(426 days)
Powered Muscle Stimulator
- · To temporarily increase local blood circulation in healthy leg muscles.
- · To stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS
- · For temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.
The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher.
The provided text describes a 510(k) premarket notification for the FlowKeepers® device, a powered muscle stimulator. The FDA's review assesses substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria that the device must meet in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance testing" section describes compliance with electrical and safety standards, rather than clinical performance metrics.
The comparison table provided (pages 5-6) highlights the technological characteristics of the FlowKeepers® and its predicate devices, implying that similarity in these characteristics, combined with compliance to safety standards, is the basis for acceptance.
| Feature / Standard | Acceptance Criteria (Implied by Predicate Equivalence & Standards) | Reported Device Performance (FlowKeepers®) |
|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications for Use (Powered Muscle Stimulator) | Temporarily increase local blood circulation in healthy leg muscles; Stimulate healthy muscles to improve/facilitate muscle performance. | Meets these indications. |
| Intended Use/Indications for Use (TENS) | Temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties, and work activities. | Meets these indications. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 3: 2007-03. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (General) | Compliance with IEC 60601-1-8:2006 & A1:2012. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (Home Healthcare Environment) | Compliance with IEC 60601-1-11 Edition 1.0 2010-04. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (Programmable Systems) | Compliance with IEC 60601-1-4. | "functioned as intended and the results observed were as expected." |
| Electrical Safety (Nerve and Muscle Stimulators) | Compliance with IEC 60601-2-10 Edition 2.0 2012-06. | "functioned as intended and the results observed were as expected." |
| Waveform | Similar to predicate (Pulsed symmetrical biphasic and bipolar). | Pulsed symmetrical biphasic and bipolar. |
| Max Output Voltage, Current, Pulse Duration, Frequency, Net Charge, Max Phase Charge, Current Density, Power Density | Parameters within acceptable range to not adversely impact safety or effectiveness, similar to other cleared devices (K160508). | Max output voltage: 166V@500Ω, 252V@2kΩ, 290V@10kΩ. Max output current: 332mA@500Ω, 126mA@2kΩ, 29mA@10kΩ. Pulse Duration: 150 µs +150 µs ±10%. Frequency: 100mHz ±10%. Net Charge per Pulse: 0 @500Ω. Maximum Phase Charge: 2.25 @500Ω. Maximum Current Density: 0.789 mA/cm²@500Ω. Maximum Power Density: 0.00177 mW/cm²@ 500Ω. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a test set or clinical study with human subjects for evaluating the FlowKeepers® device's effectiveness in terms of its stated indications (e.g., increasing local blood circulation, stimulating muscles, or pain relief).
The "Performance Testing" section refers to non-clinical tests (Electromagnetic compatibility, electrical safety, and other performance testing) conducted in accordance with specified IEC standards. These are likely bench tests and laboratory evaluations rather than tests on human subjects.
Therefore:
- Sample size for test set: Not applicable, as no human subject test set is described for performance evaluation.
- Data provenance: Not applicable. The data provenance would be from laboratory/bench testing, not patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. Since no human clinical data is presented for performance evaluation, there is no need for experts to establish ground truth for a test set. The validation is against engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable, as no human clinical test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states "non-clinical tests" were conducted. There is no mention of a clinical study, an MRMC study, or any comparison of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
No. The FlowKeepers® is a physical medical device (powered muscle stimulator), not an algorithm or AI. The performance testing revolves around the device's adherence to electrical and safety standards.
7. Type of Ground Truth Used:
The ground truth used for the "performance testing" described are the specifications and requirements defined within the cited IEC and UL standards (e.g., limits for electromagnetic emissions, electrical safety parameters, performance under various environmental conditions). The device passed these technical standards.
For demonstrating substantial equivalence, the "ground truth" is the performance and safety profile of the predicate devices, which the FlowKeepers® is compared to technologically.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that would require a "training set." The testing described is for a hardware device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set is involved.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2017
DK Electronics, LLC Avery Huff Operations Mgr 413-B Elmwood Ave, Sharon Hill, Pennsylvania 19079
Re: K160323
Trade/Device Name: FlowKeepers® Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH Dated: February 22, 2017 Received: March 7, 2017
Dear Avery Huff:
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 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.
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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 -S
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) K160323
Device Name FlowKeepers®
Indications for Use (Describe)
Powered Muscle Stimulator - To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
TENS
- For temporary relief of pain associated with sore and aching muscles of the lower extremities (legs) due to strain from exercise or normal household and work activities
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K160323
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| Submitter: | DK Electronics, LLC |
|---|---|
| Submitter Address: | 413-B Elmwood Ave, Sharon Hill, PA 19079 |
| Phone: | 855-494-5158 |
| Facsimile: | 484-494-5163 |
| Contact Person: | Avery Huff |
| Email: | avery_huff@yahoo.com |
| Date Prepared: | 4/6/2017 |
Trade Name and Classification of Device
| Trade Name of Device: | FlowKeepers® |
|---|---|
| Common Name: | Powered Muscle StimulatorNeuromuscular electrical stimulator devices (NMES) |
| Classification: | Powered Muscle Stimulator (21 CFR 890.5850) |
| Product Codes: | Primary - NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)Secondary - NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter) |
| Review Panel: | Physical Medicine |
Predicate Devices
Revitive IX® (OTC), Actegy Ltd. (K143207) – NGX, NUH 21 CFR 890.5850 Pennypad PP-904 Rapid Relief™ (OTC), HiVox Biotek, Inc. (K140650) – NUH, 21 CFR 890.5890
Intended Use/ Indications for Use
Powered Muscle Stimulator
- · To temporarily increase local blood circulation in healthy leg muscles.
- · To stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS
- · For temporary relief of pain associated with sore and aching muscles in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.
Device Description
The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher. To see how FlowKeepers® technological characteristics are similar to the predicate device, see the comparison chart below under the Substantial Equivalence heading.
Performance Testing
Electromagnetic compatibility, electrical safety testing, and other performance testing were conducted in
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accordance with the following standards
IEC 60601-1-8:2006 & A1:2012 Medical electrical equipment Part 1: General requirements for safety
IEC 60601-1-2 Edition 3: 2007-03 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic compatibility- Requirements and tests
IEC 60601-1-11 Edition 1.0 2010-04
Medical electrical equipment Part 1-11: General Requirements for basic safety and essential performance Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-4 Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-2-10 Edition 2.0 2012-06 Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators.
In all instances, the FlowKeepers® functioned as intended and the results observed were as expected.
Substantial Equivalence
The FlowKeepers® is substantially equivalent to other powered muscle stimulators such as Revitive IX® OTC (K143207). The FlowKeepers® has the same intended uses and similar indications, technological characteristics, and principles of operation as the Revitive IX® OTC. The difference in design and the minor technological differences between the FlowKeepers® and its predicate device Revitive IX® OTC raise no new issues of safety or effectiveness. Performance data demonstrate that the FlowKeepers® is as safe and effective as the predicate device. Thus, the FlowKeepers® is substantially equivalent.
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Comparison of FlowKeepers® with Revitive IX® (OTC) and
HiVox Biotek, Inc. Rapid ReliefTM Pennypad PP-904 (OTC)
| DK Electronics, LLCFlowKeepers® | Actegy Ltd.Revitive IX®(OTC) | HiVox Biotek, Inc.Rapid Relief™Pennypad PP-904 (OTC) | ||
|---|---|---|---|---|
| 510(k) Number | K160323 | K143207 | K140650 | |
| Product Codes:Model | NGX, NUHFlowKeepers® | NGX, NUHRIX | NUHPP-904 | |
| Indications for Use (IFU) | Powered Muscle Stimulator:-Temporarily increase localblood circulation in healthy legmuscles.-To stimulate healthy musclesin order to improve andfacilitate muscle performance.TENS-Temporary relief of painassociated with sore and achingmuscles in the lower extremities(legs) due to strain fromexercise, normal householdduties and work activities. | To temporarily increase localblood circulation in healthyleg muscles.To stimulate healthy musclesin order to improve andfacilitate muscle performance.For temporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, upperextremities (arms) and lowerextremities (legs) due to strainfrom exercise or normalhousehold duties. | The Rapid Relief PennypadPP-904 is indicated fortemporary relief of painassociated with sore andaching muscles in the upperand lower extremities (armand/or leg), and lower backdue to strain from exercise ornormal household and workactivities. | |
| Dimensions (mm) [WxHxD] | 140.6 mm x 67.14 mm x 10.5mm | Ø360 mm x 75 mm | 113 mm x 70 mm x 9.7 mm | |
| Waveform | Pulsed symmetrical biphasic andbipolar | Pulsed symmetrical biphasic,rectangular and bipolar | Symmetrical biphasic | |
| Shape | Rectangular | Not Available | Rectangular | |
| Power Source(s) | DC 3 V Li Ion battery CR2032 | DC 5V | DC 3 V Li Ion batteryCR2032 | |
| Number of Output Modes | 1 | 1 | 1 | |
| Number of Output Channels | 1 | 2 (1 for Foot, 1 for body pads) | 1 | |
| Automatic Shut Off | Auto Shut off at 10 hrs, lowbattery | Automatic Shut off, OverrideControl | Automatic Shut off at 60minutes, low battery | |
| Automatic Overload Trip | No | Not Available | No | |
| Automatic No-Load Trip | Yes | Not Available | No | |
| Patient Override Control | Yes | Yes | Yes | |
| Software/Firmware/Microprocessor Control | Yes | Yes | Yes | |
| Weight | 0.6 oz (with electrodes)0.8 oz (with electrodes +battery) | 1725 g (not including PSU) | 13g (with battery) | |
| Regulated Voltage Level | Yes | Not Available | Yes | |
| Regulated Current Level | No | Not Available | No | |
| Timer Range (minutes) | 600 minutes ±10% | 1 to 60 min | 15 minutes | |
| Indicator Display:On/Off Status | LEDPower On/Off, Level up/down | Not available | Power On | |
| Low Battery | Red LED | |||
| Voltage/Current Level | Level 1-15 | |||
| Compliance with VoluntaryStandards | UL 60601-1, EN60601-1-2,EN 60601-1-11, EN60601-2-10EN ISO 13485 | MDD (93/42EEC), EN60601-1,EN60601-1-2, EN 60601-1-11,EN60601-2-10 | EN 60601-1,EN60601-1-2,EN60601-2-10EN ISO 13485 | |
| Compliance with 21 CFR898* | Yes | Yes | Yes | |
| Housing Materials andConstruction | Casing/body ABS + PET,contacts NBR | Casing/body ABS, footpadsNBR | Casing/body ABS MedicalGrade Silicon, contacts | |
| DK Electronics, LLCFlowKeepers® | Actegy Ltd.Revitive IX® (OTC) | HiVox Biotek, Inc.Rapid ReliefTMPennypad PP-904 (OTC) | ||
| Maximumoutput voltage(V) (±20%) | @ 500 Ω@ 2 kΩ@ 10 kΩ | 166V252V290V | 32VNot AvailableNot Available | 57.6V89.6V96.0V |
| Maximumoutput current(±20%) | @ 500 Ω@ 2 kΩ@ 10 kΩ | 332mA126mA29mA | 10-14mANot AvailableNot Available | 115.2mA44.8mA9.6mA |
| Pulse Duration (µs) | 150 µs +150 µs ±10% | Not Available | 200 µs | |
| Frequency (Hz) | 100mHz ±10% | 20-53Hz | 2, 5, 40 Hz | |
| Net Charge per Pulse (µC) | 0 @500Ω | Not Available | 2304 @500Ω | |
| Maximum Phase Charge (µC) | 2.25 @500Ω | Not Available | 23.04 @500Ω | |
| Maximum Current Density(mA/cm²) | 0.789 mA@500Ω | Not Available | 2.828 @500Ω | |
| Maximum Power Density (< 0.25 W/cm²) | 0.00177 mW/cm²@ 500Ω | Not Available | 0.163 W/cm² @500Ω | |
| Burst Mode | No | Not Available | No |
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DISCUSSION:
The predicate device, Revitive IX® (OTC) is similar to the subject device in the following ways:
-
It provides the same kind of muscle stimulation for the same indications
-
It delivers similar pulsed symmetric biphasic bipolar electric wave.
The main differences among the predicate devices are:
-
FlowKeepers® application is restricted to the calf muscles
-
FlowKeepers® is powered by DC delivered from a small Li+ coin battery and not by AC and a transformer.
-
FlowKeepers® pulse frequency is much smaller (0.2% -0.5%) compared to the predicate device, however, the difference does not impact the safety or effectiveness relative to other Powered Muscle Stimulators and TENS devices operating under these specifications
-
FlowKeepers® is a much smaller and lighter device compared to the predicate device (2% of weight)
-
FlowKeepers® parameters such as maximum output voltage and current, frequency, and pulse duration, although not exactly similar to these particular predicates, do not
adversely impact safety or effectiveness. FlowKeepers® parameters are similar to cleared device K160508.
CONCLUSION:
The subject device, FlowKeepers®, is as safe and effective as, and functions in a manner equivalent to the predicate device. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate device.
§ 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).