(165 days)
Not Found
No
The summary describes a navigation system for surgical instruments based on intraoperative 3D images and a surgical plan. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The focus is on the accuracy and compatibility of the instruments with different navigation systems.
No
Explanation: The device is a navigation instrument system used to assist surgeons in precisely locating anatomical structures during spinal surgery for screw placement; it is not directly treating a medical condition itself.
No
The device is described as reusable surgical instruments intended to assist surgeons in precisely locating anatomical structures for the placement of spinal screws during surgery. It is a navigation aid for surgical procedures, not a device that diagnoses medical conditions.
No
The device description explicitly states it is a "reusable instrument" and an "adapter," which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a set of reusable surgical instruments used during surgery to assist the surgeon in precisely locating anatomical structures and placing screws. It works in conjunction with a navigation system and intraoperative imaging.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. Its function is entirely focused on guiding surgical procedures based on imaging and a surgical plan.
Therefore, the device falls under the category of surgical instruments or navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nav System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The quidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software and based on intraoperative 3D images provided by a compatible imaging system.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. Currently cleared Spineart® Navigation reusable instruments (K210472) feature a connecting area for the tracker compatible with the Navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spinear's eCential® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the eCential® Op.nº Navigation System to the cleared range of SPINEART® Natrument System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperative 3D images
Anatomical Site
thoracolumbar spinal surgery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, Perla TL Nav System, compatible imaging system
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)
The following testing were conducted on the SPINEART instruments to establish substantial equivalence with the predicate devices:
- ASTM F2554 Verification: Verification of the eCentiall" Navigation Adaptor designed by Spineart used in a worst case scenario, with the eCential® Op.n® Perla TL Nav system, according to the ASTM F2554 protocole
- Accuracy Verification: Verification of the SPINEART Navigation reusable instruments with the eCential® Op.nº Peda TL Nav system, according a Protocole defined by eCential®.
Performance data showed that the Navigation of the SPINEART Navigation reusable instruments with the eCential® Op.nº Perla TL Nav system using the eCential® Navigation adaptor provides an accuracy equivalent to the acceptance criteria initially defined for the SPNEART Navigation reusable instruments when used with the Medtronic® Stealthstation® System.
No clinical testing was required for the subject device.
It has been demonstrated that the SPINEART eCential® Navigation Adaptor (subject device) on the SPNEART Navigation reusable instruments (predicate device) for a use with the eCential® Op.nº Perla TL Nav system does not raise accuracy issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy
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).
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 7, 2025
Spineart Sa Estelle Lefeuvre Regulatory & Market Access Manager 3 chemin du Pré-Fleuri Plan Les Ouates, 1228 Switzerland
Re: K242890
Trade/Device Name: SPINEART Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 23, 2024 Received: February 6, 2025
Dear Estelle Lefeuvre:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
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
3
Indications for Use
Submission Number (if known)
Device Name
SPINEART Navigation Instrument System
Indications for Use (Describe)
The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nav System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The quidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software and based on intraoperative 3D images provided by a compatible imaging 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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4
| 510(k) #: | K242890 | 510(k) Summary | Prepared on: | 2025-02-06 |
|---|---|---|---|---|
| ----------- | --------- | ---------------- | -------------- | ------------ |
| Contact Details | 21 CFR 807.92(a)(1) | ||
|---|---|---|---|
| Applicant Name | SPINEART SA | ||
| Applicant Address | 3 chemin du Pr\u00e9-Fleuri PLAN LES OUATES 1228 Switzerland | ||
| Applicant Contact Telephone | +41 22 570 1203 | ||
| Applicant Contact | Ms. ESTELLE LEFEUVRE | ||
| Applicant Contact Email | elefeuvre@spineart.com |
| Device Name | 21 CFR 807.92(a)(2) | |
|---|---|---|
| Device Trade Name | SPINEART Navigation Instrument System | |
| Common Name | Orthopedic Naviagated instruments | |
| Classification Name | Orthopedic Stereotaxic Instrument | |
| Regulation Number | 882.4560 | |
| Product Code(s) | OLO |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K210472 | SPINEART Navigation Instrument System | OLO |
| K231886 | SURGIVISIO Device | OLO |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
|---|---|---|
| ---------------------------- | -- | --------------------- |
The Spineart\u00ae Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in
The Spineart® Navigation reusable instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. Currently cleared Spineart® Navigation reusable instruments (K210472) feature a connecting area for the tracker compatible with the Navigated with the Medtronic® StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spinear's eCential® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the eCential® Op.nº Navigation System to the cleared range of SPINEART® Natrument System.
Intended Use/Indications for Use
The SPINEART Navigation reusable instruments are intended to be used during the preparation and
placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasion reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nav System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The quidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nav Software and based on intraoperative 3D images provided by a compatible imaging system.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
5
Compared to predicate devices (K210472) the only modifications for use is to add the option of using the SPNEART Navigation Reusable Instrument system with the eCential® Op.nº Navigation System through the introduction of a SPINEART eCential" Navigation Adaptor and the Nav. Bs Checking Tip. The added SPINEART eCential® Navigation Adaptor and Nav. Bs Checking Tip do not alter the intended use of the SPINEART Navigation Reusable Instrument system.
Technological Comparison
21 CFR 807.92(a)(6)
The intended use, design features, technological characteristics, feature comparisons and performance assessment of the subject SPINEART Navigation Reusable Instrument system remain the same as predicate devices (SPINEART Navigation Reusable Instrument system K210472). It has been established the SPINEART eCential® Navigation Adaptor on the SPINEART Navigation reusable instruments for a use with the eCential® Op.n® Navigation System does not raise accuracy issues. The Nav. Bs Checking Tip is not involved in the accuracy. The added SPINEART eCential® Navigation Adaptor does not affectiveness of the device relative to the predicate (SPINEART Navigation Reusable Instrument system K210472), Based on the comparison to the predicates and the performance testing conducted, the subject devices are considered substantially equivalent to the predicate devices (K210472).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing were conducted on the SPINEART instruments to establish substantial equivalence with the predicate devices: -ASTM F2554 Verification: Verification of the eCentiall" Navigation Adaptor designed by Spineart used in a worst case scenario, with the eCential® Op.n® Perla TL Nav system, according to the ASTM F2554 protocole
- Accuracy Verification: Verification of the SPINEART Navigation reusable instruments with the eCential® Op.nº Peda TL Nav system, according a Protocole defined by eCential®. Performance data showed that the Navigation of the SPINEART Navigation reusable instruments with the eCential® Op.nº Perla TL Nav system using the eCential® Navigation adaptor provides an accuracy equivalent to the acceptance criteria initially defined for the SPNEART Navigation reusable instruments when used with the Medtronic® Stealthstation® System.
No clinical testing was required for the subject device.
"Not Applicable."
It has been demonstrated that the SPINEART eCential® Navigation Adaptor (subject device) on the SPNEART Navigation reusable instruments (predicate device) for a use with the eCential® Op.nº Perla TL Nav system does not raise accuracy issues.