(267 days)
Not Found
No
The device description and performance studies focus on the electrical stimulation and its physiological effects, with no mention of AI or ML algorithms for data analysis, decision-making, or adaptive stimulation. The control is a simple on/off and intensity adjustment via a single button.
Yes
The device is intended for "increasing local blood circulation" and "immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis", which are therapeutic indications.
No
The device is a neuromuscular stimulator intended for therapeutic purposes (increasing blood circulation and preventing venous thrombosis) by stimulating a nerve, not for diagnosing a condition.
No
The device description explicitly states it is a "fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casing, and a silver electrode with a hydrogel coating". This indicates it is a hardware device with embedded software, not a software-only medical device.
No, the geko™ T-1 Neuromuscular Stimulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- geko™ T-1 Function: The geko™ T-1 is a neuromuscular stimulator that applies electrical pulses to the common peroneal nerve to cause muscle contractions and increase blood circulation. It interacts directly with the patient's body and does not analyze any samples taken from the body.
The description clearly states its function is to stimulate muscles and increase blood flow, which is a therapeutic or physiological intervention, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The geko™ T-1 Neuromuscular Stimulator is intended for:
- Increasing local blood circulation, and
- Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
Product codes
IPF
Device Description
The geko™ T-1 (geko™) Neuromuscular Stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and 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. A single button controls the On/Off function and the intensity level of the device, which is achieved through changes in the delivered pulse width. The geko™ 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 geko stimulus intensity varies with the pulse width, which can be set to one of seven levels to produce the appropriate muscle contraction within the patient comfort zone (70μs, 100μs, 140μs, 200μs, 400μs, and 560μs). 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 and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.
Electrical contact is made with the patient through a hydrogel layer applied during manufacture to the integrated electrode. The patient contacting materials have been tested per the requirements of ISO 10993-1 and shown to be biocompatible for prolonged (up to 30 days) contact with intact skin. There are no separate electrode leads or electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The electrodes are applied to the posterior aspect of the knee only for stimulation of the peroneal nerve.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription use only for use in a clinical or home use setting.
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
Nonclinical Data:
- Shelf Life Testing: Real-time shelf life testing was conducted. Devices in their final packaging were stored under controlled conditions at 30°C for 27 months then subjected to full technical performance testing following 24 hours of operation. The results confirmed that the device remains fully operational in accordance with its performance specifications after 27 months of aging, and support a labelled shelf life of 24 months.
- Biocompatibility Testing: The patient contacting materials (hydrogel and adhesive strip) were subjected to biocompatibility testing per ISO 10993-1:2009 for devices in contact with intact skin, including cytotoxicity, dermal sensitization, and dermal irritation. Repeat dermal irritation testing of the hydrogel was also conducted. All tests passed.
- Software Verification and Validation: Software documentation consistent with a moderate level of concern was submitted. System validation testing demonstrated that all software requirement specifications were met and all software hazards were mitigated to risk level 1 (Accept).
- Electrical Safety and Electromagnetic Compatibility Testing: Certified by Intertek to comply with IEC 60601-1:1998 +A1:1991-11, +A2, 1995; IEC 60601-2-10:1987: +A1 2001; and IEC 60601-1-2:2007.
- Engineering Bench Testing: Oscilloscope tracings were obtained of the device output waveforms at each pulse width (intensity settings 1 through 7) under loads of 500Ω, 2 kΩ and 10kΩ. These tracings demonstrated that the net charge in the geko output waveform at all settings is 0.
Clinical Data:
- Study 1 (Tucker et al.): Sample size not explicitly stated for this part, but it established that a 1 Hz frequency electrical stimulus applied at the common peroneal nerve resulted in significant increases (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
August 21, 2014
Firstkind Limited c/o Sheila Hemeon-Heyer, JD, RAC Radcliffe Consulting, Inc. 231 Fairbanks Street West Boylston, MA 01583
Re: K133638
Trade/Device Name: geko™ T-1 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: July 25, 2014 Received: July 25, 2014
Dear Ms. 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. 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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,
Felipe Aquel -S
for Carlos L. Peña, Ph.D., M.S. 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) K133638
Device Name geko™ T-1 Neuromuscular Stimulator
Indications for Use (Describe)
The geko™ T-1 Neuromuscular Stimulator is intended for:
-
Increasing local blood circulation, and
-
Immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
te: 2014.08.21 32 -04'00'
FORM FDA 3881 (9/13)
3
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4
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: Rachel Fallon Chief Technology Officer
+44 (0) 1494 572045 Tel: Email: rachel.fallon@firstkindmedical.com
B. Date Prepared: July 25, 2014
C. Device Name and Classification Information:
| Trade Name: | geko™ T-1 Neuromuscular Stimulator (geko) |
|---|---|
| Common/usual Name: | Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered |
| Product Code, CFR: | IPF, 21 CFR 890.5850 |
| Panel code: | 89 |
| Class: | II |
- SYS*STIM ME 208 (K031017) D. Predicate Device:
Device Description: ய்
The qeko™ T-1 (qeko™) Neuromuscular Stimulator is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and 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. A single button controls the On/Off function and the intensity level of the device, which is achieved through changes in the delivered pulse width. The geko™ is applied so that the electrodes lie over the common peroneal nerve behind
5
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 geko stimulus intensity varies with the pulse width, which can be set to one of seven levels to produce the appropriate muscle contraction within the patient comfort zone (70μs, 100μs, 140μs, 200μs, 400μs, and 560μs). 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 and is used to isometrically stimulate the leg and foot muscles with a cadence and energy similar to that of walking.
Electrical contact is made with the patient through a hydrogel layer applied during manufacture to the integrated electrode. The patient contacting materials have been tested per the requirements of ISO 10993-1 and shown to be biocompatible for prolonged (up to 30 days) contact with intact skin. There are no separate electrode leads or electrodes.
F. Indications for Use:
The geko™ T-1 device is a Neuromuscular Stimulator and is intended for:
- Increasing local blood circulation, and .
- Immediate post-surgical stimulation of the calf muscles to prevent ● venous thrombosis.
G. Contraindications
Powered muscle stimulators should not be used on patients with cardiac demand pacemakers.
Powered muscle stimulators should not be used on patients with recently diagnosed deep vein thrombosis.
6
| Parameter | geko™ T-1 | SYSSTIM ME 208
(K031017) | Substantial
Equivalence |
|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
and Indications
for Use | The geko T-1 is a
neuromuscular
stimulation device and is
intended for:
Increasing local blood
circulation Immediate post-
surgical stimulation of
the calf muscles to
prevent venous
thrombosis | 1. Symptomatic relief of
chronic intractable pain,
acute post traumatic pain
or acute post-surgical pain
2. Temporary relation of
muscle spasm
3. Prevention of post-
surgical phlebo-
thrombosis through
immediate stimulation of
calf muscles
4. Increasing local blood
circulation
5. Prevention or
retardation of disuse
atrophy
6. Muscle re-education
7. Maintaining or
increasing range of motion | The indications for
use of the geko™ T-1
are a subset of the
indications for use of
the predicate device
(see #3 and #4 for
the SYSSTIM 208) |
| Clinical
application | Prescription use only for
use in a clinical or home
use setting.
Single patient use for up
to 30 hours (replacement
recommended after 24
hours) | Prescription use only for
use in a clinical or home
use setting.
The device is reusable but
the electrodes are single
use, disposable. | Substantially
equivalent. Both
devices are for
prescription use in a
clinical or home
environment. |
| Anatomical
Sites | The electrodes are
applied to the posterior
aspect of the knee only
for stimulation of the
peroneal nerve. | Electrodes can be applied
to multiple anatomical
sites, including the
posterior aspect of the
knee only for stimulation of
the peroneal nerve. | Substantially
equivalent. Both
devices can be used
for stimulation of the
peroneal nerve. |
| Parameter | geko™ T-1 | SYS*STIM ME 208
(K031017) | Substantial
Equivalence |
| Basic Unit Characteristics | | | |
| Power source | One CR2032 primary
lithium coin cell. Not
replaceable by user | Mains (line) voltage | Substantially
equivalent. Both
devices meet
electrical safety
standards. |
| -Method of Line
Current
Isolation | N/A | Transformer isolation | |
| -Patient
Leakage
Current | | | Substantially
equivalent. |
| -Normal
Condition | 1 Tucker AT, Maass A, Bain DS, Chen L, Azzam M, Dawson H, Johnston A. Augmentation of venous, arterial and microvascular blood supply in the leg by isometric neuromuscular stimulation via the peroneal nerve. Int J Angiol 2010; Spring 19(1): e31-7.
14
tolerated by all subjects. This work formed the basis for developing the geko™ T-1 device.
Subsequently, three independent investigations studied the safety and efficacy of the geko™ T-1: two in healthy subjects and one in patients undergoing elective unilateral total hip replacement. Warwick et al.2 applied the geko™ T-1 to the common peroneal nerve of 10 healthy volunteers, setting the simulation level to elicit a palpable twitch of the foot, according to the manufacturer's instructions. Assessments of blood flow velocity, volume and average velocity using Doppler ultrasound, and vessel diameter using ultrasound imaging were made with the subjects in four positions: 1) lying supine, lower limb horizontal; 2) supine, lower limb elevated at 25 to 35 degrees hip flexion; 3) standing, non weight-bearing (weight on contralateral leg only); and 4) standing, weight-bearing (weight evenly distributed on both legs). Assessments were made after 10 minutes in each position with the geko™ T-1 turned off, then repeated in each position during active stimulation. A plaster cast was then applied to the lower limb of each subject, and the assessments were repeated, first with the geko™ T-1 inactive and then with the device active.
In all postural positions, both with and without the plaster cast, peak venous velocity was significantly higher (p2 Warwick D, Shaikh A, Gadola S, Stokes M, Worsley P, Bain D, Tucker A, Gadola SD: Neuromuscular electrostimulation via the common peroneal nerve promotes lower limb flow in a below-knee cast: a potential thromboprophylaxis. Bone Joint Res, Sep 2013, 2(9):179-85. 3 Jawad H, Bain DS, Dawson H, Crawford K. A comparative study investigating the effectiveness of neuromuscular electrostimulation versus intermittent pneumatic compression in enhancing
lower limb blood flow in healthy subjects. Submitted for publication to J Thrombosis and Haemostasis.
15
subject's threshold level for muscle twitch and a setting three levels above the threshold.
The authors reported that neuromuscular stimulation using the geko™ T-1 resulted in significantly higher (p4 Unpublished study conducted at the Harbour Hospital in Poole, Dorset, UK.