Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard electrical muscle stimulation technology.

Therapeutic

No.
The "Intended Use" section explicitly states that the device "is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind" and its use on "injured or ailing muscles is contraindicated." Its purpose is to stimulate healthy muscles for performance improvement, not for therapeutic purposes.

Diagnostic

No
The device's intended use is to stimulate healthy muscles to improve performance, not to diagnose medical conditions or diseases. It explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "battery powered muscle stimulator" and includes testing for hardware components like the battery and electrical safety, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Katalyst Training System is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states the device is for stimulating healthy muscles to improve or facilitate muscle performance. This is a therapeutic or performance-enhancing use, not a diagnostic one.
IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Katalyst Training System does not interact with or analyze any biological specimens.
Device Description: The device description details its function as a muscle stimulator using electrical impulses to cause muscle contractions. This aligns with a physical therapy or fitness device, not a diagnostic one.
Lack of Diagnostic Information: The document does not mention any capability of the device to provide diagnostic information about a patient's health or condition.
Performance Studies: The performance studies focus on safety, electrical compatibility, software validation, and equivalence to a predicate muscle stimulator. There are no studies related to diagnostic accuracy or performance.

In summary, the Katalyst Training System is a muscle stimulator intended for improving muscle performance, which falls outside the scope of In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Katalyst Training System 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 Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 can be imposed on the stimulated muscles.

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

NGX

Device Description

The Katalyst Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate your muscles and help to improve muscle performance. Specifically, it uses neuromuscular electrical stimulation (NMES) to stimulate motor nerves, creating a muscle contraction to recruit more muscle fibers while training.

It is designed to be used with the Katalyst Application, which is the interface between the user and the Impulse Pack and runs on a user supplied iOS device communicates wirelessly with the Impulse Pack using Bluetooth 4.2.

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

adults only

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)

Non-Clinical Testing:

Biocompatibility Testing: The Skin contacting Base Layers have been tested to ISO 10993-5 and ISO 10993-10 standard under GLP.
Software Verification and Validation: The Impulse Pack firmware and Katalyst Application were verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation. This testing proves that all software requirement specifications were met.
Battery Testing: The Lithium-Polymer battery used in the Impulse Pack was tested by the battery manufacturer for compliance with IEC 62133.
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.
Electrical Safety and Electromagnetic Compatibility: The Katalyst Training System has been tested to AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-10.
Wireless Coexistence Testing: The performance of the Katalyst Training System was evaluated in an environment with other Katalyst Training Systems and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.

Clinical Testing:
No clinical studies are submitted to support this premarket notification submission.

Key Results: Test results demonstrate the Katalyst Training System is substantially equivalent to the predicate device.

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.

K170903

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

§ 890.5850 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).

Summary

0

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 3, 2020

Katalyst Inc. Bjoern Woltermann Chief Executive Officer 316 Occidental Ave. South Suite B300 Seattle, WA 98104

Re: K190966

Trade/Device Name: Katalyst Training System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: January 30, 2020 Received: January 31, 2020

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190966

Device Name Katalyst Training System

Indications for Use (Describe)

The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Katalyst Training System 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 Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 can be imposed on the stimulated muscles.

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)
	X

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510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitted by:

Katalyst Inc. 1201 3rd Avenue Suite 2200 Seattle WA, 98101

Contact Person:

Bjoern Woltermann - Chief Executive Officer, Katalyst Inc. Tel: (206) 488-3939 Email: bjoern@katalyst-fitness.com

Date Summary Prepared

April 3, 2019

Trade/Proprietary Name

Katalyst Training System

Common Name

Powered Muscle Stimulator for Muscle Conditioning

Classification Name

Powered Muscle Stimulator

Product Code:

Powered Muscle Stimulator, For Muscle Conditioning - 21 CFR 890.5850 Product Code NGX Review Panel: 89, Physical Medicine

Regulatory Class Class II

Predicate Devices Compex Wireless USA (K170903)

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Device Description

The Katalyst Training System is a battery powered muscle stimulator that uses electrical muscle stimulation (EMS) technology to stimulate your muscles and help to improve muscle performance. Specifically, it uses neuromuscular electrical stimulation (NMES) to stimulate motor nerves, creating a muscle contraction to recruit more muscle fibers while training.

It is designed to be used with the Katalyst Application, which is the interface between the user and the Impulse Pack and runs on a user supplied iOS device communicates wirelessly with the Impulse Pack using Bluetooth 4.2.

Indications for Use

The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.

The Katalyst Training System 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 Training System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons 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 can be imposed on the stimulated muscles.

Comparison to the Predicate Device

The similarities and differences between the technology and specifications of the subject device and its predicate devices are reflected below:

Characteristic	New Device	Predicate Device	Comparison
Manufacturer	Katalyst Inc.	DJO LLC	N/A
Device name, model	Katalyst Training System
Model 1	Compex Wireless USA	N/A
Classification name	Powered muscle stimulator	Powered muscle stimulator	Similar
Product code	NGX	NGX	Similar
Regulation number	21 CFR 890.5850	21 CFR 890.5850	Similar
Panel	Physical Medicine	Physical Medicine	Similar
Class	Class II	Class II	Similar
510(k) number	-	K170903	N/A
Prescription/OTC	OTC	OTC	Similar
Indications for use	The Katalyst Training System is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Katalyst Training	The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only. The Compex Wireless USA	The Katalyst Training System does not include TENS

System is not intended to be	is not intended for
used in conjunction with	adjunctive therapy in the
therapy or treatment of	treatment of medical
medical diseases or medical	diseases and conditions of
conditions of any kind. None	any kind. None of the
of the training programs or	Compex Wireless USA
operational parameters are	stimulation programs are
designed to target injured or	designed for injured or
ailing muscles and its use on	disease afflicted muscles. Its
such muscles is	use on such muscles is
contraindicated.	contraindicated. The work
The Katalyst Training	imposed on the muscles by
System's electrical impulses	the Compex Wireless USA
allow the triggering of action	programs is definitely not
potentials on motoneurons of	suitable for rehabilitation
motor nerves (excitations).	and physiotherapy. The
These excitations of	Compex Wireless USA
motoneurons are transmitted	electrical impulses allow the
to the muscle fibers via the	triggering of action
motor endplate where they	potentials on motoneurons
generate mechanical muscle	of motor nerves
fiber responses that	(excitations). These
correspond to muscle work.	excitations of motoneurons
Depending on the parameters	are transmitted to the muscle
of the electrical impulses	fibers via the motor endplate
(pulse frequency, duration of	where they generate
contraction, duration of rest,	mechanical muscle fiber
total session duration),	responses that correspond to
different types of muscle	muscle work. Depending on
work can be imposed on the	the parameters of the
stimulated muscles.	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
Compex Wireless USA may
	therefore be considered a
	technique of muscle training.
	The Compex Wireless USA
	TENS is used for:
	• temporary relief of pain
	associated with sore and
	aching muscles due to strain
	from exercise or normal
	household and work
	activities.
	• the symptomatic relief and
	management of chronic,
	intractable pain and relief of

Basic Device Characteristics - Comparison with Predicate Devices

5

6

		pain associated with arthritis.
Target population	It is to be used by adults only.	It is to be used by adults only.	Similar
Connection of device to electrodes	The Impulse Pack connects to the Suit through output cables that terminate with pogo pin connectors. The Suit contains an embedded cable harness which makes connection with the built-in electrodes. Neither the cable harness or the electrodes are removable. The Suit also features leads with snap connectors for connecting to the arm electrodes	Lead wires Stimulation Module is directly connected to the custom Compex female SNAP assembled in the electrode. User Interface (LCD and buttons) is physically separated (Remote Control) and communicates wirelessly with up to four (4) Stimulation Modules. Stimulation safety remains fully managed by Stimulation Module electronic circuit itself.	Different
Power source(s)	Lithium Polymer (Li-Po) rechargeable battery 7.4V, 2,050 mAh	Remote: Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 1500[mAh Stimulation Modules: Lithium Polymer (LiPo) rechargeable 3.7[V] / ≥ 450[mAh]	Similar
Method of line current isolation	N/A (battery operated device)	N/A (battery operated device)	Similar
Patient leakage current	N/A (battery operated device)	N/A (battery operated device)	Similar
Normal condition	N/A (battery operated device)	N/A (battery operated device)	Similar
Single fault condition	N/A (battery operated device)	N/A (battery operated device)	Similar
Number of output modes	One (NMES)	Two (NMES/TENS)	Different
The Katalyst Training System does not include TENS
Number of output channels	13	4	Different
Compex Wireless USA Electrodes can be applied to multiple anatomical sites. Katalyst Training
Synchronous or
alternating?	Synchronous, but never 2
channels activated at the
same time	Synchronous, but never 2
channels activated at the
same time	System
electrodes are
fixed in the suit
only allowing
stimulation to
predefined
areas of the
body
Method of
channel isolation	Multi-Channel High Voltage
Analog Switches. Except
during channel activation,
each channel is always in
high Z state	Each channel is the middle
of a H- Bridge. Except when
it is activated, each channel
is always in high impedance
state	Similar
Regulated current or
regulated voltage?	Regulated current (all
channels)	Regulated current (all
channels)	Similar
Software/firmware/m
icroprocessor
control?	Yes	Yes	Similar
Automatic overload
trip?	Yes	Yes	Similar
Automatic no-load
trip?	Yes	Yes	Similar
Automatic shut off?	"On/Off" switch	"On/Off" switch	Similar
Patient override
control?	Yes	Yes, push on On/Off button
directly pause the program	Similar
Indicator display

on/off status? | Yes | Yes | Similar |
| - Low battery? | Yes | Yes | Similar |
| - Voltage/current
level? | Yes | Yes, unit = [Energy] | Similar |
| Timer range
(minutes) | Maximum program: 60
minutes | Not publicly available | Cannot
determine |
| Compliance with
voluntary standards? | Yes
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10 | Yes
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-10 | Similar
The Katalyst
Training
System is not
intended for
use in a home
care
environment |
| Compliance with 21
cfr 898? | Yes | Yes | Similar |
| Weight | Impulse Pack - 248 g | Remote: 110 [g]
Stimulation
Module:2x60 [g]
Docking Station 800 [g] | Similar |
| Dimensions | Impulse Pack | Not publicly available | Cannot |
| | Impulse Pack
148x78 mm
Connector 1
65x32mm
Connector 2
56x32mm | | determine |
| Housing material and
construction | Plastic injection molding | Not publicly available | Cannot
determine |

7

8

Output Specification - Comparison with Predicate Devices

Characteristic	New Device	Predicate Device	Comparison
Manufacturer	Katalyst Inc.	DJO LLC	N/A
Device name, model	Katalyst Training System
Model 1	Compex Wireless USA	N/A
Waveform	Endurance:
Symmetrical Biphasic	-Endurance:
Symmetrical Biphasic	Similar
The Katalyst
Training
System does
not include
TENS
	Resistance:
Symmetrical Biphasic	-Resistance:
Symmetrical Biphasic
	Strength:
Symmetrical Biphasic	-Strength:
Symmetrical Biphasic
	Explosive Strength:
Symmetrical Biphasic	-Explosive Strength:
Symmetrical Biphasic
	Potentiation:
Symmetrical Biphasic	-Potentiation: Symmetrical
Biphasic
	Training Recovery :
Symmetrical Biphasic	-Training Recovery (same as
Active Recovery):
Symmetrical Biphasic
	Competition Recovery:
Symmetrical Biphasic	-Competition Recovery
(same as Recovery Plus):
Symmetrical Biphasic
	Warmup:
Symmetrical Biphasic	-Pre-Warmup Program:
Symmetrical Biphasic
	Muscle Relaxation:
Symmetrical Biphasic	-Muscle Relaxation (same as
Massage): Symmetrical
Biphasic
		-Pain relief TENS (same as
FM): Balanced,
asymmetrical Biphasic
	Shape	Endurance:
Rectangular	-Endurance:
Rectangular
	Resistance:	- Resistance:	Training
	Rectangular	Rectangular	System does
not include
TENS
	Strength:	-Strength:
	Rectangular	Rectangular
	Explosive Strength:	-Explosive Strength:
	Rectangular	Rectangular
	Potentiation:	-Potentiation:
	Rectangular	Rectangular
	Training Recovery :	-Training Recovery:
	Rectangular	Rectangular
	Competition Recovery:	-Competition Recovery:
	Rectangular	Rectangular
	Warmup:	-Pre-Warmup:
	Rectangular	Rectangular
	Muscle Relaxation:	-Muscle Relaxation:
	Rectangular	Rectangular
		-Pain relief TENS (same as
FM):
Maximum output
voltage (+/- 10%)	Endurance:	Endurance:	Different
	60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ	60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ
	Resistance:	Resistance:	The Katalyst
Training
System's max
voltage is less
than that of the
predicate
device
	60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ	60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ
	Strength:	Strength:
	60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ	60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ	The Katalyst
Training
System does
not include
TENS
	Explosive Strength:	Explosive Strength:
	60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ	60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ
	Potentiation:	Potentiation:
	60 V @ 500 Ω
100 V @ 2 kΩ
100 V @ 10 kΩ	60 V @ 500 Ω
152 V @ 2 kΩ
136 V @ 10 kΩ
	Training Recovery :	Training Recovery:
	60 V @ 500 Ω	60 V @ 500 Ω
	100 V @ 2 kΩ	165 V @ 2 kΩ
	100 V @ 10 kΩ	165 V @ 10 kΩ
	Competition Recovery:	Competition Recovery:
	60 V @ 500 Ω	60 V @ 500 Ω
	100 V @ 2 kΩ	165 V @ 2 kΩ
	100 V @ 10 kΩ	165 V @ 10 kΩ
	Warmup:	Pre Warmup:
	60 V @ 500 Ω	60 V @ 500 Ω
	100 V @ 2 kΩ	165 V @ 2 kΩ
	100 V @ 10 kΩ	165 V @ 10 kΩ
	Muscle Relaxation:	Muscle Relaxation:
	60 V @ 500 Ω	60 V @ 500 Ω
	100 V @ 2 kΩ	165 V @ 2 kΩ
	100 V @ 10 kΩ	165 V @ 10 kΩ
		Pain Relief TENS:
		180[V] peak on 10[kΩ]
		170[V] peak on 2[kΩ] 58[V]
		peak on 500[Ω]
Maximum output
current (+/- 10%)	Endurance:	Endurance:	Different
	120 mA @ 500 Ω	116 mA @ 500 Ω
	50 mA @ 2 kΩ	80 mA @ 2 kΩ	The Katalyst
	10 mA @ 10 kΩ	15 mA @ 10 kΩ	Training
System's max
current is
	Resistance:	Resistance:
	120 mA @ 500 Ω	116 mA @ 500 Ω	similar, but
	50 mA @ 2 kΩ	80 mA @ 2 kΩ	currents at 2
kΩ and 10 kΩ
	10 mA @ 10 kΩ	17 mA @ 10 kΩ	load resistances
are less than
	Strength:	Strength:	that of the
	120 mA @ 500 Ω	113 mA @ 500 Ω	predicate
	50 mA @ 2 kΩ	80 mA @ 2 kΩ	device
	10 mA @ 10 kΩ	15 mA @ 10 kΩ
	Explosive Strength:	Explosive Strength:	The Katalyst
	120 mA @ 500 Ω	81 mA @ 500 Ω	Training
	50 mA @ 2 kΩ	81 mA @ 2 kΩ	System does
	10 mA @ 10 kΩ	15 mA @ 10 kΩ	not include
TENS
	Potentiation:	Potentiation:
	120 mA @ 500 Ω	117 mA @ 500 Ω
	50 mA @ 2 kΩ	80 mA @ 2 kΩ
	10 mA @ 10 kΩ	16 mA @ 10 kΩ
	Training Recovery :	Training Recovery:
	120 mA @ 500 Ω	116 mA @ 500 Ω
	50 mA @ 2 kΩ
10 mA @ 10 kΩ	81mA @ 2 kΩ
16 mA @ 10 kΩ
	Competition Recovery:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ	Competition Recovery:
116 mA @ 500 Ω
81 mA @ 2 kΩ
16 mA @ 10 kΩ
	Warmup:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ	Pre Warmup:
116 mA @ 500 Ω
81 mA @ 2 kΩ
15 mA @ 10 kΩ
	Muscle Relaxation:
120 mA @ 500 Ω
50 mA @ 2 kΩ
10 mA @ 10 kΩ	Muscle Relaxation:
116 mA @ 500 Ω
81 mA @ 2 kΩ
16 mA @ 10 kΩ

Endurance:
250 to 375 μs

Resistance:
250 to 375 μs

Strength:
250 to 375 μs

Explosive Strength:
250 to 375 μs

Training Recovery :
250 to 375 μs

Competition Recovery:
250 to 375 μs

Warmup:
250 to 375 μs

Muscle Relaxation:
250 to 375 μs | Endurance:
200 to 400 [μs]

Resistance:
200 to 400 [μs]

Strength:
200 to 400 [μs]

Explosive Strength:
200 to 400 [μs]

Potentiation:
200 to 400 [μs]

Training Recovery:
200 to 400 [μs]

Competition Recovery:
200 to 400 [μs]

Pre Warmup:
200 to 400 [μs]

Muscle Relaxation:
200 to 400 [μs]

Pain Relief TENS:
70 to 300[μs] (measured at | Similar

The Katalyst
Training
system's pulse
width range is
a subset of that
of the predicate
device's.

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Although there are minor differences observed between the Katalyst Training System and the predicate device, no difference found raised any question safety and effectiveness of the new device.

Standards

The Katalyst Training System is designed and manufactured in accordance with the following standards:

AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And ● A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1, Mod.)
IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
. IEC 60601-2-10 Edition 2.1 2016-04 Medical Electrical Equipment - Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators
IEC 62133 Edition 2.0 2012-12 Secondary Cells and Batteries Containing Alkaline or Other Non-● Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, And for Batteries Made from Them, For Use in Portable Applications [Including: Corrigendum 1 (2013)]
ISO 14971 Second Edition 2007-03-01 Medical Devices - Application of Risk Management to Medical Devices
ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10 Third Edition 2010-08-01 Biological Evaluation of Medical Devices Part 10: Tests . for Irritation and Skin Sensitization
AAMI /ANSI /IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes [Including Amendment 1 (2016)]

Non-Clinical Testing

The Katalyst Training System was subjected to testing in accordance with the appropriate standards and the results are provided in this 510(k). The non-clinical tests performed are as follows:

. Biocompatibility Testing
- The Skin contacting Base Layers have been tested to ISO 10993-5 and ISO 10993-10 O standard under GLP.

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Software Verification and Validation ●
- The Impulse Pack firmware and Katalyst Application were verified in accordance with the O requirements of FDA's guidance document: General Principles of Software Validation. This testing proves that all software requirement specifications were met.
Battery Testing
- The Lithium-Polymer battery used in the Impulse Pack was tested by the battery o manufacturer for compliance with IEC 62133
Engineering Bench Testing
- In addition to the full system validation testing, the 510(k) also included testing in accordance o with the recommendations of FDA's "Guidance Document for Powered Muscle Stimulator 510(k)s" issued on June 9, 1999.
. Electrical Safety and Electromagnetic Compatibility:
- The Katalyst Training System has been tested to AAMI/ANSI ES60601-1, IEC 60601-1-2, o and IEC 60601-2-10.
Wireless Coexistence Testing:
- The performance of the Katalyst Training System was evaluated in an environment with other o Katalyst Training Systems and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.

Clinical Testing

No clinical studies are submitted to support this premarket notification submission.

Conclusion

Test results demonstrate the Katalyst Training System is substantially equivalent to the predicate device.