(64 days)
No
The description focuses on basic electrical stimulation and control via buttons, with no mention of adaptive algorithms, learning, or data processing beyond simple signal generation.
Yes
The device is intended for increasing local blood circulation and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, which are therapeutic applications.
No
The device description clearly states it is a "Neuromuscular Stimulator" intended for therapeutic purposes (increasing blood circulation and preventing venous thrombosis) by stimulating muscles, not for diagnosing conditions.
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". This indicates it is a hardware device with embedded software, not a software-only device. The performance studies also include electrical safety and hardware/firmware testing.
Based on the provided information, the geko™ Plus R-2 is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to increase local blood circulation and stimulate calf muscles to prevent venous thrombosis. This is a direct therapeutic intervention applied to the patient's body.
- Device Description: The device is a neuromuscular stimulator that applies electrical pulses to the common peroneal nerve to cause muscle contractions. This is a physical interaction with the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body. IVDs are designed to analyze these types of samples to provide diagnostic information.
The geko™ Plus R-2 is a therapeutic medical device that provides electrical stimulation to the patient.
N/A
Intended Use / Indications for Use
The geko(TM) Plus R-2 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™ Plus R-2 Neuromuscular Stimulator (geko™ Plus R-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casinq, 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 geko™ Plus R-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 stimulus intensity varies with the pulse width, which can be set to one of eight levels for the geko™ Pus R-2. 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 previously 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Validation Activities:
Electrical Safety and Electromagnetic Compatibility Testing – The geko™ Plus R-2 has been certified to comply with the applicable clauses of the following standards:
- IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements . for Safety, 3rd edition, 2005
- IEC 60601-2-10: Medical electrical equipment Part 2-10: Particular . requirements for the safety of nerve and muscle stimulators, 2nd edition,
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, 30 edition, 2007.
Hardware/Firmware Testing:
The geko™ Plus R-2 hardware and firmware were tested together in order to verify the correct functioning of the device. Testing included the following:
- Verification of output waveform characteristics via oscilloscope output tracings at 500Ω, 2kΩ and 10kΩ
- Validation of all geko™ Plus R-2 hardware and firmware functionality ●
All test results demonstrated that the geko ™ Pus R-2 meets the predefined device technical and functional requirements specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 8, 2016
Firstkind Limited % Sheila Hemeon-Heyer President Hever Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K160299
Trade/Device Name: Geko™ Plus R-2 Neuromuscular Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: March 10. 2016 Received: March 11, 2016
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
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) K160299
Device Name
geko(TM) Plus R-2 Neuromuscular Stimulator
Indications for Use (Describe)
The geko(TM) Plus R-2 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summarv
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:
Tel:
Email: | Rachel Fallon, Chief Technology Officer
+44 (0) 1494 572045
rachel.fallon@firstkindmedical.com |
- Date Prepared: B. April 8, 2016
C. Device Name and Classification Information:
| Trade Name: | gekoTM Plus R-2 Neuromuscular Stimulator |
|---|---|
| Common/usual Name: | Powered Muscle Stimulator |
| Classification Name: | Stimulator, Muscle, Powered |
| Product Code, CFR: | IPF, 21 CFR 890.5850 |
| Panel code: | 89 |
| Class: | II |
- D. Predicate Device: K152677, geko™ T-2 Neuromuscular Stimulator
ய் Device Description:
The geko™ Plus R-2 Neuromuscular Stimulator (geko™ Plus R-2) is a disposable, fully integrated unit composed of a constant current pulse generator with embedded software and battery enclosed in an over-molded plastic casinq, 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 geko™ Plus R-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.
4
The stimulus intensity varies with the pulse width, which can be set to one of eight levels for the geko™ Pus R-2. 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 previously 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™ Plus R-2 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.
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H. Substantial Equivalence
| Parameter | PredicateTM gekoTM T-2 | ProposedTM gekoTM Plus R-2 |
|---|---|---|
| Intended Use and | ||
| Indications for Use | • Increasing local blood | |
| circulation | ||
| • Immediate post-surgical | ||
| stimulation of the calf | ||
| muscles to prevent venous | ||
| thrombosis | Same | |
| Clinical application | Prescription use only for use in | |
| a clinical or home use setting. | ||
| Single patient use for up to 30 | ||
| hours | ||
| Disposable (cannot be reused) | Same | |
| Anatomical Sites | The electrodes are applied to | |
| the posterior aspect of the knee | ||
| only for stimulation of the | ||
| peroneal nerve. | Same | |
| Shelf Life | 24 months | Same |
| Power source | One CR2032 primary lithium | |
| coin cell. Not replaceable by | ||
| user | Same | |
| -Method of Line | ||
| Current Isolation | N/A | N/A |
| -Patient Leakage | ||
| Current | ||
| -Normal Condition |