(136 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and basic software for configuration and intensity adjustment. There is no mention of adaptive algorithms, learning from user data, or other characteristics typically associated with AI/ML in this context.
No.
The intended use explicitly states, "It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind."
No.
The device is intended to stimulate healthy muscles to improve performance, not to diagnose medical conditions or injuries. The text explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical conditions of any kind" and that "its use on such muscles is contraindicated."
No
The device description explicitly lists hardware components: Katalyst Suit (containing electrodes), Impulse Pack (a powered muscle stimulation device), and Katalyst Training Station (a computer-based system with touch screen and rotary encoders).
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 direct interaction with the human body for a physiological effect (muscle stimulation), not for the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system for delivering electrical muscle stimulation through electrodes worn on the body. This is a physical intervention, not a laboratory or analytical process involving biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information.
Therefore, the Katalyst Mark 1 falls under the category of a therapeutic or performance-enhancing 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 Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components:
Katalyst Suit: Worn by the client, the Katalyst Suit consists of a base layer textile (client contacting), a cable harness, and an outer layer for the cable harness to snap into corresponding electrode pads for major muscle groups. When connected to the Impulse Pack, it provides localized EMS impulses to major muscle groups at controlled intensities.
Impulse Pack: A powered muscle stimulation device specifically designed to mate with the Katalyst Suit through a single port connector. It delivers EMS impulses through a battery powered regulated booster. The Impulse Pack receives commands over Bluetooth from the Katalyst Training Station which is controlled by the operator.
Katalyst Training Station: The Katalyst Training Station is based on an MSI computer running Windows 10. It is paired with a touch screen and rotary encoders which are used to configure and run a training via the Katalyst Application. The adjustment of independent intensities for each muscle group are done using 10 smaller knobs to adjust channel intensities and 1 larger knob to control the overall master intensity.
Accessories included: Cable Harnesses for connecting Impulse packs and Katalyst Suits, Impulse Pack Charging Adaptors and Katalyst Training Station Power Cords.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
major muscle groups
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Katalyst certified 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 Katalyst Suit Base Layers 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. 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 IEC/EN 60601-1:2005, IEC 60601-2-10:2012, and IEC/EN 60601-1-2:2014.
- Battery Testing: The Lithium-Polymer battery used in the Impulse Pack was tested for compliance with IEC 62133 Edition 2.0.
- Engineering Bench Testing: Testing was conducted 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. 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 the 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)
Reference Device(s)
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
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September 20, 2018
Katalyst Inc. Bjoern Woltermann Chief Executive Officer, Katalyst Inc 316 Occidental Ave. South Suite B300 Seattle, Washington 98104
Re: K181199
Trade/Device Name: Katalyst Mark 1 Muscle Stimulation System Model 2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 22, 2018 Received: June 26, 2018
Dear Bjoern Woltermann:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K181199
Device Name
Katalyst Mark 1 Muscle Stimulation System Model 2
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) | |
|---|---|
| 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. Submitter
Katalyst Inc. 316 Occidental Avenue S. Suite B300 Seattle, WA 98104
Contact: Bjoern Woltermann - Chief Executive Officer, Katalyst Inc. Tel: (206) 488-3939 Email: bjoern@katalyst-fitness.com
Previously Cleared Devices: K171035 Katalyst Mark 1 Muscle Stimulation System
2. Date Prepared
September 20, 2018
3. Device Name and Classification Information:
Trade/Proprietary Name: Katalyst Mark 1 Muscle Stimulation System Model 2 Model Number: 2 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
4. Predicate Devices
Primary Predicate: Compex® Sport Plus (K083140) Secondary Predicate: E-Fit EF-1280 (K133225)
5. Device Description
The Katalyst Mark 1 Muscle Stimulation System Model 2, commonly referred to as Katalyst Mark 1, consists of the following three main components:
4
| Katalyst Suit | Worn by the client, the Katalyst Suit consists of a base layer textile (client
contacting), a cable harness, and an outer layer for the cable harness to
snap into corresponding electrode pads for major muscle groups. When
connected to the Impulse Pack, it provides localized EMS impulses to
major muscle groups at controlled intensities. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Impulse Pack | A powered muscle stimulation device specifically designed to mate with
the Katalyst Suit through a single port connector. It delivers EMS
impulses through a battery powered regulated booster. The Impulse Pack
receives commands over Bluetooth from the Katalyst Training Station
which is controlled by the operator. |
| Katalyst Training
Station | The Katalyst Training Station is based on an MSI computer running
Windows 10. It is paired with a touch screen and rotary encoders which
are used to configure and run a training via the Katalyst Application. The
adjustment of independent intensities for each muscle group are done
using 10 smaller knobs to adjust channel intensities and 1 larger knob to
control the overall master intensity. |
Table 014- 1 Katalyst Mark 1 Component Overview
Accessories included: Cable Harnesses for connecting Impulse packs and Katalyst Suits, Impulse Pack Charging Adaptors and Katalyst Training Station Power Cords.
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.
7. 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,
Model 2 | Compex Sport Plus
(currently marketed
as Compex Sport
Elite) | E-Fit EF-1280 | K083140 -
Different
K133225 -
Different |
5
| Manufacturer | Katalyst Inc. | DJO LLC | FIT-PRO KFT LTD. | K083140 -Different
K133225 -Different |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 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 motor endplate where they | 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 | K083140 -Similar
K133225 -Similar |
6
| | 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 | diseases or
medical
conditions of
any kind. None
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, |
| -- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
7
| | | | | | | | | is via SNAP
connectors
directly onto the
outer vest and
leg straps. | |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | duration of rest,
total session
duration),
different types
of muscle work
can be imposed
on the
stimulated
muscles. | | Power
Source(s) | Li-Po Battery
3.8V, 7.79Wh
(2050mAh)
IEC 62133: 2012 (2nd
Edition) | Rechargeable
Ni-Mh Battery
4.6V (4 cells
AA=R6) | Lead Acid
Battery
12V, 3400mAH | K083140
-Different
K133225 -
Different
Difference
does not
adversely
affect the
safety and
effectivene
ss of the
device |
| | | | 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. | | 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
effectivene
ss of the
device |
| Connection of
device to
electrodes | The Katalyst Impulse
Pack is connected to the
electrodes via a cable
harness. The connection
to the Impulse Pack is
via a standard MDR
connector, and snapping
onto the electrodes
using standard SNAP
connectors integrated in
the electrodes
themselves. | 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. | 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
is via a plastic
12pin
waterproof ip68
Connector and
the connection
to the electrodes | K083140 -
Similar
K133225 -
Similar | Waveform | Bipolar Square | Bipolar Square | Bipolar Square | K083140 -
Similar
K133225 -
Similar |
| Channels | 10 | 4 | 12 | K083140 -
Different
K133225 -
Similar | | | | | |
| Operation
Modes | 1 | 9 | 5+5 | K083140 -
Different
K133225 -
Different | | | | | |
8
9
| | | | | See section
1.10
Differences
below for
justificatio
n of
differences |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Charging
Isolation | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| Rechargeable
Integrated
Battery | Yes | Yes | Yes | K083140 -
Similar
K133225 -
Similar |
| Display /
Control
Interface | Yes; LCD Display on
Katalyst Training
Station | Yes, Integrated
(LCD) | LCD 2x40
character LCD
display with
LED backlight.
The rotary
encoder allows
for a quick
setup and ease
of use | K083140 -
Different
K133225 -
Similar |
| Per Channel
Control | Yes. Using rotary
encoder knobs for each
channel. | Yes, Using
integrated buttons. | Yes. Using
rotary encoder
knobs for each
channel. | K083140 -
Similar
K133225 -
Similar |
| Electrode
Placement | Placed into outer layer,
appropriately 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/altere
d. | K083140 -
Different
K133225 -
Similar |
| Electrode Leads | 21 CFR 898 compliant. | 21 CFR 898
compliant. | 21 CFR 898
compliant. | K083140 -
Similar
K133225 -
Similar |
| Electrode
Interface | 4mm Standard SNAP
Connector. | 4mm Standard
SNAP Connector. | 4mm Standard
SNAP
Connector. | K083140 -
Similar |
| | | | | K133225 -
Similar
K083140 -
Similar
K133225 -
Similar |
| Electrodes | 2 per channel; Max 20. | 2 per channel; Max 8. | 2 per channel; Max 24. | |
| Transthoracic
stimulation | Yes | No | Yes | K083140 -
Different
K133225 -
Similar
electrode
placement
and safety
mitigations
as
K133225 |
| Wireless
Communication
with Control
Interface | Yes. Utilizing
Bluetooth Smart (BT
LE 4.0). | No | No | K083140 -
Different
K133225 -
Different
See section
1.10
Differences
below for
justificatio
n of
differences |
| Mobile / Form
Factor | Portable with difficulty,
no mobile device, its
intended use requires a
Katalyst certified
operator. | Yes (pocket device
with travel case) | Portable with
difficulty, no
mobile device,
its intended use
requires the
qualified and
trained
operator. | K083140 -
Different
K133225 -
Similar |
| Channel
Control
Interface | Using rotary encoder
knobs for each channel
and master rotary
encoder for all
channels. | Physical Buttons
and Display on
unit. | Using rotary
encoder knobs
for each
channel and
master rotary | K083140 -
Different
K133225 -
Similar |
| | | | encoder for all
channels. | |
| 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? | No | Yes | Yes | K083140 -
Different
K133225 -
Different
See section
1.10
Differences
below for
justification
of
differences |
| Automatic
Shutoff? | On/Off Switch | On/Off Switch | On/Off Switch | K083140 -
Similar
K133225 -
Similar |
| Patient
Override
Control? | No | Yes | Yes | K083140 -
Different
K133225 -
Different
See section
1.10
Differences
below for
justification
of
differences |
| Interface
Indicators | On/Off - Yes (on
Impulse Pack via LED | On/Off - yes | On/Off - yes | K083140 -
Similar |
| and the Katalyst
application).
Low Battery - Yes (on
Impulse Pack).
Voltage/Current Level -
Yes (in the Katalyst
application).
Charging - yes (on
Impulse Pack).
Duration of training-
yes (in the Katalyst
application) | Voltage/Current
Level - yes
Charging - yes
Duration of
training
training- yes. | Low Battery -
yes
Voltage/Current
Level - yes
Charging - yes
Duration of
training
training- yes. | K133225 -
Similar | |
| Duration in
minutes | 20 | 55 | 30 minutes | K083140 -
Similar
K133225 -
Similar |
| Rx Only or
OTC | Rx Only | OTC | Rx Only | K083140 -
Different
K133225 -
Similar |
10
11
12
Table 014- 2 Device Characteristic Comparisons
8. 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 |
| 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 | K133225 - | ||
| Similar | ||||
| 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 | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 - |
| Different | ||||
| K133225 - | ||||
| Similar | ||||
| Negative Pulse Width | 175µs symmetrical | 200 μs to 400 μs | 100µs to 500µs | K083140 - |
| Different | ||||
| K133225 - | ||||
| Similar | ||||
| Frequency | 85Hz | 1 to 120Hz | 5 to 120Hz | K083140 - |
| Similar | ||||
| K133225 - | ||||
| Different | ||||
| For interferential | ||||
| modes only: | No | No | No | K083140 - |
| Similar | ||||
| K133225 - | ||||
| Similar | ||||
| -Beat Frequency | No | No | No | K083140 - |
| Similar | ||||
| K133225 - | ||||
| Similar | ||||
| For multiphasic | ||||
| waveforms only: | Yes | Yes | Yes | K083140 - |
| Similar | ||||
| K133225 - | ||||
| Similar | ||||
| - Symmetrical | ||||
| phases? | Yes | Yes | Yes | K083140 - |
| Similar | ||||
| K133225 - | ||||
| Similar | ||||
| - Phase Duration | ||||
| (include units) | ||||
| (state range, if | ||||
| applicable) | ||||
| (both phases, if | ||||
| asymmetrical) | 175µs Symmetrical | 200-400μs | ||
| Symmetrical | 100 - 500μs | |||
| Symmetrical | K083140 - | |||
| Different | ||||
| K133225 - | ||||
| Similar | ||||
| Net Charge | $0.5 [\mu C] @ 500\Omega$ | |||
| 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 | $21\mu C @ 500 \Omega$ | $48\mu C @ 500\Omega$ | $36\mu C @ 500 \Omega$ | K083140 - Similar |
| K133225 - Similar | ||||
| Maximum Current (RMS) Density | $0.788mA/cm^2 @500\Omega$ | $1.49mA/cm2 @ 500\Omega$ | $0.85mA/cm2 @ 500\Omega$ | K083140 - Different |
| K133225 - Similar | ||||
| Maximum Power Density | $8.16mW/cm^2 @ 500 \Omega$ | $27.6mW/cm2 @500\Omega$ | $6.3mW/cm2 @ 500 \Omega$ | K083140 - Different |
| K133225 - Similar | ||||
| Burst Mode (i.e., pulse trains) | ||||
| a. Pulses per burst | ||||
| b. Bursts per second | ||||
| c. Burst duration (seconds) | ||||
| d. Duty Cycle [Line (b) x Line (c)] | N/A | Unknown | Unknown | K083140 -Unknown |
| K133225 - Unknown | ||||
| ON Time | 4 second intervals | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - Different |
| K133225 - Similar | ||||
| OFF Time | 4 second intervals | Not Adjustable | 0.1 to 60 seconds, 0.1 second intervals (adjustable within range) | K083140 - Different |
| K133225 - Similar | ||||
| Treatment Training Time | 20 minutes | Not Adjustable | 1-30 minutes, 1-minute intervals (adjustable within range) | K083140 - Different |
| K133225 - Similar | ||||
| Ramp up time per impulse | 300 ms | Not Adjustable | 0 ms - 5000 ms, 100ms | K083140 - Different |
| intervals | ||||
| (adjustable | ||||
| within range) | K133225 - | |||
| Similar | ||||
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Table 014- 3 Output Specification Comparisons
9. Differences
When comparing the core design, output specifications, operating behavior, intended use and general modes of operation it can conclude there is little difference between the Compex Sport Plus, EF-1280, and the Katalyst Mark 1 Muscle Stimulation System.
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 |
|---|---|
| The Katalyst Mark 1 has only 1 | |
| operation mode compared to many | |
| modes of the predicate devices | In order to provide a consistent and predictable training |
| experience, the Katalyst Mark 1 only provide a single mode | |
| of operation. | |
| 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. This is similar to the PowerDot Pd-01 | |
| Muscle Stimulator (with PowerDot Mobile Application) | |
| (K150078) | |
| Patient Override Control | The Katalyst Mark 1 is always operated by an Katalyst |
| operator for a patient, and as such the operator can | |
| immediately turn off the device. | |
| Automatic No-Load Trip | The Katalyst Mark 1 is always operated by an Katalyst |
| operator for a patient. The Operator's Guide outlines proper | |
| no load procedures. |
Table 014- 4 Justification of differences with predicate devices
10.Non-Clinical Tests
The following non-clinical testing was provided in this 510(k):
10.1. Biocompatibility Testing
Skin contacting Katalyst Suit Base Layers have been tested to ISO 10993-10:2009 and ISO 10993-5:2009 standard under GLP.
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10.2. 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.
10.3. 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
10.4. Battery Testing
The Lithium-Polymer battery used in the Impulse Pack was tested by the battery manufacturer for compliance with IEC 62133 Edition 2.0.
10.5. 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.
11.Conclusion
Test results demonstrate the Katalyst Mark 1 Muscle Stimulation System is substantially equivalent to the predicate devices.