Spine Wave Navigated Instruments

K181596 · Spine Wave, Inc. · OLO · Oct 24, 2018 · Neurology

Device Facts

• Record ID: K181596
• Device Name: Spine Wave Navigated Instruments
• Applicant: Spine Wave, Inc.
• Product Code: OLO · Neurology
• Decision Date: Oct 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, or Proficient® Posterior Cervical Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.

Device Story

Reusable, manual stainless steel surgical instruments; used with Medtronic StealthStation® System via Medtronic NavLock™ Tracker. Instruments facilitate screw placement during cervicothoracic and thoracolumbosacral spinal surgeries. Surgeon uses instruments to precisely locate anatomical structures during open, minimally invasive, or percutaneous procedures. Device provides navigation capability by integrating with existing Medtronic navigation hardware; output is visual guidance on the StealthStation® display. Assists surgeon in accurate screw placement; potential benefit includes improved surgical precision and procedural outcomes.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with ASTM F2554 to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Reusable manual surgical instruments; stainless steel construction. Designed for use with Medtronic StealthStation® navigation system via NavLock™ Tracker. Testing performed per ASTM F2554. No active energy source; standalone mechanical instruments requiring external navigation system for functionality.

Indications for Use

Indicated for use during spinal surgery (cervicothoracic and thoracolumbosacral) to assist surgeons in locating anatomical structures for the preparation and placement of Spine Wave screws (Sniper, CapSure, or Proficient systems) in open, minimally invasive, or percutaneous procedures.

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

• Navigated Screwdrivers and Taps (K124004)
• Navigated Vertex Select Instruments (K143628)

Submission Summary (Full Text)

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October 24, 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 and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spine Wave, Inc. Amy Noccioli Regulatory Affairs Specialist 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K181596

Trade/Device Name: Spine Wave Navigated Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 26, 2018 Received: September 27, 2018

Dear Amy Noccioli:

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 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

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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Jesse Muir -S 2018.10.24 13:12:14 -04'00'

For:

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

#### K181596

Device Name

Spine Wave® Navigated Instruments

#### Indications for Use (Describe)

The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, or Proficient® Posterior Cervical Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.

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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Image /page/3/Picture/1 description: The image shows the logo for Spine Wave. The text "Spine Wave" is written in a bold, sans-serif font. A blue wave design is underneath the text, adding a visual element to the logo.

# 510(k) Summary Spine Wave® Navigated Instruments

## 1. Submitter Information

| Submitter: | Spine Wave, Inc. |
|----------------|----------------------------------------------------------|
| Address: | Three Enterprise Drive<br>Suite 210<br>Shelton, CT 06484 |
| Telephone: | 203-712-1842 |
| Telefax: | 203-944-9493 |
| Contact: | Amy Noccioli |
| Date Prepared: | June 15, 2018 |

### 2. Device Information

| Trade Name: | Spine Wave® Navigated Instruments |
|----------------------|------------------------------------|
| Common Name: | Orthopedic Stereotaxic Instruments |
| Classification: | Class II per 21 CFR 882.4560 |
| Classification Name: | Stereotaxic Instruments |
| Product Code: | OLO |

#### 3. Purpose of Submission

The purpose of this submission is to gain clearance for the Spine Wave® Navigated Instruments.

## 4. Predicate Device Information

The Spine Wave® Navigated Instruments described in this submission are substantially equivalent to the following predicates:

| Primary Predicate Device | Manufacturer | 510(k) No. |
|---------------------------------|--------------|------------|
| Navigated Screwdrivers and Taps | Medtronic | K124004 |

| Additional Predicate Device | Manufacturer | 510(k) No. |
|-------------------------------------|--------------|------------|
| Navigated Vertex Select Instruments | Medtronic | K143628 |

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## 5. Device Description

The Spine Wave® Navigated Instruments are reusable, manual, surgical instruments made from stainless steel. These instruments are to be used with the Medtronic StealthStation® System via the Medtronic NavLock™ Tracker to facilitate screw placement during cervicothoracic and thoracolumbosacral surgeries.

### 6. Indications for Use

The Spine Wave® Navigated Instruments are intended to be used during the preparation and placement of Spine Wave screws (Sniper® Spine System, CapSure® Spine System, or Proficient® Posterior Cervical Spine System) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. The Spine Wave® Navigated Instruments are designed for use with the Medtronic StealthStation® System.

# 7. Comparison of Technological Characteristics

The Spine Wave® Navigated Instruments have technological characteristics similar to those of the predicate devices, including intended use, performance, design, and material composition.

### 8. Performance Data

Spine Wave, Inc. tested the subject devices in accordance with ASTM F2554 to demonstrate that the Spine Wave® Navigated Instruments are substantially equivalent to the predicates.

#### 9. Conclusion

The indications for use, technological characteristics, and performance testing show that the Spine Wave® Navigated Instruments are substantially equivalent to the predicate devices identified in this submission and do not present any new issues of safety or effectiveness.