(328 days)
Not Found
No
The summary describes navigation instruments that work with a separate navigation system (Medtronic StealthStation). The instruments themselves are passive and made of stainless steel. There is no mention of AI/ML in the description of the instruments or their function. The navigation system it works with could potentially use AI/ML, but this summary is about the instruments, not the navigation system.
No
The GX Navigation Instruments are surgical navigation tools used to assist in the precise placement of screws during spinal surgery. They do not directly treat or alter the body, but rather aid the surgeon in performing the therapeutic procedure.
No.
The device is a surgical navigation instrument designed to assist surgeons during spinal procedures by providing precise anatomical localization, not to diagnose a medical condition.
No
The device description explicitly states the GX Navigation instruments are manufactured from Stainless Steel, indicating they are physical hardware components, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The GX Navigation Instruments are surgical instruments used during 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) or digitized landmarks.
- Lack of Specimen Analysis: The description clearly states the instruments are used during surgery and interact with the patient's anatomy directly or through imaging data. There is no mention of analyzing specimens taken from the body.
The device falls under the category of surgical instruments used for navigation and guidance during a procedure, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARX Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The GX Navigation instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use. The GX Navigation instruments are for use with systems, specifically:
ARx Spinal System
- Polyaxial Driver Non-Cannulated
- Polyaxial Driver Cannulated
- Monoaxial Driver Non-Cannulated
- Monoaxial Driver Cannulated
- Reduction Driver Non-Cannulated
- Reduction Driver Cannulated
- Monoaxial Reduction Driver Non-Cannulated
- Monoaxial Reduction Driver Cannulated
- Non-Cannulated Taps
- Cannulated Taps*
Nautilus Thoracolumbar Spinal System
- Polyaxial Driver Non-Cannulated
- Polyaxial Driver Cannulated
- Centric-T Modular Tap Driver
- Reduction Driver Non-Cannulated
- Reduction Driver Cannulated
- Non-Cannulated Taps
- Cannulated Taps
Avatar Extended Tab MIS System
- MIS Polyaxial Driver
- Non-Cannulated Taps
- Cannulated Taps
Centerline Thoracolumbar Spinal System
- Polyaxial Driver Non-Cannulated
- Polyaxial Driver Cannulated
- Reduction Driver Non-Cannulated
- Reduction Driver Cannulated
- Non-Cannulated Taps
- Cannulated Taps
Centric-T
- Centric-T Modular Tap Driver
- Non-Cannulated Taps
- Cannulated Taps
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks
Anatomical Site
Vertebra
Indicated Patient Age Range
Not Found
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)
Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18 was presented to demonstrate substantial equivalency to the Medtronic CD HORIZON® Spinal System (K170679). Additionally, design validation, including dimensional comparison and tolerance analysis, was performed to ensure the GX Navigation Instrument System is acceptable for its intended use, to ensure functionality and compatibility with the Medtronic® StealthStation® System using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instrument systems.
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.
Medtronic CD Horizon (K170679), K111953, K132760, K151196, K200070, K191575
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
August 19, 2021
Image /page/0/Picture/1 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.
Life Spine Inc. Angela Batker RA/QA Manager 13951 S Quality Drive Huntley, Illinois 60142
Re: K202836
Trade/Device Name: GX Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 11, 2021 Received: August 13, 2021
Dear Angela Batker:
We have reviewed your Section 510(k) premarket notification of intent to market the de vice 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 de vice, 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/cdrl/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.
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
1
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/cdrl-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.
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K202836
Device Name Gx Navigation Instrument System
Indications for Use (Describe)
The GX Navigation Instruments are intended to be used during the preparation and placement of Life Spine 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARX Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System, Centerline Thoracolumbar Spinal System and Centric-T System.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary GX Navigation Instrument System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine,
Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | June 29th, 2021 |
| Trade Name: | GX Navigation Instrument System |
| Common Name: | Stereotaxic Instruments |
| Classification: | CFR 882.4560, Class II, Stereotaxic instrument |
| Product Code: | OLO |
| Primary Predicate: | Medtronic CD Horizon (K170679) |
| Additional Predicates: | Life Spine Avatar/Nautilus & Centerline (K111953, K132760 &
K151196)Life Spine ARx Spinal System (K200070 &
K191575) |
Device Description:
The GX Navigation instruments are manufactured from Stainless Steel as specified in ASTM F899, non-sterile, reusable instruments designed to function with the Medtronic® StealthStation® System. Refer to the appropriate navigation system Instructions for Use and/or Surgical Technique Guide for details regarding navigation system use.
The GX Navigation instruments are for use with systems,
specifically:
4
K202836 Page 2 of 3
ARx Spinal System
- . Polyaxial Driver Non-Cannulated
- . Polyaxial Driver Cannulated
- . Monoaxial Driver Non-Cannulated
- . Monoaxial Driver Cannulated
- . Reduction Driver Non-Cannulated
- . Reduction Driver Cannulated
- Monoaxial Reduction Driver Non-Cannulated
- . Monoaxial Reduction Driver Cannulated
- . Non-Cannulated Taps
Cannulated Taps* Nautilus Thoracolumbar Spinal System
- Polyaxial Driver Non-Cannulated ●
- Polyaxial Driver Cannulated .
- . Centric-T Modular Tap Driver
- Reduction Driver Non-Cannulated .
- Reduction Driver Cannulated ●
- Non-Cannulated Taps •
- . Cannulated Taps
Avatar Extended Tab MIS System
- MIS Polyaxial Driver ●
- Non-Cannulated Taps .
- Cannulated Taps ●
Centerline Thoracolumbar Spinal System
- Polyaxial Driver Non-Cannulated .
- Polyaxial Driver Cannulated .
- Reduction Driver Non-Cannulated ●
- . Reduction Driver Cannulated
- Non-Cannulated Taps .
- . Cannulated Taps
Centric-T
- Centric-T Modular Tap Driver ●
- . Non-Cannulated Taps
- . Cannulated Taps
Indications for Use:
The GX Navigation Instruments are intended to be used during the preparation and placement of LifeSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures ineither open or minimally invasive procedures. These
5
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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The GX Navigation Instruments are compatible with the following Life Spine implant systems: ARx Spinal System, Avatar Extended Tab MIS System, Nautilus Thoracolumbar Spinal System,Centerline Thoracolumbar Spinal System and Centric-T System.
Technological Characteristics:
The GX Navigation System is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of just the GX Navigation Instrument System which are made from Stainless Steel according to F899. This this is the same material used in the predicate devices.
Performance Data:
Testing according to Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems testing to ASTM F2554-18 was presented to demonstrate substantial equivalency to the Medtronic CD HORIZON® Spinal System (K170679). Additionally, design validation, including dimensional comparison and tolerance analysis, was performed to ensure the GX Navigation Instrument System is acceptable for its intended use, to ensure functionality and compatibility with the Medtronic® StealthStation® System using the NavLock tracker, and to demonstrate substantial equivalence to the predicate instrument systems.
Substantial Equivalence:
GX Navigation Instrument System was shown to be substantially equivalent to the predicate devices Medtronic CD HORIZON® Spinal System (K170679), LifeSpine Nautilus/Avatar (K111953/K132760/K151196 & Life Spine ARX (K200070/K191575) in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of The GX Navigation Instrument System.