(110 days)
No
The device description outlines a simple electrical stimulator with preset programs and user-adjustable intensity. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
Yes
The device is described as an "electrical stimulator" used to achieve specific health benefits, such as increasing blood circulation, preventing venous thrombosis and disuse atrophy, and reducing edema, which are all therapeutic outcomes.
No
The device is described as an electrical stimulator used for therapeutic purposes like increasing blood circulation, preventing muscle atrophy, and reducing edema, not for diagnosing medical conditions.
No
The device description explicitly states it is a "portable, battery powered, hand-held 4-channel electrical stimulator (single unit)", indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the FA100 SCCD is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a physiological state, health, disease, or congenital abnormality.
- The FA100 SCCD is an electrical stimulator. It applies electrical pulses to the calf muscles to achieve therapeutic effects like increasing blood circulation, preventing thrombosis, and reducing edema. It does not analyze any biological samples.
The description clearly indicates that the device is a physical therapy device that directly interacts with the patient's body through electrical stimulation, not through the analysis of in vitro samples.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IPF
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:
-
- 4 Hz (program AA)
-
- 9 Hz (program VE - the default setting of the device)
-
- 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 by the user to achieve the maximum tolerable contraction. Otherwise, the pulse shape (rectangular, symmetrical, bi-phasic), pulse width (500 microsec), and stimulation pattern (sequential channel activation) are the same for all three programs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Calf muscles, legs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, with therapy session as recommended by the patient's healthcare provider (inference).
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)
Study Type: Clinical study comparing the FA100 SCCD to compression therapy for edema treatment.
Sample Size: 15 patients with chronic venous insufficiency (CVI) in both legs.
Key Results:
- The FA100 SCCD was used in the home on one leg for 2 hours daily for 30 days. The compression device was used for the same length of time on the other leg.
- After 30 days of treatment, the average circumference at both the ankle and calf decreased for the legs treated with the FA100 SCCD (21.9% and 19.5%, respectively, both p
§ 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).
0
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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
1
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 (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,
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: (214) 461-3225 Email: Jacob@FlowAid.com
- 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:
-
- 4 Hz (program AA)
-
- 9 Hz (program VE - the default setting of the device)
-
- 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
4
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
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
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
battery cells | Rechargeable lithium-ion
polymer battery | Both devices are
battery powered. |
| Method of Isolating
User from Mains | Plastic slider over the
charging port prevents
charging when electrode
cable is connected to the
device | Not stated in 510(k)
Summary | New device cannot be
used for treatment
when the battery is
connected to mains
for charging. |
| Number of Output
Modes | 1
NMES | 3
NMES
Pulsed stimulation
Interferential stimulation | New device is a subset
of predicate device.* |
| Number of Output
Channels | 4 | 2 | New device has 4
output channels, but |
| Synchronous or
alternating? | Sequential Stimulation of
electrode pairs:
4-1, 1 - 2, 2 - 3, 3 - 4 | Unknown | only 2 are active at a
time.* |
| Method of channel
isolation? | Capacitor | Transformer | Both are accepted
methods of channel
isolation. |
| | New Device | Predicate Device | Basis for Substantial
Equivalence |
| Regulated current or
voltage | Current regulated | Current regulated | Same |
| Microprocessor
controlled? | Yes | Yes | Same |
| Automatic overload
trip | Yes | No | Automatic overload
trip of new device is
added safety feature. |
| Automatic no-load trip | Yes | Yes | Same |
| Automatic shut-off | Yes - at end of battery life,
approximately 50 hours of
continuous treatment | Yes | Same |
| Patient over-ride
control | Yes | Yes | Same |
| Indicator Display: | | | Same |
| - On/off status | Yes | Yes | |
| - Low battery | Yes | Yes | |
| - Voltage/ current
level | Yes – numerical indication
of signal intensity (voltage
value) | Yes | |
| Number of Preset
Programs | 3 | 3 for NMES | Same for NMES |
| Timer range in minutes | No timer
Device will operate until
turned off by user or
battery depleted. | 10 – 60 min in 5 min
increments | Timer not needed for
safe application. |
| Compliance with
voluntary standards | Yes | Yes | Same |
| Compliance with 21
CFR 898 | Yes | Not stated in 510(k)
Summary | Compliant with
electrode
performance
standard. |
| Weight | 230 g, including batteries | 340 g, including battery | Both are lightweight
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
Construction | Injection molded plastic | Injection molded plastic | Same |
| | New Device | Predicate Device | Basis for Substantial
Equivalence |
| Output Specifications | | | |
| Waveform | Symmetrical bi-phasic
rectangular wave with 0
net DC | NMES - Symmetrical bi-
phasic square wave with 0
net DC | Essentially the same. |
| Maximum output
voltage (500 Ω load) | 80 V (±10%) | Not stated in 510(k)
Summary | 80V is within the
acceptable range of
max voltage for NMES
devices.* |
| Maximum output
current (500 Ω load) | 160 mA (±10%) | 100 mA | 160 mA is within the
acceptable range of
max current for NMES
devices.* |
| Pulse Width | Fixed – 500 µsec | 70 – 300 µsec | 500 µsec is within the
acceptable range of
pulse widths for NMES
devices.* |
| Frequency | 4 Hz, 9 Hz, or 14 Hz
depending on therapy
setting | 10 – 80 Hz | 4, 9 and 14 Hz are
within the acceptable
range of frequencies
for NMES devices.* |
| Net charge - how
achieved | 0 µC, phase balancing | 0 µC, phase balancing | Same |
| Maximum phase
charge | 8 µC | 30 µC for NMES
60 µC for Pulsed | 8 µC is within the
acceptable range of
phase charge for
NMES devices* |
| Maximum Current
Density | 6.4 mA/cm² | 0.19 mA/cm² for NMES
(average)
0.13 mA/cm² for Pulsed
(average) | 6.4 mA/cm² is within
the acceptable range
of current densities
for NMES devices.* |
| Maximum Power
Density | 0.000041 W/cm² | 0.019 W/cm² for NMES
(average)
0.013 W/cm² for Pulsed
(average) | 0.000041 W/cm² is
within the acceptable
range of power
densities for NMES
devices.* |
| Burst mode | N/A | N/A | Same |
| ON Time (sec)
OFF Time (sec) | Sequential channel
activation. Channel ON and
OFF times depend on
program (frequency). | ON: 1 – 30 s
OFF: 1-60 s | Sequential continuous
contraction pattern of
new device is
substantially
equivalent to |
| | New Device | Predicate Device | Basis for Substantial
Equivalence |
| | Program AA (4 Hz)
ON: 1 s, OFF: 3 s
Program VE (9 Hz):
ON: 0.44 s; OFF: 1.32 s
Program PA (14 Hz):
ON: 0.29 s; OFF: 0.87 s
One channel always ON for
continuous stimulation. | | predicate and other
NMES devices that
offer varying ON / OFF
patterns for electrode
stimulation.* |
| Electrodes | Manufactured by Top Rank,
China and cleared under
K132588.
Hydrogel applied to silver
electrode. Biocompatibility
has been established.
Single patient use, can be
reused many times before
disposal, recommend
replacing every 10 days. | Electrode pads not
described in 510(k)
Summary | FA100 SCCD
electrodes were
previously cleared by
FDA. |
5
6
7
8
*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.
-
- 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.
-
- 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
9
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).
-
- 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).
-
- 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).
-
- 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.
-
- 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.
-
- 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).
-
- 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
10
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, | |
| Litman L, Rosenblum J. | |
| Sequential contraction | |
| compression devices reduce leg | |
| circumference in patients with | |
| chronic venous insufficiency. J | |
| Vasc Med & Surg 2016; | |
| 4(4):283. doi 10.4172/2329- | |
| 6925.1000283. | Compared the use of the FA100 SCCD to compression therapy for the |
| treatment of edema in 15 patients with chronic venous insufficiency (CVI) in | |
| both legs. The FA100 SCCD was used in the home on the same leg for 2 | |
| hours daily for 30 days. The compression device was used for the same | |
| length of time on the other leg. After 30 days of treatment, the average | |
| circumference at both the ankle and calf decreased for the legs treated | |
| with the FA100 SCCD (21.9% and 19.5%, respectively, both p |