(106 days)
Not Found
No
The summary describes a standard electrical muscle stimulation device with Bluetooth connectivity and a mobile app, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is intended to stimulate healthy muscles to improve performance and tone, which is not a therapeutic purpose.
No
The device is intended to stimulate healthy muscles to improve or facilitate muscle performance and strengthen muscles, which are therapeutic rather than diagnostic functions.
No
The device description explicitly lists hardware components such as a control unit, abdominal garment, gel pads, USB cable, and a Bluetooth module, indicating it is a hardware device with software control.
Based on the provided information, the SLENDERTONE® Connect Abs, Type 570 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This involves direct interaction with the body (neuromuscular electrical stimulation) to affect muscle function.
- Device Description: The device is described as a "portable, neuromuscular, electrical stimulation system." This type of device delivers electrical impulses to the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The SLENDERTONE® Connect Abs does not perform any such analysis of specimens.
Therefore, the SLENDERTONE® Connect Abs is a therapeutic or performance-enhancing device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SLENDERTONE® Connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
Product codes
NGX
Device Description
The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was conducted in accordance with the following international standards for safety:
IEC 60601-1: 2005/A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance
Medical electrical equipment Part 1-6: General IEC 60601-1-6:2010 requirements for basic safety and essential performance -Collateral standard: Usability Medical electrical equipment - part 1-2: general EN 60601-1-2:2007 requirements for for safety - collateral standard:
electromagnetic compatibility requirements and tests IEC 60601-2-10:2012 Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Biological evaluation of medical devices. Tests for irritation ISO 10993-10:2010 and skin sensitization
The performance of SLENDERTONE® Connect Abs for wireless co-existence was evaluated in an environment with equipment operating in the ISM band i.e. Bluetooth and Wi-Fi devices, cellphones, cordless phones etc.. The device met all specified requirements.
BLE module testing was conducted in accordance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013. Safety of Technology Equipment and FCC Rule Part 15.247:2012.
Battery testing was conducted in accordance with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications.
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
§ 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 Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic 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
November 1, 2016
Bio-Medical Research Ltd Anne-Marie Keenan Regulatory Affairs Specialist Parkmore Business Park West Galway, H91 NHT7 Ireland
Re: K161974
Trade/Device Name: SLENDERTONE® Connect Abs, Type 570 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 3, 2016 Received: October 5, 2016
Dear Anne-Marie Keenan:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Michael J. Hoffmann -A
for
Carlos L. Peña, PhD, MS 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) K161974
Device Name SLENDERTONE® Connect Abs, Type 570
Indications for Use (Describe)
The SLENDERTONE® Connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the abdominal muscles and for the development of a firmer abdomen.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510k SUMMARY
| I. SUBMITTER | |
|---|---|
| Name: | Anne-Marie Keenan |
| Address: | Bio-Medical Research Ltd., |
| Parkmore Business Park West, | |
| Galway, IRELAND | |
| Telephone: | +353 91 774316 |
| Fax: | +353 91 774301 or +353 91 774302 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | July 14, 2016 |
| II. DEVICE | |
| Trade Name of Device: | SLENDERTONE® Connect Abs, Type 570 |
| Common Name: | Powered muscle stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Regulation Description: | Stimulator, muscle, powered, for muscle conditioning |
| Product Code: | NGX |
| Device Class: | 2 |
| III. PREDICATE DEVICES | |
| 510(k) Number: | K151903 |
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | SLENDERTONE® Connect Abs, Type 570 |
The listed predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.
4
V. INDICATIONS FOR USE
The SLENDERTONE® Connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following tables summarizes the similarities and differences between the technological characteristics of the modified device versus the predicate device;
Table I Unit Characteristics
Table II Output Characteristics (values representing maximum power limit of 180mW)
Users may securely download additional treatment programs through the mobile application. The program parameters and resulting outputs for any such program are limited in accordance with the Table II.
5
| Table I
Basic Unit Characteristics | Modified Device
Slendertone Connect Abs | Predicate Device
Slendertone Connect Abs | Justification |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | K161974 | K151903 | N/A |
| 2. Device Name, Model | Slendertone® Connect
Abs,
Type 570 | Slendertone® Connect Abs,
Type 570 | Same |
| 3. Manufacturer (Contract) | JDI Electronics Factory
Cima Industrial Center
Chang Ping, Dongguan
Guangdong, CHINA
Owner Operator: Blue
Ocean Innovation Ltd
RM 1813, Fo Tan
Industrial Centre
26-28 Au Pui Wan Street
Fo Tan, Hong Kong | Blue Ocean Innovation Ltd
RM 1813, Fo Tan Industrial Centre
26-28 Au Pui Wan Street
Fo Tan, Hong Kong | |
| 4. Power Source | 3.7V Lithium Polymer
Single Cell Rechargeable | 3.7V Lithium Polymer Single Cell
Rechargeable | Same |
| - Method of line Isolation | No line connection
possible when connected
to body | No line connection possible when
connected to body | Same |
| - Patient Leakage Current | Not applicable, no line
connection, no AC
charger connection or
operation. Connection
method does not allow
AC charger connection to
Patient. | Not applicable, no line connection,
no AC charger connection or
operation. Connection method
does not allow AC charger
connection to Patient. | Same |
| 5. No. of Output Modes | 1 (Symmetric, Pulsed,
Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | Same |
| 6. Number of Output
Channels | 2 | 2 | Same |
| - Synchronous/Alternating? | Synchronous | Synchronous | Same |
| - Method of channel
isolation | Transistor | Transistor | Same |
| 7. Regulated Current or
Regulated Voltage | Constant Current | Constant Current | Same |
| 8. Software/Firmware/Micro
processor Control? | Yes | Yes | Same |
| 9. Mobile Apps | iOS + Android | iOS only | Different, but does not
adversely impact the safety
and effectiveness of the
subject device |
| 10. Automatic overload
Trip? | Yes | Yes | Same |
| 11. Automatic No-Load | Yes | Yes | Same |
| Table I | Modified Device | Predicate Device | Justification |
| Basic Unit Characteristics
Trip? | Slendertone Connect Abs | Slendertone Connect Abs | |
| 12. Automatic Shut Off | Yes | Yes | Same |
| 13. Patient Override
Control? | Yes, pause button stops treatment immediately. | Yes, pause button stops treatment immediately. | Same |
| 14. Indicator Display
- On/Off Status?
- Low Battery?
- Voltage/Current Level? | Yes, Unit LED and Smart device
Yes, Unit LED and Smart device
Yes, via Smart device | Yes, Unit LED and Smart device
Yes, Unit LED and Smart device
Yes, via Smart device | Same |
| 15. Timer range (minutes) | 20-30 minutes | 20-30 minutes | Same |
| 16. Compliance with
Voluntary Standards? | IEC 60601-1: 2005 & A1:2012
IEC 60601-2-10:2012
EN 60601-1-2: 2007
IEC 60601-1-11:2010
IEC 60601-1-6:2010
IEC 62133:2012
FCC Rule Part 15.247:2012 | IEC 60601-1: 2005 & A1:2012
IEC 60601-2-10:2012
EN 60601-1-2: 2007
IEC 60601-1-11:2010
IEC 60601-1-6:2010
IEC 62133:2012
FCC Rule Part 15.247:2012 | Same |
| 17. Compliance with CFR
21 898? | Yes | Yes | Same |
| 18. Weight (unit) | 37g (including batteries) | 37g (including batteries) | Same |
| 19. Dimensions (un.)
{W x H x D} | 70 x 50 x 14 mm approx. | 70 x 50 x 14 mm approx. | Same |
| 20. Housing Materials and
Construction | Injection molded thermosetting plastic | Injection molded thermosetting plastic | Same |
| Table II | Modified Device | Predicate Device | Justification |
| Output Characteristics | Slendertone Connect Abs | Slendertone Connect Abs | |
| Waveform | Pulsed, Symmetrical, Biphasic | Pulsed, Symmetrical, Biphasic | Same |
| Shape | Rectangular, with interphase
interval | Rectangular, with interphase
interval | Same |
| Maximum Output
Voltage (RMSV) (+/-10%) | 9.47V @ 500Ω
17.5V @ 2kΩ
6.2V @ 10kΩ | 9.47V @ 500Ω
17.5V @ 2kΩ
6.2V @ 10kΩ | Same |
| $ Vp2x2xPW √1/freq $ | | | |
| Maximum Output
Current (RMSA) (+/-10%) | 18.9mA @ 500Ω
8.75mA @ 2kΩ
620µA @ 10kΩ | 18.9mA @ 500Ω
8.75mA @ 2kΩ
620µA @ 10kΩ | Same |
| Pulse Width | 900 µs | 900 µS | Same |
| Baseline to peak current
@500Ω | 80mA | 80mA | Same |
| Frequency (Hz) | 10 to 80 Hz | 10 to 80 Hz | Same |
| - Phase Duration | 100 - 400µS | 100 - 400µS | Same |
| Net Charge (µC per
pulse) | 0@500Ω
Symmetric, biphasic and
leading polarity alternates for
each successive pulse | 0@500Ω
Symmetric, biphasic and
leading polarity alternates for
each successive pulse | Same |
| Maximum Phase Charge
(µC)
C= Ip*PW | 1 phase 32 µC @500Ω
2 phase 64 µC @500Ω | 1 phase 32 µC @500Ω
2 phase 64 µC @500Ω | Same |
| Maximum Current
Density (mA/cm²) | 0.28 mA/cm² @500Ω | 0.28 mA/cm² @500Ω | Same |
| Maximum Power Density
(W/ cm²)
Using smallest electrode
conductive surface area | 2.57 mW/ cm² @500Ω | 2.57 mW/ cm² @500Ω | Same |
| Contraction Time | 0.5 - 5 sec | 0.5 - 5 sec | Same |
| Relaxation Time | 0.5 - 6 sec | 0.5 - 6 sec | Same |
| Additional Features (if
applicable) | N/A | N/A | Same |
6
7
VII. PERFORMANCE DATA
Performance testing was conducted in accordance with the following international standards for safety:
IEC 60601-1: 2005/A1:2012 Medical electrical equipment. General requirements for basic safety and essential performance
8
- Medical electrical equipment Part 1-6: General IEC 60601-1-6:2010 requirements for basic safety and essential performance -Collateral standard: Usability Medical electrical equipment - part 1-2: general EN 60601-1-2:2007 requirements for for safety - collateral standard:
- electromagnetic compatibility requirements and tests IEC 60601-2-10:2012 Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Biological evaluation of medical devices. Tests for irritation ISO 10993-10:2010 and skin sensitization
The performance of SLENDERTONE® Connect Abs for wireless co-existence was evaluated in an environment with equipment operating in the ISM band i.e. Bluetooth and Wi-Fi devices, cellphones, cordless phones etc.. The device met all specified requirements.
BLE module testing was conducted in accordance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013. Safety of Technology Equipment and FCC Rule Part 15.247:2012.
Battery testing was conducted in accordance with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications.
VIII. CONCLUSION
The modified SLENDERTONE® Connect Abs, Type 570 has
9
- . The same principles of operation as the predicate device with no differences in technological characteristics.
- . The same Intended Use and Indications for Use as the predicate device.
Modifications to the SLENDERTONE® Connect Abs has not resulted in any new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device.