(36 days)
Not Found
No
The summary describes manually operated instruments used with a navigation system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation system itself is mentioned, but its specific technology is not detailed in a way that indicates AI/ML is part of the Spineology instruments.
No
The device, Spineology Navigation Instruments, is a set of manual surgical instruments (awls, bone taps, drills, screwdrivers) intended to assist surgeons in precisely locating anatomical structures during spinal surgery. It is used in conjunction with a navigation system and pedicle screw systems. Its function is to guide the placement of other therapeutic devices (pedicle screws), rather than directly providing therapy itself.
No
The device is described as surgical navigation instruments used during the preparation and placement of pedicle screws for spinal surgery, assisting the surgeon in precisely locating anatomical structures. It is not indicated for diagnosing medical conditions.
No
The device description explicitly states that the Spineology Navigation Instruments are non-sterile, reusable instruments including awls, bone taps, drills, and screwdrivers, which are physical hardware components.
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 Description and Intended Use: The Spineology Navigation Instruments are described as surgical instruments (awls, bone taps, drills, screwdrivers) used during spinal surgery to assist the surgeon in precisely locating anatomical structures. They are used in conjunction with a navigation system that utilizes imaging data (CT, MR, fluoroscopy).
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is to provide guidance and tools for surgical procedures based on imaging and anatomical landmarks.
Therefore, the Spineology Navigation Instruments fall under the category of surgical instruments and navigation aids, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
Anatomical Site
spinal segments of the thoracic, lumbar, and sacral spine; skull, long bone, or vertebra
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeon during spinal surgery
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)
Spineology performed design verification activities to demonstrate that the design outputs of the subject Spineology Navigation Instruments met the design input requirements. Due to the substantial equivalence of the primary technological characteristics of the subject Spineology Navigation Instruments as compared to the predicate device, existing verification and validation testing previously provided to FDA was used to support the safety and effectiveness of the subject devices. Previously conducted testing included, but was not limited to, the following:
- Instrument mating testing which evaluated the connection between the Medtronic NavLock Tracker Array and Spineology Navigation Instruments.
- Registration testing which ensured that Spineology Navigation Instruments can be registered to the Medtronic StealthStation System.
- Accuracy testing which included side-by-side comparison of Spineology Navigation Instruments to equivalent Medtronic Navigation Instruments intended for use with the Medtronic StealthStation System.
In addition to design verification, Spineology conducted a risk assessment to confirm that the subject Spineology Navigation Instruments do not introduce new issues of safety or effectiveness.
Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device.
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).
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 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.
May 2, 2018
Spineology Inc. % Jacqueline Hauge Regulatory Affairs Manager Spineology, Inc. 7800 3rd Street North, Suite 600 St. Paul, Minnesota 55128
Re: K180796
Trade/Device Name: Spineology Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 26, 2018 Received: March 27, 2018
Dear Jacqueline Hauge:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
ic product radiation control provisions (Sections 531-542 of the Act): 21 CFR
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
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)
K180796
Device Name Spineology Navigation Instruments
Indications for Use (Describe)
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
| 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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| Date Prepared: | March 26, 2018 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North, Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Jacqueline A. Hauge |
| Regulatory Affairs Manager | |
| Phone: 651.256.8534 | |
| Fax: 651.256.8505 | |
| Email: jhauge@spineology.com |
Device Name and Classification
| Trade Name: | Spineology Navigation Instruments |
|---|---|
| Common Name: | Orthopedic Stereotaxic instrument |
| Classification Name: | Stereotaxic Instrument |
| Product Codes: | OLO |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 882.4560 |
| Panel: | Orthopedic |
Predicate Device
Spineology Navigation Instruments (Spineology Inc.) K172518
Purpose 1.
The purpose of this Premarket Notification is to obtain FDA clearance for the addition of Spineology Navigation Instruments to Spineology's FDA cleared Navigation Instrument set.
2. Device Description
A. Spineology Navigation Instruments
Spineology Navigation Instruments are non-sterile, reusable instruments; including awls, bone taps, drills, and screwdrivers that are operated manually. These instruments are manufactured from stainless steel in accordance with ASTM F899 and are intended to be used within the context and limitations of the indications for use for Spineology's FDA-cleared Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and the Medtronic Synergy Experience StealthStation® System S7 (v2.1.0).
4
B. Spineology Pedicular Fixation Systems
Spineology Fortress, Threshold V2, and Palisade Pedicular Fixation Systems consist of screws, curved and straight rods, and Connector devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. All screws are available with or without a hydroxyapatite coating. These systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
3. Indications for Use
Spineology Navigation Instruments are intended to be used during the preparation and placement of Spineology's Fortress, Threshold V2, and Palisade pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitalized landmarks of the anatomy.
Technological Characteristics 4.
When compared to the predicate device, Spineology Navigation Instruments have the same intended use and equivalent technological characteristics, including:
- Primary Design Features, including but not limited to, critical dimensions, distal (functional) end features (i.e., implant/inserter interface), and proximal end mating features (i.e., Medtronic NavLock Tracker Array interface)
- Materials of Construction
- . Fundamental Scientific Technology
- Function/Performance
- . Use with Medtronic StealthStation System
- . Principle of Operation
5. Non-Clinical Testing
Spineology performed design verification activities to demonstrate that the design outputs of the subject Spineology Navigation Instruments met the design input requirements. Due to the substantial equivalence of the primary technological characteristics of the subject Spineology Navigation Instruments as compared to the predicate device, existing verification and validation testing previously provided to FDA was used to support the safety and effectiveness of the subject devices. Previously conducted testing included, but was not limited to, the following:
- . Instrument mating testing which evaluated the connection between the Medtronic NavLock Tracker Array and Spineology Navigation Instruments.
- . Registration testing which ensured that Spineology Navigation Instruments can be registered to the Medtronic StealthStation System.
5
- . Accuracy testing which included side-by-side comparison of Spineology Navigation Instruments to equivalent Medtronic Navigation Instruments intended for use with the Medtronic StealthStation System.
In addition to design verification, Spineology conducted a risk assessment to confirm that the subject Spineology Navigation Instruments do not introduce new issues of safety or effectiveness.
6. Clinical Testing
Clinical testing was not performed or required to establish the substantial equivalence of Spineology Navigation Instruments to the predicate device.
7. Conclusion
Spineology has demonstrated the substantial equivalence of the subject Spineology Navigation Instruments through the comparison of these devices to the legally marketed predicate device and confirmed that the intended use is the same and any difference in technological characteristics between the subject and predicate device do not raise new issues of safety and effectiveness.