(288 days)
No
The description focuses on programmable electrical stimulation parameters and safety features, with no mention of AI or ML capabilities for data analysis, adaptive stimulation, or learning from patient responses.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions" and lists several therapeutic applications such as "Temporary Relaxation of muscle spasms" and "Helps to relearn voluntary motor functions of the extremities."
No
Explanation: The device is described as a "Neuromuscular electronic stimulator" and a "constant-current powered muscle stimulator" designed for therapeutic purposes like muscle spasms, disuse atrophy, and re-education. While it performs impedance measurements, this is for operational safety and efficacy of stimulation, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of a stimulator (hardware), cables, and a software package. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a neuromuscular electronic stimulator. It delivers electrical pulses to the body for therapeutic purposes (muscle stimulation, re-education, etc.).
- Intended Use: The intended uses listed are all related to applying electrical stimulation to the body for treatment of medical conditions. None of the uses involve analyzing samples taken from the body.
- Device Description: The description focuses on the electrical stimulation capabilities, parameters, and connections, not on any components or processes related to analyzing biological specimens.
Therefore, the g.Estim FES is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As powered muscle stimulator:
- · Temporary Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood flow in the treatment area
- Muscle re-education
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- · Maintaining or increasing range of motion
As external functional neuromuscular stimulator:
- · Helps to relearn voluntary motor functions of the extremities
The device must be used by trained and qualified personnel.
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZI
Device Description
The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch.
The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset.
The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected.
A foot switch or hand switch can be used to trigger the stimulator.
The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
"The device must be used by trained and qualified personnel."
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2020
g.tec medical engineering GmbH Christoph Guger CEO Siemingerstrasse 14 Schiedlberg, 4521 Austria
Re: K200088
Trade/Device Name: g.Estim FES Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZI Dated: July 29, 2020 Received: July 31, 2020
Dear Dr. Guger:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 Ballard, PhD Assistant 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) K200088
Device Name g.Estim FES
Indications for Use (Describe)
Neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As powered muscle stimulator:
- · Temporary Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood flow in the treatment area
- Muscle re-education
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- · Maintaining or increasing range of motion
As external functional neuromuscular stimulator:
- · Helps to relearn voluntary motor functions of the extremities
The device must be used by trained and qualified personnel.
| 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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3
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
g.tec medical engineering GmbH Sierningstrasse 14 4521 Schiedlberg Austria
| Phone: | ++43 (7251) 22240-12 |
|---|---|
| Fax: | ++43 (7251) 22240-39 |
| Contact Person: | Christoph Guger |
| Date: | 28.10.2020 |
| 807.92(a)(2) | |
| Trade Name: | g.Estim FES |
| Common Name: | Electrical muscle stimulator |
| Classification Names(s): | Powered muscle stimulator |
| (per 21 CFR section 21 CFR 890.5850) | |
| External functional neuromuscular stimulator | |
| (per 21 CFR section 21 CFR 882.5810) | |
| Product Code: | IPF, GZI |
807.92(a)(3)
Predicate Devices/ Reference Devices
| Secondary Predicate | Reference | Primary Predicate | |
|---|---|---|---|
| Manufacturer: | Mettler Electronics | ||
| Corp | Thought Technology Ltd | Otto Bock Healthcare | |
| Product GmbH | |||
| Trade Name | SYS*STIM 208/208A | MyoTRac Infiniti | STIWELL med 4 |
| 510(k) document control number | K031017 | K053266 | K080950 |
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe, Tel .: +43 7251 22240, Fax: +43 7251 22240-39, office@gtec.at, www.gtec.at
4
807.92(a)(4)
Device Description
The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch.
The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset.
The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected.
A foot switch or hand switch can be used to trigger the stimulator.
The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.
g.Estim FES works in the same manner as the approved predicate devices.
5
807.92(1)(5)
Indications for Use
Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As powered muscle stimulator:
- Temporary Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy .
- Increasing local blood flow in the treatment area .
- · Muscle re-education
- . Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Maintaining or increasing range of motion .
As external functional neuromuscular stimulator
- · Helps to relearn voluntary motor functions of the extremities
The device must be used by trained and qualified personnel.
6
807.92(a)(6)
Technological Characteristics
| | Item | g.tec medical engineering
GmbH
g.Estim FES
this Submission | Mettler Electronics Corp.
SYSSTIM 208/208A
K031017 for IPF
(secondary) | Thought Technology Ltd
MyoTrac Infiniti K053266
for IPF (reference) | Otto Bock Healthcare
Product GmbH
STIWELL med4 K080950
for IPF and GZI (primary) | Comments |
|------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended use | Neuromuscular electronic
stimulator indicated for use
under medical supervision for
adjunctive therapy in the
treatment of medical diseases
and conditions. | Powered Muscle Stimulation | Muscle Stimulation and EMG
Biofeedback | Neuromuscular electronic
stimulator indicated for use
under medical supervision for
adjunctive therapy in the
treatment of medical diseases
and conditions | Equivalent with predicate
K080950, which covers all
indications claimed also by this
submission (including the
indications of the other
predicate devices).
Indications for product code |
| 2. | Indication for
use | As powered muscle
stimulator:
• Temporary Relaxation
of muscle spasms
• Prevention or retardation
of disuse atrophy
• Increasing local blood
flow in the treatment
area
• Muscle re-education
• Prevention of post-
surgical phlebo-
thrombosis through
immediate stimulation
of calf muscles
• Maintaining or
increasing range of
motion
As external functional
neuromuscular stimulator:
• Helps to relearn
voluntary motor
functions of the
extremities
The device must be used by
trained and qualified personnel. | • Temporary Relaxation
of muscle spasms
• Prevention or retardation
of disuse atrophy
• Increasing local blood
flow in the treatment
area
• Muscle re-education
• Prevention of post-
surgical phlebo-
thrombosis through
immediate stimulation
of calf muscles
• Maintaining or
increasing range of
motion
• Symptomatic relief of
chronic intractable pain,
acute post traumatic
pain or acute post
surgical pain | • Relaxation of muscle
spasms
• Prevention or retardation
of disuse atrophy
• Increasing local blood
circulation
• Muscle re-education
• Immediate post-surgical
stimulation of calf
muscles to prevent
venous thrombosis
• Maintaining or
increasing range of
motion
• Biofeedback, Relaxation
& Muscle Re-Education | As powered muscle
stimulator:
• Relaxation of muscle
spasm
• Prevention or retardation
of disuse atrophy
• Increasing local blood
circulation
• Muscle re-education
• Immediate post-surgical
stimulation of calf
muscles to prevent
venous thrombosis
• Maintaining or
increasing range of
motion
As external functional
neuromuscular stimulator:
• Helps to relearn
voluntary motor
functions of the
extremities
As a transcutaneous
electrical nerve stimulator
for pain relief:
• Symptomatic relief and
management of chronic
(long-term), intractable
pain | IPF (green) are equivalent in
safety and effectiveness.
Indications for product code
GZI (blue) are identical.
Additional product codes of the
predicate devices not claimed
by the current submission
(orange) are:
• reduction of pain (GZJ),
• biofeedback (HCC)
• incontinence treatments
(KPI) |
| Item | g.tec medical engineering
GmbH
g.Estim FES | Mettler Electronics Corp.
SYSSTIM 208/208A
K031017 for IPF | Thought Technology Ltd
MyoTrac Infiniti K053266
for IPF | Otto Bock Healthcare
Product GmbH
STIWELL med4 K080950 | Comments | |
| | this Submission | | | for IPF and GZI | | |
| | | | | Adjunctive treatment in
the management of post-
surgical pain and post
traumatic acute pain
As a biofeedback device: Biofeedback, relaxation
and muscle re-education
purposes
As a nonimplanted electrical
continence device: Acute and ongoing
treatment of stress, urge
or mixed urinary
incontinence and where
the following results
may improve urinary
control: Inhibition of the
detruser muscles
through reflexive
mechanisms and
strengthening of pelvic
floor muscles Incontinence treatment
for assessing EMG
activity of the pelvic
floor and accessory
muscles such as the
abdominal and the
gluteus muscles | | |
| | Item | g.tec medical engineering
GmbH
g.Estim FES
This Submission | Mettler Electronics Corp.
SYS*STIM 208/208A
K031017
(secondary predicate) | Thought Technology Ltd
MyoTrac Infiniti K053266
(reference) | Otto Bock Healthcare
Product GmbH
STIWELL med4 K080950
(primary predicate) | Comments |
| 3. | Power sources | USB and battery, 2 x 9 V | 110V AC, 60Hz +-10% | not publicly available | Battery Pack Li-ion 11,1 V | g.Estim FES is powered by a
combination of batteries and
USB power. The applied part is
powered by conventional
batteries and fulfills IEC 60601-
1, therefore it is equivalent in
safety and effectiveness. |
| 4. | Line current
isolation | The applied part is powered by
conventional batteries. The
applied part is isolated from the
rest of the circuit by 2 MOP
according to IEC 60601-1. | AC power supply is converted
to DC power supply through
transformer. Hence there is an
insulation of mains from
circuitry. From circuitry to
output again, there is insulation
through the transformer, there
by double separation between
mains and the human body. | not publicly available | Medical Class II Power
Adapter- Mascot (12,6 VDC-
15,1W)) | State of the art isolation strategy
- equivalent in safety and
effectiveness. |
| 5. | Patient leakage
current | Type BF according to IEC
60601-1
NC max: