(466 days)
The MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
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.
The provided text describes the Medtronic Sofamor Danek MSB Sacroiliac Joint Fusion Device and its 510(k) summary (K110472). However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Product Description: Materials, sizes, design options (solid vs. holes for graft material), and cannulation.
- Indications for Use: Sacroiliac joint fusion for disruptions and degenerative sacroiliitis.
- Non-Clinical Performance Data: Engineering calculations, push-out, torque-to-fail, and four-point bending testing performed according to ASTM standards (F543-07 and F2193-02). These tests are about structural integrity and mechanical properties, not clinical performance or diagnostic accuracy.
- Technological Comparison: Statement that characteristics "do not raise any new questions of safety or effectiveness."
- Substantial Equivalence: A list of predicate devices to which the MSB device is compared, based on technological characteristics and safety/effectiveness. This is the primary "proof" for 510(k) clearance – demonstrating equivalence to an already legally marketed device.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The document describes a traditional medical device (implant) and its path to FDA clearance via substantial equivalence to predicate devices, rather than a device requiring a clinical performance study with defined acceptance criteria for metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of what can be inferred or stated based on the given text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| ASTM F543-07: | Testing performed according to ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws). |
| ASTM F2193-02: | Testing performed according to ASTM F2193-02 (Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System). |
| Engineering Calculations: | Demonstrated that under worst-case conditions, the device would not raise new safety/effectiveness issues. |
| Push-out, Torque-to-fail, Four-point bending: | Testing performed and found substantially equivalent to the SI-Bone device and Pioneer Cannulated Screw test items. |
| Substantial Equivalence to Predicate Devices: | Demonstrated substantial equivalence to multiple predicate devices (e.g., iFuse Implant System, Pioneer Cannulated Screw System, Globus Medical SI-LOK Sacroiliac Joint Fixation System, Zyga's Simmetry, DePuy SIJF Cannulated Screw System, Synthes 6.5 Cannulated Screw, Alphatec Cannulated Bone Screws). This implies the device's overall safety and effectiveness are comparable to these established devices. |
Missing from the text: Specific numerical acceptance thresholds (e.g., "minimum push-out force of X Newtons") and the exact numerical results for the reported device performance. The text only states that testing was performed and found to be substantially equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The document describes non-clinical, engineering, and mechanical testing, not a clinical "test set" with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable/Not Provided. Ground truth (in the context of clinical or diagnostic studies) is not mentioned as this is not a diagnostic device or a study involving human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a static implant device, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For non-clinical testing, the "ground truth" or reference standards are defined by the ASTM specifications for mechanical properties (e.g., bone screw strength, bending characteristics).
8. The sample size for the training set
- Not Applicable. This device did not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable.
{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
{4}------------------------------------------------
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
§ 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.