(153 days)
PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) (K150078)
No
The document does not mention AI, ML, or any related terms or concepts in the device description, intended use, or performance studies.
No
The device explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind." Its purpose is to "stimulate healthy muscles in order to improve or facilitate muscle performance." Therefore, it is not a therapeutic device.
No
The device description focuses on muscle stimulation for performance enhancement and explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind" and its use on "injured or ailing muscles is contraindicated." It does not mention any diagnostic capabilities.
No
The device description clearly lists hardware components (Katalyst Suit, Impulse Pack, accessories) in addition to the software application.
Based on the provided information, the Katalyst Mark 1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a system for delivering electrical impulses to muscles via electrodes worn on the body. This is consistent with a muscle stimulation device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a medical condition.
- Predicate Devices: The predicate devices listed (Compex® Sport Plus, E-Fit EF-1280) are also muscle stimulation devices, not IVDs.
Therefore, the Katalyst Mark 1 falls under the category of a muscle stimulation device, which is a type of physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
Product codes
NGX
Device Description
The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components:
Katalyst Suit: Worn by the client, the Katalyst Suit is a compression textile with embedded electrodes connected by a cable harness. When connected to the Impulse Pack it provides localized EMS impulses to major muscle groups at controllable intensities.
Impulse Pack: A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers electrical impulses through a battery powered regulated booster. The Impulse Pack is operator controlled wirelessly via the Katalyst Application over Bluetooth.
Katalyst Application: Controlled by the Operator, the Katalyst Application is run on a Microsoft Surface Pro 3 running Windows 10 Professional. It is used to configure and run a Katalyst training, including the setting of independent intensities for each muscle group channel.
Accessories included: cable harnesses and an Impulse Pack charging cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Katalyst Mark 1 is Rx only.
The Katalyst Mark 1 should only be operated by a certified Katalyst Operator.
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)
Non-Clinical Tests:
Biocompatibility Testing: Skin contacting electrodes pads have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP.
Software Verification and Validation: Impulse Pack firmware and Katalyst Application software documentation, consistent with a Moderate level of concern, is provided with this 510(k). System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level.
Electrical Safety and Electromagnetic Compatibility Testing: The Katalyst Suit and the Impulse Pack have been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards: IEC/EN 60601-1:2005 "Medical Electrical Equipment - Part 1: General Requirements for Safety" Edition 3.1, IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators." Edition 2.0, IEC/EN 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances. Edition 4.0.
Battery Testing: Lithium-Polymer battery, used in Impulse Pack was tested by battery manufacturer for compliance with IEC 62133 Edition 2.0.
Engineering Bench Testing: In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω, 2 kΩ and 10 kΩ. Also, several system validation testing scenarios covering mitigation of wireless risks in accordance with FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" were added to our full system testing protocol.
Conclusion: Test results demonstrate the Katalyst Mark 1 Muscle Stimulation System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Compex® Sport Plus (K083140), E-Fit EF-1280 (K133225)
Reference Device(s)
PowerDot Pd-01 Muscle Stimulator (with PowerDot Mobile Application) (K150078)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a stream.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2017
Katalyst Inc. Amish Patel Chief Product Officer 316 Occidental Avenue South B300 Seattle, Washington 98104
Re: K171035
Trade/Device Name: Katalyst Mark 1 Muscle Stimulation System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: August 1, 2017 Received: August 3, 2017
Dear Mr. Patel:
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.
1
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 devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for 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 Industry and Consumer Education (DICE) 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,
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171035
Device Name
Katalyst Mark 1 Muscle Stimulation System
Indications for Use (Describe)
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
| 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) |
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3
510(K) SUMMARY
This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1.1 Submitter
Katalyst Inc. 316 Occidental Avenue S. B300 Seattle, WA 98104
Contact: Amish Patel, Chief Product Officer Tel: 406-616-3671 Email: devices@katalyst-fitness.com
1.2 Date Prepared
September 6, 2017
1.3 Device Name and Classification Information:
Trade/Proprietary Name: Katalyst Mark 1 Muscle Stimulation System Common Name: Powered Muscle Stimulator for Muscle Conditioning Classification Name: Powered Muscle Stimulator Classification: 21 CFR 890.5850, Class II Product Code: NGX Panel: 89, Physical Medicine
1.4 Predicate Devices
Primary Predicate: Compex® Sport Plus (K083140)
Secondary Predicate: E-Fit EF-1280 (K133225)
1.5 Device Description
The Katalyst Mark 1 Muscle Stimulation System consists of the following three main components:
| Katalyst Suit | Worn by the client, the Katalyst Suit is a compression textile
with embedded electrodes connected by a cable harness. When
connected to the Impulse Pack it provides localized EMS
impulses to major muscle groups at controllable intensities. |
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
| Impulse Pack | A powered muscle stimulation device specifically designed to
mate with the Katalyst Suit through a single port connector. It
delivers electrical impulses through a battery powered regulated
booster. The Impulse Pack is operator controlled wirelessly via
the Katalyst Application over Bluetooth. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Katalyst
Application | Controlled by the Operator, the Katalyst Application is run on a
Microsoft Surface Pro 3 running Windows 10 Professional. It is
used to configure and run a Katalyst training, including the
setting of independent intensities for each muscle group channel. |
Accessories included: cable harnesses and an Impulse Pack charging cable.
1.6 Indications for Use:
The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only.
1.7 Contraindications
The Katalyst Mark 1 should only be operated by a certified Katalyst Operator. Trainings should not be used by anyone under 18 years of age, with a cardiac pacemaker, with known heart conditions, with a history of cardiac arrhythmia, who is pregnant, with an implanted defibrillator, or with other implanted metallic or electronic device. Such use could cause cardiac arrhythmia, electric shock, burns, electrical interference, or death. Other contraindications are provided in the operator guide.
1.8 Basic Device Characteristics - Comparison with Predicate Devices
| Characteristic | New Device
(Katalyst Mark 1
Muscle Stimulation
System) | Primary Predicate
Compex Sport Plus
(K083140) | Secondary
Predicate:
E-Fit EF-1280
(K133225) | Similar/
Different |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Device Name,
Model | Katalyst Mark 1 Muscle
Stimulation System | Compex Sport Plus
(currently marketed) | E-Fit EF-1280 | K083140 -
Different |
| Manufacturer | | as Compex Sport Elite) | | K133225 - Different
K083140 - Different |
| | Katalyst Inc. | DJO LLC | FIT PRO, LLC | K133225 - Different
K083140 - Similar
K133225 - Similar |
| Indications for Use | The Katalyst Mark 1 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.
The Katalyst Mark 1 is Rx only. | The Compex® Sport Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The Compex® Sport Plus is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Compex® Sport Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
The Compex® Sport Plus electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the | E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
The E-Fit EF-1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None | |
5
6
| | motor endplate
where they generate
mechanical muscle
fiber responses that
correspond to
muscle work.
Depending on the
parameters of the
electrical impulses
(pulse frequency,
duration of
contraction,
duration of rest,
total session
duration), different
types of muscle
work can be
imposed on the
stimulated muscles.
The various types of
muscle work that
the Compex® Sport
Plus can impose on
the stimulated
muscles are able to
improve or facilitate
muscle
performance.
The Compex®
Sport Plus may
therefore be
considered a
technique of muscle
training | of the E-Fit EF-
1280 training
programs is
designed for
injured or ailing
muscles and its
use on such
muscles is
contraindicated.
The E-Fit EF-
1280 electrical
impulses allow
the triggering of
action potentials
on
motoneurones of
motor nerves
(excitations).
These
excitations of
motoneurones
are transmitted
to the muscle
fibers via the
motor endplate
where they
generate
mechanical
muscle fiber
responses that
correspond to
muscle work.
Depending on
the parameters
of the electrical
impulses (pulse
frequency,
duration of
contraction,
duration of rest,
total session
duration),
different types
of muscle work |
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
7
| Connection of
device to
electrodes | The Katalyst Impulse
Pack unit is connected to
the electrodes via a cable
electrode harness. The
connection to the
Impulse Pack is via a
ROHS compliant
standard DB-25 Female
connector, and snapping
onto the electrodes using
standard 4mm SNAP
connectors integrated in
the electrodes
themselves. The SNAP
headers are combined
and over molded in the
lead cables. | With 6-pole cables
including female
custom SNAP
plugged on the
custom Compex
female SNAP
assembled in the
electrode. Entire
electronic circuit for
four (4) Stimulation
Channels and User
Interface is
combined into same
casing, connected to
the electrodes with
6-pole cables. | on the
stimulated
muscles.
The various
types of muscle
work that the E-
Fit EF-1280 can
impose on the
stimulated
muscles are able
to improve or
facilitate muscle
performance.
The E-Fit EF-
1280 may
therefore be
considered a
technique of
muscle training.
The EF-1280
unit is connected
to the electrodes
via a cable
electrode
harness which is
connected to the
EMS device
with a physical
connection. The
connection to
the EMS device
1s via a plastic
12pin
waterproof ip68
Connector and
the connection
to the electrodes
is via SNAP
connectors
directly onto the
outer vest and | K083140 -
Similar
K133225 -
Similar | | | | LED backlight.
The rotary
encoder allows
for a quick setup
and ease of use | Different
See section
1.10
Differences
below for
justification
of
differences |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Power
Source(s) | Li-Po Battery
3.8V, 7.79Wh | Rechargeable Ni-Mh
Battery 4.6V (4 cells | leg straps.
Lead Acid
Battery | K083140 -
Different | Per Channel
Control | Yes. Using Windows 10
control application | Yes, Using
integrated buttons. | Yes. Using
rotary encoder
knobs for each
channel. | K083140 -
Similar
K133225 -
Similar |
| | (2050mAh) | AA=R6) | | K133225 - | Electrode
Placement | Integrated into wearable
body suit and positioned
over corresponding
muscle group positions.
Cannot be
modified/altered. | Not defined.
Placement of
electrodes is
dictated by the
operator. | Placed into outer
layer,
appropriately
positioned over
corresponding
muscle group
positions.
Cannot be
modified/altered. | K083140 -
Different
K133225 -
Similar |
| | IEC 62133: 2012 (2nd
Edition) | | 12V, 3400mAH | Different | Electrode
Leads | 21 CFR 898 compliant. | 21 CFR 898
compliant. | 21 CFR 898
compliant. | K083140 -
Similar
K133225 -
Similar |
| Charging
System | AC/DC wall plug in,
distributed directly to the
device. 18.0[v], 1.33[A] | AC/DC 9[v] 0.4[A]
Distributed directly to
the device | AC/DC wall
plug in,
distributed
directly to the
device. | K083140 -
Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectivenes
s of the
device | Electrode
Interface | 4mm Standard SNAP
Connector. | 4mm Standard
SNAP Connector. | 4mm Standard
SNAP
Connector. | K083140 -
Similar
K133225 -
Similar |
| Waveform | Bipolar Square | Bipolar Square | Bipolar Square | K083140 -
Similar
K133225 -
Similar | Electrodes | Only 2 per channel; Max
20. | 2 per channel; Max
8. | 2 per channel;
Max 24. | K083140 -
Similar
K133225 -
Similar |
| Channels | 10 | 4 | 12 | K083140 -
Different
K133225 -
Similar | Transthoracic
stimulation | Yes | No | Yes | K083140 -
Different
K133225 -
Similar
electrode
placement
and safety
mitigations
as K133225 |
| Operation
Modes | 3 | 9 | 5+5 | K083140 -
Similar
K133225 -
Different | | | | | |
| Charging
Isolation | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar | | | | | |
| Rechargeable
Integrated
Battery | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar | | | | | |
| Display /
Control | Yes; (LCD Display on
Microsoft Surface Pro 3 | Yes, Integrated
(LCD) | LCD 2x40
character LCD | K083140 -
Different | | | | | |
8
9
10
| Communication
with Control
Interface | Bluetooth Smart (BT LE
4.0). | | | Different
K133225 -
Different
See section
1.10
Differences
below for
justification
of
differences |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Mobile / Form
Factor | Yes (tablet, handheld
device and wearable
suit). | Yes (pocket device
with travel case) | Portable with
difficulty, no
mobile device,
its intended use
requires the
qualified and
trained operator. | K083140 -
Similar
K133225 -
Similar |
| Channel
Control
Interface | Touch User Interface
provided by Katalyst
Application on Surface
Pro 3 PC | Physical Buttons
and Display on unit. | Using rotary
encoder knobs
for each channel
and master
rotary encoder
for all channels. | K083140 -
Different
K133225 -
Different
See section
1.10
Differences
below for
justification
of
differences |
| Instant Shutoff | Physical Button | Physical Button | Physical Button | K083140 -
Similar
K133225 -
Similar |
| Microprocessor
Controlled? | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| Automatic
overload trip? | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| Automatic No-
Load Trip? | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| Automatic
Shutoff? | On/Off Switch | On/Off Switch | On/Off Switch | K083140 -
Similar
K133225 -
Similar |
| Patient
Override
Control? | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| Interface
Indicators | On/Off - Yes (on
Impulse Pack via LED
and in application)
Low Battery - Yes (on
Impulse Pack)
Voltage/Current Level -
Yes (in application).
Charging - yes on
Impulse Pack.
Duration of training- yes
(in application) | On/Off - yes
Low Battery - yes
Voltage/Current
Level - yes
Charging - yes
Duration of training
training- yes. | On/Off - yes
Low Battery -
yes
Voltage/Current
Level - yes
Charging - yes
Duration of
training
training- yes. | K083140 -
Similar
K133225 -
Similar |
| Duration in
minutes | 40 (shown on display) | 55 | 30 minutes | K083140 -
Similar
K133225 -
Similar |
11
Table 10: Device Characteristic Comparisons
1.9 Output Specification - Comparison with Predicate Devices
| Characteristic | New Device
(Katalyst Mark 1
Muscle Stimulation
System) | Primary Predicate:
Compex Sport Plus
(K083140) | Secondary
Predicate: E-
Fit EF-1280
(K133225) | Similar/
Different |
|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Waveform | Symmetrical
Biphasic | Symmetrical
Biphasic | Symmetrical
Biphasic | K083140 -
Similar
K133225 - |
| | | | | Similar |
| Shape | Rectangular | Rectangular | Rectangular | K083140 -
Similar
K133225 -
Similar |
| Maximum Output
Voltage (+/- 10%) | 60 V @ 500 Ω
96 V @ 2 kΩ
114.2 V @ 10 kΩ | 60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | 36 V @ 500 Ω | K083140 -
Similar
K133225 -
Different |
| Maximum Output
Current (+/- 10%) | 120 mA @ 500 Ω
48 mA @ 2 kΩ
11 mA @ 10 kΩ | 120 mA @ 500 Ω
82 mA @ 2 kΩ
16 mA @ 10 kΩ | 72 mA @ 500 Ω | K083140 -
Similar
K133225 -
Different |
| Positive Pulse Width | 75µs or
175µs | 200 µs to 400 µs | 100µs to
500µs | K083140 -
Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectiveness
of the device |
| Negative Pulse Width | 75µs or
175µs | 200 µs to 400 µs | 100µs to
500µs | K083140 -
Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectiveness
of the device |
| Frequency | 85Hz or 100Hz | 1 to 120Hz | 5 to 120Hz | K083140 -
Similar
K133225 -
Different |
| For interferential
modes only: | No | No | No | K083140 -
Similar
K133225 -
Similar |
| | | | | |
| For multiphasic
waveforms only: | Yes | Yes | Yes | Similar
K133225 -
Similar |
| - Symmetrical
phases? | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| - Phase Duration
(include units)
(state range, if
applicable)
(both phases, if
asymmetrical) | 75µs Symmetrical or
175uSec
Symmetrical | 70-200µs
Symmetrical | 100 - 500µs
Symmetrical | K083140 -
Similar
K133225 -
Different |
| Net Charge
[µC/pulse] | $0.5 [\mu C] @ 500\Omega$
Excitation pulse fully
compensated | $0 [\mu C] @ 500\Omega$
Excitation pulse
fully compensated | $0 [\mu C] @ 500\Omega$
Excitation
pulse fully
compensated | K083140 -
Similar
K133225 -
Similar |
| Maximum Phase
Charge [µC] | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 -
Similar
K133225 -
Similar |
| Maximum Current
(RMS) Density
[mA/cm2] | $2.4mA/cm^2 @500\Omega$ | $1.49mA/cm^2 @ 500\Omega$ | $0.85mA/cm^2 @ 500\Omega$ | K083140 -
Different
K133225 -
Different
See section
1.10
Differences
below for
justification
of
differences |
| Maximum Power
Density [mW/cm2] | $5.04mW/cm^2 @ 500 \Omega$ | $27.6mW/cm^2 @500\Omega$ | $6.3mW/cm^2 @ 500 \Omega$ | K083140 -
Similar
K133225 -
Similar |
| Burst Mode
(i.e., pulse trains) | N/A | Unknown | Unknown | K083140 -
Unknown
K133225 - |
| c. Burst duration
(seconds) | | | | |
| d. Duty Cycle [Line
(b) x Line (c)] | | | | |
| ON Time (seconds) | 1 or 4, 1 second
intervals
(software adjustable
modes) | Not Adjustable | 0.1 to 60
seconds, 0.1
second
intervals
(adjustable
within range) | K083140 -
Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectiveness
of the device |
| OFF Time (seconds) | 1 or 4, 1 second
intervals
(software adjustable
modes) | Not Adjustable | 0.1 to 60
seconds, 0.1
second
intervals
(adjustable
within range) | K083140 -
Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectiveness
of the device |
| Treatment Training
Time | 1-40 minutes, 1-
minute intervals
(software adjustable
within range) | Not Adjustable | 1-30 minutes,
1-minute
intervals
(adjustable
within range) | K083140 -
Different
K133225 -
Similar
Difference
does not
adversely
affect the
safety and
effectiveness
of the device |
| Ramp up time per
impulse | 0 seconds or 300ms
(software adjustable
within range) | Not Adjustable | 0 ms - 5000
ms, 100ms
intervals
(adjustable
within range) | K083140 -
Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectiveness
of the device |
| | | | | does not
adversely
affect the
safety and
effectiveness
of the device |
12
13
14
15
Table 11: Output Specification Comparisons
1.10 Differences
Fundamentally, when we compare the core design, output specifications, operating behavior, intended use and general modes of operation we can conclude there is little difference between the Compex Sport Plus, EF-1280, and the Katalyst Mark 1 Muscle Stimulator.
The following table outlines the essential differences with justifications for how the differences do not adversely impact the safety and effectiveness of the subject device.
| Difference | Additional Details | Justification for how
the difference does
not adversely impact
safety and
effectiveness |
|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Katalyst Mark 1's use of
wireless communication
between the controller
device and the impulse
generator. | In order to better utilize
modern interfaces alongside
with strong and robust
platforms. Katalyst utilizes a
Bluetooth Smart connection
between its interface controller
and the impulse pack. | System validation
testing scenarios
covering mitigation of
wireless risks in
accordance with
FDA's “Radio
Frequency Wireless
Technology in Medical
Devices - Guidance for
Industry and Food and
Drug Administration
Staff” were added to
our full system testing
protocol to ensure safe
and effective use
In addition, this is
similar to the
PowerDot Pd-01
Muscle Stimulator
(with PowerDot
Mobile Application)
(K150078) |
| Using a tablet / touch
interface to control
channel impulse
intensities. | The touch application is used
to control the impulse
intensities wirelessly via
Bluetooth. | Impulse Pack
firmware and Katalyst
Application software
documentation,
consistent with a
Moderate level of
concern, is provided
with this 510(k).
System Validation
Testing proves that all
software requirement
specifications were
met and all software
hazards were mitigated
to Accepted risk level
In addition, this is
similar to the
PowerDot Pd-01
Muscle Stimulator
(with PowerDot
Mobile Application)
(K150078) |
| The Katalyst Mark 1 has a
current density (RMS)
greater than 2mA/cm² | As outlined in IEC 60601-2-10
additional warnings and
guidance are included in the
Operator's Guide to properly
advice operators on proper
procedures to increase to
intensities. | The Katalyst Mark 1
has been tested and
conformed to the IEC
60601-2-10:2012
"Medical electrical
equipment - Part 2-10:
Particular
requirements for the
basic safety and
essential performance
of nerve and muscle
stimulators." Edition
2.0 standard.
Furthermore, the
subject device has
complied with the
recommendations set
forth in FDA's
"Guidance Document
for Powered Muscle
Stimulator 510(k)s" |
| | issued on June 9, 1999
In addition, Compex
Sport (K011880) has a
current density of
3.84mA/cm² which
includes similar
warnings and
guidance. | |
16
17
1.11 Non-Clinical Tests
The following non-clinical testing was provided in this 510(k):
Biocompatibility Testing
Skin contacting electrodes pads have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP.
Software Verification and Validation
Impulse Pack firmware and Katalyst Application software documentation, consistent with a Moderate level of concern, is provided with this 510(k).
System Validation Testing proves that all software requirement specifications were met and all software hazards were mitigated to Accepted risk level.
Electrical Safety and Electromagnetic Compatibility Testing
The Katalyst Suit and the Impulse Pack have been designed to comply and tested for compatibility with the applicable clauses of the following FDA-recognized standards:
- . IEC/EN 60601-1:2005 "Medical Electrical Equipment - Part 1: General Requirements for Safety" Edition 3.1
- . IEC 60601-2-10:2012 "Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators." Edition 2.0
- . IEC/EN 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances. Edition 4.0
Battery Testing
Lithium-Polymer battery, used in Impulse Pack was tested by battery manufacturer for compliance with IEC 62133 Edition 2.0.
18
Engineering Bench Testing
In addition to the full system validation testing, the 510(k) also included testing in accordance with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999. Oscilloscope tracings were obtained of the device output waveforms under maximum supported voltage and pulse widths under loads of 500 Ω. 2 kΩ and 10 kΩ. Also, several system validation testing scenarios covering mitigation of wireless risks in accordance with FDA's "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" were added to our full system testing protocol.
Conclusion 1.12
Test results demonstrate the Katalyst Mark 1 Muscle Stimulation System is substantially equivalent to the predicate devices.