to provide stabilization of the sacroiliac joint until fusion occurs. This product is . manufactured from medical grade titanium alloy (Ti-6AL-4V) conforming to ASTM F136. The device is offered in a variety of sizes ranging from 5mm to 12mm in diameter and from 20mm to 60mm in length. One design option consists of a solid outer form. The alternative design contains holes along the sides of the implants which can be used to pack graft material. Both versions are cannulated and may be implanted via a minimally invasive approach.
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)
Engineering calculations were provided to demonstrate that under worst-case conditions the subject devices will not raise any new issues of safety or effectiveness. Engineering analysis of the MSB device measured against the SI-Bone device and test items similar to the Pioneer Cannulated Screw found that the devices were substantially equivalent. Additionally, push out, torque-to-fail and four-point bending testing was also performed in accordance with ASTM F543-07. Standard Specification and Test Methods for Metallic Medical Bone Screws and ASTM F2193-02, Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110838, K092375, K080398, K102903, K112028, K111801, K051296, K021932, K914004
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
MEDTRONIC Sofamor Danek MSB Sacroiliac Joint Fusion Device 510(k) Summary - K110472 Mav 2012
MAY 2 9 2012
12
Company:
Medtronic Sofamor Danek, Inc. 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133
Contact:
Lee Grant Senior Principal, Regulatory Affairs
Product Name: Regulation Name: Classification:
MSB Sacroiliac Joint Fusion Device Smooth or Threaded Metallic Bone Fastener 21 CFR 888.3040 - Product Code: OUR
Description:
The MSB Sacroiliac Joint Fusion Device is designed to provide stabilization of the sacroiliac joint until fusion occurs. This product is . manufactured from medical grade titanium alloy (Ti-6AL-4V) conforming to ASTM F136. The device is offered in a variety of sizes ranging from 5mm to 12mm in diameter and from 20mm to 60mm in length. One design option consists of a solid outer form. The alternative design contains holes along the sides of the implants which can be used to pack graft material. Both versions are cannulated and may be implanted via a minimally invasive approach.
Indications for Use:
The MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Non-Clinical Performance Data:
Engineering calculations were provided to demonstrate that under worst-case conditions the subject devices will not raise any new issues of safety or effectiveness. Engineering analysis of the MSB device measured against the SI-Bone device and test items similar to the Pioneer Cannulated Screw found that the devices were substantially equivalent. Additionally, push out, torque-to-fail and four-point bending testing was also performed in accordance with ASTM F543-07. Standard Specification and Test Methods for Metallic Medical
1
Bone Screws and ASTM F2193-02, Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.
Technological Comparison:
The MSB Sacroiliac Joint Fusion Device technological characteristics do not raise any new questions of safety or effectiveness.
Substantial Equivalence:
Documentation was provided which demonstrated that the subject device is substantially equivalent to the iFuse Implant System manufactured by SI-Bone (K110838, SE 04/21/11, K092375, SE 09/04/09 and K080398, SE 11/26/08); as well as the Pioneer Cannulated Screw System (K102903, SE 10/20/10); Globus Medical SI-LOK Sacroiliac Joint Fixation System (K112028, SE 12/09/11); Zyga's SimmetryTM Sacroiliac Joint Fusion System (K111801, 7/21/11), the DePuy SIJF Cannulated Screw System (K051296, SE 08/26/05), the Synthes 6.5 Cannulated Screw (K021932, SE 09/06/02) and the Alphatec Cannulated Bone Screws (K914004, SE 12/05/91).
长川0472
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 2 9 2012
Medtronic Sofamor Danek, Inc. % Mr. Lee Grant 1800 Pyramid Place Memphis. Tennessee 38132
Re: K110472
Trade/Device Name: MSB Sacroiliac Joint Fusion Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: OUR Dated: May 22, 2012 Received: May 23, 2012
Dear Mr. Grant:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Lee Grant
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Eunel Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K110472
Device Name: MSB Sacroiliac Joint Fusion Device
Indications for Use: The MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Prescription Use X_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ausnt
(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Bargices
510(k) Number K110472