Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on optoelectronic motion capture and 3D reconstruction, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
The device is described as a system for motion analysis for recording and analyzing human movement patterns, not for providing therapy.

Diagnostic

No

The device is described as a system for motion analysis for recording and analyzing human movement patterns, primarily for rehabilitation, sports medicine, and ergonomics. It doesn't mention diagnosing diseases or conditions, but rather analyzing movement.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is based on optoelectronic technology and uses passive reflective markers, infrared cameras, and strobes, indicating significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SMART-D device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics." This involves analyzing physical movement, not biological samples or substances from the body.
Device Description: The device uses optoelectronic technology and reflective markers to track and analyze external body movement. It does not interact with or analyze biological samples.
Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. The SMART-D does not perform any of these functions.

The SMART-D is a motion analysis system, which falls under a different category of medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SMART-D is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics.

Product codes (comma separated list FDA assigned to the subject device)

LXJ

Device Description

SMART-D is a motion capture and analysis system. It is based on optoelectronic technology and uses passive reflective markers, infrared cameras and strobes.

SMART-D executes the three-dimensional reconstruction of trajectories of a certain number of small reflective markers on the body to be analyzed.

Using a set of cameras placed all around the volume where the action is performed, the system acquires the movement of the subject; cameras position is computed after a calibration step.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

optical (optoelectronic technology)

Anatomical Site

human movement

Indicated Patient Age Range

All population

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The non-clinical tests performed on the SMART-D System provided in Appendix 4, demonstrate that the SMART-D System is as effective and performs as the predicate devices. The acceptance criteria for each test item included the appropriate device specification or expected operation results. All acceptance criteria were met in the testing and the overall performance bench testing concluded that the SMART-D system had passed all the performance requirements defined by the System Requirement Specifications (provided in Appendix 2). The effectiveness and performance of the system are tested through the subtest: SMART capture, SMART tracker, SMART analyser, SMART clinic.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030714, K033514

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.5360 Measuring exercise equipment.

(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Summary

0

510(k) NOTIFICATION

APR 1 7 2014

1 Summary of safety and effectiveness

Company Name:	BTS SPA
Company Address:	Via della Croce Rossa 11, PD Italy 35129
Company Phone:	+39 049 981 5520
Company Fax:	+39 049 792 9260

Contact Person:	Mr. Enrico Bisson
Title:	Quality and Regulatory Affairs Consultant
Email:	enrico.bisson@isoplan.org
Company Phone:	+39 049 981 5520
Company Fax:	+39 049 792 9260

April 17th 2014

Date Summary Prepared:

Device Identification

A.	Generic Device Name:	System, optical position/movement recording
B.	Trade/Proprietary Name:	SMART-D
C.	Classification:	Unclassified
D.	Product Code:	LXJ

Device description

SMART-D is a motion capture and analysis system. It is based on optoelectronic technology and uses passive reflective markers, infrared cameras and strobes.

SMART-D executes the three-dimensional reconstruction of trajectories of a certain number of small reflective markers on the body to be analyzed.

Using a set of cameras placed all around the volume where the action is performed, the system acquires the movement of the subject; cameras position is computed after a calibration step.

Intended Use

SMART-D is a system for motion analysis, intended for the recording and analysis of human movement patterns in the fields of rehabilitation, sports medicine, ergonomics.

1

510(k) NOTIFICATION

BTS Spa

Substantial equivalents

The SMART-D device is of comparable type and is substantially equivalent to the following predicate devices:

Predicate Device	510(K) Holder	510(k) No.
PEAK MOTUS	PEAK PERFORMANCE
TECHNOLOGIES, INC	K030714	16 May 2003
CODA CX1 MOTION
ANALYSIS SYSTEM	CHARNWOOD DYNAMICS
LTD.	K033514	6 Jan 2004

In further support of a substantial equivalence determination, Section 12 provides a comparison chart of SMART-D and the predicate devices.

Technological characteristics

A comparison of the technological characteristics of SMART-D and the predicate devices has been performed. The results of this comparison demonstrate that the system for motion analysis SMART-D is equivalent to the marketed predicate devices.

The two tables below show the comparison of technical characteristics of SMART-D system compared to the characteristics of predicate devices:

Table 1 contains the summary of the technical characteristics which are the same for both devices; ー
Table 2 contains the summary of the different technical characteristics and provides an explanation of how they are comparable to the predicate device.

Table 1 - Same Technical Characteristics
Characteristics	SMART-D System	PEAK MOTUS	CODA CX1 MOTION
ANALYSIS SYSTEM
CFR Section	Unclassified	Unclassified	Unclassified
Pro-code	LXJ	LXJ	LXJ
Classification name	System, optical position/movement
recording	System, optical position/movement
recording	System, optical position/movement
recording
Intended / Indications
For Use	SMART-D is a system for
motion analysis,
intended for the
recording and analysis of
human movement
patterns in the fields of
rehabilitation, sports
medicine, ergonomics.	Computer and video
system used to quantify
and graphically display
human movement
patterns and techniques
for uses such as
assessment and training
of limb or body motion
in gait analysis,
prosthetic design,
pre/post rehabilitation
evaluation, physical
therapy, and the like.	The Coda CX I Motion
Analysis System has
general application to
measurement and
recording of 3D position
and movement,
including human
movement. It is
appropriate for use in
assessment of the 3D
motion of the limbs and
body of patients who
have some impairment
			of movement functions
of either a neurological
or orthopaedic cause.
System Components	Workstation + Cameras

Software | Workstation + Cameras
Software | Workstation + Cameras
Software |
| Software tools | SMARTcapture,
SMARTtracker,
SMARTanalyzer,
SMARTclinic to achieve:
a) Real-time
visualization of signals of
all integrated devices'
b) 3D kinematics
reconstruction
Validated by
international scientific
community protocols
c) Tool for easy
construction of analysis
protocols
d) Multimedia
customizable and web
reporting | Vicon Motus
a) Advanced video or
3D-optical-motion-
capture module
b) 2D and/or 3D
kinematic calculation and
display software
Analog acquisition
module
c) 3D pan and tilt
module
KineCalc mathematical
analysis module
d) Peak Motus Gait
Analysis Template | a) Realtime displays to
verify marker location
Fully labelled data
appears immediately
after acquisition from
Codamotion active
marker system
b) Switch between
different projects in
seconds
Options for simultaneous
EMG and Force Vector
Overlay
Full standardised gait
analysis package
available
c) Graphs and stick
figure displays
Highly configurable
analysis setups |
| Contraindications | Not needed | Not needed | Not needed |
| Target population | All population | All population | All population |
| Electrical Safety | AAMI/ANSI ES60601-
1:2005 and further
amendments | SAME | SAME |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Power Supply | 110 V, 60 Hz | 110 V, 60 Hz | 110 V, 60 Hz |
| Frame rate | 200 fps | VCam/SV Cam
200 fps | Not available |
| Acquisition
Frequencies | 250 Hz (up to 500 Hz) | up to 250 Hz progressive
up to 500 Hz progressive
up to 1000 Hz
progressive | Sampling Rates vs.
Marker Numbers
100Hz for 56 markers
400Hz for 12 markers |
| Light emission | Infrared | Infrared | Not available |
| Characteristics | SMART-D System | PEAK MOTUS | CODA CX1 MOTION ANALYSIS SYSTEM |
| Max Input power | 950 W | 15-20 W for single unit | Not available |
| Number of cameras | Up to 16 digital TVC | up to 12 cameras on one PC | Up to 16 digital inputs |
| Resolution (pixel) | 800 H x 600 V | MCam-2 59.94: 1272 H x 1024 V
MCam-2 100: 1266 H x 1024 V
MCam-2 119.88: 1266 H x 940 V
MCam-2 250: 816 H x 656 V
MCam-2 500: 498 H x 480 V
MCam-2 1000: 498 H x 210 V
VCam/SV Cam : 648 H x 493 V
MCam (PAL): 1011 H x 1024 V
1000 H x 972 V
MCam (NTSC): 1012 H x 987 V
947 H x 881 V
All Vicon MX cameras are built for speed at their full frame resolutions - 370fps for the 4 Megapixel F40, 240fps for the MX-3+ and a massive 500fps for the 2 Megapixel F20. On top of this all | 1/10th of pixel in a 5 Megapixel camera |

2

Confidential

.

·

.

3

Confidential

Section5 Rev 4

4

| run at speeds up to
2000fps at reduced,
windowed resolutions
particularly high

i for a
speed applications

The Resolution (pixels) does not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.

The only effect that this characteristic produces is a better or worse capability to detect the markers in the space and displaying them on the video.

up to progressive	120Hz	Sampling Rates vs. Marker Numbers
up to progressive	250 Hz	100Hz for 56 markers
up to progressive	500 Hz	200Hz for 28 markers
up to progressive	1000 Hz	400Hz for 12 markers
		800 Hz for 6 markers

The Acquisition frequency does not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.

The only effect that this characteristic produces is a different quantity of data in the time (frames in the time) to reconstruct the trajectory of the markers in the space.

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The weight of workstation does not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.

The three devices are not portable, so the weight does not influence their use and application.

------------	------------------------------------------	--------------------------------------------------	----------------------------------------

The Dimensions of workstation do not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as it does not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.

The three devices are not portable, so the dimensions do not influence their use and application. Moreover the difference of dimensions between the three workstations is negligible respect to the environment in which they have to be placed.

| Sensor
Technical
Characteristics | Wave
length: | 880 nm | Not available | Not available |
|----------------------------------------|-----------------|------------------------------------------------------------------------------------------|---------------|---------------|
| | Output
angle | 40° | Not available | Not available |
| | Modulation | Square
wave
synchronized with the
acquisition frequency,
Duty Cycle 0+0.5 ms | Not available | Not available |
| Lens | | C-mount compatible
(std. 8 mm) | Not available | Not available |

5

The Lenses and Sensor technical characteristics do not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as they do not influence the intended use, the performance, the safety and effectiveness of the system than the predicate devices.

The difference brouqht by those differences is in the quality of the image provided to the system.

| Options | None | SAME | Tripod Mount for cx1
units |
|---------|------|------|---------------------------------------------------------------|
| | | | Gait Wand Set |
| | | | Wired Strobe Adapter
unit and Drive Box
Extension Cable |
| | | | External Strobe Panel
for Active Hub or Mini
Hub |

The options do not bring a point of non-substantial equivalence between the SMART-D System and the predicate devices, as they do not influence the intended use, the safety and effectiveness of the system than the predicate devices.

Options are optional configurations or accessories to the main system which are not needed for its normal functioning and do not influence it.

Performance Data

The performance data indicate that the system for motion analysis SMART-D meets all specified requirements, and is substantially equivalent to the predicate device.

Conclusions

The non-clinical tests performed on the SMART-D System provided in Appendix 4, demonstrate that the SMART-D System is as effective and performs as the predicate devices. The acceptance criteria for each test item included the appropriate device specification or expected operation results. All acceptance criteria were met in the testing and the overall performance bench testing concluded that the SMART-D system had passed all the performance requirements defined by the System Requirement Specifications (provided in Appendix 2). The effectiveness and performance of the system are tested through the subtest: SMART capture, SMART tracker, SMART analyser, SMART clinic, which verify the same functionalities of the predicate devices as described in the comparison below:

| Functionality | SMART-D System | PEAK MOTUS | CODA CX1 MOTION
ANALYSIS SYSTEM |
|----------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibration and Signals
acquisition | SMARTcapture: a) Real-
time visualization of
signals of all integrated
devices | Vicon Motus
a) Advanced video or
3D-optical-motion-
capture module
Analog acquisition
module | a) Realtime displays to
verify marker location
Fully labelled data
appears immediately
after acquisition from
Codamotion active
marker system |
| Trajectory
reconstruction, signal | SMARTtracker: b) 3D | b) 2D and/or 3D | b) Switch between |

6

510(k) NOTIFICATION

| elaboration | kinematics
reconstruction
Validated by
international scientific
community protocols | kinematic calculation and
display software | different projects in
seconds
Options for simultaneous
EMG and Force Vector
Overlay
Full standardised gait
analysis package
available |
|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Management of
acquired data,
customizable analysis
protocols | SMARTanalyzer: c) Tool
for easy construction of
analysis protocols | c) 3D pan and tilt
module
KineCalc mathematical
analysis module | c) Graphs and stick
figure displays
Highly configurable
analysis setups |
| Report drafting, data
visualization | SMARTclinic: d)
Multimedia customizable
and web reporting | d) Peak Motus Gait
Analysis Template | |

The EMC and Electrical Safety Tests performed on the SMART-D System and the predicate devices are the same and demonstrate that the SMART-D System complies with the AAMI/ANSI ES60601-1:2005 and further amendments and IEC 60601-1-2, and that it is as safe, as effective and performs as well as the predicate devices.

7

Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 17, 2014

BTS Spa c/o Enrico Bisson ISO plan Via Della Croce Rossa. I I Padova, Italy. 35129

Re: K131660 Trade/Device Name: SMART-D Regulatory Class: Unclassified Product Code: 1_XJ Dated: March 12, 2014 Received: March 18, 2014

Dear Mr. Bisson:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.

8

Page 2 - Enrico Bisson

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/ResourcesforYou/Industry/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/Safety/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,

Felipe Aguel -S

Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

9

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K131660

Device Name

SMART-D

Indications for Use (Describe)

SMART-D is a system for motion analysis, intended for the recording and analysis of human movement in the fields of rehabilitation, sports medicine, ergonomics.

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

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Date: 2014.04.17 13:35:53 -04'00'

FORM FDA 3881 (1/14)

10

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