(141 days)
No
The summary does not mention AI or ML, and the device description and performance studies focus on standard TENS/EMS technology and electrical/software safety.
Yes
The device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), which are explicitly described as being used for symptomatic relief, management of chronic pain, temporary relief of pain, relaxation of muscle spasms, and other therapeutic indications.
No
The device is described as a transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulation (EMS) device used for pain relief and muscle conditioning, not for diagnosing medical conditions.
No
The device description explicitly states it includes an "electrical impulse generator," a "cradle" for charging, and is delivered with "disposable electrodes and compatible connector cables." These are hardware components, making it a hardware device controlled by software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that actiTENS is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulation (EMS) device. These are therapeutic devices used for pain relief and muscle stimulation.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. actiTENS does not perform any such analysis of bodily specimens.
- Device Description: The description details a device that delivers electrical impulses to the body via electrodes, which is consistent with TENS/EMS technology, not IVD technology.
- Performance Studies: The performance studies listed focus on electrical safety, software validation, and benchtop performance, which are relevant for a therapeutic electrical stimulation device, not an IVD. There are no studies related to analyzing biological samples or diagnostic accuracy.
- Key Metrics: The "Not Applicable" for Key Metrics like Sensitivity, Specificity, PPV, and NPV further indicates it's not a diagnostic device, as these metrics are crucial for evaluating the performance of IVDs.
In summary, the actiTENS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
actiTENS is intended to be used as:
- Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
- Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.
- Electrical Muscle Stimulation (EMS), used for the following indications:
- Temporary relaxation of muscle spasms
- Prevent or retard disuse atrophy
- Increase of local blood flow in the treatment area
- Re-educate muscles
- Maintain or increase the range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode.
Product codes
GZJ, NGX, NYN, IPF
Device Description
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
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
22 and older.
Intended User / Care Setting
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
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 following performance data were provided in support of the substantial equivalence determination:
- Sterilization: N/A - Device is non-sterile.
- Shelf-life Testing: The electrodes are already cleared under K070807, and shelf-life testing for the electrodes is provided in that submission. The battery is the only component that is likely to be impacted by time-dependent product degradation for the controller. The balance of the hardware is not expected to be negatively impacted by time-dependent product degradation. Information regarding the battery shelf-life was provided by the battery manufacturer and the battery shelf-life is 12 months.
- Biocompatibility Testing: Biocompatibility of the electrodes was provided in a previous 510(k) submission (K070807).
- Electrical safety and electromagnetic compatibility (EMC): The following electrical safety and EMC testing reports were provided:
- Electrical Safety Testing IEC 60601-1, plus national deviations to address the differences between IEC 60601-1:2005 and ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
- EMC Testing IEC 60601-1-2
- Usability IEC 60601-1-6
- Home Use Environment IEC 60601-1-11
- Nerve and Muscle Stimulators IEC 60601-2-10
- Software Verification and Validation Testing: Software verification and validation testing was provided in accordance with IEC 62304 and FDA guidance documents.
- Benchtop Performance Testing: The following benchtop performance testing was provided:
- Transportation Testing ASTM D4169-16
- Lithium Battery UL 1642
- Usability IEC 62366-1
- Lithium Battery IEC 62133-2
- Animal Performance Testing: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
- Human Clinical Performance Testing: Clinical testing was not required to demonstrate the safety and effectiveness of the device.
Key results: The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 22, 2020
Sublimed % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K202159
Trade/Device Name: actiTENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, NGX, NYN, IPF Dated: July 30, 2020 Received: August 3, 2020
Dear Robert Packard:
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
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 medical devices and radiation-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
2
Indications for Use
510(k) Number (if known) K202159
Device Name actiTENS
Indications for Use (Describe)
actiTENS is intended to be used as:
-
· Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
-
Symptomatic relief and management of chronic, intractable pain
-
Adjunctive treatment for post-surgical and post-trauma acute pain
-
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
-
Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.
· Electrical Muscle Stimulation (EMS), used for the following indications:
- Temporary relaxation of muscle spasms
- Prevent or retard disuse atrophy
- Increase of local blood flow in the treatment area
- Re-educate muscles
- Maintain or increase the range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode.
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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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
- -SUBMITTER SUBLIMED 137 rue de Mayoussard Moirans, F-38430 France Tel: +33(0)4-76-93-37-15
Contact Person: Corinne Bulteau Date Prepared: December 22, 2020
| II. DEVICE | |
|---|---|
| Trade/Device Name: | actiTENS |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Regulation: | 21 CFR § 882.5890 |
| Regulatory Class: | Class II |
| Product Classification Code: | GZJ, NGX, NYN, IPF |
| III. PREDICATE DEVICE | |
|---|---|
| Predicate Manufacturer: | JKH USA, LLC |
| Predicate Trade Name: | JKH Stimulator Plus |
| Predicate 510(k): | K182203 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.
4
It is available for prescription only.
V. INDICATIONS FOR USE
actiTENS is intended to be used as:
· Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
-
Symptomatic relief and management of chronic, intractable pain
-
Adjunctive treatment for post-surgical and post-trauma acute pain
-
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
-
Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.
· Electrical Muscle Stimulation (EMS), used for the following indications:
- Temporary relaxation of muscle spasms
- Prevent or retard disuse atrophy
- Increase of local blood flow in the treatment area
- Re-educate muscles
- Maintain or increase the range of motion
- Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE
The table below provides a comparison of indications for use and technological characteristics between the subject device and the predicate device in order to demonstrate substantial equivalence:
5
Comparison with Predicate Device:
Table 1: Comparison of actiTENS with JKH Stimulator Plus (K182203).
| Feature | actiTENS | JKH Stimulator Plus -
K182203 | Comparison |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | actiTENS is intended to be
used as:
• Transcutaneous Electrical
Nerve Stimulator (TENS),
used for the following
indications:
- Symptomatic relief and
management of chronic,
intractable pain - Adjunctive treatment for
post-surgical and post-trauma
acute pain - Temporary relief of pain
associated with sore and
aching muscles due to strain
from exercise or normal
household and work activities - Relief of pain associated
with arthritis
Programs P1, P2, P3, P4, P5,
P6, P7, P8, P10, P11, P12 and
P13 correspond to TENS
mode.
• Electrical Muscle
Stimulation (EMS), used for
the following indications: | Over-the-Counter Use:
TENS (Modes 1, 2, 4, 6,
8):
PL-029K12 and PL-
029K13 are used for
temporary relief of pain
associated with sore and
aching muscles in the
shoulder, waist, back, arm,
and leg, due to strain from
exercise or normal household
work activities. PL-0219K12
and PL-
029K13 are also intended
for symptomatic relief an
management of chronic,
intractable pain and relief of
pain associated with
arthritis.
The device of PL-029K12
may be used during sleep.
The device of PL-029K12 is
labeled for use only with its
own compatible electrodes.
PMS (also called EMS,
Modes 1, 3, 7):
PL-029K12 and PL- | The subject device is not
intended for OTC use, and
the prescription use of the
subject device is identical to
the indications of the
predicate model PL-
029K12. |
6
| - Temporary relaxation of
muscle spasms | 029K13 are also intended to
temporarily increase local
blood circulation in the
healthy muscles of lower
extremities. |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| - Prevent or retard disuse
atrophy | Heating:
The device of PL-029K13
is intended for temporary
relief of minor aches and
pains. |
| - Increase of local blood flow
in the treatment area | Prescription Use:
PL-029K12 and PL-
029K13 are intended for
the following use: |
| - Re-educate muscles | -Symptomatic relief and
management of chronic,
interactable pain |
| - Maintain or increase the
range of motion | -Adjunctive treatment for
post-surgical and post-
trauma acute pain |
| - Prevention of venous
thrombosis of the calf
muscles immediately after
surgery | -Relief of pain associated
with arthritis |
| Program P9 corresponds to
EMS mode. | -Temporary relaxation of
muscle spasm |
| | -Prevention or retardation of
disuse atrophy |
| | -Muscle re-education |
| | -Maintaining or increasing
range of motion |
| | -Increase of local blood
flow in the treatment area |
| | -Prevention of post-
surgical venous
thrombosis through |
7
| | | immediate stimulation of
calf muscles | |
|-----------------------------------------|------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription or OTC | Prescription | OTC and Prescription | The subject device does not
include OTC indications,
but this eliminates the risks
associated with OTC use. |
| Power Source(s) | Rechargeable | Rechargeable or non-
rechargeable battery | The subject device is
limited to use with the
rechargeable lithium-ion
battery, but this does not
introduce any new risks. |
| Compliance with Voluntary
Standards? | Yes | Yes | Same |
| Compliance With 21 CFR
898? | Yes | Yes | Same |
| Functions and design | Electrical stimulation | Electrical stimulation and
heat | The subject device does not
include the IRT product
classification, and this
eliminates the risks
associated with that
function. |
| Maximum skin temperature | N/A | 43°C | The subject device does not
include the IRT product
classification and does not
provide heat |
8
| actiTENS | JKH Stimulator Plus – K182203 | Comparison | ||
|---|---|---|---|---|
| Maximum output | ||||
| voltage (Volts+/- 20%) at | ||||
| 500Ω | P1 | 30.2 PL- 029K12: 57.6 | Maximum output voltage of the subject | |
| device is in the range or below this of the | ||||
| predicate device. These technological | ||||
| differences between the subject and | ||||
| predicate device do not raise new safety | ||||
| and effectiveness questions | ||||
| P2 | 30.2 PL- 029K13: 46.0 | |||
| P3 | 30 | |||
| P4 | 30.2 | |||
| P5 | 30.2 | |||
| P6 | 30 | |||
| P7 | 30.2 | |||
| P8 | 30.2 | |||
| P9 | 29.5 | |||
| P10 | 29.1 | |||
| P11 | 29.3 | |||
| P12 | 30.2 | |||
| P13 | 30.2 | |||
| Maximum output | ||||
| voltage (Volts+/- 20%) at | ||||
| 2KΩ | P1 | 57.9 PL- 029K12: 96.0 | Maximum output voltage of the subject | |
| device is in the range or below this of the | ||||
| predicate device. These technological | ||||
| differences between the subject and | ||||
| predicate device do not raise new safety | ||||
| and effectiveness questions | ||||
| P2 | 57.9 PL- 029K13: 90.4 | |||
| P3 | 57.9 | |||
| P4 | 57.9 | |||
| P5 | 57.9 | |||
| P6 | 57.9 | |||
| P7 | 57.9 | |||
| P8 | 57.9 | |||
| P9 | 57.9 | |||
| P10 | 57.9 | |||
| P11 | 57.9 | |||
| P12 | 57.9 | |||
| P13 | 57.9 | |||
| Maximum output | ||||
| voltage (Volts+/- 20%) at | ||||
| $10KΩ$ | P1 | |||
| P2 | ||||
| P3 | ||||
| P4 | ||||
| P5 | ||||
| P6 | ||||
| P7 | ||||
| P8 | ||||
| P9 | ||||
| P10 | ||||
| P11 | ||||
| P12 | ||||
| P13 | N/A | PL-029K12: 134 | ||
| PL-029K13: 124 | The EIG monitors the impedance of each | |||
| channel and stop any running program (or | ||||
| refuse to launch one) if the measured | ||||
| impedance is out of a specified range. This | ||||
| feature ensures a proper installation of the | ||||
| EIG, the cables and electrodes. If an | ||||
| electrode peels off, stopping the stimulation | ||||
| program quickly enough prevents the | ||||
| patient from feeling an electric discharge as | ||||
| the attached surface diminishes. The 10 | ||||
| $kOhm$ is at the upper range and the EIG | ||||
| refused to launch a stimulation program, | ||||
| thus the measurement could not be | ||||
| performed | ||||
| Maximum output | ||||
| current(mA+/- 20%) at | ||||
| $500Ω$ | P1 | |||
| P2 | ||||
| P3 | ||||
| P4 | ||||
| P5 | ||||
| P6 | ||||
| P7 | ||||
| P8 | ||||
| P9 | ||||
| P10 | ||||
| P11 | ||||
| P12 | ||||
| P13 | 60.4 | |||
| 60.4 | ||||
| 60 | ||||
| 60.4 | ||||
| 60.4 | ||||
| 60 | ||||
| 60.4 | ||||
| 60.4 | ||||
| 59 | ||||
| 58.2 | ||||
| 58.6 | ||||
| 60.4 | ||||
| 60.4 | 60.4 PL-029K12: 115.2 | |||
| 60.4 PL-029K13: 92.0 | Maximum output current of the subject | |||
| device is in the range or below this of the | ||||
| predicate device. These technological | ||||
| differences between the subject and | ||||
| predicate device do not raise new safety | ||||
| and effectiveness questions | ||||
| Maximum output | ||||
| current(mA+/- 20%) at | ||||
| 2KΩ | P1 | 28.95 | PL-029K12: 48.0 | Maximum output current of the subject |
| device is in the range or below this of the | ||||
| predicate device. These technological | ||||
| differences between the subject and | ||||
| predicate device do not raise new safety | ||||
| and effectiveness questions | ||||
| P2 | 28.95 | PL-029K13: 45.2 | ||
| P3 | 28.95 | |||
| P4 | 28.95 | |||
| P5 | 28.95 | |||
| P6 | 28.95 | |||
| P7 | 28.95 | |||
| P8 | 28.95 | |||
| P9 | 28.95 | |||
| P10 | 28.95 | |||
| P11 | 28.95 | |||
| P12 | 28.95 | |||
| P13 | 28.95 | |||
| Maximum output | ||||
| current(mA+/- 20%) at | ||||
| 10kΩ | P1 | N/A | PL-029K12: 13.4 | The EIG monitors the impedanceof each |
| channel and stop any running program (or | ||||
| refuse to launch one) if the measured | ||||
| impedance is out of a specified range. This | ||||
| feature ensures a proper installation of the | ||||
| EIG, the cables and electrodes. If an | ||||
| electrode peels off, stopping the stimulation | ||||
| program quickly enough prevents the | ||||
| patient from feeling an electric discharge as | ||||
| the attached surface diminishes. The 10 | ||||
| kOhm is at the upper range and the EIG | ||||
| refused to launch a stimulation program, | ||||
| thus the measurement could not be | ||||
| performed | ||||
| P2 | PL- 029K13: 12.4 | |||
| P3 | ||||
| P4 | ||||
| P5 | ||||
| P6 | ||||
| P7 | ||||
| P8 | ||||
| P9 | ||||
| P10 | ||||
| P11 | ||||
| P12 | ||||
| P13 | ||||
| P1 | 197.5 | |||
| Pulse Width (µSec) | P2 | 147 PL-029K12: 100 | These technological differences between | |
| the subject and predicate device do not | ||||
| raise new safety and effectiveness | ||||
| questions | ||||
| P3 | 247.5 PL-029K13: 92 | |||
| P4 | 197.5 | |||
| P5 | 147.5 | |||
| P6 | 200 or 147 | |||
| P7 | 147.5 | |||
| P8 | modulated 100-200 | |||
| P9 | 247.5 | |||
| P10 | 147.5 | |||
| P11 | 147.5 | |||
| P12 | 57.5 | |||
| P13 | 177.5 | |||
| Frequency (Hz) | P1 | 100 PL-029K12: 156.2 | Frequencies of the subject device is in the | |
| range or below this of the predicate | ||||
| device. These technological differences | ||||
| between the subject and predicate device | ||||
| do not raise new safety and effectiveness | ||||
| questions | ||||
| P2 | 80 PL-029K13: 178.5 | |||
| P3 | 2 | |||
| P4 | 100 | |||
| P5 | 100 | |||
| P6 | 2 or 100 | |||
| P7 | 100 | |||
| P8 | modulated 2-80 | |||
| P9 | 50 | |||
| P10 | 80 | |||
| P11 | 80 | |||
| P12 | 80 | |||
| P13 | 10 |
Table 2: Comparison of actiTENS with JKH Stimulator Plus (K182203) with regards to TENS and EMS performance.
9
10
11
12
| Maximum Phase
| charge (µC) at 500Ω | ||||
|---|---|---|---|---|
| Maximum Phase | ||||
| charge (µC) at 500Ω | P1 | 11.9 | PL-029K12: 23.0 | The maximum phase charge is in the same |
| range than the maximum phase charge of | ||||
| the predicate. Furthermore the highest | ||||
| value for the predicate is over than the | ||||
| intended device. This raises no new safety | ||||
| or effectiveness questions. | ||||
| P2 | 8.9 | PL-029K13: 16.9 | ||
| P3 | 14.9 | |||
| P4 | 11.9 | |||
| P5 | 8.9 | |||
| P6 | 12.0 | |||
| P7 | 8.9 | |||
| P8 | 12.1 | |||
| P9 | 14.6 | |||
| P10 | 8.6 | |||
| P11 | 8.6 | |||
| P12 | 3.5 | |||
| P13 | 10.7 | |||
| Maximum current | ||||
| density (mA/cm2) at | ||||
| 500Ω | P1 | 3.0 | PL-029K12: 3.26 | The maximum current density is in the |
| same range than the maximum current | ||||
| density of the predicate. Furthermore the | ||||
| highest value for the predicate is over than | ||||
| the intended device. This raises no new | ||||
| safety or effectiveness questions. | ||||
| P2 | 3.0 | PL-029K13: 3.29 | ||
| P3 | 3.0 | |||
| P4 | 3.0 | |||
| P5 | 3.0 | |||
| P6 | 3.0 | |||
| P7 | 3.0 | |||
| P8 | 1.7 | |||
| P9 | 2.9 | |||
| P10 | 2.9 | |||
| P11 | 2.9 | |||
| P12 | 3.0 | |||
| P13 | 3.0 |
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The subject device and predicate device have equivalent indications for use and technological characteristics, with the exception that the subject device does not include over-the-counter-use (NUH product classification) and the subject device does not include heat as a modality (IRT product classification).
The predicate device claims two main functions: electrical stimulation and heat. The predicate device modalities work independently. Each modality has its own independent therapeutic effect. The subject device claims only the electrical stimulation effect as many devices cleared by the FDA, while the heating modality is exempt from 510(k) clearance. This technological difference between the subject and predicate device does not raise new safety and effectiveness questions. Concerning the maximum output voltage and the maximum output current, the subject device has been developed as a current generator with a maximum setpoint current of 60mA and has been limited by hardware to deliver output voltage of 60V. Thus it delivers a current of 60mA at 60V for 1KΩ. Above this charge the maximum output power will decrease. In each case the maximum output current and maximum output voltage are lower than the predicate. The subject device presents a maximum phase charge lower than the predicate device. In addition, the output voltage, phase charge, current density and average power density depends on the output current that is set by the user. The output current always starts at 0mA and is increased manually by the user with a 0.5mA increment, to achieve a strong but comfortable sensation, so the output voltage, output current, phase charge, current density and average power density delivered are therapeutically effective with the subject device. These technological differences between the subject and predicate device do not raise new safety and effectiveness questions.
Maximum output current and maximum output voltage at 10k Ω are not defined in the subject device because 10k Ω is the upper limit of the range of charge at which the subject device stops delivering currents. For the comfort and safety of the patient a limited range of charge has been defined in the subject device, to forbid electric current generation in case of short circuit or if an electrode is peeling off of the patient skin.
The difference of frequencies and pulse width between the subject device and predicate device does not raise new types of safety or effectiveness questions because the user chooses the frequency and the pulse width through different kind of programs using the mobile application and programs are using standard TENS stimulation frequencies and pulse width. The maximum current density and maximum average power density are directly linked to the pads surfaces used with the device. The only recommended pads with the subject device are 4.5cmX4.5cm then the density is calculating using the voltage and current generator capacities. The subject device presents maximum current density and maximum average power density higher than the predicate but the maximum power density is less than 250 mW/cm² as required by the guidance for Powered Muscle Stimulator the maximum power density is also less than 250 mW/cm². These technological differences between the subject and predicate device do not raise new safety and effectiveness questions.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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Sterilization
N/A - Device is non-sterile.
Shelf-life Testing
The electrodes are already cleared under K070807, and shelf-life testing for the electrodes is provided in that submission.
The battery is the only component that is likely to be impacted by time-dependent product degradation for the controller. The balance of the hardware is not expected to be negatively impacted by time-dependent product degradation.
Information regarding the battery shelf-life was provided by the battery manufacturer and the battery shelf-life is 12 months.
Biocompatibility Testing
Biocompatibility of the electrodes was provided in a previous 510(k) submission (K070807).
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC testing reports were provided:
- Electrical Safety Testing IEC 60601-1, plus national deviations to address the differences . between IEC 60601-1:2005 and ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
- EMC Testing IEC 60601-1-2
- Usability IEC 60601-1-6 ●
- Home Use Environment IEC 60601-1-11 ●
- . Nerve and Muscle Stimulators IEC 60601-2-10
Software Verification and Validation Testing
Software verification and validation testing was provided in accordance with IEC 62304 and FDA guidance documents.
Benchtop Performance Testing
The following benchtop performance testing was provided:
- Transportation Testing ASTM D4169-16 ●
- Lithium Battery UL 1642 ●
- Usability IEC 62366-1 ●
- Lithium Battery IEC 62133-2 .
Animal Performance Testing
Animal performance testing was not required to demonstrate safety and effectiveness of the
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device.
Human Clinical Performance Testing
Clinical testing was not required to demonstrate the safety and effectiveness of the device.
VIII. CONCLUSIONS
The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.