(87 days)
No
The summary describes a physical implant system and surgical instruments, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is intended for "sacroiliac fusion for conditions including sacroiliac joint dysfunction" and "improved pain, patient function, and quality of life," which clearly indicates a therapeutic purpose.
No
The device is described as an implant system for sacroiliac fusion, which is a treatment, not a diagnostic tool. Its intended use and description focus on surgical implantation and treatment outcomes, not on identifying or diagnosing 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 medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of donations with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The iFuse Implant System is described as porous plasma spray coated titanium implants and associated surgical instruments intended for sacroiliac fusion. This is a surgical procedure involving the implantation of a device into the body to stabilize a joint.
- Lack of Specimen Examination: The description and intended use do not involve the examination of any specimens (blood, tissue, etc.) from the human body.
Therefore, based on the provided information, the iFuse Implant System is a surgical implant and not an In Vitro Diagnostic device.
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.
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 a diameter of 4-7mm. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718, and K152681.
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)
Data to support claims of improvement in pain, patient function and quality of life come from prospective and retrospective studies, including SIFI (Sacroiliac Joint Eusion with iFuse Implant System). SIFI is a prospective multicenter single-arm clinical trial of 172 patients with 149 patients followed for 24 months. SIFI showed clinically important and statistically significant improvements in SI joint pain, disability due to SI joint pain, and quality of life (by two measures). Patient satisfaction rates were high.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714, K150875, K152681
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2016
SI-BONE, Incorporation Ms. Roxanne Dubois VP, Regulatory Affairs and Quality Assurance 3055 Olin Avenue, Suite 2200 San Jose, California 95128
Re: K160652
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: March 4, 2016 Received: March 8, 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
1
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" (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,
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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Indications for Use
510(k) Number (if known) K160652
Device Name iFuse Implant System®
Indications for Use (Describe)
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 sacroilitis. 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.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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. Email: rdubois@si-bone.com Mobile: 408-828-5019; Office: 408-207-0700; Facsimile: 408-557-8312
Date Prepared: April 26, 2016
Trade Name of Device: iFuse Implant System®
Common or Usual Name: Orthopedic Rod
Classification Name: 21 C.F.R. 888.3040 - Smooth or threaded metallic bone fastener; Product Code OUR
Predicate Devices: iFuse Implant System by SI-BONE, Inc. (K080398, K092375, K110838. K122074, K123850, K131405, K141049 and K150714, K150875, K152681)
Indications for Use
The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac ioint 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.
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. The fusion rods are implanted using instrumentation previously described in K080398, K092375, K110838, K122074, K123850, K131405, K141049, K150714, K150875, K151718, and K152681.
Technological Characteristics
The iFuse Implant System consists of a series of metallic (titanium), porous plasma spray coated rods, intended for surgical implant 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.
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Non-clinical Performance Data
Non-clinical performance testing was not required to support the modified labeling that is the subject of this 510(k).
Clinical Tests
Data to support claims of improvement in pain, patient function and quality of life come from prospective and retrospective studies, including SIFI (Sacroiliac Joint Eusion with iFuse Implant System). SIFI is a prospective multicenter single-arm clinical trial of 172 patients with 149 patients followed for 24 months. SIFI showed clinically important and statistically significant improvements in SI joint pain, disability due to SI joint pain, and quality of life (by two measures). Patient satisfaction rates were high.
Substantial Equivalence and Conclusion
The iFuse Implant System is substantially equivalent to the predicate device.