(187 days)
No
The summary describes a robotic assistance system for surgical instrument positioning and guidance, relying on navigation systems and imaging modalities. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on mechanical positioning and integration with existing navigation technology.
No.
The device is a robotic assistance system intended to guide surgical instruments and screws, not to provide therapy itself.
No
The device is a robotic assistance system used for positioning and orientation of surgical instruments and screws during surgery, not for diagnosing medical conditions.
No
The device description explicitly states that the AQrate™ Robotic Assistance System is a medical robotic system with a robotic arm fixed to a mobile cart, hardware, and software. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the AQrate™ Robotic Assistance System is not an IVD (In Vitro Diagnostic) device.
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.
- AQrate™ Function: The AQrate™ system is a robotic assistance system used during surgery to guide instruments for spatial positioning and orientation. It interacts directly with the patient's anatomy during a procedure, not with samples taken from the body.
- Intended Use: The intended use clearly states its role in guiding instruments during surgery for procedures like spinal screw placement.
- Device Description: The description confirms it's a medical robotic system used for positioning surgical instruments and screws.
The system's function is to provide physical guidance and positioning during a surgical procedure, which falls under the category of surgical assistance or navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AQrateTM Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instrument guides are designed for use with the Medronic 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The system is indicated for the placement of spinal screws.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The AQrateTM Robotic Assistance System is a medical robotic system with a robotic arm fixed to a mobile cart, hardware, and software. The system allows for accurate positioning of surqical instruments and screws during spinal surgery with the use of a robotic arm. The instruments may be navigated or tracked relative to the patient's anatomy on reconstructed images using the Medtronic StealthStation® System.
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 of the anatomy.
Anatomical Site
skull, a long bone, or vertebra (for the Medtronic StealthStation® System); spinal (specifically for the placement of spinal screws).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons; during 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)
Verification testing was conducted on AQrateTM to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:
- Non-clinical system, software, and instrument verification
- Surgical simulations conducted on phantom models
- Compliance conformity assessments per:
- IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2014
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability 2010 + A1:2013
Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and IEC 62304:2006 Medical Device Software - Software life cycle processes.
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.
ExcelsiusGPSTM (K171651), Globus Navigation Instruments (K180690)
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.
Medtronic StealthStation (K133444)
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 and 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.
Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403
January 29, 2019
Re: K182000
Trade/Device Name: AQrate Robotic Assistance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 8, 2019 Received: January 9, 2019
Dear Kelly Baker:
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.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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,
Image /page/1/Figure/5 description: The image shows a digital signature. The signature is from Jesse Muir -S. The date of the signature is 2019.01.29. The time of the signature is 15:52:33-05'00'.
Date: 2019.01.29 15:52:33 -05'00'
For: 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) K182000
Device Name
AQrate Robotic Assistance System
Indications for Use (Describe)
The AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument guide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instrument guides are designed for use with the Medronic 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The system is indicated for the placement of spinal screws.
| 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: AQrate™ Robotic Assistance System
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
610-930-1800 |
|--------------------------|------------------------------------------------------------------------------------------------------------|
| Contact: | Kelly J. Baker, Ph.D.
Senior Vice President, Regulatory and Clinical Affairs |
| Date Prepared: | January 8, 2019 |
| Device Name: | AQrate™ Robotic Assistance System |
| Common Name: | Robotic Assistance System |
| Classification: | Per 21 CFR as follows:
§882.4560 Stereotaxic instrument
Product Code(s): OLO
Regulatory Class: II |
| Primary Predicate: | ExcelsiusGPS™ (K171651) |
| Additional
Predicate: | Globus Navigation Instruments (K180690) |
| Reference: | Medtronic StealthStation (K133444) |
Purpose:
The purpose of this submission is to request clearance of the AQrate™ System.
Device Description:
The AQrate™ Robotic Assistance System is a medical robotic system with a robotic arm fixed to a mobile cart, hardware, and software. The system allows for accurate positioning of surqical instruments and screws during spinal surgery with the use of a robotic arm. The instruments may be navigated or tracked relative to the patient's anatomy on reconstructed images using the Medtronic StealthStation® System.
Indications for Use:
The AQrate™ Robotic Assistance System is intended to be used for spatial positioning and orientation of an instrument holder or instrument quide to be used by surgeons to guide instruments during surgery in either open or percutaneous procedures. The instruments and instrument guides 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
4
a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The system is indicated for the placement of spinal screws.
Technological Characteristics:
AQrate™ has similar technological characteristics to the predicate devices including the main system components, workflow, user interface, software features, and design. The AQrate™ System is comparable to the predicates in terms of intended use, fundamental scientific technology, technological characteristics and principle of operation. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Performance Testing:
Verification testing was conducted on AQrate™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system:
- Non-clinical system, software, and instrument verification ●
- Surgical simulations conducted on phantom models ●
- . Compliance conformity assessments per:
- o IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance, 2005, Amendment 1, 2012
- o IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements for Basic Safety and Essential Performance – Collateral Standard Electromagnetic Compatibility, 2014
- o IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements for Basic Safety and Essential Performance - Usability 2010 + A1:2013
Software Verification and Validation Testing
Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and IEC 62304:2006 Medical Device Software - Software life cycle processes.
Basis of Substantial Equivalence:
AQrate™ has been found to be substantially equivalent to the predicate devices with respect to technological characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate devices.