(145 days)
No
The device description details a fixed pulse rate and user-controlled intensity levels, with no mention of adaptive algorithms or learning capabilities. The software is described as "embedded software" without any indication of AI/ML functionality.
Yes
The device is described as a 'neuromuscular stimulator' and its intended uses include increasing local blood circulation, edema reduction, and preventing venous thrombosis, all of which are therapeutic outcomes.
No
The device is a neuromuscular stimulator designed for therapeutic purposes, such as increasing blood circulation and preventing venous thrombosis, not for diagnosing medical conditions.
No
The device description explicitly states that the device is a "fully integrated neuromuscular stimulator device" composed of hardware components including a pulse generator, battery, plastic casing, and electrodes, in addition to embedded software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a device that applies electrical stimulation to the body (specifically the common peroneal nerve) to achieve a therapeutic effect (increasing blood circulation, reducing edema, preventing venous thrombosis). This is a form of in vivo treatment, meaning it acts directly on the living body.
The device's function and intended use are entirely focused on direct physical intervention and therapeutic outcomes within the patient's body, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
- Increasing local blood circulation
- Edema reduction
- Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
- Stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism
Product codes
IPF
Device Description
The geko™ T-2 and geko™ T-3 are single patient use, disposable (after 24 hours), fully integrated neuromuscular stimulator devices. Each model is composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a 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 changes in the delivered pulse width. The devices are 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 stimulus intensity varies with the pulse width, which can be set a follows depending on the device model:
- geko™ T-2: 7 levels ranging from 50 usec to 400 µsec @ 27 mA
- geko™ T-3: 11 levels ranging from 35 to 280 µsec @ 27 mA, 280 to 400 µsec @ . 38 mA, and 400 to 560 µsec at 54 mA
The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz for all device models and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.
Both device models have the same principles of operation and the same indications for use. The choice of device model depends on the level of stimulation needed to achieve a visible contraction (twitch) of the patient's calf and dorsiflexion of the foot.
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 muscles, leg 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)
A clinical study was conducted to demonstrate the safety and effectiveness of the geko™ in preventing venous thromboembolism (VTE) in a group of patients hospitalized following stroke.
The study included all patients admitted to and followed by the Acute Stoke Unit (ASU) at the Royal Stoke University Hospital (RSUH) in Stoke-On-Trent England between November 1, 2016 and March 3, 2018, with a confirmed diagnosis of acute stroke (ischemic or haemorrhagic) or transient ischemic attack (TIA).
VTE prophylaxis was prescribed for all stroke patients who were non-ambulatory, defined as not able to walk unaided, and at risk for VTE according to hospital protocol.
VTE prophylaxis was by pharmacological means (anticoagulants) unless contraindicated in which case mechanical intermittent pneumatic compression (IPC) was employed. Patients for whom IPC was contraindicated were prescribed the geko™.
Patients who began with IPC but became intolerant or non-compliant were allowed to switch to the geko™. Patients who refused VTE prophylaxis were also followed in the study.
Patients were assessed for VTE risk within 24 hours of admission, and IPC or geko™, when prescribed, was begun within 3 days of admission for 98.7% (657/666) of the patients.
Both IPC and geko™ were applied bi-laterally and used 24 hours/day until hospital discharge. Patients were assessed for incidence of VTE for 90 days following hospital discharge.
A total of 1000 patients were entered into this clinical study. All patients were followed for the 90 day study period. The methods of VTE prophylaxis employed during their period of hospital admission were:
- Pharmacological anti-coagulation (N=125)
- IPC only (N=463)
- geko™ only (N=122)
- IPC & geko™ (started with IPC but switched to geko™ due to non-tolerance or noncompliance with IPC) (N=81)
- Refused VTE prophylaxis treatment (N=22)
- No VTE prophylaxis treatment required (N=187)
The results of this study were that of the 122 patients who received VTE prophylaxis with the geko™ only, none experienced a VTE within the 90-day period of this study. By comparison, 2.4% (11/463) of the patients who received VTE prophylaxis with IPC only, 1.2% (1/81) of patients who started with IPC then switched to geko™, and 4.8% (1/22) of patients who refused VTE prophylaxis experienced a VTE within the 90-day period of this study. Comparison of the results between the geko™ only and IPC only groups demonstrates that the geko™ was non-inferior to IPC within 0.5% (p=0.05) in preventing VTE in this patient population.
In addition, geko™ was shown to be a safe and well-tolerated therapy. While no adverse device-related events (serious or otherwise) were reported for either geko™ or IPC in this study, 81 subjects switched from IPC to geko™ due to non-compliance or dissafisfaction with the IPC.
This was a real-world clinical study. The safety and effectiveness of the devices for prevention of venous thrombosis in non-surgical patients has not been demonstrated in a randomized, controlled clinical study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K180082 for geko™ T-2, K181059 for geko™ T-3
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).
0
September 18, 2019
Firstkind Limited % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K191113
Trade/Device Name: geko™ T-2 and geko™ T-3 Neuromuscular Stimulators Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: April 23, 2019 Received: April 26, 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/ofdocs/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); 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 mediation-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,
Amber T. Ballard -S
For Vivek Pinto, Ph.D. Director (Acting) 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
2
Indications for Use
510(k) Number (if known) K191113
Device Name
geko T-2 and geko T-3 Neuromuscular Stimulators
Indications for Use (Describe)
- · Increasing local blood circulation
- · Edema reduction
- · Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
- · Stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
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: | +44 (0) 845 222 2921 |
| Email: | neil.buckley@firstkindmedical.com |
- B. Date Prepared: September 18, 2019
C. Device Name and Classification Information:
| Trade Name: | geko™ T-2 and geko™ T-3 Neuromuscular Stimulators |
|---|---|
| Classification Name: | Stimulator, Muscle, Powered |
| Product Code, CFR: | IPF, 21 CFR 890.5850 |
| Panel code: | 89 |
| Class: | II |
| Predicate Devices: | K180082 for geko™ T-2 |
| K181059 for geko™ T-3 |
Device Description: ய்
D.
The geko™ T-2 and geko™ T-3 are single patient use, disposable (after 24 hours), fully integrated neuromuscular stimulator devices. Each model is composed of a constant current pulse generator with embedded software and a lithium-ion battery enclosed in a 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 changes in the delivered pulse width. The devices are 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 stimulus intensity varies with the pulse width, which can be set a follows depending on the device model:
4
- geko™ T-2: 7 levels ranging from 50 usec to 400 µsec @ 27 mA
- geko™ T-3: 11 levels ranging from 35 to 280 µsec @ 27 mA, 280 to 400 µsec @ . 38 mA, and 400 to 560 µsec at 54 mA
The asymmetric biphasic waveform results in a net charge of zero to the patient during each pulse cycle. The pulse rate is fixed at a frequency of 1 Hz for all device models and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.
Both device models have the same principles of operation and the same indications for use. The choice of device model depends on the level of stimulation needed to achieve a visible contraction (twitch) of the patient's calf and dorsiflexion of the foot.
F. Indications for Use:
- Increasing local blood circulation
- Edema reduction ●
- o Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis
- . Stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism
G. Technical Comparison with the Predicate Device and Discussion of Differences
As shown in the table below, there have been no technological changes to the geko™ device models since they were previously 510(k) cleared. The sole purpose of this 510(k) is to add a new indication for use for prevention of venous thrombosis in non-surqical patients at risk for venous thromboembolism (VTE). The new indication for use is supported by clinical data summarized in Section H.
| Parameter | Predicate geko™
T-2 | Proposed geko™
T-2 | Predicate geko™
T-3 | Proposed geko™
T-3 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K180082 | K191113 | K181059 | K191113 |
| Indications for
Use | Increasing local
●
blood circulation
Edema reduction
●
Immediate post-
●
surgical stimulation
of calf muscles to
prevent venous
thrombosis | Increasing local
blood circulation
Edema reduction
●
Immediate post-
surgical
stimulation of calf
muscles to
prevent venous
thrombosis
Stimulation of the
calf muscles to
prevent venous
thrombosis in
non-ambulatory | Increasing local
●
blood circulation
Edema reduction
Immediate post-
surgical stimulation
of calf muscles to
prevent venous
thrombosis | · Increasing local
blood circulation
Edema reduction
●
Immediate post-
●
surqical
stimulation of calf
muscles to
prevent venous
thrombosis
Stimulation of the
●
calf muscles to
prevent venous
thrombosis in
non-ambulatory |
5
| Parameter | Predicate geko™
T-2 | Proposed geko™
T-2 | Predicate geko™
T-3 | Proposed geko™
T-3 |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| | | patients | | patients |
| Number of
output modes | Single mode with 7
discrete pulse width
settings which define
the stimulation levels | Same | Single mode with 11
discrete pulse width
settings which define
the stimulation levels | Same |
| Number of
output channels | Single | Same | Single | Same |
| Method of
stimulus
regulation | Current regulated | Same | Current regulated | Same |
| Microprocessor
controlled? | Yes | Same | Yes | Same |
| Automatic
overload trip | Yes | Same | Yes | Same |
| Automatic no-
load trip | Yes | Same | Yes | Same |
| Automatic shut-
off | Yes | Same | Yes | Same |
| Patient over-
ride control | Yes | Same | Yes | Same |
| Indicator
displays | | Same | | Same |
| - On/Off status
- Low battery
- Stimulus level | Yes
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 (50 µs/27 mA) up to
7 flashes for Level 7
(400 µs/27 mA) | | Yes
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
(35 µs/27 mA) up to
11 flashes for Level 11
(560 µs/54 mA). | |
| Waveform | Asymmetrical,
biphasic, rectangular
waveform with charge
balancing second
phase | Same | Asymmetrical,
biphasic, rectangular
waveform with charge
balancing second
phase | Same |
| Maximum
output voltage | 14.0 V @ 500 Ω
53.5 V @ 2000 Ω
255 V @ 10,000 Ω
All voltages (±10%) | Same | 27.0 V @ 500 Ω
108 V @ 2000 Ω
255 V @ 10,000 Ω
All voltages (±10%) | Same |
| Maximum
output current | 27 mA @ 500 Ω
27 mA @2000 Ω
25.5 mA @ 10,000 Ω | Same | 54 mA @ 500 Ω
54 mA @ 2000 Ω
54 mA @ 10,000 Ω | Same |
6
| Parameter | Predicate geko™
T-2 | Proposed geko™
T-2 | Predicate geko™
T-3 | Proposed geko™
T-3 |
|------------------------------------|-----------------------------------------------|-----------------------|-----------------------------------------------------|-----------------------|
| | All currents (±15%) | | All currents (±15%) | |
| Pulse widths | 50, 70, 100, 140, 200,
280, 400 $\mu$ s | Same | 35, 50, 70, 100, 140,
200, 280, 400, 560 $\mu$ s | Same |
| Frequency | 1 Hz, fixed | Same | 1 Hz, fixed | Same |
| Net charge | 0 $\mu$ C at 500Ω,
capacitor coupled | Same | +/- 0.1 $\mu$ C at 500Ω,
phase balancing | Same |
| Maximum phase
charge | 18.3 $\mu$ C at 500 Ω | Same | 40 $\mu$ C at 500 Ω | Same |
| Maximum
current density | 6.67 mA/cm² | Same | 13.3 mA/cm² | Same |
| Maximum
power density | 0.000044 W/cm² | Same | 0.000088 W/cm² | Same |
| Timer range in
minutes | 1800 min max (30 hr
run time) | Same | 1800 min max (30 hr
run time) | Same |
| Power source | One 3V lithium coin
cell | Same | One 3V lithium coin
cell | Same |
| Weight | 10 g | Same | 10 g | Same |
| Dimensions | 7.8" x 1.2" x 0.4" | Same | 7.8" x 1.2" x 0.4" | Same |
| Patient
contacting
materials | Hydrogel (KM10T) | Same | Hydrogel (KM10T) | Same |
| Housing
material | Polypropylene
Plastic injection
molding | Same | Polypropylene
Plastic injection
molding | Same |
H. Discussion of Performance Data
A clinical study was conducted to demonstrate the safety and effectiveness of the geko™ in preventing venous thromboembolism (VTE) in a group of patients hospitalized following stroke. The study included all patients admitted to and followed by the Acute Stoke Unit (ASU) at the Royal Stoke University Hospital (RSUH) in Stoke-On-Trent England between November 1, 2016 and March 3, 2018, with a confirmed diagnosis of acute stroke (ischemic or haemorrhagic) or transient ischemic attack (TIA). VTE prophylaxis was prescribed for all stroke patients who were non-ambulatory, defined as not able to walk unaided, and at risk for VTE according to hospital protocol. VTE prophylaxis was by pharmacological means (anticoagulants) unless contraindicated in which case mechanical intermittent pneumatic compression (IPC) was employed. Patients for whom IPC was contraindicated were prescribed the geko™. Patients who began with IPC but became intolerant or non-compliant were allowed to switch to the geko™. Patients who refused VTE prophylaxis were also followed in the study. Patients were assessed for VTE risk within 24 hours of admission, and IPC or geko™, when prescribed, was begun within 3 days of admission for 98.7% (657/666) of the patients. Both IPC and geko™ were applied bi-laterally and used 24
7
hours/day until hospital discharge. Patients were assessed for incidence of VTE for 90 days following hospital discharge.
A total of 1000 patients were entered into this clinical study. All patients were followed for the 90 day study period. The methods of VTE prophylaxis employed during their period of hospital admission were:
- Pharmacological anti-coagulation (N=125)
- . IPC only (N=463)
- . geko™ only (N=122)
- IPC & geko™ (started with IPC but switched to geko™ due to non-tolerance or noncompliance with IPC) (N=81)
- Refused VTE prophylaxis treatment (N=22)
- No VTE prophylaxis treatment required (N=187) ●
The results of this study were that of the 122 patients who received VTE prophylaxis with the geko™ only, none experienced a VTE within the 90-day period of this study. By comparison, 2.4% (11/463) of the patients who received VTE prophylaxis with IPC only, 1.2% (1/81) of patients who started with IPC then switched to geko™, and 4.8% (1/22) of patients who refused VTE prophylaxis experienced a VTE within the 90-day period of this study. Comparison of the results between the geko™ only and IPC only groups demonstrates that the geko™ was non-inferior to IPC within 0.5% (p=0.05) in preventing VTE in this patient population.
In addition, geko™ was shown to be a safe and well-tolerated therapy. While no adverse device-related events (serious or otherwise) were reported for either geko™ or IPC in this study, 81 subjects switched from IPC to geko™ due to non-compliance or dissation with the IPC.
This was a real-world clinical study. The safety and effectiveness of the devices for prevention of venous thrombosis in non-surgical patients has not been demonstrated in a randomized, controlled clinical study.
. Conclusion
The clinical data presented in this 510(k) supports the safety and effectiveness of the geko™ devices when used to prevent venous thrombosis in hospitalized patients who are at risk for VTE. Therefore, this 510(k), with the new indication for use, is substantially equivalent to the previously cleared 510(k)s for the geko™ T-2 and geko™ T-3.