(29 days)
Not Found
No
The summary describes a mechanical implant system and surgical instruments, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended for "sacroiliac joint fusion for conditions including sacroiliac joint dysfunction," which indicates it is used for the treatment of a medical condition.
No
Explanation: The device is described as an implant system used for sacroiliac joint fusion, which is a therapeutic treatment. It does not mention any function for diagnosing conditions.
No
The device description explicitly states it consists of "porous plasma spray coated titanium implants and associated surgical instruments," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "sacroiliac joint fusion for conditions including sacroiliac joint dysfunction...". This describes a surgical procedure to treat a condition within the body.
- Device Description: The device is described as "porous plasma spray coated titanium implants and associated surgical instruments." These are physical implants and tools used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a surgical intervention.
N/A
Intended Use / Indications for Use
The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a diameter of 4-7mm. Surgical treatment is accomplished using instrumentation similar to that previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049.
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)
No performance data is required to support this Special 510(k).
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.
K080398, K092375, K110838, K122074, K123850, K131405, K141049
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
SI-BONE, Incorporated Ms. Roxanne Dubois Vice President, Regulatory Affairs and Quality Assurance 3055 Olin Avenue, Suite 2200 San Jose, California 95128
Re: K150714
Trade/Device Name: SI-BONE iFuse Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: March 17, 2015 Received: March 19, 2015
Dear Ms. Dubois:
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
1
Page 2 - Ms. Roxanne Dubois
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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K150714
Device Name: SI-BONE iFuse Implant System
Indications for Use:
The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
3
510(k) SUMMARY
iFuse Implant System®
510(k) Owner's Name, Address, and Telephone Number
SI-BONE, Inc. 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 (408) 207-0700
Contact Person
Roxanne Dubois Vice President, Regulatory Affairs & Quality SI-BONE iFuse Implant System rdubois@si-bone.com 3055 Olin Avenue, Suite 2200 San Jose, CA 95128 408-207-0700 x2236 Office 408-828-5019 Mobile 408-557-8312 Fax
Date Prepared: March 17, 2015
Trade Name of Device: iFuse Implant System®, including iFuse Surgical Instruments
Common or Usual Name: Orthopedic Rod and Surgical Instruments
Classification Name:
21 C.F.R. 888.3040 - Smooth or threaded metallic bone fixation fastener
Product Code: OUR
Predicate Devices:
SI Joint Fusion System by SI-BONE, Inc. (K080398, K092375, K110838, K122074, K123850, K131405, K141049).
Intended Use
The iFuse Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description
The iFuse Implant System® consists of porous plasma spray coated titanium implants and associated surgical instruments. The iFuse Implant lengths range from 30-90mm with a
4
diameter of 4-7mm. Surgical treatment is accomplished using instrumentation similar to that previously described in K080398, K092375, K110838, K122074, K123850, K131405 and K141049.
Technological Characteristics
This 510(k) does not involve any changes to the technological characteristics of the removal system since the predicate devices are also used to remove an implant. The proposed Removal System manual instruments supplement the existing Removal Adapter.
Performance Data
No performance data is required to support this Special 510(k).
Substantial Equivalence
The iFuse Implant System has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, the iFuse Implant System is substantially equivalent to the predicate device.
Conclusions
The iFuse Implant System, including iFuse Surgical Instruments, is substantially equivalent to the predicate device.