(78 days)
Not Found
No
The device description and performance studies focus on electrical stimulation, hardware/firmware functionality, and biocompatibility, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive stimulation.
Yes
The device description and intended use explicitly state therapeutic indications such as increasing local blood circulation and edema reduction, which are medical treatments. It also states that it is a neuromuscular stimulator.
No
Explanation: The "Intended Use / Indications for Use" section specifies the device's purpose is to increase local blood circulation and reduce edema, which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it is a "fully integrated unit composed of a constant current pulse generator with embedded software, a lithium coin-cell battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating". This indicates the device includes significant hardware components beyond just software. The performance studies also include hardware/firmware testing and electrical safety testing, further confirming it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are "Increasing local blood circulation" and "Edema reduction." These are physiological effects on the body, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is a neuromuscular stimulator that applies electrical pulses to the skin to stimulate nerves and muscles. This is a therapeutic or physiological intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device's function is to directly interact with the patient's body to achieve a physiological effect (increased blood circulation and edema reduction). This falls under the category of a therapeutic or physiological medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Increasing local blood circulation
- Edema reduction
Product codes
IPF
Device Description
The geko™ W-2 neuromuscular stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software, a lithium coin-cell battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through choosing one of 10 stimulus settings.
The geko™ W-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking. Each geko™ W-2 provides two 6-hour treatments with a 6 hour minimum rest period between treatments. Two optional accessories are available to hold the geko W-2 in place during treatment, if needed: a knee strap and an adhesive tape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
common peroneal nerve behind the knee, calf and foot muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Design Validation Activities:
Biocompatibility testing: Cytotoxicity testing according to ISO 10993-5 and Sensitization and Irritation testing according to ISO 10993-10 resulted in the KM40A hydrogel being biocompatible.
Electrical safety testing: Not needed as no changes related to electrical hardware.
Electromagnetic compatibility testing: Conducted to IEC 60601-1-2:2014, all tests passed.
Hardware/Firmware testing: Verification of output waveform characteristics via oscilloscope output tracings at 500Ω, 2kΩ and 10kΩ, and validation of all geko™ W-2 hardware and firmware functionality. All tests passed.
Performance testing: Durability of the device when used multiple times was verified by assessing device operation when applied and removed from a test substrate 100 times, and assessing device adhesion when applied and removed for a total of 10 use cycles. All test samples passed all repeat test cases.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2020
Firstkind Limited % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002
Re: K193045
Trade/Device Name: geko™ W-2 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: December 19, 2019 Received: December 19, 2019
Dear Sheila Hemeon-Heyer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193045
Device Name geko™ W-2
Indications for Use (Describe)
-
Increasing local blood circulation
-
Edema reduction
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)
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510(k) Summary - K193045
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| A. Submitter: | Firstkind Limited
Hawk House
Peregrine Business Park
High Wycombe, UK
HP13 7DL |
|----------------|--------------------------------------------------------------------------------------------|
| Contact: | Neil Buckley
Head of Quality and Regulatory Affairs |
| Tel:
Email: | +44 (0) 845 2222 921
neil.buckley@firstkindmedical.com |
- B. Date Prepared: November 1, 2019
C. Device Name and Classification Information:
| Trade Name: | geko™ W-2 |
|---|---|
| Common Name: | Neuromuscular stimulator |
| Classification Name: | Stimulator, Muscle, Powered |
| Product Code, CFR: | IPF, 21 CFR 890.5850 |
| Panel code: | 89 |
| Class: | II |
- Predicate Devices: qeko™ Plus R-2 as cleared under K180082 D.
Device Description: E.
The geko™ W-2 neuromuscular stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software, a lithium coin-cell battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating which provides a means of attachment of the device and electrical contact with the patient. Two buttons are used to control the On/Off function and increase or decrease the intensity level of the device output, which is achieved through choosing one of 10 stimulus settings.
The geko™ W-2 is applied so that the electrodes lie over the common peroneal nerve behind the knee. Stimulation of the common peroneal nerve causes contraction of the calf muscles through the direct activation of the motor neurons, resulting in increased blood flow. The pulse rate is fixed at a frequency of 1 Hz and is used to isometrically stimulate the calf and foot muscles with a cadence and energy similar to that of walking. Each geko™
4
W-2 provides two 6-hour treatments with a 6 hour minimum rest period between treatments. Two optional accessories are available to hold the geko W-2 in place during treatment, if needed: a knee strap and an adhesive tape.
F. Indications for Use:
- Increasing local blood circulation .
- Edema reduction ●
G. Technical Comparison with the Predicate Device and Discussion of Differences
| Parameter | Proposed
gekoTM W-2 | Predicate
gekoTM Plus R-2 (K180082) |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Increasing local blood circulation
• Edema reduction | Increasing local blood circulation
• Edema reduction
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis |
| # output modes | 1 | 1 |
| # output channels
- Synchronous or
alternating? - Method of channel
isolation? | 1
N/A
N/A | 1
N/A
N/A |
| Method of stimulus
regulation | Current regulated | Current regulated |
| Microprocessor
controlled? | Yes | Yes |
| Automatic overload
trip | Yes | Yes |
| Automatic no-load
trip | Yes | Yes |
| Automatic shut-off | Yes | Yes |
| Patient over-ride
control | Yes | Yes |
| Parameter | Proposed
gekoTM W-2 | Predicate
gekoTM Plus R-2 (K180082) |
| Indicator displays | | |
| - On/Off status | Yes | Yes |
| - Low battery | Yes | Yes |
| - Stimulus level | Yes (device switches off) | Yes (device switches off) |
| | Yes. Stimulation level (pulse
width) is indicated by the number
of times the LED flashes in
sequence, e.g., a single flash for
Level 1 (25 $\mu$ s/54 mA) up to 10
flashes for Level 10 (560 $\mu$ s/54
mA). | Yes. Stimulation level (pulse
width) is indicated by the number
of times the LED flashes in
sequence, e.g., a single flash for
Level 1 (50 $\mu$ s/54 mA) up to 8
flashes for Level 8 (560 $\mu$ s/54
mA). |
| Waveform | Asymmetrical, biphasic,
rectangular waveform with charge
balancing second phase | Asymmetrical, biphasic,
rectangular waveform with charge
balancing second phase |
| Maximum output
voltage | 27.0 V @ 500 Ω | 27.0 V @ 500 Ω |
| | 108 V @ 2000 Ω | 108 V @ 2000 Ω |
| | 255 V @ 10,000 Ω | 255 V @ 10,000 Ω |
| | All voltages (±10%) | All voltages (±10%) |
| Maximum output
current | 54 mA @ 500 Ω | 54 mA @ 500 Ω |
| | 54 mA @ 2000 Ω | 54 mA @ 2000 Ω |
| | 25.5 mA @ 10,000 Ω | 25.5 mA @ 10,000 Ω |
| | All currents (±15%) | All currents (±15%) |
| Pulse widths | 25, 35, 50, 70, 100, 140, 200,
280, 400, 560 $\mu$ s | 50, 70, 100, 140, 200, 280, 400
and 560 $\mu$ s |
| Frequency | 1 Hz, fixed | 1 Hz, fixed |
| Net charge | 0 $\mu$ C at 500Ω, capacitor coupled | 0 $\mu$ C at 500Ω, capacitor coupled |
| Maximum phase
charge | 40 $\mu$ C at 500 Ω | 40 $\mu$ C at 500 Ω |
| Maximum current
density | 13.3 mA/cm² | 13.3 mA/cm² |
| Maximum power
density | 0.000088 W/cm² | 0.000088 W/cm² |
| Timer range in
minutes | 720 minutes max (two 6-hour run
times) | 1800 minutes max (one 30-hour
run time) |
| Power source | One 3V lithium coin cell | One 3V lithium coin cell |
| Weight | 10 g | 10 g |
| Dimensions | 7.8" x 1.2" x 0.4" | 7.8" x 1.2" x 0.4" |
| Patient contacting
materials | Hydrogel (KM40A) | Hydrogel (KM10T) |
| Parameter | Proposed
gekoTM W-2 | Predicate
gekoTM Plus R-2 (K180082) |
| Housing material | Polypropylene
Plastic injection molding | Polypropylene
Plastic injection molding |
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The differences between the proposed geko™ W-2 and the predicate geko™ PWS R-2 model are:
- . More stimulus levels are available to the user: 10 in the geko™ W-2 as compared to 8 in the qeko™ Pus R-2. The qeko W-2 offers two additional short pulse widths (25 & 35 us) that are below the lowest pulse width available on the predicate models.
- . The geko™ W-2 provides two doses of 6 hours each, with an enforced rest of 6 hours minimum between the doses as compared to the single 30 hour run time for a geko™ Plus R-2.
- . The geko™ W-2 uses KM40A instead of KM10T hydrogel.
The reason for these changes is to provide a geko model for patients who only require a lower level or stimulation and/or have sensitive skin. The geko W-2 provides a full range of stimulus intensities including two levels below those currently available for the geko™ Plus R-2. In addition, the KMT40A hydrogel of the geko W-2 has a lower adhesive strength and may be less irritative to sensitive skin than the KMT10T hydrogel used in the other geko models, including the geko PMS R-2. Finally, the 6 hour off treatment protocol gives sensitive skin a chance to rest in between treatment sessions.
Because the geko™ W-2 is limited to 6 hour treatment durations with a minimum of 6 hour rest between treatments, the device is not indicated for prevention of venous thrombosis, which requires continuous (or near continuous) therapy for longer than 6 hours. Therefore, the indications for use of the geko™ W-2 are a subset of the prior geko models. Otherwise, as can be seen from the Technical Comparison Table, the indications for use, technical specifications, mechanism of action, and device operation for the geko™ W-2 are the same as for the predicate device.
H. Design Validation Activities
The device changes described in this Special 510(k) were implemented under the company's design change procedures. A risk assessment of the changes resulted in the following verification and validation activities:
Biocompatibility testing for the new hydrogel for medical devices in contact with intact skin:
- Cytotoxicity testing according to ISO 10993-5 o
- Sensitization and Irritation testing according to ISO 10993-10 O
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The testing demonstrated that the KM40A hydrogel is biocompatible for its intended use contact.
Electrical safety testing was not needed as there are no changes in the geko W-2 as compared to the predicate geko™ Plus R-2 related to the electrical hardware.
Electromagnetic compatibility testing was conducted to IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. Although no electronic hardware changes were made to the geko W-2 as compared to the geko™ Pus R-2, EMC testing was conducted to assure compliance to the current version of the standard. Testing included all requirements for a non-rechargeable, battery powered medical device. Testing was conducted with the device in continuous operating mode at the highest stimulus setting. All tests were passed.
Hardware/Firmware testing – As with the prior geko models, the geko™ W-2 hardware and firmware were tested together in order to verify the correct functioning of the device. All tests were passed. Testing included:
- . Verification of output waveform characteristics via oscilloscope output tracings at 500Ω, 2kΩ and 10kΩ
- Validation of all geko™ W-2 hardware and firmware functionality .
Performance testing - The durability of the device when used multiple times was verified under internal test protocols that included: 1) assessing the device operation when applied and removed from a test substrate 100 times; and 2) assessing device adhesion when applied and removed for a total of 10 use cycles. All test samples passed all repeat test cases.
l. Conclusion
The information and testing presented in this 510(k) demonstrated that the geko™ W-2 is substantially equivalent to the predicate geko device models, specifically the geko™ Plus R-2, for the indications for use of increasing local circulation and edema reduction.