(139 days)
Not Found
No
The description focuses on basic electrical stimulation and a single button control for intensity, with no mention of adaptive algorithms, learning, or data processing beyond simple pulse generation.
No.
The intended use explicitly states, "The firefly™ T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical conditions of any kind."
No
The device is intended for muscle stimulation to improve or facilitate muscle performance, not for diagnosing conditions. The "Intended Use / Indications for Use" explicitly states it "is not intended to be used in conjunction with therapy or treatment diseases of medical conditions of any kind."
No
The device description explicitly states it is a "disposable, fully integrated neuromuscular stimulator for muscle conditioning 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 the device includes significant hardware components beyond just software.
Based on the provided information, the firefly™ T-1 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "stimulation of healthy muscles in order to improve or facilitate muscle performance." This is a direct interaction with the body for a physiological effect, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a neuromuscular stimulator that applies electrical pulses to the common peroneal nerve to cause muscle contraction and increase blood flow. This is a physical intervention, not a test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosis or monitoring of medical conditions through laboratory testing.
In summary, the firefly™ T-1 is a therapeutic or performance-enhancing device that directly interacts with the body, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly " T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
Product codes
NGX
Device Description
The firefly™ T-1 device is a disposable, fully integrated neuromuscular stimulator for muscle conditioning 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 firefly™ T-1 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The firefly™ T-1 with the embedded electrodes is 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
Over-the-counter (non-prescription) use in athletic training facilities or the home.
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)
The safety and effectiveness of the firefly™ T-1 has been evaluated in independent clinical studies. The early work of Tucker et al. 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).
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KJ34001 Page 1 of 11
510(k) Summary
MAY 1 5 2014
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 Tel: +44 (0) 1494 572045 rachel.fallon@firstkindmedical.com Email:
B. Date Prepared: May 9, 2014
Device Name and Classification Information: ﻥ
| Trade Name: | firefly™ T-1 |
|---|---|
| Common Name: | Powered Muscle Stimulator for Muscle Conditioning |
| Classification: | 21 CFR 890.5850, Class II |
| Product Code: | NGX |
| Panel: | 89, Physical Medicine |
Predicate Device: Compex® Sport Plus (K083140) D.
E. Device Description:
The firefly™ T-1 device is a disposable, fully integrated neuromuscular stimulator for muscle conditioning 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 firefly™ T-1 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.
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The firefly™ T-1 stimulus intensity varies with the pulse width, which can be set to one of seven levels to produce the appropriate muscle contraction within the user comfort zone (70us, 100us, 140us, 200us, 280µs, 400µs, and 560us). The asymmetric biphasic waveform results in a net charge of zero to the user 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 user through a hydrogel layer applied during manufacture to the integrated electrode. The firefly™ T-1 skin 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.
An optional firefly™ T-1 strap can be purchased separately and secured over the firefly™ T-1 to assure good electrode contact even for active users. The strap is made of soft neoprene sponge with a nylon cover.
F. Indications for Use:
The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly " T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
G. Contraindications
This device should not be used by anyone with a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.
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H. Technical Comparison with the Predicate Device and Discussion of Differences
| Parameter | firefly™ T-1 | Compex® Sport Plus
(K083140) | Substantial
Equivalence |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and
Indications for
Use | Intended for the
stimulation of healthy
muscles in order to
improve or facilitate
muscle performance.
The firefly T-1 device is
not intended to be used
in conjunction with
therapy or treatment
diseases of medical or
medical conditions of
any kind. | Intended to stimulate
healthy muscles in order
to improve or facilitate
muscle performance.
Compex® Sport is not
intended to be used in
conjunction with therapy
or treatment of medical
diseases or medical
conditions of any kind.
None of the Compex®
Sport training programs
are designed for injured
or ailing muscles and its
use on such muscles is
contraindicated. | Same |
| Use environment | Over-the-counter (non-
prescription) use in
athletic training facilities
or the home. | Over-the-counter (non-
prescription) use in
athletic training facilities
or the home. | Same. Both devices
are for OTC use by
athletes. |
| Anatomical Sites | The firefly™ T-1 with the
embedded electrodes is
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. |
| Stimulator Parameters | | | |
| Power source
-Method of Line | One CR2032 primary
lithium coin cell. Not
replaceable by user | Battery
NIMH, rechargeable | Substantially
equivalent. Both
devices are battery
powered. |
| Current Isolation | N/A | N/A | |
| -Patient Leakage
Current
-Normal | 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.
9
on the subject verbal rating scale, while the lowest frequency of 1 Hz was well tolerated by all subjects. This work formed the basis for developing the firefly™ T-1 device.
Subsequently, two independent investigators studied the safety and efficacy of the device technology (also implemented in the geko™ T-1) for increasing blood flow. Warwick et al.2 and Jawad et al.3 both applied the device to the common peroneal nerve of healthy volunteers, setting the simulation level to elicit a palpable twitch of the foot, according to the manufacturer's instructions. In the first study, blood flow measurements were obtained 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, weightbearing (weight evenly distributed on both legs) both with and without a plaster cast applied. In the second study, the impact on blood flow from electrical stimulation was compared to that from intermittent pneumatic compression (IPC) devices. Both studies demonstrated significant increases in blood flow when using the firefly™T-1 electrostimulation device with no safety concerns.
A clinical study of the firefly™ T-1 conducted by Ferguson et al.4. examined the effects of the electrical stimulation alone compared to graduated compression socks alone or passive recovery (no`intervention) on muscle soreness, strength, and markers of muscle damage and inflammation following intense intermittent exercise in 21 healthy males. The study results demonstrated that athletes using the firefly™ T-1 had significantly lower scores for perceived muscle soreness at 24 and 48 hours post exercise as compared to the groups using graduated compression socks or passive recovery.
2 Warwick D. Shaikh A. Gadola S. Stokes M. Worslev 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.
4 Ferguson R, Dodd M, Paley V: Neuromuscular electrical stimulation via the peroneal nerve reduces muscle soreness following intermittent exercise. Submitted for publication to Eur J Applied Physiol.
10
l. Conclusions
The information and testing presented in this 510(k) demonstrates that the firefly™ T-1 device performs as designed and intended and is substantially equivalent for use as a neuromuscular stimulator for muscle conditioning.
11
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/11/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of an eagle, represented by three curved lines that suggest the bird's wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2014
Firstkind Ltd c/o Sheila Hemeon-Hever Radcliffe Consulting, Inc. 231 Fairbanks Street West Boylston, MA 01583
Re: K134001
Trade/Device Name: firefly T-1 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: April 17, 2014 Received: April 18, 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
12
Page 2 - Ms. Sheila Hemeon-Hever
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 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/McdicalDcvices/Safety/ReportalProblem/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 Aguel -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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K134001
Device Name firefly™ T-1
Indications for Use (Describe)
The firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical conditions of any kind.
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)
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)
്കുകയും 2014.05.15
പ്രോമന്ത്രം 2014.05.15 16:09:31 -04'00'
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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