EGPS Navigated Instruments

K240160 · Astura Medical · OLO · Oct 17, 2024 · Neurology

Device Facts

• Record ID: K240160
• Device Name: EGPS Navigated Instruments
• Applicant: Astura Medical
• Product Code: OLO · Neurology
• Decision Date: Oct 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position 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. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).

Device Story

EGPS Navigated Instruments consist of reusable manual surgical tools, including drills and drivers, designed for spinal surgery. Instruments function as accessories to the Globus Medical Excelsius GPS Robotic Navigation Platform. Surgeon uses instruments in open or minimally invasive procedures to prepare bone and place Astura Medical screws. Navigation platform provides guidance based on pre-operative CT scans or intra-operative fluoroscopy; instruments interface with platform's navigation/robotic tracking components. Output is physical placement of spinal implants. Benefit includes increased precision in anatomical targeting during screw implantation.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by non-clinical bench testing, specifically comparative dimensional analysis against the predicate device.

Technological Characteristics

Materials: Stainless steel per ASTM F899. Form factor: Manual surgical instruments (drills, drivers). Connectivity: Designed for use with Globus Medical Excelsius GPS Robotic Navigation Platform. Sterilization: Reusable (requires reprocessing).

Indications for Use

Indicated for use during spinal surgery to assist surgeons in precisely locating anatomical structures for the preparation and placement of Astura Medical screws in open or minimally invasive procedures. Limited to use with Olympic and Masada spinal fixation systems and the Globus Medical Excelsius GPS Robotic Navigation Platform.

Regulatory Classification

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.

Predicate Devices

• Globus EXCELSIUS GPS (K171651)

Reference Devices

• Olympic (K153446)
• Olympic MIS (K182239)
• Masada (K231694)

Submission Summary (Full Text)

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October 17, 2024

Astura Medical Parker Kelch Quality Manager 4949 W Royal Ln. Irving, Texas 75063

Re: K240160

Trade/Device Name: EGPS Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 13, 2024 Received: September 13, 2024

Dear Mr. Kelch:

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"

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(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 (OS) 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 Rule"). 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-device-advicecomprehensive-regulatory-assistance/unique-device-identification-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

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by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/2/Picture/3 description: The image shows the name "Shumaya Ali -S" in a large, clear font. The text is likely part of a document or presentation. The name is written in a simple, sans-serif typeface, making it easily readable.

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

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## Indications for Use

510(k) Number (if known) K240160

Device Name EGPS Navigated Instruments

#### Indications for Use (Describe)

The EGPS Navigated Instruments are indicated for use during the preparation and placement of Astura Medical screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The EGPS Navigated Instruments are reusable and are specifically designed for use with the Globus Medical Excelsius GPS® Robotic Navigation Platform which is intended for precisely locating anatomical structures and for the special position 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. Use of the EGPS Navigated Instrument System is limited to use only with the Olympic and Masada spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada K231694).

| 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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## 510(k) Summary: Astura EGPS Navigated Instruments

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

| Date Prepared | October 14, 2024 |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical |
| | 4949 W Royal Ln |
| | Irving, TX 75063 |
| Contact | Parker Kelch |
| | 4949 W Royal Ln |
| | Irving, TX 75063 |
| | Phone: [phone] x503 |
| | Email: [e-mail] |
| Trade Name | EGPS Navigated Instruments |
| Common Name | Stereotaxic Instrument |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Class | II |
| Product Code | OLO |
| CFR Section | 21 CFR section 882.4560 |
| Device Panel | Orthopedic |
| Predicate Device | Globus EXCELSIUS GPS (K171651) |
| Device Description | Astura Medical EGPS Navigated Instruments are non-sterile, reusable |
| | instruments including a drill and drivers that can be operated manually. |
| | These instruments are intended to be used with the Globus Medical |
| | Excelsius GPS® Robotic Navigation Platform to aid in implantation of |
| | associated Astura Medical screw implants. The instruments are |
| | manufactured from stainless steel per ASTM F899. |
| Materials | Stainless Steel ASTM F899 |
| Substantial Equivalence<br>Claimed to Predicate<br>Device | The EGPS Navigated instruments are substantially equivalent to the<br>predicate device in terms of intended use, design, mechanical safety and<br>performance. |
| Indications for Use | The EGPS Navigated Instruments are indicated for use during the<br>preparation and placement of Astura Medical screws during spinal<br>surgery to assist the surgeon in precisely locating anatomical structures in<br>either open or minimally invasive procedures. The EGPS Navigated<br>Instruments are reusable and are specifically designed for use with the<br>Globus Medical Excelsius GPS® Robotic Navigation Platform which is<br>intended for use as an aid for precisely locating anatomical structures and<br>for the special positioning and orientation of an instrument holder or<br>guide tube to be used by surgeons for navigating and/or guiding<br>compatible surgical instruments in open or percutaneous procedures<br>provided that the required fiducial markers and rigid patient anatomy can<br>be identified on CT scans or fluoroscopy. Use of the EGPS Navigated |
| | Instrument System is limited to use only with the Olympic and Masada<br>spinal fixation systems (Olympic K153446, Olympic MIS K182239, Masada<br>K231694). |
| Non-clinical Test<br>Summary | The following analyses were conducted: |
| | Comparative dimensional analysis of subject instruments with predicate |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-Clinical<br>and Clinical | Astura Medical considers the EGPS Navigated Instruments to be<br>substantially equivalent to the predicate device listed above. This<br>conclusion is based upon the devices' similarities in geometry, principles<br>of operation, technology, and indications for use. |

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