Precision Spine Navigation Instrumentation

K181606 · Precision Spine, Inc. · OLO · Sep 27, 2019 · Neurology

Device Facts

• Record ID: K181606
• Device Name: Precision Spine Navigation Instrumentation
• Applicant: Precision Spine, Inc.
• Product Code: OLO · Neurology
• Decision Date: Sep 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Precision Spine Navigation Instrumentation are intended to be used 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. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Device Story

Precision Spine Navigation Instrumentation consists of non-sterile, reusable, manually operated surgical instruments; used in conjunction with Medtronic StealthStation System. Instruments facilitate precise location of anatomical structures during spinal surgery for preparation and placement of Precision Spine screw implants. Surgeon uses instruments in open or minimally invasive procedures; system references rigid anatomical structures (vertebra) via CT/MR models, fluoroscopy, or digitized landmarks. Output provides visual guidance to surgeon for screw implantation; assists in accurate anatomical positioning. Benefits include enhanced surgical precision during spinal instrumentation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included accuracy and precision testing per ASTM F2554-10, mating interface assessments, CMM inspection, instrument verification, and simulated use testing.

Technological Characteristics

Non-sterile, reusable, manually operated stainless steel instruments (ASTM F899). Designed for integration with Medtronic StealthStation System. No electronic components or software algorithms contained within the instrumentation itself.

Indications for Use

Indicated for use during spinal surgery to assist surgeons in locating anatomical structures for the preparation and placement of Precision Spine screws in open or minimally invasive procedures. Designed for use with the Medtronic Stealth Station System in conditions where stereotactic surgery is appropriate.

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

• Alphatec Spine Navigation Instruments (K153603)
• Navigated CD HORIZON® SOLERA® Screwdrivers and Taps (K140454)

Reference Devices

• Reform Pedicle Screw System (K121172)
• Reform® Midline Cortical Screw System (K173130)

Submission Summary (Full Text)

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September 27, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health and Human Services logo, which is a stylized human figure. On the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Precision Spine % Ms. Meredith May Partnership Manager Empirical Consulting LLC 4628 Northpark Dr. Colorado Springs, Colorado 80918

Re: K181606

Trade/Device Name: Precision Spine Navigation Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 4, 2019 Received: September 5, 2019

Dear Ms. May:

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

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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 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 (QS) 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 medical devices and radiation-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.

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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## 4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.

510(k) Number (if known) K181606 Device Name Precision Spine Navigation Instrumentation

Indications for Use (Describe)

Precision Spine Navigation Instrumentation are intended to be used 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. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Type of Use (Select one or both, as applicable) മ Prescription Use (Part 21 CFR 801 Subpart D) 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 [e-mail] "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."

FORM FDA 3881 (7/17)

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# 5.510(K) SUMMARY

| Submitter's Name: | Precision Spine |
|----------------------------|----------------------------------------------------------------|
| Submitter's Address: | 2050 Executive Drive<br>Pearl, MS 39208 |
| Submitter's Telephone: | 973-455-7150 |
| Contact Person: | Meredith L May RAC<br>Empirical Consulting LLC<br>719-337-7579 |
| Date Summary was Prepared: | 12 Jun 18 |
| Trade or Proprietary Name: | Precision Spine Navigation Instrumentation |
| Common or Usual Name: | Orthopedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR §882.4560 |
| Product Code: | OLO |
| Classification Panel: | Orthopedics |

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

Precision Spine Navigated Instruments are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899

### INDICATIONS FOR USE

Precision Spine Navigation Instrumentation are intended to be used 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. Precision Spine Navigation Instrumentation are specifically designed for use with the Medtronic Stealth Station System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

#### TECHNOLOGICAL CHARACTERISTICS

Precision Spine Navigated Instruments are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Precision Spine screw implants. The instruments are manufactured from stainless steel per ASTM F899.

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Precision Spine Navigation Instrumentation is made from material that conforms to ASTM. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for Use
- Materials of manufacture
- Structural support mechanism ●

#### Table 5-1 Predicate Devices

| 510k<br>Number | Trade or Proprietary or Model Name | Manufacturer | Predicate<br>Type |
|----------------|--------------------------------------------------------|--------------------------------------|-------------------|
| K153603 | Alphatec Spine Navigation Instruments | Alphatec Spine, Inc. | Primary |
| K140454 | Navigated CD HORIZON® SOLERA®<br>Screwdrivers and Taps | Medtronic Sofamor Danek,<br>USA Inc. | Additional |
| K121172 | Reform Pedicle Screw System | Spinal USA | Reference |
| K173130 | Reform® Midline Cortical Screw System | Precision Spine | Reference |

#### Performance Data

The following testing was performed:

- Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard ● Practice for Measurement of Positional Accuracy of computer Assisted Surgical Systems
- Mating Interface Assessments ●
- CMM Inspection ●
- Instrument Verification ●
- o Simulated Use

The accuracy and precision testing of the position and orientation of the Precision Spine Navigation Instrumentation when used with Medtronic's O-Arm, StealthStation, and NavLock Spinal Instruments systems was performed, per ASTM F2554-10, Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems

#### CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Precision Spine Navigation Is substantially equivalent to the predicate device.