Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on image display, tracking, and localization using optical tracking, with no mention of AI or ML for image analysis, decision support, or other functions.

Therapeutic

No.
The device is a computer workstation that helps surgeons track instruments and visualize patient anatomy during surgery; it does not directly treat or diagnose a disease.

Diagnostic

No

The device is described as a computer workstation that displays patient-specific images, tracks surgical instruments, and assists with surgical procedures. Its purpose is "planning and intraoperative guidance" and helping the surgeon perform interventions with precision. It does not perform diagnosis or disease detection.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the NAV3i Platform consists of a mobile cart, a computer system, a monitor, and a Navigation Camera, which are all hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the NAV3i Platform is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
NAV3i Platform's Function: The NAV3i Platform is a surgical navigation system. Its purpose is to track surgical instruments in relation to a patient's anatomy using imaging data (CT, microscope images) and anatomical landmarks. It provides guidance during a surgical procedure.
No Specimen Analysis: The description clearly states the device displays patient-specific images and tracks instruments in relation to the patient's body. There is no mention of analyzing biological specimens.

Therefore, the NAV3i Platform falls under the category of a surgical guidance or navigation system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Product codes

HAW, OLO

Device Description

The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k).

The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized.

The NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user.

There are two reasons for the traditional 510(k) submission. Firstly, it is intended to "unbundle" the clearance of the platform from the Stryker Navigation System as a whole. The predicate device submission included the platform as a component of the Stryker Navigation System -ENT Module. Secondly, some design modifications have been introduced to increase the user's comfort, to provide a more modern industrial design and to offer state-of-the-art technology for computer interfaces and components.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT images or microscope images

Anatomical Site

target anatomical site on a patient

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Non-clinical Testing:

User Need Validation: Scope of the test is to validate the Indications For Use and the user needs of the NAV3i Platform under simulated use case situations. Result: Validation successful, all user needs met.
Human Factors Engineering (HFE): This test is conducted to validate the NAV3i Platform with respect to use errors following the FDA guidance paper Draft Guidance for Industry and Food and Drug Administration Staff. Applying Human Factors and Usability Engineering to Optimize Medical Device Design. Result: Validation successful, device safe and effective with respect to use errors.
Safety Test regarding risk analysis: Implementation and effectiveness of all risk control measures specified in the NAV3i Platform risk analysis are tested and verified. Result: Risk Control measures are effective and mitigate the associated risks.
Product Safety Test regarding medical electrical equipment: Compliance with AAMI/ANSI ES60601-1:2005/A1:2012 for medical electrical equipment is tested. Part 1: General requirements for basic safety and essential performance Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. Result: Compliance with standards' requirements demonstrated, no deviations.
Accuracy Test: The Stryker Navigation System's accuracy is tested using the NAV3i Platform, a Stryker Navigation Software Application, Smart Instruments and Accessories following the ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Result: All accuracy specifications met with statistical significance.
Integration Tests with Stryker Navigation Software Applications: The NAV3i Platform is restricted to operation with Stryker Navigation Software Application Modules only. To demonstrate compatibility of the NAV3i Platform with existing Application Modules, integration tests have been performed. The integration of SpineMap 3D Navigation, OrthoMap 3D
Navigation, Versatile Hip Navigation, Express Knee Navigation, Precision Knee Navigation, Fluoro Navigation, FluoroMap Navigation and CranialMap Navigation Software Application Modules has been tested with the NAV3i Platform according to Design Input requirements under simulated clinical use conditions. Result: All Application Modules meet specifications on NAV3i Platform as on previous platforms.
Startup Reliability: Tested NAV3i Platform start up reliability over lifetime including Stryker Navigation Software Application Modules across multiple usages. The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods. Result: Device electronically reliable over the specified lifetime.
Robustness for every day use: Tested NAV3i Platform robustness by simulating transport inside hospital and intraoperative use over lifetime. The number of test samples and test runs required to simulate reliability over lifetime was defined using statistical methods. Result: Device mechanically robust over the specified lifetime.
Shipment Test: Test of shipment conditions of the NAV3i Platform in transport cases was performed according to ASTM D 4169-09. Result: Device fully functional after shipment.

No clinical testing has been conducted.

Key Metrics

Accuracy: All accuracy specifications met with statistical significance.

Predicate Device(s)

K002732

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

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

Summary

0

K130874

stryker®

Navigation

SEP 2 7 2013

510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

Applicant Name:	Stryker Leibinger GmbH & Co. KG - Navigation
	Boetzinger Strasse 41
	D-79111 Freiburg, Germany
	Phone number: +49-761-4512117
	Fax number: +49-761-451249117
Registration No.:	3007582679
Name of Contact Person:	Lilian Eckert
	lilian.eckert@stryker.com
Date prepared:	24 September 2013

2. Device Name

Trade Name:	Stryker NAV3i Platform
Common Name:	Navigation System Platform
Classification
Name:	Product Code	Device	Regulation
Number	Class	Review Panel
	Primary Code:
HAW	Neurologic
stereotaxic
instrument	21 CFR
§882.4560	II	Neurology
	Secondary
Code:
OLO	Orthopedic
stereotaxic
instrument	21 CFR
§882.4560	II	Orthopedic

1

3. Legally Marketed Predicate Device

The legally marketed predicate device is the Cart I Platform (trade name: Stryker Navigation Cart) as cleared in K002732 Stryker Navigation System - ENT Module.

510(k) Number	Product Code Trade Name		Manufacturer
K002732	HAW	Stryker Navigation Cart	Stryker Leibinger GmbH &
Co. KG
Boetzinger Strasse 41
D-79111 Freiburg,
Germany

4. Device Description

The Stryker NAV3i Platform is a modular component of the Stryker Navigation System and is intended to run Stryker Navigation surgical software for surgical procedures using stereotactic techniques. The surgical navigation software used on this device is cleared as a separate 510(k).

The Stryker Navigation System is a planning and intraoperative guidance system which assists in various surgical procedures. It allows for the localization of surgical instruments and visualization of their position relative to patient specific images and/or patient specific anatomical landmark information assisting the surgeon in performing the intervention at a high level of precision. For localization, active optical tracking based on infrared light is used. Using three linear sensors, the Navigation Camera detects signals from infrared light emitting diodes which are attached to the instruments to be localized.

The NAV3i Platform consists of a mobile cart, a computer system, a monitor and a Navigation Camera. During surgery, the placed close to the operating room table but not within the sterile field. Articulated arms allow for the alignment of the Navigation Camera and the monitor to the operative field. The NAV3i Platform features for entering medical images such as CT images or microscope images which are required for navigation. The computer is used to install and run Stryker Navigation Software. while the monitor conveys navigation information to the user.

There are two reasons for the traditional 510(k) submission. Firstly, it is intended to "unbundle" the clearance of the platform from the Stryker Navigation System as a whole. The predicate device submission included the platform as a component of the Stryker Navigation System -ENT Module. Secondly, some design modifications have been introduced to increase the user's comfort, to provide a more modern industrial design and to offer state-of-the-art technology for computer interfaces and components.

2

5. Indications for Use

The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

6. Substantial Equivalence Comparison

The indications for use of the subject device Stryker NAV3i Platform are equivalent to the predicate device Cart I Platform for the Stryker Navigation System. Furthermore, the technological characteristics of the modified NAV3i Platform are substantially equivalent to the original Cart I Platform. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the NAV3i Platform is substantially equivalent to the predicate device.

The following table gives an overview of the substantial equivalence reflecting all modifications being made between the predicate device and the subject device.

Topic	Predicate Device	Subject Device	Equivalence assessment
LiveCam (USB
Video Camera)	LiveCam was not offered.	Built-in LiveCam allows for
easy positioning of the
Navigation Camera.	Equivalent:
This feature did not exist in
the predicate device but
does not alter the operating
principle nor is it affecting
the essential performance.
Monitor	The main monitor used by
the surgeon:
18 inch flat screen monitor
mounted on an articulated
arm.	The main monitor used by
the surgeon:
32 inch flat screen monitor
mounted on an articulated
arm.	Equivalent:
Changes do not affect the
technology or the operating
principle of the platform.
IO-Tablet	Contained mouse and
keyboard.	Mouse and touch screen
monitor with implemented
keyboard functionality are
integrated in the IO-Tablet,
IO-Tablet doubles as
operator's monitor for the
OR staff.	Equivalent:
Ergonomic improvements
by intuitive touch
functionality and state-of-
the-art technology for a
data input device do not
change the performance
specification.
Topic	Predicate Device	Subject Device	Equivalence assessment
Computer	Windows PC based on
Intel architecture.
Configured Windows NT
operating system.	Windows PC based on
Intel state of the art
architecture. Configured
Windows XP operating
system.	Equivalent:
Performance specification
changes due to additional
state of the art PC
interfaces and a new
version of the operating
system.
RFID Card
Reader for
licensing and
logistic reasons	Not existing.	RFID Card Reader for
single case licensing
integrated in the IO-Tablet.	Equivalent:
The addition of the RFID
Card Reader does not add
any performance features
and has no effect on the
essential performance of
the NAV3i Platform.
Network
connectivity	Connection type: Standard
Ethernet connection and
modem connection.	Connection type: Standard
Ethernet connection and
WLAN connection.	Equivalent:
The extended network
connectivity does not add
any performance features
in regards to the
indications for use of the
NAV3i Platform.
Remote
Service
Connectivity	Remote service access by
Virtual Network Computing
(VNC) remote desktop
service over network or
modem connection.	Remote service access is
offered by a remote access
client over Ethernet or
WLAN.	Equivalent:
This represents the same
technology for the remote
service access.
Navigation
Camera	Active optical
measurement system
localizing infrared light
emitting diodes (LED)
using three linear sensors
and a working space of
1.00 meter in diameter.
The system is
encapsulated in two
separate housings: the
camera and the localizer
computer.	Active optical
measurement system
localizing infrared light
emitting diodes (LED)
using three linear sensors
and a working space of
1.25 meter in diameter.
The system is
encapsulated in one
housing and is called
Navigation Camera.	Equivalent:
The modified design of the
Navigation Camera does
not impact the operating
principle, control
mechanism, technology or
energy source. Therefore,
the change does not affect
the essential performance
of the NAV3i Platform.
Topic	Predicate Device	Subject Device	Equivalence assessment
Power Supply	External power source:
AC Power supply, 120V,
50/60Hz including off-the-
shelf uninterruptible power
supply (UPS) for power
interruptions less than or
equal to 10 minutes.	External power source:
AC Power supply,
100/240V, 50/60Hz.
including off-the-shelf
uninterruptible power
supply (UPS) for power
interruptions less than or
equal to 6 minutes.	Equivalent:
The time difference does
not alter the operating
principle and does not
raise new safety or
effectiveness issues.
Articulated
arms	Weight balanced
articulated arms have the
monitor and localization
camera mounted.
Approximately 1000 mm
arms with three joints for
camera and monitor
movement are offered.	Same mechanical principal
of spring arms with the
same degrees of freedom.
Change in arm lengths:
monitor arm length is about
900 mm, Navigation
Camera arm length is
about 1300 mm.	Equivalent:
Improved ergonomics for
alignment and handling of
the Navigation Camera and
monitor in the OR space.
The operating principle of
the Platform is not affected.
Cart Housing	The Cart I Platform is
equipped with 4 castors
with brakes. The cart
housing contains the
computer, the computer
interfaces as well as the
two articulated arms
carrying the camera and
the monitor.	The NAV3i Platform is
equipped with 4 castors
with brakes and additional
cable guards. The cart
housing contains the
computer, the computer
interfaces as well as the
two articulated arms
carrying the Navigation
Camera and the monitor.	Equivalent:
The industrial design is
changed but the
mechanical structure and
functioning is similar. The
performance of the
platform is not changed
and no new safety and
effectiveness issues are
raised.
Dimensional
Specifications	Outer dimensions:
Length x Width x Height:
762 x 762 x 1880 mm
Weight: 249.5 kg	Outer dimensions:
Length x Width x Height:
960 x 720 x 1920 mm
Weight: 250 kg	Equivalent:
Only slight modifications
which do not impact the
performance of the Stryker
Navigation Platform and do
not raise new safety and
effectiveness issues.

Table 1

3

:

.

1

.

4

.

5

The following table gives an overview of all design features which remain the same between the predicate device and the subject device.

Table 2

Design features which remain the same
Control
mechanism	The Platform is controlled by a standard PC interface including mouse and keyboard
input functions and a display. In addition, the Stryker Navigation Application
Software can be remotely controlled by Stryker Smart Instruments over an infrared
communication interface. During surgery, the software is controlled via Stryker
Smart Instruments.
Operating
principle	The Platform runs Stryker Navigation Application Software on a Windows PC based
system. For patient data import and export, the Platform provides standard state-of-
the-art storage media and network interfaces. For video import the system provides
a standard state-of-the-art video interface to capture live video. The Platform offers
an active optical localization device, i.e. the Navigation Camera. The Navigation
Camera allows three-dimensional localization of the Stryker Smart Instruments
which are equipped with LEDs by detecting the position of the light center of each
infrared LED.
Movability	The Platform is equipped with four castors and is movable within a hospital.
General design	Both devices have articulated arms to carry the monitor and the camera and have a
housing body to carry a Windows-based computer.
Microscope
data interface	Both platform models encompass a microscope data interface.

The modifications do not alter the basic technology, do not raise any new issues regarding safety and effectiveness and support substantial equivalence of the subject device.

6

7. Non-clinical Testing

Validation activities, including usability testing, have been conducted to provide assurance that the device meets the performance requirements under the indications for use conditions. In addition, verification tests, such as electrical safety acc. to IEC 60601-1, have been performed to show that the device is safe and effective. The following table contains a complete list of all tests performed to support substantial equivalence, gives a basic description of the test procedure in the column "Basic description" and the conclusion or results obtained from the test in the column "Conclusion/Result".

Test	Basic description	Conclusion/Result
User Need
Validation	Scope of the test is to validate the Indications For Use and the
user needs of the NAV3i Platform under simulated use case
situations.	Validation
successful, all user
needs met
Human
Factors
Engineering
(HFE)	This test is conducted to validate the NAV3i Platform with
respect to use errors following the FDA guidance paper Draft
Guidance for Industry and Food and Drug Administration Staff.
Applying Human Factors and Usability Engineering to Optimize
Medical Device Design.	Validation
successful, device
safe and effective
with respect to use
errors
Safety Test
regarding
risk analysis	Implementation and effectiveness of all risk control measures
specified in the NAV3i Platform risk analysis are tested and
verified.	Risk Control
measures are
effective and
mitigate the
associated risks
Product
Safety Test
regarding
medical
electrical
equipment	Compliance with AAMI/ANSI ES60601-1:2005/A1:2012 for
medical electrical equipment is tested.
Part 1: General requirements for basic safety and essential
performance
Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests	Compliance with
standards'
requirements
demonstrated, no
deviations
Accuracy
Test	The Stryker Navigation System's accuracy is tested using the
NAV3i Platform, a Stryker Navigation Software Application,
Smart Instruments and Accessories following the ASTM
F2554-10 Standard Practice for Measurement of Positional
Accuracy of Computer Assisted Surgical Systems.	All accuracy
specifications met
with statistical
significance

7

Test	Basic Description	Conclusion/ Result
Integration
Tests with
Stryker
Navigation
Software
Applications	The NAV3i Platform is restricted to operation with Stryker
Navigation Software Application Modules only. To demonstrate
compatibility of the NAV3i Platform with existing Application
Modules, integration tests have been performed. The
integration of SpineMap 3D Navigation, OrthoMap 3D
Navigation, Versatile Hip Navigation, Express Knee
Navigation, Precision Knee Navigation, Fluoro Navigation,
FluoroMap Navigation and CranialMap Navigation Software
Application Modules has been tested with the NAV3i Platform
according to Design Input requirements under simulated
clinical use conditions.	All Application
Modules meet
specifications on
NAV3i Platform as
on previous
platforms
Startup
Reliability	Tested NAV3i Platform start up reliability over lifetime including
Stryker Navigation Software Application Modules across
multiple usages. The number of test samples and test runs
required to simulate reliability over lifetime was defined using
statistical methods.	Device electronically
reliable over the
specified lifetime
Robustness
for every day
use	Tested NAV3i Platform robustness by simulating transport
inside hospital and intraoperative use over lifetime. The
number of test samples and test runs required to simulate
reliability over lifetime was defined using statistical methods.	Device mechanically
robust over the
specified lifetime
Shipment
Test	Test of shipment conditions of the NAV3i Platform in transport
cases was performed according to ASTM D 4169-09.	Device fully
functional after
shipment

All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence.

8. Clinical Testing

No clinical testing has been conducted.

9. Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the NAV3i Platform performs as safely and effectively as the legally marketed device identified in section 3. According to the comparison based on the requirements of 21 CFR 807.87 and the information provided herein, it is concluded that the NAV3i Platform is substantially equivalent to the predicate device with respect to its indications for use, technological characteristics and performance characteristics.

8

Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 27, 2013

Stryker Navigation Ms. Lilian Eckert Senior Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg. Baden-Wuerttemberg 79111 Germany

Rc: K130874

Trade/Device Name: NAV3i Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Neurologic Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, OLO Dated: August 26, 2013 Received: August 28. 2013

Dear Ms. Eckert:

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. Issing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 (sec above) into cither 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

9

Page 2 - Ms. Eckert

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

10

Indications for Use

510(k) Number (if known):

Device Name: Styker NAV3i Platform

Indications For Use:

The NAV3i Platform is a computer workstation that, when used with specific Stryker Navigation surgical software, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient.

The clinical setting and target population for the NAV3i Platform is that of a patient undergoing a surgical procedure using stereotactic techniques.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S
-------------------

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K130874 510(k) Number __

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