(60 days)
No
The summary describes a surgical drill system and navigation aids. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on mechanical function and navigation accuracy.
No
The DuraPro™ Oscillating System is described as a surgical tool for manipulating tissue and bone, and the ExcelsiusGPS® and ExcelsiusHub™ are navigation aids. These devices facilitate surgical procedures but do not directly treat a disease or condition; rather, they enable the surgeon to perform therapeutic interventions.
No.
Explanation: The device, the DuraPro™ Oscillating System, is described as an instrument for drilling, burring, and manipulating tissue during surgical procedures. Its intended use focuses on aiding the spatial positioning and orientation of surgical instruments and the placement of bone screws and interbody fusion devices, which are interventional actions rather than diagnostic ones.
No
The device description explicitly states that the DuraPro™ Oscillating System consists of electrical drill handpieces/attachments powered by an oscillating motor with a foot switch, which are hardware components. While it can be navigated using software systems (ExcelsiusGPS® or ExcelsiusHub™), the core device itself is not software-only.
Based on the provided information, none of the described devices are IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens derived from the human body. This includes things like blood, urine, tissue samples, etc., to provide information for diagnosis, monitoring, or screening.
- The devices described are surgical instruments and navigation systems. They are used directly on the patient during surgical procedures to manipulate tissue, bone, and guide instruments. They do not analyze samples taken from the patient.
The intended uses clearly state their purpose in surgical procedures for drilling, burring, removing tissue, and aiding in the placement of spinal and orthopedic devices. This is a completely different function from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DuraPro™ Oscillating System is indicated for drilling, burring, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.
ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or quiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans or fluoroscopy.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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 navigation and guidance accuracy of the DuraPro™ Oscillating System was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification. Verification and validation testing and comparison to the predicate devices demonstrate that the subject DuraPro™ Oscillating System can be used in accordance with their indications.
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.
K233638, K183644, K190653, K171651, K191100, K211616
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.
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 shows the date April 29, 2024. The month is spelled out, followed by the day and year. The text is in a simple, sans-serif font and is easy to read. The date is likely part of a document or calendar.
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
Globus Medical, Inc. Jennifer Antonacci Senior Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avene Audubon, Pennsylvania 19403
Re: K240568
Trade/Device Name: DuraPro™ Oscillating System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: February 29, 2024 Received: February 29, 2024
Dear Jennifer Antonacci:
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.
1
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" (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 QS regulation requires device manufacturers to review and approve changes to device design and production (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.
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 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
2
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
DuraPro™ Oscillating System
Indications for Use (Describe)
The DuraPro™ Oscillating System is indicated for drilling, burring, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.
ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or quiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
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) Summary: DuraPro™ Oscillating System
Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 610-930-1800
- Primary Contact: Jennifer Antonacci, Ph.D. Senior Group Manager, Regulatory Affairs
- Date Prepared: February 29, 2024
- Device Name: DuraPro™ Oscillating System
- Common Name: Orthopedic Stereotaxic Instrument
- Classification: Per 21 CFR as follows: &882.4560 Stereotaxic instrument Product Code(s): OLO Regulatory Class: II, Panel Code: 87
Primary Predicate: VERZA™ High Speed Drills (K233638)
Spacer (K222270)
Additional
| Predicates: | Medtronic Stealth-Midas MR8 System (K183644)
ExcelsiusGPS® High Speed Drill Instruments (K190653)
ExcelsiusGPS® (K171651, K191100)
ExcelsiusHub™ (K211616) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices: | Electrical Drill System [XPS4000, Midas Rex EHS system
Integrated Power Console (IPC)] (K081475)
HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable |
Purpose:
The purpose of this submission is to request clearance of DuraPro™ Oscillating System for use with ExcelsiusGPS® and ExcelsiusHub™.
Device Description:
DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.
5
Indications for Use:
The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.
ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surqeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.
Technological Characteristics:
The subject DuraPro™ Oscillating System has the same technological characteristics as predicate instruments including design, intended use, material composition, function, and range of sizes.
| Features | Subject
DuraPro™ Oscillating System | Predicate &
Reference
Devices |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Indications | The DuraPro™ Oscillating System is indicated for
drilling, burring, removing, and otherwise
manipulating hard and soft tissue, bone, and other
bone related tissue during spinal and orthopedic
procedures. | Similar |
| | ExcelsiusGPS® is intended for use as an aid for
precisely locating anatomical structures and for the
spatial positioning and orientation of an instrument
holder or guide tube to be used by surgeons for
navigating and/or guiding compatible surgical
instruments in open or percutaneous procedures
provided that the required fiducial markers and rigid
patient anatomy can be identified on CT scans or
fluoroscopy. The system is indicated for the
placement of spinal and orthopedic bone screws and
interbody fusion devices. | |
| | ExcelsiusHub™ is intended for use as an aid for
precisely locating anatomical structures to be used | |
6
| Features | Subject
DuraPro™ Oscillating System | Predicate &
Reference
Devices |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| | by surgeons for navigating compatible surgical
instruments in open or percutaneous procedures
provided that the required fiducial markers and rigid
patient anatomy can be identified on CT scans or
fluoroscopy. The system is indicated for the
placement of spinal and orthopedic bone screws and
interbody fusion devices. | |
| Instruments | Navigated and guided instruments | Same |
| Materials | Stainless steel, PEEK, Radel, Titanium alloy | Same |
| Biocompatibility | Stainless steel, PEEK, Radel, and titanium alloy
have a history of biocompatibility as instrument
materials per ASTM specifications and predicate
devices. | Same |
| Performance | The navigation and guidance accuracy of the DuraPro™ Oscillating
System was evaluated using intra-operative imaging and accuracy
verification testing. Testing confirmed that accuracy values meet the
product requirement specification. | |
| Electrical
Safety/EMC | Electrical safety and EMC testing were conducted on the DuraPro™
Oscillating System. Testing confirmed the system meets all
standards. | |
Performance Testing:
The navigation and guidance accuracy of the DuraPro™ Oscillating System was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification. Verification and validation testing and comparison to the predicate devices demonstrate that the subject DuraPro™ Oscillating System can be used in accordance with their indications.
Basis of Substantial Equivalence:
The DuraPro™ Oscillating System has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices.