OLYMPIC Navigated Instruments

K172166 · Astura Medical · OLO · Apr 27, 2018 · Neurology

Device Facts

• Record ID: K172166
• Device Name: OLYMPIC Navigated Instruments
• Applicant: Astura Medical
• Product Code: OLO · Neurology
• Decision Date: Apr 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® 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 of the anatomy.

Device Story

OLYMPIC Navigated Instruments consist of non-sterile, reusable manual surgical tools (taps, drivers) used for spinal screw placement. Instruments interface with Medtronic StealthStation® System (v 2.1.0) to provide real-time navigation. Surgeon uses instruments in conjunction with navigation system to track position relative to patient anatomy (CT/MR models, fluoroscopy, or digitized landmarks). System provides visual guidance to surgeon, facilitating precise anatomical localization during spinal procedures. Benefits include improved accuracy in screw placement and potential for reduced invasiveness. Used in clinical settings by surgeons.

Clinical Evidence

No clinical data. Bench testing only: dimensional analysis compared to predicates and anatomical simulated use testing to verify navigation accuracy.

Technological Characteristics

Materials: Stainless steel per ASTM F899. Form factor: Manual surgical instruments (taps, drivers). Connectivity: Designed for integration with Medtronic StealthStation® System. Sterilization: Non-sterile (reusable).

Indications for Use

Indicated for patients undergoing spinal surgery requiring preparation and placement of OLYMPIC PSFS screws; intended for use in open or minimally invasive procedures to assist surgeons in locating anatomical structures via stereotactic navigation.

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

• Medtronic Instruments (K143628)
• Medtronic Instruments (K143375)
• Medtronic Instruments (K140454)

Reference Devices

• OLYMPIC Posterior Spinal Fixation System (Screws), K143446

Submission Summary (Full Text)

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April 27, 2018

Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size in blue.

Astura Medical Parker Kelch Quality Manager 3186 Lionshead Avenue Suite 100 Carlsbad, California 92010

Re: K172166

Trade/Device Name: OLYMPIC Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 29, 2018 Received: March 30, 2018

Dear Parker 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 (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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172166

Device Name OLYMPIC NAVIGATED INSTRUMENTS

#### Indications for Use (Describe)

The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® 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 of the anatomy.

| 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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### 510(k) Summary: OLYMPIC NAVIGATED INSTRUMENTS

| Date Prepared | July 17, 2017 |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By | Astura Medical<br>3186 Lionshead Ave, Suite 100<br>Carlsbad, Ca 92010<br>Phone: [phone] |
| Contact | Parker Kelch<br>3186 Lionshead Ave, Suite 100<br>Carlsbad, Ca 92010<br>Phone: [phone] x413<br>Email: [e-mail] |
| Trade Name | Olympic navigated instruments |
| Common Name | Navigated instruments |
| Classification Name | Stereotaxic instrument |
| Class | Class II |
| Product Code | OLO |
| Cfr Section | 21 CFR Section 882.4560 |
| Device Panel | Orthopedic |
| Primary Predicate Device | Medtronic Instruments (K143628, K143375, K140454) |
| Reference Device(s) | OLYMPIC Posterior Spinal Fixation System (Screws), K143446 |
| Device Description | The OLYMPIC NAVIGATED INSTRUMENTS are comprised of nonsterile,<br>reusable instruments including taps and drivers that can be operated<br>manually. These instruments are intended to be used with the Medtronic<br>StealthStation® System (v 2.1.0) and are manufactured from stainless<br>steel, as specified in ASTM F899. |
| Materials | Stainless Steel per ASTM F899 |
| Substantial Equivalence<br>Claimed to Predicate<br>Devices | The OLYMPIC NAVIGATED INSTRUMENTS are substantially equivalent to<br>the predicate devices in terms of intended use, design, materials used,<br>mechanical safety and performances. |
| Indications for Use | The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the<br>preparation and placement of OLYMPIC PSFS screws during spinal surgery<br>to assist the surgeon in precisely locating anatomical structures in either<br>open or minimally invasive procedures. These instruments are designed<br>for use with the Medtronic StealthStation® System, which is indicated for<br>any medical condition in which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid anatomical structure, such as<br>a skull, a long bone, or vertebra, can be identified relative to a CT or MR<br>based model, fluoroscopy images, or digitized landmarks of the anatomy. |
| NON-CLINICAL TEST<br>SUMMARY | The following analyses were conducted:<br>● Dimensional analysis compared to predicate<br>● Anatomical simulated use and navigation accuracy<br>The results of these evaluations indicate that the OLYMPIC NAVIGATED<br>INSTRUMENTS are equivalent to the predicate devices. |
| CONCLUSIONS: NON-<br>CLINICAL AND CLINICAL | Astura medical considers the OLYMPIC NAVIGATED INSTRUMENTS to be<br>equivalent to the predicate devices listed above. This conclusion is based<br>upon the devices' similarities in principles of operation, technology,<br>materials, and indications for use. |

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

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