(112 days)
Not Found
No
The summary describes navigated surgical instruments used with a robotic navigation platform. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The navigation is based on identifying anatomical structures from CT or fluoroscopy scans, which is a standard navigation approach, not necessarily involving AI/ML.
No
The device is described as navigated instruments (taps and drivers) used during spinal surgery to assist the surgeon, not to directly treat a disease or condition. It aids in the placement of screws, which are therapeutic, but the instruments themselves are not.
No
The device is used to assist surgeons in precisely locating anatomical structures and guiding surgical instruments during spinal surgery for the placement of screws; it does not diagnose medical conditions.
No
The device description explicitly states that the E-GPS Navigated Instruments are "non-sterile, reusable instruments including taps and drivers that can be operated manually" and are "manufactured from stainless steel." This indicates the device is a physical instrument, not solely software.
No, 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 E-GPS Navigated Instruments are surgical instruments (taps and drivers) used during spinal surgery to assist in the placement of screws. They are used on the patient's anatomy, not on specimens taken from the patient.
- Intended Use: The intended use clearly states they are for "use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures." This is an intraoperative surgical aid, not a diagnostic test performed on a sample.
The device is a surgical navigation and instrument system, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS 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 E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
Precision Spine E-GPS Navigated Instruments are non-sterile, reusable instruments including taps 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 Precision Spine 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)
The E-GPS Navigated Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance.
The results of this engineering analysis show that the subject is substantially equivalent to the cleared 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.
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
July 14, 2022
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 the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Precision Spine, Inc. % Nathan Wright Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K220862
Trade/Device Name: E-GPS Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 15, 2022 Received: June 16, 2022
Dear Nathan Wright:
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
1
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 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 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,
For: 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) K220862
Device Name E-GPS Navigated Instruments
Indications for Use (Describe)
The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS 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 E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC).
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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K220862 - 510(K) SUMMARY
| Submitter's Name: | Precision Spine, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl, Mississippi 39208 | |
| Submitter's Telephone: | 1-601-420-4244 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 1-719-351-0248 | |
| nwright@empiricaltech.com | |
| Image: Empirical Testing Corp. Logo | |
| Date Summary was Prepared: | March 22, 2022 |
| Trade or Proprietary Name: | E-GPS Navigated Instruments |
| Common or Usual Name: | Orthopedic Stereotaxic Instruments |
| Classification: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Orthopedic - Stereotaxic, Trauma and Restorative Devices (DHT6C) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
Precision Spine E-GPS Navigated Instruments are non-sterile, reusable instruments including taps 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 Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899.
INDICATIONS FOR USE
The E-GPS Navigated Instruments are indicated for use during the preparation and placement of Precision Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The E-GPS 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 E-GPS Navigated Instrument System is limited to use only with the Reform® Spinal Fixation System (Reform® Ti Modular, Reform® Ti CT Modular MIS, Reform® Modular, and Reform® MC').
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of the safety and effectiveness. Specifically, the following characteristic are the similar between the subject and predicates:
- Device design and dimensions ●
- Indications for use ●
- Materials of manufacture ●
- . Principles of operation
4
Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Product
Code | Predicate
Type |
|----------------|---------------------------------------|-----------------------|-----------------|-------------------|
| K171651 | EXCELSIUS GPS™ | Globus Medical Inc. | OLO | Primary |
| K200303 | Reform Pedicle Screw System | Precision Spine | NKB, KWP | Additional |
| K173130 | Reform® Midline Cortical Screw System | Precision Spine, Inc. | NKB | Additional |
PERFORMANCE DATA
The E-GPS Navigated Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance.
The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate.
CONCLUSION
The overall technology characteristics and engineering analysis lead to the conclusion that the E-GPS Navigated Instruments are substantially equivalent to the predicate device.