(272 days)
No
The summary describes navigated surgical instruments used with a robotic navigation platform, but there is no mention of AI or ML in the device description, intended use, or performance studies. The navigation is based on pre-operative imaging (CT or fluoroscopy) and fiducial markers, which is a standard approach for surgical navigation and does not inherently involve AI/ML.
No
The device, consisting of a drill and drivers, is intended to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spinal surgery for the placement of Astura Medical screws. It is an instrument used in a procedure, but it does not directly treat or diagnose a disease or condition itself, which are typical functions of a therapeutic device.
No
The EGPS Navigated Instruments are used during preparation and placement of screws in spinal surgery to assist in precisely locating anatomical structures and navigating/guiding surgical instruments. They are tools for surgical assistance, not for diagnosing conditions or diseases.
No
The device description explicitly states the instruments are "reusable instruments including a drill and drivers" manufactured from stainless steel, indicating they are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The EGPS Navigated Instruments are surgical instruments used during spinal surgery to assist in the placement of screws. They are used in conjunction with a robotic navigation platform to guide the surgeon's actions on the patient's anatomy.
- Lack of Specimen Analysis: The description does not mention the collection, preparation, or analysis of any biological specimens from the patient. The input is imaging data (CT scans or fluoroscopy) and the output is guidance for surgical instrument placement.
Therefore, the function and intended use of the EGPS Navigated Instruments fall under the category of surgical navigation and instrumentation, not in vitro diagnostics.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans or fluoroscopy
Anatomical Site
spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons / Not Found
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)
Comparative dimensional analysis of subject instruments with predicate
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.
Globus EXCELSIUS GPS (K171651)
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.
Olympic K153446, Olympic MIS K182239, Masada K231694
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: 469-501-5530 x503 | |
| Email: parker@asturamedical.com | |
| 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 | |
| Claimed to Predicate | |
| Device | The EGPS Navigated instruments are substantially equivalent to the |
| predicate device in terms of intended use, design, mechanical safety and | |
| performance. | |
| Indications for 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 use as an aid for precisely locating anatomical structures and | |
| for the special 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. 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). | |
| Non-clinical Test | |
| 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 | |
| and Clinical | Astura Medical considers the EGPS Navigated Instruments to be |
| substantially equivalent to the predicate device listed above. This | |
| conclusion is based upon the devices' similarities in geometry, principles | |
| of operation, technology, and indications for use. |
5