Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on light-based sensing and visual feedback based on color changes, not AI/ML algorithms for analysis or prediction. There is no mention of training data, test data, or AI/ML specific performance metrics.

Therapeutic

No.
The device is indicated for use during an invasive procedure (pedicle screw pilot hole drilling) to provide visual feedback to the surgeon, assisting in the prevention of soft tissue contact and vertebral cortex perforation. It is a tool for procedural guidance and aims to prevent harm during a medical procedure, rather than directly treating a disease or condition.

Diagnostic

Yes

The device aids surgeons by providing visual feedback on tissue changes at the tip of the probe, indicating potential contact with soft tissues or vertebral cortex perforation during pedicle screw pilot hole drilling. This real-time feedback helps in diagnosing the tissue type and preventing errors.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of a "single use, disposable device" which is a hardware component containing electronics, an LED, and fiber optics, in addition to the software application. The performance studies also include testing of hardware aspects like insertion force, torque, and electrical safety.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Waypoint GPS™ Function: The Waypoint GPS™ is a surgical guidance device used during a procedure (pedicle screw placement). It provides real-time visual feedback based on the color of the tissue at the tip of the probe. This feedback is used to help the surgeon avoid soft tissues and potential vertebral cortex perforation.
No Sample Analysis: The device does not analyze a sample taken from the patient's body. It directly interacts with the tissue during the surgical procedure.

The Waypoint GPS™ is a surgical instrument with a guidance function, not a diagnostic test performed on a biological sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

QWP

Device Description

The Waypoint GPS™ is comprised of a single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to surgeons during pilot hole drilling for pedicle screw placement. Waypoint GPS™ probe is single use disposable and consists of a handle containing electronics and a stainless-steel shaft with distal LED and fiber optics for visualizing the tissues immediately in contact with the distal end of the probe. The device produces visual signals to indicate changes in color associated with possible verforation. It uses light to provide visual alerts to indicate a change in anatomical structure to prevent placement in soft tissues or vertebral cortex perforation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Within a sterile field in an operating room

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Biocompatibility Testing: Passed. Non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic. Relevant for substantial equivalence as material differences do not raise new safety questions.
Insertion Force: Passed. Each shaft completed 15 insertions into Sawbones without mechanical failure, demonstrating it can reliably create multiple pilot holes.
Torque on the shaft: Passed. Each shaft withstood 15 torque cycles without mechanical failure, demonstrating it can reliably create multiple pilot holes.
Torque to failure testing: Passed. Each shaft withstood the target torque, indicating reliability for creating multiple pilot holes.
Simulated Use Testing: Passed. Each device successfully completed pairing with tablet, color calibration, color testing, and battery monitoring after stress testing, demonstrating reliable performance and communication.
Visualization and color: Passed. Each device successfully displayed correct colors and RGB values, demonstrating reliable color output.
Electrical Safety and electromagnetic compatibility (EMC): Passed. Compliance with IEC 60601-1 and IEC 60601-1-2. Relevant due to electrical components in both subject and predicate devices.
Software Verification and Validation Testing: Passed. Conducted as per FDA guidance for moderate level of concern software. Relevant due to software in both subject and predicate devices.
Sterilization Validation: Passed. In accordance with ISO 11135-1:2014 using the Overkill test method. Relevant for terminally sterilized products.
Distribution and Aging: Passed. Devices and package system passed climactic conditioning, accelerated aging, and package performance testing. Insertion force, torque, simulated use, visualization, and color testing were performed on unaged and aged devices, confirming sterile barrier and device reliability over time.
Cadaver study: Passed. Multiple users successfully performed device setup, calibration, pilot hole creation, and interpretation of tablet display results in modified sawbone and cadavers, demonstrating user proficiency.
GLP Animal Study (In vivo performance testing): Users correctly identified GPS device tip location in all procedures (100%). Users successfully distinguished between cortical bone, cancellous bone, and a breach by the change in color and change in red, green, blue (RGB) values displayed on the table. Users correctly identified PediGuard tip location in most procedures (95%). Users were able to distinguish between cortical bone, cancellous bond, and breach by the change in cadence and pitch the predicate device emitted. The results demonstrated with statistical significance (0.050) that the subject device (WayPoint GPS System) is non-inferior to the predicate PediGuard device. The total number GPS procedures (including transverse processes) demonstrated the device performs as intended and users adequately interpret results with 95/95. This study provides in vivo objective evidence that the technical differences between the subject device and the predicate do not affect the intended use, and user interpretation of the subject device is equivalent to the predicate device.

Key Metrics

Not Found

Predicate Device(s)

K201454

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.

Summary

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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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 707.799.6732
		E-mail: twittwer@mededge.io
	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
Pedicle System™
(Subject Device)	SpineGuard
PediGuard With DSG
Connect Technology
(Predicate Device)	Comment
510(k)	K222106	K201454
Class	II	II	Same
Product Code	QWP	PDQ, ETN	Primary product code is the same
Indications
for Use (IFU)	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.	The PediGuard is indicated for
use during pedicle screw pilot
hole drilling to provide
feedback to the surgeon via
visual and audible alerts that
indicate a change in impedance
at the tip of the probe and may
indicate contact of the tip with
soft tissues and possible
vertebral cortex perforation.
The PediGuard system is
indicated for use in both open
and percutaneous (MIS)
surgical approaches to the
spine. PediGuard is also
indicated for use with
fluoroscopic guidance in
percutaneous (MIS) surgical
approaches to the spine.
The PediGuard also is
specifically indicated for use in
intraoperative
electromyographic ("EMG")
surveillance to assist in the
location and evaluation of
spinal nerves during surgery of
the spine, by administration of
low voltage electrical energy to
tissues and nerves during
surgery of the spine, and EMG
monitoring of muscle groups
associated with those nerves.	Subject device has a narrower
indication for use that the
predicate (does not include
fluoroscopic guidance or EMG
surveillance). Description of
output (color versus
impedance) does not change
the indication for use. User
validation testing demonstrates
this difference does not raise
new questions of safety of
effectiveness.
Item	Waypoint Guided
Pedicle System™
(Subject Device)	SpineGuard
PediGuard With DSG
Connect Technology
(Predicate Device)	Comment
Output	Visual	Visual and Auditory	User validation testing of the
subject device and side-by-side
animal testing of the subject
device and predicate device
demonstrates this difference
does not raise new questions of
safety of effectiveness.
Connection	Software application on tablet
allows for visualization	Software application on tablet
allows for visualization	Same
Principles of
operation	Shaft serves as bone awl and
provides visual feedback
indicating if device has
perforated vertebral cortex	Shaft serves as bone awl and
nerve locator by providing
visual and auditory feedback
indicating if device has
perforated vertebral cortex	Pre-clinical performance testing of
the subject device, and side-by-side
animal testing of the subject device
and predicate device demonstrates
that this difference does not raise
new questions of safety or
effectiveness.
Technical
Principles of
Operation	Spectral reflectance: the electro-
optical property of a material to
reflect light. Photons of a specific
wavelength are reflected back to a
sensor. These wavelengths appear
on the display tablet as the color
information for the respective
tissue type.
● Cortical bone has lowest
absorbance => more
photons reflect back to
sensor => lighter color
● Cancellous bone has higher
absorbance of green / blue
& reflects red => red to
dark displayed
● Cortical breach (void) =>
highest absorbance => lack
of light reflected back to
sensor => dark or black
color	Electrical conductivity: the
property of a material to allow
current flow. Electrical
conductance between two
electrodes is measured as
current. Current is monitored
in feedback circuitry that
generates an output frequency
in an audible range.
● Cortical bone has low
conductivity => lower
current => low, slow signal
● Cancellous bone has
comparatively medium
conductivity => medium
signal
● Periosteum and blood have
high conductivity
(indicates cortical breach)
=> larger measurement to
convert => higher pitched,
faster sound	Pre-clinical animal testing,
including side-by-side testing of the
subject device and the predicate
device demonstrate that the
technical difference does not raise
new questions of safety or
effectiveness.
Handle Shape	Gearshift Knob-Handle	Gearshift T-Handle	Same
Components	Single piece, Stainless Steel Shaft,
plastic handle	Single piece, Stainless Steel Shaft,
plastic handle, ceramic insulator
or modular with removable handle	Same external components.
Performance bench testing
demonstrates differences in
internal components do not raise
new questions of safety of
effectiveness.
Item	Waypoint Guided
Pedicle System™
(Subject Device)	SpineGuard
PediGuard With DSG
Connect Technology		Comment
		(Predicate Device)
Shaft / bone
awl material	17-4PH Stainless Steel	Inner electrode: 316L Stainless
Steel (ASTM F138) Outer
electrode and/or shaft: 304
Stainless Steel (ASTM F899),
316L Stainless Steel and/or 17-
4PH (ASTM F899)	Biocompatibility testing and
performance testing of the subject
device demonstrates material
differences do not raise
new questions of safety of
effectiveness.
Safety
Features	Device cannot be turned off until
battery exhausted. Prevents reuse
of device.	Device cannot be turned off until
battery exhausted. Prevents reuse
of device.	Same
Internally
Powered	Lithium-Ion Battery
Chemistry: Li/MnO2
Max output current: 3.0mA	Lithium-Ion Battery
Chemistry: Li/MnO2
Max output current: 5.5mA	Same battery type; run time of
subject device is lower than
predicate. Electrical safety and
performance testing demonstrates
difference does not
raise new questions of safety of
effectiveness.
Sterility	Sterile	Sterile	Same
Single Use or
Reusable	Single use	Single use	Same
Distal Shaft
Shape	Straight, cannulated	Curved or straight; or straight
(cannulated) with removable inner
starter stylet (optional) and
sensory needle	Same as 1 predicate model
Dimensions	Shaft Length: 200mm
Diameter of cutting edge: 4.0mm	Shaft Lengths: 120mm & 160mm
Outer Diameters: 4.0mm - 5.5mm	OD is within predicate range.
Performance and cadaver testing of
the subject device demonstrates
difference does not raise new
questions of safety of effectiveness.
Circuit Board	Capacitors, Resistors and Diodes

Firmware (programmable chip)
on circuit board | Capacitors, Resistors and Diodes
Firmware (programmable chip)
on circuit board | Same | |
| Anatomical
Site | Spine | Spine | Same | |
| Where used | Within a sterile field in an
operating room | Within a sterile field in an
operating room | Same | |

III. PREDICATE DEVICE(S)

The subject device is equivalent to the following devices:

K201454 DSG Connect Technology

IV. DEVICE DESCRIPTION:

The Waypoint GPS™ is comprised of a single use, disposable device and a software application that is downloaded onto the provided tablet. The system is intended to surgeons during pilot hole drilling for pedicle screw placement. Waypoint GPS™ probe is single use disposable and consists of a handle containing electronics and a stainless-steel shaft with distal LED and fiber optics for visualizing the tissues immediately in contact with the distal end of the probe. The device produces visual signals to indicate changes in color associated with possible verforation. It uses light to provide visual alerts to indicate a change in anatomical structure to prevent placement in soft tissues or vertebral cortex perforation.

v. INDICATION 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.

VI. SUBSTANTIAL EQUIVALENCE

The subject Waypoint GPS™ system is similar to the predicate in several ways. Both devices provide real- time feedback to the surgeon during the preparation of the pedicle screw pilot holes, alerting the tip of the sensor senses a change in the surrounding tissues. The subject and predicate devices have the same

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intended use and use environment with similar indication for use and user interface. Both the subject device and predicate are provided as sterile, battery operated, hand-held probes comprised of similar materials. Performance testing has demonstrated that the primary technical difference (use of electrical impedance verses spectral reflectance) raises no new issues of safety and effectiveness. Thus, the subject Waypoint GPS is substantially equivalent to the predicate PediGuard.

Table 1: Substantial Equivalence Review

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VII. PERFORMANCE DATA

Table 2 below lists all of the testing that has been performed on the Waypoint GPS System.

Table 2: Performance Test Summary

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Test	Test Method Summary	Results
Biocompatibility
Testing
Cytotoxicity Sensitization Intracutaneous
Reactivity Acute Systemic
Toxicity Material Mediated
Pyrogenicity	FDA Guidance “Use of International Standard
ISO 10993, 'Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing and
ISO 10993-1, Biological Evaluation of medical
Devices Part 1: Evaluation and Testing within a
risk management process.
(ISO 10993-5, ISO 10993-10, 10993-11)	Passed. Non-cytotoxic, non-sensitizing, non-
irritating, non-toxic, non-pyrogenic.
This test is relevant in determining
substantial equivalence because it
demonstrates any material differences
between the subject device and the predicate
do not raise new questions of safety.
Insertion Force	Device shafts and finished devices were tested
to demonstrate that it can complete a minimum
of 15 insertions into Sawbones at a specified
depth without mechanical failure similar to a
standard bone awl.	Passed. Each shaft was able to successfully
complete 15x insertions without mechanical
failure. This test is relevant in determining
substantial equivalence because it
demonstrates the subject device can create
multiple pilot holes during one clinical
procedure and perform as a bone awl.
Torque on the shaft	Device shafts and finished devices were
subjected to 15x torque on the shaft cycles.
This was done to demonstrate that the device
can ultimately function as a standard bone awl.
Testing was performed with the tip of the shaft
being at a specified depth in Sawbones and a
torsion machine was used to apply force. Each
device was tested repeatedly 15 times.	Passed. Each shaft was able to successfully
withstand 15x torque on a shaft cycle without
mechanical failure. This test is relevant in
determining substantial equivalence because
it demonstrates the subject device can
reliably create multiple pilot holes during
one clinical procedure and perform as a bone
awl.
Torque on the shaft	Torque to failure testing was performed on
device shafts. This testing was performed by
holding both ends of the device using vices and
then rotating the proximal end using a torsion
machine.	Passed. Each shaft was able to successfully
withstand the target torque. This test is
relevant in determining substantial
equivalence because it demonstrates the
subject device shaft can reliably be used in
creating multiple pilot holes during one
clinical procedure as a bone awl.
Simulated Use Testing	Complete devices were tested for pairing of
device with tablet, color calibration, color
testing, and battery monitoring. Each device
was tested 2 times before and after being
subjected to Insertion Force and Torque on the
shaft.	Passed. Each device was able to successfully
complete each of the procedure steps
required for intended use. This test is
relevant to determining substantial
equivalence because it demonstrates that the
WayPoint GPS System (device and tablet)
reliably performs as intended under worst
case conditions. The reliability of the device
communication and pairing to the tablet
supports substantial equivalence of the
proposed device to the predicate device with
tablet communication feature.
Visualization and color	Complete devices were tested for visualization
and color. This testing included monitoring the
tablet screen to see if RGB value and the color
changed as probe contacts with different colors
and recording RGB values for each color card
used.	Passed. Each device was able to successfully
complete the test cycle and display correct
colors and RGB values. This test is relevant
in determining substantial equivalence
because it demonstrates the device output
(change in color) is reliably achieved, similar
to the change in sound of the predicate
device
Test	Test Method Summary	Results
Electrical Safety and
electromagnetic
compatibility (EMC)	Testing was conducted in compliance with the
IEC 60601-1 standard for safety and IEC
60601-1-2 standard for EMC.	Passed. This test is relevant in determining
substantial equivalence because the subject
device and predicate device both contain
electrical components in their the device
design.
Software Verification
and Validation Testing	Testing was conducted as recommended by
FDA's "Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices." For moderate level of
concern software	Passed. This test is relevant in determining
substantial equivalence because the subject
device and predicate device both contain
software in the device design.
Sterilization Validation	Testing was conducted in accordance with ISO
11135-1:2014 - Sterilization of Healthcare
Products – Ethylene Oxide: Requirements for
development, validation, and routine control of
a sterilization process for medical devices. The
Overkill test method was used.	Passed. This test is relevant in determining
substantial equivalence because the subject
device and predicate device are both
terminally sterilized products.
Distribution and Aging	Devices and the package system were subjected
to climactic conditioning, accelerated aging,
and package performance testing as outlined in
ASTM D4169-22 using Distribution Cycle 13.
Individual pouches were then subjected to
gross leak detection (bubble) per ASTM
F2096-11, and seal strength (peel) testing per
ASTM F88/F88M-21.	Passed. Insertion force, torque, simulated
use, visualization, and color testing were all
performed on unaged and aged devices
demonstrating sterile barrier packaging and
device performance reliability over time.
This test is relevant in determining
substantial equivalence because both devices
are terminally sterilized and required to
reliably perform as intended through stated
expiration date.
Cadaver study	Multiple users performed device set up,
calibration, pilot hole creation, and
interpretation of tablet display results per the
Instructions for use. Each user performed the
procedure in a modified sawbone that included
different colors, and a cadaver.	Passed. This test is relevant to determining
substantial equivalence because it
demonstrates users can perform the device
procedure and correctly interpret the device
output in the same procedure and intended
use and the predicate.
GLP Animal Study	In vivo performance testing. Multiple users
performed pilot hole procedures in ovine
lumbar vertebrae using the GPS device and the
predicate PediGuard device. Each pilot hole
was planned for a specific depth (cortical bone,
cancellous bone, or breach of cortical bone).
Fluoroscopic CT was used to verify pilot hole
depth, GPS, and PediGuard results. Additional
procedures were performed in the transverse
processes using GPS with direct visualization
confirmation. Users reported the device tip
location for both the subject device (color
description) and predicate device (auditory
description) locations. Data output was also
recorded for each device procedure. The side-
by-side comparison data was powered to

90%. | Passed. Users correctly identified GPS
device tip location in all procedures (100%).
Users successfully distinguished between
cortical bone, cancellous bone, and a breach
by the change in color and change in red,
green, blue (RGB) values displayed on the
table.
Users correctly identified PediGuard tip
location in most procedures (95%). Users
were able to distinguish between cortical
bone, cancellous bond, and breach by the
change in cadence and pitch the predicate
device emitted.
The results demonstrated with statistical
significance (0.050) that the subject device
(WayPoint GPS System) is non-inferior to
the predicate PediGuard device.
The total number GPS procedures (including
transverse processes) demonstrated the
device performs as intended and users
adequately interpret results with 95/95. |
| Test | Test Method Summary | Results |
| GLP Animal Study
(continued) | | This study is relevant in determining the
substantial equivalence of the subject device
because it provides in vivo objective
evidence that the technical differences
between the subject device and the predicate
do not affect the intended use. Further the
side-by-side in vivo testing demonstrates that
user interpretation of the subject device is
equivalent to the predicate device. |

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CONCLUSIONS VIII.

Waypoint Orthopedics considers the Guided Pedicle System™ (GPS) to be substantially equivalent to the predicate device listed above. This conclusion is based upon the devices' similarities in intended use, indication for use, anatomical sites, principles of operation, and materials. As confirmed through bench testing the Waypoint GPS™ is as safe and effective for its intended purpose as the predicate device.