Waypoint GPS

K222106 · Waypoint Orthopedics, Inc. · QWP · May 12, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K222106
• Device Name: Waypoint GPS
• Applicant: Waypoint Orthopedics, Inc.
• Product Code: QWP · Ear, Nose, Throat
• Decision Date: May 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Indications for Use

The Waypoint GPS™ is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and possible vertebral cortex perforation. The Waypoint GPS™ is indicated for use in both open and percutaneous (MIS) procedures.

Device Story

Waypoint GPS is a single-use, sterile, battery-operated handheld probe used by surgeons in operating rooms for pedicle screw pilot hole drilling. The device functions as a bone awl; it utilizes spectral reflectance to analyze tissue at the probe tip. Photons of specific wavelengths are reflected back to a sensor, which the system processes to display color information on a tablet. Cortical bone reflects lighter colors; cancellous bone reflects red/darker colors; cortical breaches reflect black/dark colors. The surgeon monitors the tablet display to interpret tissue type and identify potential perforations. This visual feedback assists in safe pilot hole creation, reducing the risk of vertebral cortex perforation. The device is designed for single use and cannot be turned off until the battery is exhausted, preventing reuse.

Clinical Evidence

Bench testing included biocompatibility (ISO 10993), insertion force, torque, simulated use, visualization/color accuracy, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software V&V, and sterilization validation. A GLP in vivo ovine lumbar study compared the subject device to the predicate. Results showed 100% user identification of tip location for the subject device and 95% for the predicate. Statistical analysis (p<0.05) demonstrated the subject device is non-inferior to the predicate.

Technological Characteristics

Single-use, sterile, battery-operated (Li/MnO2) handheld probe. Shaft: 17-4PH stainless steel. Sensing principle: spectral reflectance (electro-optical). Connectivity: tablet-based visualization via software application. Software: moderate level of concern. Sterilization: Ethylene Oxide (ISO 11135-1). Standards: ASTM D4169-22 (distribution/aging), ASTM F2096-11 (leak), ASTM F88/F88M-21 (seal).

Indications for Use

Indicated for use during pedicle screw pilot hole drilling in open and percutaneous (MIS) spinal procedures to provide visual feedback of tissue changes at the probe tip, indicating potential soft tissue contact or vertebral cortex perforation.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• SpineGuard PediGuard With DSG Connect Technology (K201454)

Submission Summary (Full Text)

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May 12, 2023

Waypoint Orthopedics, Inc. Tiffini Wittwer Regulatory Affairs 300 Applebrooke Drive Malvern, Pennsylvania 19355

Re: K222106

Trade/Device Name: Waypoint Guided Pedicle System (GPS) Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: QWP Dated: April 7, 2023 Received: April 12, 2023

Dear Tiffini Wittwer:

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, Patrick Antkowiak -S Patrick Antkowiak

Acting Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine 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) K222106

Device Name Waypoint Guided Pedicle System (GPS)™

Indications for Use (Describe)

The Waypoint GPS™ is indicated for use during pedicle screw pilot hole drilling to provide visual feedback to the surgeon of changes in color to the tissue at the tip of the probe that may indicate contact with soft tissues and possible vertebral cortex perforation. The Waypoint GPS™ is indicated for use in both open and percutaneous (MIS) procedures.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) Summary - K222106

#### SUBMITTER: I.

| | Company | Waypoint Orthopedics, Inc. | | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | 300 Applebrooke Drive | | |
| | | Malvern, PA 19355 | | |
| | Contact Person: | Tiffini Wittwer | | |
| | | Regulatory Affairs Consultant | | |
| | | Phone: [phone] | | |
| | | E-mail: [e-mail] | | |
| | Date Prepared: | April 7, 2023 | | |
| | II. DEVICE | | | |
| | Trade Name: | Waypoint Guided Pedicle System (GPS)™ | | |
| | Common Name: | Nerve Stimulator | | |
| | Classification Name: | Neurosurgical Nerve Stimulator / Locator (21 CFR 874.1820) | | |
| | Regulatory Class: | II | | |
| | Product Code: | OWP | | |
| Item | Waypoint Guided<br>Pedicle System™<br>(Subject Device) | SpineGuard<br>PediGuard With DSG<br>Connect Technology<br>(Predicate Device) | Comment | |
| 510(k) | K222106 | K201454 | | |
| Class | II | II | Same | |
| Product Code | QWP | PDQ, ETN | Primary product code is the same | |
| Indications<br>for Use (IFU) | The Waypoint GPS™ is<br>indicated for use during<br>pedicle screw pilot hole<br>drilling to provide visual<br>feedback to the surgeon of<br>changes in color to the tissue<br>at the tip of the probe that may<br>indicate contact with soft<br>tissues and possible vertebral<br>cortex perforation. The<br>Waypoint GPS™ is indicated<br>for use in both open and<br>percutaneous (MIS)<br>procedures. | The PediGuard is indicated for<br>use during pedicle screw pilot<br>hole drilling to provide<br>feedback to the surgeon via<br>visual and audible alerts that<br>indicate a change in impedance<br>at the tip of the probe and may<br>indicate contact of the tip with<br>soft tissues and possible<br>vertebral cortex perforation.<br>The PediGuard system is<br>indicated for use in both open<br>and percutaneous (MIS)<br>surgical approaches to the<br>spine. PediGuard is also<br>indicated for use with<br>fluoroscopic guidance in<br>percutaneous (MIS) surgical<br>approaches to the spine.<br>The PediGuard also is<br>specifically indicated for use in<br>intraoperative<br>electromyographic ("EMG")<br>surveillance to assist in the<br>location and evaluation of<br>spinal nerves during surgery of<br>the spine, by administration of<br>low voltage electrical energy to<br>tissues and nerves during<br>surgery of the spine, and EMG<br>monitoring of muscle groups<br>associated with those nerves. | Subject device has a narrower<br>indication for use that the<br>predicate (does not include<br>fluoroscopic guidance or EMG<br>surveillance). Description of<br>output (color versus<br>impedance) does not change<br>the indication for use. User<br>validation testing demonstrates<br>this difference does not raise<br>new questions of safety of<br>effectiveness. | |
| Item | Waypoint Guided<br>Pedicle System™<br>(Subject Device) | SpineGuard<br>PediGuard With DSG<br>Connect Technology<br>(Predicate Device) | Comment | |
| Output | Visual | Visual and Auditory | User validation testing of the<br>subject device and side-by-side<br>animal testing of the subject<br>device and predicate device<br>demonstrates this difference<br>does not raise new questions of<br>safety of effectiveness. | |
| Connection | Software application on tablet<br>allows for visualization | Software application on tablet<br>allows for visualization | Same | |
| Principles of<br>operation | Shaft serves as bone awl and<br>provides visual feedback<br>indicating if device has<br>perforated vertebral cortex | Shaft serves as bone awl and<br>nerve locator by providing<br>visual and auditory feedback<br>indicating if device has<br>perforated vertebral cortex | Pre-clinical performance testing of<br>the subject device, and side-by-side<br>animal testing of the subject device<br>and predicate device demonstrates<br>that this difference does not raise<br>new questions of safety or<br>effectiveness. | |
| Technical<br>Principles of<br>Operation | Spectral reflectance: the electro-<br>optical property of a material to<br>reflect light. Photons of a specific<br>wavelength are reflected back to a<br>sensor. These wavelengths appear<br>on the display tablet as the color<br>information for the respective<br>tissue type.<br>● Cortical bone has lowest<br>absorbance => more<br>photons reflect back to<br>sensor => lighter color<br>● Cancellous bone has higher<br>absorbance of green / blue<br>& reflects red => red to<br>dark displayed<br>● Cortical breach (void) =><br>highest absorbance => lack<br>of light reflected back to<br>sensor => dark or black<br>color | Electrical conductivity: the<br>property of a material to allow<br>current flow. Electrical<br>conductance between two<br>electrodes is measured as<br>current. Current is monitored<br>in feedback circuitry that<br>generates an output frequency<br>in an audible range.<br>● Cortical bone has low<br>conductivity => lower<br>current => low, slow signal<br>● Cancellous bone has<br>comparatively medium<br>conductivity => medium<br>signal<br>● Periosteum and blood have<br>high conductivity<br>(indicates cortical breach)<br>=> larger measurement to<br>convert => higher pitched,<br>faster sound | Pre-clinical animal testing,<br>including side-by-side testing of the<br>subject device and the predicate<br>device demonstrate that the<br>technical difference does not raise<br>new questions of safety or<br>effectiveness. | |
| Handle Shape | Gearshift Knob-Handle | Gearshift T-Handle | Same | |
| Components | Single piece, Stainless Steel Shaft,<br>plastic handle | Single piece, Stainless Steel Shaft,<br>plastic handle, ceramic insulator<br>or modular with removable handle | Same external components.<br>Performance bench testing<br>demonstrates differences in<br>internal components do not raise<br>new questions of safety of<br>effectiveness. | |
| Item | Waypoint Guided<br>Pedicle System™<br>(Subject Device) | SpineGuard<br>PediGuard With DSG<br>Connect Technology | | Comment |
| | | (Predicate Device) | | |
| Shaft / bone<br>awl material | 17-4PH Stainless Steel | Inner electrode: 316L Stainless<br>Steel (ASTM F138) Outer<br>electrode and/or shaft: 304<br>Stainless Steel (ASTM F899),<br>316L Stainless Steel and/or 17-<br>4PH (ASTM F899) | Biocompatibility testing and<br>performance testing of the subject<br>device demonstrates material<br>differences do not raise<br>new questions of safety of<br>effectiveness. | |
| Safety<br>Features | Device cannot be turned off until<br>battery exhausted. Prevents reuse<br>of device. | Device cannot be turned off until<br>battery exhausted. Prevents reuse<br>of device. | Same | |
| Internally<br>Powered | Lithium-Ion Battery<br>Chemistry: Li/MnO2<br>Max output current: 3.0mA | Lithium-Ion Battery<br>Chemistry: Li/MnO2<br>Max output current: 5.5mA | Same battery type; run time of<br>subject device is lower than<br>predicate. Electrical safety and<br>performance testing demonstrates<br>difference does not<br>raise new questions of safety of<br>effectiveness. | |
| Sterility | Sterile | Sterile | Same | |
| Single Use or<br>Reusable | Single use | Single use | Same | |
| Distal Shaft<br>Shape | Straight, cannulated | Curved or straight; or straight<br>(cannulated) with removable inner<br>starter stylet (optional) and<br>sensory needle | Same as 1 predicate model | |
| Dimensions | Shaft Length: 200mm<br>Diameter of cutting edge: 4.0mm | Shaft Lengths: 120mm & 160mm<br>Outer Diameters: 4.0mm - 5.5mm | OD is within predicate range.<br>Performance and cadaver testing of<br>the subject device demonstrates<br>difference does not raise new<br>questions of safety of effectiveness. | |
| Circuit Board…