FA100 SCCD (Sequential Continuous Contraction Device)

K162987 · Flowaid Medical Technologies, Corp · IPF · Feb 14, 2017 · Physical Medicine

Device Facts

• Record ID: K162987
• Device Name: FA100 SCCD (Sequential Continuous Contraction Device)
• Applicant: Flowaid Medical Technologies, Corp
• Product Code: IPF · Physical Medicine
• Decision Date: Feb 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Increasing local blood circulation, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Preventing or retarding disuse atrophy, Edema reduction

Device Story

FA100 SCCD is a portable, battery-powered, 4-channel neuromuscular electrical stimulator (NMES). Device provides continuous, sequential electrical stimulation to calf muscles to induce muscle contraction. User selects one of three preset pulse frequencies (4 Hz, 9 Hz, 14 Hz) and adjusts stimulus intensity via LCD interface to achieve maximum tolerable contraction. Device operates via microprocessor control, delivering symmetrical bi-phasic rectangular pulses (500 µsec width). Used in home settings by patients as recommended by healthcare providers. Output sequence rotates through four channels to promote blood flow and prevent atrophy. Device includes automatic overload and no-load trip safety features. Benefits include edema reduction, prevention of venous thrombosis, and maintenance of muscle function. Healthcare providers use output to monitor therapy adherence and adjust settings for patient comfort.

Clinical Evidence

Prospective study of 15 patients with chronic venous insufficiency (CVI). Compared FA100 SCCD to compression therapy over 30 days (2 hours daily). Primary endpoints: change in ankle and calf circumference. Results: FA100 SCCD treated legs showed significant reduction in circumference (ankle 21.9%, calf 19.5%, p<.001), outperforming compression therapy. No adverse events reported.

Technological Characteristics

Portable 4-channel NMES; battery-powered (4x 1.2V NiMH); injection-molded plastic housing. Symmetrical bi-phasic rectangular waveform; 500 µsec fixed pulse width; 4/9/14 Hz frequency settings. Current regulated; microprocessor-controlled. Safety features: automatic overload/no-load trip, automatic shut-off. Connectivity: standalone. Sterilization: N/A (single-patient use electrodes). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62304.

Indications for Use

Indicated for increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, preventing or retarding disuse atrophy, and edema reduction.

Regulatory Classification

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.

Predicate Devices

• IF 3Wave (K050046)

Reference Devices

• RS-4i Plus Sequential Stimulator (K112348)
• Sys*Stim 208/208A (K031017)
• geko T-1 (K133638)

Submission Summary (Full Text)

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

February 14, 2017

FlowAid Medical Technologies, Corp. Mr. Jacob Brezel CEO 44 Wall Street New York, New York 10005

Re: K162987

Trade/Device Name: FA100 SCCD (Sequential Continuous Contraction Device) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: January 4, 2017 Received: January 5, 2017

Dear Mr. Brezel:

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 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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely,

# Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for 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) K162987

Device Name

FA100 SCCD (Sequential Continuous Contraction Device)

Indications for Use (Describe)

- · Increasing local blood circulation
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Preventing or retarding disuse atrophy
- Edema reduction

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

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

# K162987

Traditional 510(k) Summary, as required by 21 CFR 807.92

A. Submitter: FlowAid Medical Technologies Corp. 44 Wall Street, 2nd Floor, New York, NY 10005

Contact person: Mr. Jacob Brezel, CEO Phone: [phone] Email: [e-mail]

- B. Date Prepared: February 13, 2017
#### ﻥ Device Name and Classification:

| Trade name: | FA100 SCCD (Sequential Continuous Contraction Device) |
|----------------------|-------------------------------------------------------|
| Common name: | Neuromuscular Electrical Stimulator (NMES) |
| Classification name: | Powered Muscle Stimulator |
| Regulatory Class: | Class II |
| Product Code: | IPF |
| Review Panel: | Physical Medicine |

- D. Predicate Device: IF 3Wave - K050046
#### ن Device Description:

The FA100 SCCD is a portable, battery powered, hand-held 4-channel electrical stimulator (single unit) intended to provide continuous, sequential stimulation of the calf muscles. The FA100 SCCD designed to be user friendly and simple to use, with a large liquid crystal display (LCD) screen that displays the treatment mode currently in use and the selected intensity level for the patient to select a comfortable therapy session as recommended by the patient's healthcare provider.

The FA100 SCCD system provides three preset treatment programs, which enable the patient to choose among three pulse frequencies:

- 1. 4 Hz (program AA)
- 2. 9 Hz (program VE - the default setting of the device)
- 3. 14 Hz (program PA)

Pulse frequency is the only difference between the three programs and is selected for patient comfort during the treatment as recommended by the patient's healthcare provider. The stimulation provided by the FA100 SCCD rotates in a continuous, sequential pattern through the four channels. The rotation through the channels is directly related to the frequency setting, i.e., slowest for the 4 Hz program and fastest for the 14 Hz program. All programs effectively contract the muscles and increase blood flow. The only other parameter that can be varied is the stimulus intensity, which is set

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by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 µsec), and stimulation pattern (sequential channel activation) are the same for all three programs.

#### Indication for Use/Intended Use: F.

The FA100 SCCD is indicated for use in:

- Increasing local blood circulation,
- . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- Preventing or retarding disuse atrophy
- Edema reduction

## G. Substantial Equivalence

The table below provides the basic unit characteristics and output specifications for the subject and predicate device as outlined in the Powered Muscle Stimulator Guidance Document issued on June 9, 1999.

| | New Device | Predicate Device | Basis for Substantial<br>Equivalence |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K162987 | K050046 | N/A |
| Device Name & Model | FA100 SCCD | IF 3Wave | NA |
| Manufacturer | FlowAid | Empi | N/A |
| Indications for Use | As a muscle stimulator Increase local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Prevention or retardation of disuse atrophy Reduction of edema | As a muscle stimulator Increase local blood circulation Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Relax muscle spasms Prevent or retard disuse atrophy Maintain or increase range of motion Muscle re-education As a Pulsed DC Stimulator Reduction of edema (under the negative electrode) Reduction of muscle spasm | Indications for new device are a subset of those for predicate device.* Clinical data is provided to support indications for use. |
| | New Device | Predicate Device | Basis for Substantial<br>Equivalence |
| | | Influencing local blood circulation (under the negative electrode) Retardation or prevention of disuse atrophy Facilitation of voluntary motor function Maintenance or increase of range of motion As an interferential stimulator Relieve acute pain Relieve and manage chronic pain Relax muscle spasms Maintain and increase the range of motion Increase local blood circulation | |
| Basic Unit Characteristics | | | |
| Power Source | Four 1.2VDC GP NiMH<br>battery cells | Rechargeable lithium-ion<br>polymer battery | Both devices are<br>battery powered. |
| Method of Isolating<br>User from Mains | Plastic slider over the<br>charging port prevents<br>charging when electrode<br>cable is connected to the<br>device | Not stated in 510(k)<br>Summary | New device cannot be<br>used for treatment<br>when the battery is<br>connected to mains<br>for charging. |
| Number of Output<br>Modes | 1<br>NMES | 3<br>NMES<br>Pulsed stimulation<br>Interferential stimulation | New device is a subset<br>of predicate device.* |
| Number of Output<br>Channels | 4 | 2 | New device has 4<br>output channels, but |
| Synchronous or<br>alternating? | Sequential Stimulation of<br>electrode pairs:<br>4-1, 1 - 2, 2 - 3, 3 - 4 | Unknown | only 2 are active at a<br>time.* |
| Method of channel<br>isolation? | Capacitor | Transformer | Both are accepted<br>methods of channel<br>isolation. |
| | New Device | Predicate Device | Basis for Substantial<br>Equivalence |
| Regulated current or<br>voltage | Current regulated | Current regulated | Same |
| Microprocessor<br>controlled? | Yes | Yes | Same |
| Automatic overload<br>trip | Yes | No | Automatic overload<br>trip of new device is<br>added safety feature. |
| Automatic no-load trip | Yes | Yes | Same |
| Automatic shut-off | Yes - at end of battery life,<br>approximately 50 hours of<br>continuous treatment | Yes | Same |
| Patient over-ride<br>control | Yes | Yes | Same |
| Indicator Display: | | | Same |
| - On/off status | Yes | Yes | |
| - Low battery | Yes | Yes | |
| - Voltage/ current<br>level | Yes – numerical indication<br>of signal intensity (voltage<br>value) | Yes | |
| Number of Preset<br>Programs | 3 | 3 for NMES | Same for NMES |
| Timer range in minutes | No timer<br>Device will operate until<br>turned off by user or<br>battery depleted. | 10 – 60 min in 5 min<br>increments | Timer not needed for<br>safe application. |
| Compliance with<br>voluntary standards | Yes | Yes | Same |
| Compliance with 21<br>CFR 898 | Yes | Not stated in 510(k)<br>Summary | Compliant with<br>electrode<br>performance<br>standard. |
| Weight | 230 g, including batteries | 340 g, including battery | Both are lightweight<br>and portable. |
| Dimensions | 2.8" x 5.1" x 1.1" | 3.9" x 6.3" x 1.4" | Both are small. |
| Housing Materials of<br>Construction | Injection molded plastic | Injection molded plastic | Same |
| | New Device | Predicate Device | Basis for Substantial<br>Equivalence |
| Output Specifications | | | |
| Waveform | Symmetrical bi-phasic<br>rectangular wave with 0<br>net DC | NMES - Symmetrical bi-<br>phasic square wave with 0<br>net DC | Essentially the same. |
| Maximum output<br>voltage (500 Ω load) | 80 V (±10%) | Not stated in 510(k)<br>Summary | 80V is within the<br>acceptable range of<br>max voltage for NMES<br>devices.* |
| Maximum output<br>current (500 Ω load) | 160 mA (±10%) | 100 mA | 160 mA is within the<br>acceptable range of<br>max current for NMES<br>devices.* |
| Pulse Width | Fixed – 500 µsec | 70 – 300 µsec | 500 µsec is within the<br>acceptable range of<br>pulse widths for NMES<br>devices.* |
| Frequency | 4 Hz, 9 Hz, or 14 Hz<br>depending on therapy<br>setting | 10 – 80 Hz | 4, 9 and 14 Hz are<br>within the acceptable<br>range of frequencies<br>for NMES devices.* |
| Net charge - how<br>achieved | 0 µC, phase balancing | 0 µC, phase balancing | Same |
| Maximum phase<br>charge | 8 µC | 30 µC for NMES<br>60 µC for Pulsed | 8 µC is within the<br>acceptable range of<br>phase charge for<br>NMES devices* |
| Maximum Current<br>Density | 6.4 mA/cm² | 0.19 mA/cm² for NMES<br>(average)<br>0.13 mA/cm² for Pulsed<br>(average) | 6.4 mA/cm² is within<br>the acceptable range<br>of current densities<br>for NMES devices.* |
| Maximum Power<br>Density | 0.000041 W/cm² | 0.019 W/cm² for NMES<br>(average)<br>0.013 W/cm² for Pulsed<br>(average) | 0.000041 W/cm² is<br>within the acceptable<br>range of power<br>densities for NMES<br>devices.* |
| Burst mode | N/A | N/A | Same |
| ON Time (sec)<br>OFF Time (sec) | Sequential channel<br>activation. Channel ON and<br>OFF times depend on<br>program (frequency). | ON: 1 – 30 s<br>OFF: 1-60 s | Sequential continuous<br>contraction pattern of<br>new device is<br>substantially<br>equivalent to |
| | New Device | Predicate Device | Basis for Substantial<br>Equivalence |
| | Program AA (4 Hz)<br>ON: 1 s, OFF: 3 s<br>Program VE (9 Hz):<br>ON: 0.44 s; OFF: 1.32 s<br>Program PA (14 Hz):<br>ON: 0.29 s; OFF: 0.87 s<br>One channel always ON for<br>continuous stimulation. | | predicate and other<br>NMES devices that<br>offer varying ON / OFF<br>patterns for electrode<br>stimulation.* |
| Electrodes | Manufactured by Top Rank,<br>China and cleared under<br>K132588.<br>Hydrogel applied to silver<br>electrode. Biocompatibility<br>has been established.<br>Single patient use, can be<br>reused many times before<br>disposal, recommend<br>replacing every 10 days. | Electrode pads not<br>described in 510(k)<br>Summary | FA100 SCCD<br>electrodes were<br>previously cleared by<br>FDA. |

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*See Discuss of Differences below.

# Discussion of Differences

FDA has cleared more than 500 powered muscle stimulators under Product Code IPF, encompassing a wide variety of technical specifications, all of which have been found safe and effective for neuromuscular electrical stimulation. Where appropriate, other legally marketed NMES devices are cited below to demonstrate that the technological differences of the FA100 SCCD as compared to the named predicate device do not raise new questions of safety or effectiveness that have not previously been considered by FDA for NMES devices. In addition, clinical data from studies of the FA100 SCCD are summarized in Section I of this 510(k) Summary to support the safety and effectiveness of the new device for its indications for use.

- 1. Indications for Use: The FA100 SCCD indications for use are a subset of the predicate indications for use. The proposed indications for the FA100 SCCD are all supported by clinical studies conducted using the device (see Section I). The FA100 SCCD does not have any indications for use that are not also cleared for the predicate device; therefore, no new questions of safety or effectiveness are raised by this difference.
- 2. Number of output channels: The FA100SCCD has four output channels as compared to two for the predicate device. However, this does not raise any new questions of safety or effectiveness because only one channels is active at any one time to drive one electrode pair. In addition, FDA has cleared many other NMES devices that have

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more than two output channels (e.g., RS-4i Plus Sequential Stimulator, K112348, providing options of 2, 4, or 8 electrodes applied to multiple anatomical sites).

- 3. Maximum output current (stimulus intensity): The stimulus intensity of the FA100 SCCD is set to achieve visible contraction of the calf muscles at a level tolerable to the patient. Stimulus intensity can be varied from 1V to 80V in 1V increments. The maximum voltage corresponds to a maximum current of 160 mA, which is somewhat higher than that of the predicate device (100 mA max), but is within the specifications for other legally marketed NMES devices (e.g., Sys*Stim 208/208A, K031017, with a maximum output voltage of 92 V and a maximum output current of 184 mA).
- 4. Pulse width: The FA100 SCCD has a fixed pulse width of 500 µsec, which is somewhat longer than that of the predicate device (300 usec max), but is within the specifications for other legally marketed NMES devices (e.g., geko T-1, K133638, 560 usec max pulse width).
- 5. Frequency: The FA100 SCCD offers three stimulus settings that differ only in the pulse frequency: 4 Hz, 9 Hz and 14 Hz. While the two lowest frequencies are somewhat lower than the range offered by the predicate device (10 – 80 Hz), they are within the range offered by other legally marketed NMES devices (e.g., geko T-1, K133638, 1 Hz fixed pulse frequency). Clinical data are provided to demonstrate that the low frequency settings of the FA100 SCCD are safe and effective for the device intended uses.
- 6. Maximum phase charge: The 8 µC max phase charge for the FA100 SCCD is lower than that of the predicate device (30 µC max for NMES), which indicates added safety for the new device. Clinical data are provided to demonstrate that the FA100 SCCD is effective for its intended uses.
- 7. Maximum current density: The 6.4 mA/cm² max current density for the FA100 SCCD is higher than the current density stated in the 510(k) summary for the predicate device (0.19 mA/cm² for NMES); however, this is stated as an average, not maximum, current density. The max current density for the FA100 SCCD is the same as that for the geko T-1 (6.67 mA/cm², see K133638).
- Maximum power density: The 0.000041 W/cm² max power density for the FA100 8. SCCD is lower than for the predicate device (0.019 W/cm² for NMES, stated as average), but is the same as that of the geko T-1 (0.000044 W/cm², see K133638).
- 9. Stimulation sequence (On/Off times): The FA100 SCCD provides a continuous sequential stimulation pattern in which one of the four channels are on at a time. The On and Off times for each channel are driven by the chosen frequency. The predicate device and many other powered muscle stimulators provide flexibility to enable varying On and Off times for each channel.

## H. Non-Clinical Performance Data

To demonstrate safety and effectiveness of the FA100 SCCD and to comply with the requirements of the FDA Guidance Document "Guidance Document for Powered Muscle Stimulator 510k's) and to demonstrate substantial equivalence to the predicate device, FlowAid has completed a number of non-clinical performance tests. The FA100 SCCD

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meets established requirements for overall design, electrical safety and software validation confirming that the design outputs meet design input requirements and established specifications.

The FA100 SCCD device successfully passed all testing in accordance with internal requirements, national and international standards and the FDA Guidance Document cited above. These included:

- Electrical safety per IEC 60601-1:2012
- EMC testing per IEC 60601-1-2: 2007
- Electrical testing per IEC 60601-2-10:2012 (Particular requirements for the ● safety of nerve and muscle stimulators)
- . Electrical testing per IEC 60601-1-11:2010 (Basic safety, equipment used in home health environment
- . Software validation per IEC 62304:2006

The FA100 SCCD passed all the testing in accordance with internal requirements, national standards, and international standards. Internal verification and validation testing confirms that all product specifications and user requirements have been met, which support the intended use and technological characteristic of the device when compared to the predicate device. The information presented supports that the FA100 SCCD is substantially equivalent to the referenced predicate device.

#### l. Clinical Performance Data:

| Publication | Summary |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gimmelreich D, Karsilnikov V,<br>Litman L, Rosenblum J.<br>Sequential contraction<br>compression devices reduce leg<br>circumference in patients with<br>chronic venous insufficiency. J<br><i>Vasc Med &amp; Surg</i> 2016;<br>4(4):283. doi 10.4172/2329-<br>6925.1000283. | Compared the use of the FA100 SCCD to compression therapy for the<br>treatment of edema in 15 patients with chronic venous insufficiency (CVI) in<br>both legs. The FA100 SCCD was used in the home on the same leg for 2<br>hours daily for 30 days. The compression device was used for the same<br>length of time on the other leg. After 30 days of treatment, the average<br>circumference at both the ankle and calf decreased for the legs treated<br>with the FA100 SCCD (21.9% and 19.5%, respectively, both p<.001). In<br>addition, the average changes in ankle and calf circumference were greater<br>for the FA100 SCCD treated legs as compared to the legs treated with<br>compression. No adverse events were reports. |

#### J. Statement of Substantial Equivalence:

FlowAid has demonstrated that the FA100 SCCD (Sequential Continuous Contraction Device) is substantially equivalent to the predicate device because it has the same intended use as a powered muscle stimulator, is intended to be used for a subset of the indications for use, and has similar technological characteristics. Clinical data are provided to demonstrate that the FA100 SCCD is safe and effective for the proposed indications for use.