(106 days)
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.
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.
This document is a 510(k) premarket notification for a medical device, the SLENDERTONE® Connect Abs, Type 570. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.
Therefore, the information requested regarding a study for acceptance criteria (sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, and ground truth for training set) is not present in this document. This typically means such a study was not required or was deemed unnecessary for a 510(k) submission based on substantial equivalence.
However, the document does list various performance testing conducted in accordance with international safety standards. These tests are the "acceptance criteria" in the context of this submission, demonstrating the device's adherence to safety and essential performance requirements.
Here's the breakdown of what is available and what is not:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| IEC 60601-1: 2005/A1:2012 (Medical electrical equipment. General requirements for basic safety and essential performance) | Device tested in accordance with standard. |
| IEC 60601-1-6:2010 (Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) | Device tested in accordance with standard. |
| EN 60601-1-2:2007 (Medical electrical equipment - part 1-2: general requirements for for safety - collateral standard: electromagnetic compatibility requirements and tests) | Device tested in accordance with standard. |
| IEC 60601-2-10:2012 (Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators) | Device tested in accordance with standard. |
| 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) | Device tested in accordance with standard. |
| ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | Device tested in accordance with standard. |
| ISO 10993-10:2010 (Biological evaluation of medical devices. Tests for irritation and skin sensitization) | Device tested in accordance with standard. |
| Wireless co-existence in ISM band (Bluetooth, Wi-Fi, cellphones, cordless phones, etc.) | The device met all specified requirements. |
| BLE module testing (EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013 and FCC Rule Part 15.247:2012) | Device tested in accordance with standards. |
| Battery testing (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) | Device tested in accordance with standard. |
Regarding the study that proves the device meets the acceptance criteria, the following information is NOT available in the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document states "Performance testing was conducted," but does not detail the methodology, sample sizes of devices or participants, or data provenance for these engineering and safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable for this type of testing. The "acceptance criteria" here relate to engineering safety and performance standards for a powered muscle stimulator, not diagnostic accuracy requiring expert panel review or ground truth establishment in a clinical imaging or diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of testing. Adjudication methods are typically used in clinical studies involving interpretation of results, which is not the nature of these engineering and safety compliance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware with firmware/software, not an algorithm in the sense of a diagnostic AI. The "standalone" performance here refers to the device's electrical and mechanical safety compliance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Implicit. For engineering and safety standards, the "ground truth" is defined by the parameters and methodologies outlined in the referenced international standards (e.g., electrical safety limits, biocompatibility requirements, electromagnetic compatibility limits). Compliance is measured against these defined benchmarks.
8. The sample size for the training set:
- Not applicable. This device uses pre-programmed functionalities and does not indicate any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As no training set is mentioned or implied.
In summary, this 510(k) submission successfully demonstrates substantial equivalence through a comparison of technological characteristics to a predicate device and via compliance with relevant safety and performance standards, rather than presenting a clinical study with subjective endpoints that would require the detailed information you requested.
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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
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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
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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)
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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.
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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.
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| Table IBasic Unit Characteristics | Modified DeviceSlendertone Connect Abs | Predicate DeviceSlendertone Connect Abs | Justification |
|---|---|---|---|
| 1. 510(k) Number | K161974 | K151903 | N/A |
| 2. Device Name, Model | Slendertone® ConnectAbs,Type 570 | Slendertone® Connect Abs,Type 570 | Same |
| 3. Manufacturer (Contract) | JDI Electronics FactoryCima Industrial CenterChang Ping, DongguanGuangdong, CHINAOwner Operator: BlueOcean Innovation LtdRM 1813, Fo TanIndustrial Centre26-28 Au Pui Wan StreetFo Tan, Hong Kong | Blue Ocean Innovation LtdRM 1813, Fo Tan Industrial Centre26-28 Au Pui Wan StreetFo Tan, Hong Kong | |
| 4. Power Source | 3.7V Lithium PolymerSingle Cell Rechargeable | 3.7V Lithium Polymer Single CellRechargeable | Same |
| - Method of line Isolation | No line connectionpossible when connectedto body | No line connection possible whenconnected to body | Same |
| - Patient Leakage Current | Not applicable, no lineconnection, no ACcharger connection oroperation. Connectionmethod does not allowAC charger connection toPatient. | Not applicable, no line connection,no AC charger connection oroperation. Connection methoddoes not allow AC chargerconnection to Patient. | Same |
| 5. No. of Output Modes | 1 (Symmetric, Pulsed,Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | Same |
| 6. Number of OutputChannels | 2 | 2 | Same |
| - Synchronous/Alternating? | Synchronous | Synchronous | Same |
| - Method of channelisolation | Transistor | Transistor | Same |
| 7. Regulated Current orRegulated Voltage | Constant Current | Constant Current | Same |
| 8. Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| 9. Mobile Apps | iOS + Android | iOS only | Different, but does notadversely impact the safetyand effectiveness of thesubject device |
| 10. Automatic overloadTrip? | Yes | Yes | Same |
| 11. Automatic No-Load | Yes | Yes | Same |
| Table I | Modified Device | Predicate Device | Justification |
| Basic Unit CharacteristicsTrip? | Slendertone Connect Abs | Slendertone Connect Abs | |
| 12. Automatic Shut Off | Yes | Yes | Same |
| 13. Patient OverrideControl? | 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 deviceYes, Unit LED and Smart deviceYes, via Smart device | Yes, Unit LED and Smart deviceYes, Unit LED and Smart deviceYes, via Smart device | Same |
| 15. Timer range (minutes) | 20-30 minutes | 20-30 minutes | Same |
| 16. Compliance withVoluntary Standards? | IEC 60601-1: 2005 & A1:2012IEC 60601-2-10:2012EN 60601-1-2: 2007IEC 60601-1-11:2010IEC 60601-1-6:2010IEC 62133:2012FCC Rule Part 15.247:2012 | IEC 60601-1: 2005 & A1:2012IEC 60601-2-10:2012EN 60601-1-2: 2007IEC 60601-1-11:2010IEC 60601-1-6:2010IEC 62133:2012FCC Rule Part 15.247:2012 | Same |
| 17. Compliance with CFR21 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 andConstruction | 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 interphaseinterval | Rectangular, with interphaseinterval | Same |
| Maximum OutputVoltage (RMSV) (+/-10%) | 9.47V @ 500Ω17.5V @ 2kΩ6.2V @ 10kΩ | 9.47V @ 500Ω17.5V @ 2kΩ6.2V @ 10kΩ | Same |
| $ Vp2x2xPW √1/freq $ | |||
| Maximum OutputCurrent (RMSA) (+/-10%) | 18.9mA @ 500Ω8.75mA @ 2kΩ620µA @ 10kΩ | 18.9mA @ 500Ω8.75mA @ 2kΩ620µA @ 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 perpulse) | 0@500ΩSymmetric, biphasic andleading polarity alternates foreach successive pulse | 0@500ΩSymmetric, biphasic andleading polarity alternates foreach successive pulse | Same |
| Maximum Phase Charge(µC)C= Ip*PW | 1 phase 32 µC @500Ω2 phase 64 µC @500Ω | 1 phase 32 µC @500Ω2 phase 64 µC @500Ω | Same |
| Maximum CurrentDensity (mA/cm²) | 0.28 mA/cm² @500Ω | 0.28 mA/cm² @500Ω | Same |
| Maximum Power Density(W/ cm²)Using smallest electrodeconductive 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 (ifapplicable) | N/A | N/A | Same |
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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
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- 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
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- . 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.
N/A