Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states the software is embedded firmware for a microcontroller, a real-time loop that is event-driven based on button inputs, and there is no operating system. There is no mention of AI, ML, or related concepts.

Therapeutic

Yes
The device is intended to temporarily increase local blood circulation and is compared to a predicate TENS/NMES Stimulator (K092990), which are therapeutic devices.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" states the device is "To temporarily increase local blood circulation," which describes a therapeutic function, not a diagnostic one. There is no mention of identifying or characterizing a disease or condition. The device also mentions a predicate device which is a TENS/NMES Stimulator, which is a therapeutic device.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components including a battery-powered electrical stimulator, disposable gel electrodes, boots, and batteries, in addition to the embedded software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
StimSox™ Function: The StimSox™ System is described as a device that uses electrical stimulation to temporarily increase local blood circulation in healthy leg muscles. It applies electrical currents externally to the body.
Lack of Sample Analysis: There is no mention of the StimSox™ System analyzing any biological samples from the patient. Its function is based on applying electrical stimulation directly to the body.

Therefore, based on the provided information, the StimSox™ System falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The StimSox™ System is indicated to temporarily increase local blood circulation in healthy leg muscles.

Product codes

IPF

Device Description

The StimSox™ System is comprised of a battery powered electrical stimulator, disposable gel electrodes, two left foot boots, two right foot boots, three AAA batteries and user manual.

Device Characteristics

The StimSox™ Stimulator software is embedded firmware written for a microcontroller. The software in the StimSox™ Stimulator is for input controls and output display. There is no operating system. It is a real-time loop that is event driven based on the three buttons on the box.

Environment of Use

The StimSox™ System is designed to be used in healthcare facilities or home use. The StimSox™ System is intended to be provided to the patient by a medical practitioner.

Materials of Use

The patient contacting gel electrodes provided with the StimSox™ System are commercially cleared gel electrodes. The gel electrode materials were successfully tested per ISO 10993 for Cytotoxicity, Irritation and Sensitization. The results verified the gel electrode materials to be non-cytotoxic, non-irritating and non-sensitizing. The gel electrodes are intended to be disposed of after one use.

The material that makes up the patient contacting portion of the boot is made of medical grade 100% Nylon Fabric with a Polyester Foam Core and Nylon Tricot Backing Nylon. Each boot is intended to be used for up to 7 days of use.

Key Performance Specifications

The duration of patient use for the StimSox™ System will typically be 10 – 14 days as recommended by the ACCP (American College of Chest Physicians) or as prescribed by the patient's medical provider.

The StimSox™ Stimulator is a biphasic electrical stimulator that outputs a stimulating waveform in a prescribed pattern. The stimulator attaches to the outside of the StimSoxTM boot. The key features of this stimulator are:

1. Battery powered with certified electronics.
1. Protected from inadvertent changes of stimulation level using timed autolock.
1. Simple user interface.
Designed to be worn through all phases of immobility to full mobility 4. while performing normal daily activity, with the exception of driving or bathing.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

leg muscles, foot, calf muscles

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical practitioner, healthcare facilities or home use

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

The following performance data were provided in support of the substantial equivalence determination:

Risk Analysis results demonstrate acceptable potential and mitigated hazards.
Electrical Safety and Electromagnetic Compatibility (EMC)
Biocompatibility for Gel Electrodes
Software Verification

The data provided demonstrates that the StimSox™ is substantially equivalent to its predicate, and raises no new safety or effectiveness issues.

Key Metrics

Not Found

Predicate Device(s)

K092990

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

April 15, 2016

StimMed. LLC % Marlene Wright Barton President Wright Regulatory Consulting, LLC 3900 Galt Ocean Drive, Apt. 2501 Ft Lauderdale, Florida 33308

Re: K151922

Trade/Device Name: StimSox™ System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: April 11, 2016 Received: April 12, 2016

Dear Ms. Barton:

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.

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

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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Michael J. Hoffmann -A

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

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Indications for Use

510(k) Number (if known) K151922

Device Name StimSox(TM) System

Indications for Use (Describe)
To temporarily increase local blood circulation in healthy leg muscles.

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary StimSox™ System

I. SUBMITTER:

StimMed LLC

388 Evans Street Williamsville, New York 14221

Phone: 888-784-6633 Fax: 716-631-1273

Contact Person:	Robert E. Kaplan, MD
	President, StimMed LLC
	388 Evans Street
	Williamsville, NY 14221
	Fax: 716-883-3203
	REKaplanMD@aol.com

Date Prepared: April 13, 2016

II. DEVICE

Name of Device: StimSox™ System Common or Usual Name: Powered Muscle Stimulator Classification Name: Powered Muscle Stimulator (21 CFR 890.5850) Regulatory Class: Class II Product Code: IPF

III. PREDICATE DEVICE

Device Name: AMD 6605 TENS/NMES Stimulator 510(k) Number: K092990

To the best of our knowledge, the predicate device has not been the subject of any design related recalls.

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IV. DEVICE DESCRIPTION

Device Identification

The StimSox™ System is comprised of a battery powered electrical stimulator, disposable gel electrodes, two left foot boots, two right foot boots, three AAA batteries and user manual.

Device Characteristics

The StimSox™ Stimulator software is embedded firmware written for a microcontroller. The software in the StimSox™ Stimulator is for input controls and output display. There is no operating system. It is a real-time loop that is event driven based on the three buttons on the box.

Environment of Use

The StimSox™ System is designed to be used in healthcare facilities or home use. The StimSox™ System is intended to be provided to the patient by a medical practitioner.

Materials of Use

The patient contacting gel electrodes provided with the StimSox™ System are commercially cleared gel electrodes. The gel electrode materials were successfully tested per ISO 10993 for Cytotoxicity, Irritation and Sensitization. The results verified the gel electrode materials to be non-cytotoxic, non-irritating and non-sensitizing. The gel electrodes are intended to be disposed of after one use.

The material that makes up the patient contacting portion of the boot is made of medical grade100% Nylon Fabric with a Polyester Foam Core and Nylon Tricot Backing Nylon. Each boot is intended to be used for up to 7 days of use.

Key Performance Specifications

The duration of patient use for the StimSox™ System will typically be 10 – 14 days as recommended by the ACCP (American College of Chest Physicians) or as prescribed by the patient's medical provider.

The StimSox™ Stimulator is a biphasic electrical stimulator that outputs a stimulating waveform in a prescribed pattern. The stimulator attaches to the outside of the StimSoxTM boot. The key features of this stimulator are:

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1. Battery powered with certified electronics.
1. Protected from inadvertent changes of stimulation level using timed autolock.
1. Simple user interface.
Designed to be worn through all phases of immobility to full mobility 4. while performing normal daily activity, with the exception of driving or bathing.

INDICATIONS FOR USE V.

The StimSox™ System is indicated to temporarily increase local blood circulation in healthy leg muscles.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

| Comparison Feature | StimSoxTM
K151922 | AMD 6605
K092990 | Justification |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | StimMed, LLC | Advantageous Medical
Devices, LLC | N/A |
| Indications for Use | The StimSoxTM System is indicated
to temporarily
increase local blood
circulation in
healthy leg muscles. | Indications for TENS
function:
• Symptomatic relief
and management of
chronic (long-term),
intractable pain and an
adjunctive treatment in
the management of
post-surgical pain or
post-traumatic acute
pain.

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Electrode placement differences:

The predicate electrodes are placed on the calf muscles while the subject device electrodes are placed on the foot. However, in one study (Thrombosis and Haemostasis. Kaplan RE et al., Throm Haemost 2002;88:2004), stimulation of the foot vs. stimulation of the calf muscles were compared. It was found that the electrodes on the foot were more comfortable and increased the venous femoral and popliteal blood flow for both calf and plantar muscles. This study was not conducted with the predicate, however, it serves as a rationale that subject device can be atleast as safe and effective as the predicate device given similar parameters of operation.

Similarities:

Both the StimSox™ System and the predicate device have the following similarities:

Use commercially available gel electrodes ●
Battery operated (Direct Current (DC)) ●
Regulated current ●
Include an indicator display ●
Provide preset programs ●
Include continuous treatment time ●

Conclusion

The StimSox™ stimulator has the same technological characteristics as the predicate just fewer options for treatment programming as it is designed for NMES and the

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predicate is 510 (k) cleared for TENS and NMES. These differences do not raise any additional risks of safety or effectiveness.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Risk Analysis results demonstrate acceptable potential and mitigated hazards. ●
Electrical Safety and Electromagnetic Compatibility (EMC)
- o IEC 60601-1-6/A1:2013
- IEC 62366/A1:2014 O
- IEC 60602-1-11:2010 o
- IEC 60601-1-2:2007 (Ed. 3.0) о
- o IEC 60601-2-10: 2012
Biocompatibility for Gel Electrodes ●
- o Sensitization
- o Irritation
- o Cytotoxicity
Software Verification

The data provided demonstrates that the StimSox™ is substantially equivalent to its predicate, and raises no new safety or effectiveness issues.

VIII. OVERALL CONCLUSIONS

The performance data provide evidence that the StimSox™ System will perform as intended for the specified use conditions. The StimSox™ System is designed and verified for performance and safety. The performance of the StimSox™ System is determined to be substantially equivalent in indications, technical functions and operation to the predicate device. The Risk Analysis does not demonstrate any design or safety concerns.