(25 days)
Not Found
No
The summary describes a navigation system that uses imaging data for surgical guidance, but it does not mention any AI or ML components. The technology described is image-based navigation, not AI/ML-driven analysis or decision support.
No
The device is a navigation instrument set used to assist surgeons in precisely locating anatomical structures for implant placement. It does not exert a therapeutic effect itself.
No
The device is a navigation instrument set that assists surgeons in precisely locating anatomical structures. It does not provide a diagnosis.
No
The device description explicitly states that the device is comprised of "reusable manual surgical instruments," which are hardware components. It also describes how these instruments interface with a navigation system, further indicating a hardware component.
Based on the provided information, 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 Function: The iFuse-Navigation Instrument Set is a set of surgical instruments used during a surgical procedure to assist the surgeon in precisely locating anatomical structures for implant placement. It works in conjunction with a navigation system and imaging data.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. Its function is to guide the surgeon's actions based on imaging and anatomical references.
Therefore, the device falls under the category of surgical instruments used for guidance and navigation during a procedure, not as a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. IFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
iFuse Implant System - iFuse-Navigation Instrument Set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System®. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
pelvis or vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Performance testing conducted on the proposed device demonstrates that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The following testing were successfully performed for the 4.0 mm Navigation Broach: registration with Medtronic StealthStation and dimensional analysis.
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.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2020
SI-BONE, Inc. Nancy Kaiser Sr. Regulatory Affairs Manager 471 El Camino Real, Suite 101 Santa Clara, California 95050
Re: K203110
Trade/Device Name: iFuse Implant System - iFuse Navigation Instrument Set Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 14, 2020 Received: October 15, 2020
Dear Nancy Kaiser:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203110
Device Name
iFuse Implant System - iFuse-Navigation Instrument Set
Indications for Use (Describe)
iFuse-Implant System - iFuse-Navigation Instrument Set is intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. IFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
| 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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iFuse Implant System. Minimally Invasive Sacroiliac Joint Surgery
510(k) SUMMARY - iFuse Implant System - iFuse-Navigation Instrument Set
I. DATE PREPARED
October 14, 2020
510(k) SUBMITTER II.
SI-BONE, Inc. 471 El Camino Real, Suite 101, Santa Clara, CA 95050 Phone: 408-207-0700 Fax: 408-557-8312
| Contact Person: | Susan Noriega, Sr. Director Regulatory Affairs |
|---|---|
| FDA Establishment |
Registration No .: 3007700286
III. DEVICE
| Trade Name of Device: | iFuse Implant System - iFuse-Navigation Instrument Set |
|---|---|
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | II |
| Regulation Number: | 21 CFR 882.4560- Stereotaxic instrument |
| Product Code: | OLO |
IV. PREDICATE DEVICE
SI-BONE, Inc., iFuse Implant System - iFuse-Navigation: K172268
V. DEVICE DESCRIPTION
iFuse Implant System - iFuse-Navigation Instrument Set is comprised of reusable manual surgical instruments specifically designed for use with the iFuse Implant System®. These instruments are designed to interface with the already-cleared Medtronic StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures for placement of iFuse implants. This surgical imaging technology provides visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to dynamic, graphical representation of multi-plane 3D images (and 2D images) providing indication of instrument and implant placement.
VI. INDICATIONS FOR USE
iFuse Implant System - iFuse-Navigation Instrument Set intended to be used with the iFuse Implant System to assist the surgeon in precisely locating anatomical structures in iFuse procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of
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the anatomy. iFuse-Navigation instruments are intended to be used with the Medtronic StealthStation System.
VII. SUMMARY OF SUBSTANTIAL EQUIVALENCE
The iFuse Navigation instruments, specifically the 7.0 mm Navigation Broach, described and cleared in 510(k) number K172268, serves as the predicate device for this premarket notification. The 4.0 mm Navigation Broach, the subject of this Special 510(k), has the same intended use/ indications for use and similar technological characteristics as the 7.0 mm Navigation Broach described and cleared in K177268. Furthermore, there have been no changes in the operating principle, component materials, manufacturing processes or sterilization method since FDA's clearance of K177268. Therefore, the iFuse-Navigation Instrument Set with 4.0 mm Navigation Broach is substantially equivalent to the predicate device currently marketed under K177268.
VIII. SUMMARY OF VERIFICATION AND VALIDATION ACTIVITIES
Performance testing conducted on the proposed device demonstrates that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The following testing were successfully performed for the 4.0 mm Navigation Broach: registration with Medtronic StealthStation and dimensional analysis.
IX. CONCLUSION
No new issues of safety or effectiveness are raised by the modifications. Based on all information in this Special 510(k), the iFuse Implant System - iFuse-Navigation Instrument Set with 4.0 mm Navigation Broach is substantially equivalent to the identified predicate device currently marketed under K177268.