The X-Force external, non-invasive, non-narcotic, clectrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffess associated with pain, from rheumatoid arthritis of the Hand.

These devices are to be used or sold only under the direct supervision or order of a licensed practitioner. A prescription is required to obtain this product can be used in the home or clinic by all patients in need.

Device Description

The X-FORCE device is a microcomputer controlled digital device featuring a NT Mode output. The device provides simple programming facility to customize the treatment. The panel and its keys provide easy selection for treatment. It is device that deploys the use of electrotherapy and compression to treat Osteoarthritis (OA) and rheumatoid arthritis of the knee or hand.

The X-Force consists of electrodes, the lead wires, and the signal generator. The device is portable and rechargeable battery operated. The lead wires connect the electrodes to the device. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

AI/ML Overview

The provided text describes a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called "X-Force" and compares it to a predicate device, "J-Stim 1000".

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" through a table or specific quantitative thresholds for performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device, the J-Stim 1000. The key "acceptance criterion" here is that the new device, X-Force, is "as safe, as effective and performs as well as its predicate device."

The "reported device performance" is essentially that the X-Force operates under the same principles and delivers similar electrical parameters as the J-Stim 1000. The comparison focuses on technological characteristics and basic unit characteristics, where "similarity" or "sameness" acts as the performance metric.

Acceptance Criteria (Implied)	Reported Device Performance (X-Force vs. J-Stim 1000)
Intended Use Equivalence	Both devices are indicated for use as adjunctive therapy in reducing pain and symptoms associated with osteoarthritis of the knee and pain/stiffness from rheumatoid arthritis of the hand.
Technological Characteristics Equivalence	- Energy Source: Similar (Rechargeable battery vs. 9V Alkaline). X-Force has more battery backup, which is deemed not to affect safety or effectiveness. - Device Housing: Similar (ABS material, different sizes/weights). - Channels: Same (Two Channels). - Modes: Same (One). - Display: Similar (Customized LCD). - Waveform: Same (NT (HiVolt) - Pulsed Monophasic). - Treatment Timer: Same (YES). - Target Populace: Same.
Basic Unit Characteristics Equivalence	- Power Source: Different (Rechargeable 4x1.2V vs. 9V Li-ion). - Line Current Isolation: Same (battery operated, isolated from mains). - Patient Leakage Current: Same (less than 100μA normal, less than 300µA single fault, Referenced IEC 60601-1). - Output Modes/Channels: Same (Synchronous, 1 mode, 2 channels). - Regulated Output: Same (Regulated Voltage). - Max Output Current/Voltage/Phase Charge/Current Density/Power Density: All reported as identical. - Software/Firmware/Microprocessors: Same (YES). - Automatic Trips/Shut-off/Patient Override: All same (YES). - Indicator Display: Same (YES for On/Off, Low Battery, Voltage/Current). - Timer: Same (YES). - Compliance with 21 CFR 898: Same (YES). - Program Lock Feature: X-Force has this, J-Stim 1000 does not. This is deemed not to affect safety or effectiveness. - Digital Control of Output Power: X-Force uses digital control via microcontroller, J-Stim 1000 uses analog pots. This difference is presented without explicit safety/effectiveness impact beyond it being a technological variation.
Safety and Effectiveness (Overall Equivalence Conclusion)	X-Force is concluded to be as safe, as effective, and performs as well as the predicate device, J-Stim 1000.

2. Sample Size Used for the Test Set and the Data Provenance

The submission explicitly states:

"Non-Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"
"Clinical Testing: Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device"

This means there was no specific test set or clinical study conducted for the X-Force device to prove its performance in an independent test, nor is there data provenance like country of origin or retrospective/prospective status for such a test set. The submission relies entirely on the established safety and effectiveness of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Since no specific test set or clinical study was conducted for the X-Force device, there were no experts used to establish ground truth for a test set in this submission. The ground truth for the device's equivalence is based on engineering and performance specifications comparison to the predicate device.

4. Adjudication Method for the Test Set

As no test set was used, there was no adjudication method applied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This device (TENS stimulator) is not an AI-powered diagnostic device, and the submission does not involve any "human readers" or "AI assistance" in the context of interpreting medical images or data. Therefore, no MRMC comparative effectiveness study was done.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not an algorithm-only device. It is a physical medical device. There's no standalone algorithm performance study as it's not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this submission is the established safety and effectiveness of the predicate device (J-Stim 1000), as previously determined by the FDA's approval (K073386). The new device (X-Force) claims equivalence through comparative analysis of its specifications and intended use against this established ground truth.

8. The Sample Size for the Training Set

Since no new clinical or non-clinical testing was performed for the X-Force for this submission, there was no specific training set in the context of device performance studies. The "training" in an abstract sense comes from the design and manufacturing experience informed by devices like the predicate.

9. How the Ground Truth for the Training Set Was Established

Given that no specific training set was used for this submission, the question of how its ground truth was established is not applicable. The submission leverages the pre-existing FDA approval of the predicate device as its basis for demonstrating safety and effectiveness.

Summary

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NOV 10 2011 K///55 7

ANNEXURE `IV′

SUMMARY

"Traditional 510(k) summary"

SUBMITTER'S NAME	:	Seven Seas Distribution and Manufacturing LLC
ADDRESS	:	2620 S Maryland Pkwy Ste 14 Unit 835
		Las Vegas, Nevada, 89109, United States
TELEPHONE	:	213-6132356
FAX	:	213-6132344
E-MAIL ADDRESSS	:	sales@sevenseasdm.com
CONTACT PERSON	:	Mark Ioele
TELEPHONE	:	213-6132356
FAX	:	213-6132344
Date of summary submission	:	25th April 2011
Resubmitting on	:	12th October 2011

For Seven Seas Distribution and Manufacturing LLC Mark Ioele

MPL

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ANNEXURE `IV′

Traditional 510(k)

NEW DEVICE FOR WHICH SUBMITTING

Trade Name	: X-Force
Common Name	: TENS (Transcutaneous Electrical Nerve Stimulator)
Classification Name	: Transcutaneous electrical nerve stimulator for painrelief (21 CFR 882.5890, Product Code NYN)

Device's Classification Panel : Neurology

LEGALLY MARKETING DEVICE

J-Stim 1000 : Transcutaneous Electrical Nerve Stimulator

Manufacturer : Pain Management Technologies, Inc.

Address : 1340 Home Ave. , Bldg A, Akron, OH 44310

DESCRIPTION OF NEW DEVICE X-Force

Device Features:

l Digital LCD display
. Dual channel
. Soft fabric comfortable garment
. Low battery indicator
l ABS Portable handy device
1 Parameter locking

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ACCESSORIES:

X-Force comes complete with all the necessary accessories and below is a list of items that are included:

Units are supplied with:

. Electrode Cable (2 Pin 2 Core); Length: 1.25 meter conforming to 21 CFR 898
. Knee Belt listed in the 510(k) - K073386 of Jstim 1000
. Elbow Belt and Conductive Patches listed in 510(k) - K943009
. Conductive Gel
. Battery Rechargeable AA size 1.2 V (4 in qty.)
. External Battery Charging Adaptor Adaptor Specifications
- o INPUT: 100-240V AC-50/60Hz
- OUTPUT: 5.5V DC O
. Instruction Manual

INTENDED USE OF NEW DEVICE "X-FORCE"

The X-Force external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the Hand.

INTENDED USE OF PREDICATE DEVICE "J-STIM 1000"

The J-Stim 1000 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

The J-Stim 1000 is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the Hand.

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ANNEXURE 'IV'

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

S.No	Description	New DeviceX-Force	Predicate DeviceJSTIM (K073386)	Remarks
1	Energy Source	Rechargeable battery (4 X 1.2V)operated, more battery backup compare to Predicate device	9V Alakaline battery operated	Similar
2	Device Housing	Material - ABSSize - (142 X 62 X 26) mm12.875 ounce (365 Grams) with battery,8.924 ounce (253 Grams) without battery	Material - ABSSize - (45 x 30 x 15) mm2.8 ounce (65 Grams) with battery, 1.6 ounce (45.8 Grams) without battery	Similar
3	Number of OutputChannels	Two Channels	Two Channels	Same
4	Number of Modes	One	One	Same
6	Display	Customized LCD	Customized LCD	Similar
7	Waveform	NT (HiVolt) - Pulsed Monophasic	NT (HiVolt) - Pulsed Monophasic	Same
7	Treatment Timer	YES	YES	Same
8	Target ofpopulaces	Therapist in Neurology at health clinic and Chiropractor.	Therapist in Neurology at health clinic and Chiropractor.	Same

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COMPARISON OF BASIC UNIT CHARACTERISTICS:

S.N	FEATURES OF DEVICE	NEW DEVICE	PREDICATE DEVICE
1	510(K) Number	K111557	K073386
2	Device Name, Model	X Force	JStim 1000
3	Manufacturer	Seven Seas Distribution andManufacturing LLC	Pain ManagementTechnologies, Inc.
4	Power source	Rechargeable Battery(4 X 1.2V- AA size)	9V Li ion battery
5	Method of Line CurrentIsolation	(a) Since Instrumentsoperates on battery, hence itis completely isolated fromMains Supply.	(a) Since Instrumentsoperates on battery, hence itis completely isolated fromMains Supply.
6	Patient Leakage CurrentNormal conditionSingle Fault condition	(b) Patient Leakage CurrentNormal condition = less than100μΑSingle fault condition = lessthan 300µA* Reference: IEC 60601-1	(b) Patient Leakage CurrentNormal condition = less than100μΑSingle fault condition = lessthan 300µA* Reference: IEC 60601-1
7	Number of Output Modes	1	1
8	Number of OutputChannelsSynchronous or Alternating?	SynchronousChannel 1 and 2 arecompletely isolated. Both havedesignated Amplifier & controlcircuit, Only power supply andground are common.	SynchronousChannel 1 and 2 arecompletely isolated. Bothhave designated Amplifier &control circuit Only powersupply and ground arecommon
9	Regulated Current orRegulated Voltage	Regulated Voltage	Regulated Voltage
10	Maximum Output Current	Iavg =0.2mA @ 500Ω	Iavg =0.2mA @ 500Ω
11	Maximum Output Voltage	Vavg. =0.108Vavg @ 500Ω	Vavg. =0.108Vavg @ 500Ω
12	Maximum Phase Charge	24.3 μC @ 500Ω	24.3 μC @ 500Ω
13	Maximum Current Density	0.0021 mA/cm² @ 500Ω	0.0021 mA/cm² @ 500Ω
14	Maximum Power Density	0.00022 mW/cm² @ 500Ω	0.00022 mW/cm² @ 500Ω
15	Software/Firmware/Microprocessors Controls?	YES	YES
16	Automatic Overload Trip?	YES	YES
17	Automatic No-Load Trip	YES	YES
18	Automatic Shut off?	YES	YES
19	Patient Override Control?	YES	YES
20	Indicator Display:On/Off Status?Low Battery?Voltage/Current Level?	YESYESYES	YESYESYES
21	Timer	YES	YES
22	Compliance with VoluntaryStandards	NO	NO
23	Compliance With 21 CFR898	YES, the electrode cable cannever be plugged in the AC	YES, the electrode cable cannever be plugged in the AC
24	Weight	12.875 ounce (365 Grams) with battery, 8.924 ounce (253 Grams) without battery	2.8 ounce (65 Grams) with battery, 1.6 ounce (45.8 Grams) without battery
25	Dimension (L X B X H)	(142 X 62 X 26) mm	(45 x 30 x 15) mm
26	Housing Material	ABS resine	ABS resine

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ANNEXURE 'IV'

SUMMARY:

XForce functions in the same way as the predicate device Jstim 1000. The intended

use, operational characteristics of both the devices are similar.

Indication Comparison:	Indented use of X Force and Predicate Device are same i.e.X Force is indicated for use as an adjectiveTherapy in reducing the level of pain and symptomsassociated with Osteoarthritis of the knee andRheumatoid Arthritis of the Hand.
	Technological Comparison: The technological characteristics (Energy Source, Design,Material and Physical Characteristics) of modified devicehas been compared with Jstim 1000 and found to besame as the predicate device Jstim 1000.Below are the differences:
1)	Power source: Jstim 1000 has power source of 9Voltwhere as X-Force have Power source of 1.2 DC X 4Battery) which are more power full compare to 9VDCbattery thus giving more battery backup. This changeonly increase battery backup of Unit and there is noeffect on the safety or effectiveness of the device.
2)	Program Lock feature: X-Force have Program Lockfeature which is not present in Jstim 1000. This featuregive user to lock the used parameter, this functiondoesn't affect any parameter which can make New devicedifferent from Predicate
3)	Digital Control of Output Power: Jstim 1000 outputpower is controlled through Analog pots where in X-ForceOutput power is controlled digitally throughMicrocontroller.
Labeling Comparison	: Labeling of the device compares to that of predicatedevice.
Non-Clinical Testing	: Not Applicable as Jstim 1000 is already FDA Approvedand the New Device X-Force is same as Predicate Device
Clinical Testing	: Not Applicable as Jstim 1000 is already FDA Approvedand the New Device X-Force is same as Predicate Device
Conclusion	: Drawn from the comparison between the modified deviceX-Force with predicate device J Stim 1000, itdemonstrates that X-Force is as safe, as effective andperforms as well as its predicate device.

ﺎﺭ ﺗﻮ

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending from its body.

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

Seven Seas Distribution and Manufacturing, LLC c/o Mr. Mark Ioele President 2620 S. Maryland Pkwy, Ste. 14 Unit 835 Las Vegas, Nevada 89109

NOV 1 0 2011

Re: K111557

Trade/Device Name: X Force Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NYN Dated: October 12, 2011 Received: October 27, 2011

Dear Mr. Ioele:

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.

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Page 2 - Mr. Mark loele

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices 、 Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/8/Picture/0 description: The image shows a black and white drawing of a person running. The person is in a sprinting position, with one leg forward and the other leg back. The arms are bent at the elbows, and the hands are clenched into fists. The person's head is turned to the side, and the face is not visible. The background is white.

SEVEN SEAS DISTRIBUTION ANI) MANUFACTURING LLC

INDICATIONS FOR USE

510(K) No : K111557

Device Name : X Force

Indications For Use:

The X-Force is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffess associated with pain, from rheumatoid arthritis of the Hand.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ERIC NELSON

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111557

2620 S. Maryland Parkway suite 14, Unit 835 Las Vegas, Nevada 89109 800.571.1846 Tel 702.974.1651

Page 1 of __ 1_

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).