(165 days)
No
The summary describes a surgical implant system and associated instruments, with no mention of AI or ML capabilities.
Yes
The device is intended for sacroiliac fusion to treat conditions like sacroiliac joint dysfunction and degenerative sacroiliitis, with clinical studies demonstrating improved pain, patient function, and quality of life, which are direct therapeutic outcomes.
No.
The iFuse Implant System is a device designed for sacroiliac fusion, which is a treatment for specific conditions. It is an implantable system used to address sacroiliac joint dysfunction and degenerative sacroiliitis, rather than to diagnose these conditions.
No
The device description explicitly states that the iFuse Implant System consists of porous plasma spray coated titanium implants and associated surgical instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The iFuse Implant System is described as a system of porous plasma spray coated titanium implants and associated surgical instruments. These are physical devices intended to be surgically implanted into the body.
- Intended Use: The intended use is for sacroiliac fusion, which is a surgical procedure to stabilize the sacroiliac joint. This is a treatment, not a diagnostic test performed on a sample.
The information provided clearly indicates that this is a surgical implant system, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.
Product codes
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 diameters of 4mm-7.0mm, 7.5mm, and 10.75mm. The iFuse Implants are implanted using instrumentation described in this submission as well as in K110838, K122074 K123850 K131405, K141049, K150714, K150875 and K151718.
The iFuse Implant System consists of a series of metallic (titanium), porous plasma spray coated rods intended for surgical implantation within the bone to create biological fixation, immediate stabilization and fusion. This 510(k) does not involve any changes to the technological characteristics of the device.
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 testing was required to support this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718, K112028
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.
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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 top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and the background is white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 1, 2016
SI-BONE, Incorporated Ms. Roxanne Dubois Vice President, Regulatory Affairs and Quality Assurance 3055 Olin Avenue, Suite 2200 San Jose, California 95128
Re: K152681
Trade/Device Name: 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: January 18, 2016 Received: January 19, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K152681
Device Name: iFuse Implant System®
Indications for Use:
The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.
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 Center for Devices and Radiological Health (CDRH) (Signature)
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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, VP, Regulatory and Quality, SI-BONE, Inc. rdubois@si-bone.com Email: Mobile: 408-828-5019
Office: 408-207-0700 x2236 Facsimile:
Date Prepared: February 22, 2016
Trade Name of Device: iFuse Implant System®
Common or Usual Name: Sacroiliac Joint Fixation
Regulation Number: 21 CFR 888.3040 - Smooth or threaded metallic bone fastener
Product Code: OUR; Sacroiliac Joint Fixation
Predicate Devices:
iFuse Implant System by SI-BONE, Inc. (K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718) Globus SI-LOK Sacroiliac Joint Fixation System (K112028)
Intended Use
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. Clinical studies have demonstrated that treatment with the iFuse Implant System improved pain, patient function, and quality of life at 12 months post-implantation.
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 diameters of 4mm-7.0mm, 7.5mm, and 10.75mm. The iFuse Implants are implanted using instrumentation described in this submission as well as in K110838, K122074 K123850 K131405, K141049, K150714, K150875 and K151718.
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Technological Characteristics
The iFuse Implant System consists of a series of metallic (titanium), porous plasma spray coated rods intended for surgical implantation within the bone to create biological fixation, immediate stabilization and fusion. This 510(k) does not involve any changes to the technological characteristics of the device.
Performance Data
No performance testing was required to support this premarket notification.
Substantial Equivalence and Conclusion
The iFuse Implant System is substantially equivalent to the predicate devices.