E-GPS Navigated Instruments

K220862 · Precision Spine, Inc. · OLO · Jul 14, 2022 · Neurology

Device Facts

• Record ID: K220862
• Device Name: E-GPS Navigated Instruments
• Applicant: Precision Spine, Inc.
• Product Code: OLO · Neurology
• Decision Date: Jul 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

E-GPS Navigated Instruments consist of reusable, manually operated stainless steel taps and drivers; designed for use with Globus Medical Excelsius GPS Robotic Navigation Platform. System utilizes CT or fluoroscopy imaging to identify fiducial markers and patient anatomy; provides navigation assistance for precise positioning of surgical instruments during spinal screw implantation. Used by surgeons in OR settings for open or minimally invasive spinal procedures. Output consists of physical guidance for instrument placement; aids surgeon in anatomical localization. Benefits include increased precision during spinal fixation procedures. Compatible exclusively with Reform Spinal Fixation System.

Clinical Evidence

Bench testing only. Evaluation performed via engineering analysis and geometric comparison to predicate devices to establish accuracy performance.

Technological Characteristics

Reusable manual surgical instruments (taps, drivers). Material: Stainless steel per ASTM F899. Principle: Mechanical navigation assistance via integration with robotic navigation platform. Non-sterile.

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of Precision Spine screws in open or minimally invasive procedures. Used by surgeons to assist in locating anatomical structures.

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

• EXCELSIUS GPS™ (K171651)
• Reform Pedicle Screw System (K200303)
• Reform® Midline Cortical Screw System (K173130)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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<br>Pearl, Mississippi 39208 |
| Submitter's Telephone: | 1-601-420-4244 |
| Contact Person: | Nathan Wright MS<br>Empirical Testing Corp.<br>1-719-351-0248<br>[e-mail]<br>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

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#### Predicate Devices

| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Product<br>Code | Predicate<br>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.