Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a microcomputer-controlled electrotherapy device with simple programming, but there is no mention of AI, ML, or related concepts. The focus is on electrical stimulation and compression.

Therapeutic

Yes
The device is indicated for use as an adjunctive therapy in reducing pain and symptoms associated with osteoarthritis and rheumatoid arthritis, which are therapeutic purposes.

Diagnostic

No
The device description and intended use state that the X-Force system is an electrotherapy device for reducing pain and stiffness associated with osteoarthritis and rheumatoid arthritis. It applies electrotherapy and compression as a treatment, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "microcomputer controlled digital device" that "deploys the use of electrotherapy and compression." It also lists hardware components like "electrodes, the lead wires, and the signal generator." This indicates it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
X-Force Function: The description clearly states that the X-Force is an "external, non-invasive, non-narcotic, electrotherapy system." It applies electrical stimulation and compression externally to the knee or hand.
No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is to deliver therapy directly to the body surface.

Therefore, the X-Force falls under the category of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 stiffess associated with pain, from rheumatoid arthritis of the Hand.

Product codes

NYN

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.

Device Features:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee, Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Therapist in Neurology at health clinic and Chiropractor.

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)

Not Applicable as Jstim 1000 is already FDA Approved and the New Device X-Force is same as Predicate Device

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

Not Found

Predicate Device(s)

K073386

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

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

1

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 pain
relief (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

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.

Device Features:

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

2

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.

3

ANNEXURE 'IV'

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

| S.
No | Description | New Device
X-Force | Predicate Device
JSTIM (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 - ABS
Size - (142 X 62 X 26) mm
12.875 ounce (365 Grams) with battery,
8.924 ounce (253 Grams) without battery | Material - ABS
Size - (45 x 30 x 15) mm
2.8 ounce (65 Grams) with battery, 1.6 ounce (45.8 Grams) without battery | Similar |
| 3 | Number of Output
Channels | 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 of
populaces | Therapist in Neurology at health clinic and Chiropractor. | Therapist in Neurology at health clinic and Chiropractor. | Same |

:

.

4

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 and
Manufacturing LLC	Pain Management
Technologies, Inc.
4	Power source	Rechargeable Battery(4 X 1.2V

AA size) | 9V Li ion battery |
| 5 | Method of Line Current
Isolation | (a) Since Instruments
operates on battery, hence it
is completely isolated from
Mains Supply. | (a) Since Instruments
operates on battery, hence it
is completely isolated from
Mains Supply. |
| 6 | Patient Leakage Current
Normal condition
Single Fault condition | (b) Patient Leakage Current
Normal condition = less than
100μΑ*
Single fault condition = less
than 300µA*

Reference: IEC 60601-1 | (b) Patient Leakage Current
Normal condition = less than
100μΑ*
Single fault condition = less
than 300µA*
Reference: IEC 60601-1 |
| 7 | Number of Output Modes | 1 | 1 |
| 8 | Number of Output
Channels
Synchronous or Alternating? | Synchronous
Channel 1 and 2 are
completely isolated. Both have
designated Amplifier & control
circuit, Only power supply and
ground are common. | Synchronous
Channel 1 and 2 are
completely isolated. Both
have designated Amplifier &
control circuit Only power
supply and ground are
common |
| 9 | Regulated Current or
Regulated 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? | YES
YES
YES | YES
YES
YES |
| 21 | Timer | YES | YES |
| 22 | Compliance with Voluntary
Standards | NO | NO |
| 23 | Compliance With 21 CFR
898 | YES, the electrode cable can
never be plugged in the AC | YES, the electrode cable can
never 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 |

5

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 adjective
Therapy in reducing the level of pain and symptoms
associated with Osteoarthritis of the knee and
Rheumatoid Arthritis of the Hand. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Technological Comparison: The technological characteristics (Energy Source, Design,
Material and Physical Characteristics) of modified device
has been compared with Jstim 1000 and found to be
same as the predicate device Jstim 1000.
Below are the differences: |
| 1) | Power source: Jstim 1000 has power source of 9Volt
where as X-Force have Power source of 1.2 DC X 4
Battery) which are more power full compare to 9VDC
battery thus giving more battery backup. This change
only increase battery backup of Unit and there is no
effect on the safety or effectiveness of the device. |
| 2) | Program Lock feature: X-Force have Program Lock
feature which is not present in Jstim 1000. This feature
give user to lock the used parameter, this function
doesn't affect any parameter which can make New device
different from Predicate |
| 3) | Digital Control of Output Power: Jstim 1000 output
power is controlled through Analog pots where in X-Force
Output power is controlled digitally through
Microcontroller. |
| Labeling Comparison | : Labeling of the device compares to that of predicate
device. |
| 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 |
| Conclusion | : Drawn from the comparison between the modified device
X-Force with predicate device J Stim 1000, it
demonstrates that X-Force is as safe, as effective and
performs as well as its predicate device. |

ﺎﺭ ﺗﻮ

6

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.

7

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

8

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 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.

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

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