(267 days)
No
The description focuses on standard electrostimulation and infrared technology with pre-programmed treatment options, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The intended use states it is for "improvement of muscle tone of buttocks muscles," which is a beauty/cosmetic purpose, not a therapeutic one for a medical condition.
No
The document states that the device applies transcutaneous electrical muscle stimulation for the purpose of improving muscle tone and is used in environments like Health Spa's and Beauty Salons. This describes a device for aesthetic or physical improvement, not for identifying a medical condition or disease.
No
The device description explicitly lists multiple hardware components including a main power switch, control panel, infrared unit, and distribution of electro-stimulation channels, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the Slim UP® ULTRA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to apply transcutaneous electrical muscle stimulation (EMS) for the improvement of muscle tone of the buttocks. This is a physical application to the body, not a test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details components for electrical stimulation and infrared heating, all of which are applied externally to the body. There is no mention of components for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Measuring biomarkers.
The Slim UP® ULTRA is clearly described as a beauty appliance used for physical muscle stimulation.
N/A
Intended Use / Indications for Use
Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.
Product codes
NGX
Device Description
Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation. Slim UP® is used in environments such as Health Spa's and Beauty Salons. Slim UP® ULTRA has following major components: - Main power switch ■ - . Control panel - Infrared unit - 트 Distribution of electro-stimulation channels. Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case. Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect. Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Buttocks
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health Spa's and Beauty Salons.
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 testing was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Patient applied parts of Slim UP® ULTRA are biocompatible as per the International standard ISO 10993-1:2009- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Electrical safety and electromagnetic compatibility (EMC)
The following standards have been complied within designing, manufacturing and testing of Slim UP® ULTRA:
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General ● Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
- IEC 60601-2-10:2000: Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
- EN ISO 14121-1:2007- Safety of machinery -- Risk assessment -- Part 1: Principles. o
Software Verification and Validation Testing
Software validation was completed to check the safety requirements implemented by the firmware resident on the Microcontroller used on the Slim Up® Ultra, in order to provide objective evidence that the firmware itself operates as indicated in the user manual and does not cause any risks connected to its use.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, layered on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
Aime Medical, Inc % Mr. John O'Brien Regulatory Consultant AJW Technology Consultants, Inc. 445 Apollo Beach Blvd. Apollo Beach, Florida 33572
Re: K151722
Trade/Device Name: Slim UP ULTRA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: February 18, 2016 Received: February 19, 2016
Dear Mr. O'Brien:
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151722
Device Name SLIM UP® ULTRA
Indications for Use (Describe)
Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.
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 (As required by 807.92)
I. SUBMITTER
Company Name: Aime Medical Inc. Address: 1258 West Bay Drive, Suite F. Largo, FL 33770 USA
Phone: +1-727-286-6227 Contact Person: Paul Guilbaud Email: paulg@AimeMedicalinc.com Date Prepared: 16 Feb 2016
REGULATORY CORRESPONDENT
AJW Technology Consultants, Inc 445 Apollo Beach, Blvd Apollo Beach, FL 33572
Phone: 813-645-2855 x101 Fax: 813-645-2856
Contact Person: John O'Brien Email: jobrien@ajwtech.com
II. DEVICE
Name of Device: Common or Usual Name: Classification Name: Regulation Number: Device Panel: Regulatory Class: Main Product Code:
Slim UP® ULTRA Power muscle Stimulator. Power Muscle Stimulator 890.5850 Physical Medicine II NGX
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III. PREDICATE DEVICE
| 510(k) Number: | K123075 |
|---|---|
| Product Code: | NGX |
| Manufacturer: | Well Life Healthcare Limited |
| Trade Name: | Buttock Muscle Stimulator Model WL 2413B; Buttock Muscle |
| Stimulator Model WL-2413E |
The predicate has not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
Slim UP® ULTRA is a new beauty appliance that works on the principles of Electrostimulation.
Slim UP® is used in environments such as Health Spa's and Beauty Salons.
Slim UP® ULTRA has following major components:
- Main power switch ■
- . Control panel
- Infrared unit
- 트 Distribution of electro-stimulation channels.
Slim UP® ULTRA electrostimulation section has 8 channels for body electrostimulation with compensated two-phase rectangular waveform, with individual intensity adjustment and 5 different multi-phase treatment programs diversified to meet the needs of the single case.
Slim UP® ULTRA infrared section has 6 infrared ray sources housed in a height-adjustable, mobile arm that adapts to any couch, ensuring the ideal working distance is maintained at all times. IR source is used for patient comfort only. It does not have any therapeutic effect.
Slim UP® ULTRA is a latest-generation machine occupying only half a square meter. It can be located in any booth, can be adapted to any bed and can be moved anywhere.
5
The table below describes the list of associated accessories included with device.
| Description | Quantity |
|---|---|
| Polycarbonate arc | 1 |
| 100W IR lamp | 7 |
| Nylon screw+ washer for fixing the polycarbonate arc | 5 |
| Protective goggles | 3 |
| 4 mm hexagonal wrench | 1 |
| Threaded pivot for fixing IR apparatus | 2 |
| Temperature probe | 1 |
| Disc for electrostimulation | 100 |
| 510k cleared electrode with conductive gel under (K091163) | 54 |
V. INDICATIONS FOR USE
Slim UP® ULTRA is indicated for the use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrode for the purpose of improvement of muscle tone of buttocks muscles.
6
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I
Subject and predicate devices are intended for similar treatment condition based on the principle of operation they uses
| Parameter | Name of Device | Product Code | Regulation Number | 510 K Number | Intended use | Predicate Device | Predicate Difference |
|---|---|---|---|---|---|---|---|
| Slim UP® ULTRA | Slim UP® ULTRA | NGX, NUV | 878.4810, 890.5850 | K151722 | Slim UP® ULTRA is indicated for the | ||
| use by healthy persons to apply | |||||||
| transcutaneous electrical muscle | |||||||
| stimulation (EMS) through skin contact | |||||||
| electrode for the purpose of | |||||||
| improvement of muscle tone of | |||||||
| buttocks muscles. | Buttock Muscle Stimulator | ||||||
| (WL 2413 E Model) | - | ||||||
| NGX | - | ||||||
| 890.5850 | - | ||||||
| K123075 | - | ||||||
| Buttock Muscle Stimulator, model WL- | |||||||
| 2413E, is -intended for use by healthy | |||||||
| persons to apply transcutaneous | |||||||
| electrical muscle stimulation (EMS) | |||||||
| through skin contact electrode for the | |||||||
| purpose of improvement of muscle tone | |||||||
| of the buttocks muscles | Same |
7
| Parameter | Slim UP® ULTRA | Predicate Device | Predicate
Difference |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Name of Device | Slim UP® ULTRA | Buttock Muscle Stimulator
(WL 2413 E Model) | |
| Product Component | 1. Main power switch
2. Control panel
3. Infrared generation unit
4. Electro-stimulation channels
5. Skin contact electrodes | 1. Electronic Stimulator Module
2. Skin contact electrodes
3. Conductive gel,
4. 3AAA batteries,
5. 2 read wires
6. Storage bag | - |
| Treatment Energy | Electrostimulation | Electrostimulation | Same |
| Energy source | 1) 16 Electrodes (K091163)
2) 6 IR Lamps | K082065, Silicon pad electrodes (7.0 cm diameter) | Different |
| Pigmentation Effect | No | No | Similar |
| Dimensions | 95 cm x 129 cm x 187 cm (WDH) | 64 X20 X90 (WDH) | Different |
| Weight | 161 Kg | 0.08 Kg (80 Gm) (including batteries) | Different |
| Electrical Requirement | 230VAC, Single-phase | 1.5 V x 3 AAA size battery | Different |
| Safety features and
compliance with safety
standard | Compliant | Compliant | Same |
| Patient body contact
material | Biocompatible | Biocompatible | Same |
| Parameter | Slim UP® ULTRA | Predicate Device | Predicate Difference |
| Name of Device | Slim UP® ULTRA | Buttock Muscle Stimulator (WL 2413 E Model) | Different |
| Treatment Time | Between 15 and 60 minutes depend on treatment program selected | 20-40 Minutes | Different |
| Compliance with Voluntary Standards? | Compliant | Compliant | Same |
| Housing Materials and Construction | Polycarbonate arc
Nylon screw and washer for fixing the polycarbonate arc | ABS | Different |
| Principle of Operation | Slim UP® ULTRA works on the basic principles of Electrostimulation. Skin contact electrodes are applied on treatment area. | The Buttock Muscle Stimulator, model WL-241 3E, comprises an electronic stimulator module with silicon pad electrodes which connect the signals from the stimulator to the skin. The electrodes are placed on skin | Same |
| Anatomical Site of Application | Buttocks | Buttocks | Same |
| Number of Electrode Used | 16 Electrostimulation electrode | K082065, Silicon Pad Electrode (7.0 cm diameter) | Different |
| Mode OR Program name | 2 TONE (F2 work phase) | WL-2413E | Different |
| Wave form | Biphasic | Biphasic | Same |
| Shape | Rectangular | Rectangular | Same |
8
AIME MEDICAL - SLIM UP ULTRA -AI RESPONSE
7 of 16
9
| Parameter | Name of Device | Slim UP® ULTRA | Slim UP® ULTRA | Predicate Device
Buttock Muscle Stimulator
(WL 2413 E Model) | Predicate Difference |
|----------------------------------|----------------|----------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------|----------------------|
| Maximum output voltage | | 100Vpp @ 500Ω
184Vpp @ 1 KΩ
234Vpp @ 2 KΩ
240Vpp @ 10 KΩ
(Single Phase) | | 40.8 V @500Ω
70.0 V @2KΩ
106.0 V @10KΩ | Different |
| Maximum output current | | 100mA @ 500Ω
92 mA @ 1 KΩ
58.5 mA @ 2 KΩ
12 mA @ 10 KΩ
(calculated on single positive pulse) | | 81.6mA@500 Ω
35.0mAr@2KΩ
10.6mA@10KΩ | Different |
| Duration of primary phase (µsec) | | 400 µsec | | 300 µsec | Different |
| Pulse duration | | 400 µsec | | 720 µsec | Different |
| Frequency (Hz) | | 40 Hz | | 70 Hz | Different |
| For multiphase | | Symmetrical phases
Yes | | Yes | Same |
| Waveform Phase duration ms only | | | 800 µsec | Not Applicable | Same |
| Method of Line current Isolation | | | Type BF | Type BF | Same |
| Number of output mode | | | | 04 | Same |
| Pulse per burst | | | Same for each program | Same for each program | Same |
| Burst per second | | | Same for each program | Same for each program | Same |
10
| Parameter | Slim UP® ULTRA | Predicate Device
Buttock Muscle Stimulator
(WL 2413 E Model) | Predicate
Difference |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------|
| Name of Device | Slim UP® ULTRA | | |
| Burst duration | Same for each program | Same for each program | Same |
| Duty cycle | Same for each program | Same for each program | Same |
| Method of achieving
zero net charge/pulse | Biphasic symmetric wave for each
pulse | Biphasic symmetric wave for each
pulse | Same |
| Regulated Current or
Regulated Voltage? | Voltage | Voltage | Same |
| Software/Firmware/Mic
roprocessor control? | Yes | Yes | Same |
| Automatic Shut Off? | Yes | Yes | Same |
| RMS (Root Mean
Square) Current | 100mA during the active phase of the
current pulse, square wave with null
medium value and period of 600μs | 38.644mA (500Ω)
16.907 mA (2KΩ)
5.120 mA (10 Ω) | Different |
| Prescription or OTC | Prescription | OTC | Different |
| Number of Treatment
Programs | 7 different programs that should be
chosen based on the individual
requirements of each case | N/A | Different |
| Method for Channel
Isolation | Sole transformer on all channels from
12V and the tension that goes to the
electrostimulation channels (it is not an
insulating transformer).
If current goes over 100mA (short
output transistor) a safety circuit
intervenes by resetting the machine | Output coil | Different |
| Sterilization | Provided Non Sterile | Provided Non sterile | Same |
9 of 16
11
| Comparison Feature | Slim UP Ultra | Predicate Device | Remarks |
|---|---|---|---|
| Net Charge | 0 @ 500Ω (symmetrical positive and negative pulses) | 0 (symmetrical stimulation biphasic wave) | Same |
| Max Phase Charge | 40 μC @ 500Ω | 24μc | Different |
| Max Average Current Density (jmax) | 0.089 mA/cm² @ 500Ω | 0.0997 mA/cm2 | Different |
| Max Power Density (W/cm²) | 0.00014 W/cm² @ 500Ω with electrodes 4x9 cm | 0.00399 watts/cm2 | Different |
| Burst Mode | Yes | Yes | Same |
Significant output characteristics
12
Similarities in Technological characteristics:
- o Intended use
- Product components ●
- Treatment energy .
- Pigmentation effect .
- Safety feature and compliance with safety standard 0
- Patient body contact material o
- Compliance with voluntary standards o
- Principle of operation o
- Anatomical site of application o
- o Waveform
- Shape o
- Symmetrical phases for multiphase waveform only ●
- Method of line current isolation ●
- Number of output mode ●
- Pulse per Burst ●
- Burst per Second ●
- Bust duration ●
- Duty cycle
- Method for achieving zero net charge/pulse ●
- Current/ Voltage regulation ●
- Software/firmware control ●
- Automatic shut off ●
- Sterilization ●
- Net Charge ●
- Max Phase Charge ●
- o Burst Mode
Differences in Technological characteristics
- Energy Source ●
- Physical characteristics (weight, dimensions) ●
- Electrical Requirements ●
- Treatment Time o
- Housing material & construction ●
- Number of Electrode ●
- Mode or program name ●
- Maximum output voltage ●
- o Maximum output current
- Duration of primary phase o
13
- Pulse duration ●
- Frequency ●
- Root Mean Square (RMS) Current ●
- Prescription or OTC ●
- Number of Treatment programs
- 0 Method for channel isolation
- 0 Maximum Phase Charge
- O Max. current density
- Max, power density
Justification of predicate differences:
Differernce-1: Energy Source - IR source
Predicate device: Buttock muscle stimulator does not contain IR modality.
New Device: The Slim UP® ULTRA contains IR modality in addition to Electrostimulation modality.
Intended Use: Same
Different questions of Safety and effectiveness? No
Justification of Difference:
IR source does not have any therapeutic effect it is just used for patient comfort only. Also IR modality used in subject device is not able to raise and maintain body temperature above 38-41 degree Celsius for 10 minutes. IR source used in Slim UP® ULTRA is similar to reference device i.e. Syneron Medical's Velashape (K122579). So this minor technological difference does not raise any new questions of safety and efficacy.
Difference-2: Physical Characteristics (Dimension and weight)
Predicate device: Buttock muscle stimulator is 0.08 Kg in weight and has physical dimensions of 64cm Width X20cm Diameter X90 cm Height.
New Device: The Slim UP® ULTRA has physical dimension of 95cm Width X 129cm Diameter X 187cm Height and 161 Kg in weight.
Intended Use: Same
Different questions of Safety and effectiveness? No
Justification of Difference:
The difference in physical dimensions and weight doesn't introduce any additional safety issues. Due to its compact size Slim UP® ULTRA can be located in any booth, can be adapted to any bed and can be moved anywhere.
14
Difference-3: Housing material and construction
Predicate device:
Buttock muscle stimulator has asbestos as primary housing material.
New Device:
Different parts of Slim UP® ULTRA were made from different housing material. It has polycarbonate arc, nylon screw and washer for fixing the polycarbonate arc.
- Intended Use: Same
Different questions of Safety and effectiveness? No Justification of difference:
This predicate difference will not raise any questions of safety and efficacy as patient body contact parts of Slim UP® ULTRA are biocompatible and Slim UP® ULTRA complies with international safety standard EN ISO 14121-1:2007- Safety of the equipment. Risk evaluation part-1: Principles.
Difference-4: Number of electrodes
Predicate device: The information regarding number of electrodes in predicate device is not available.
New device: Slim UP® ULTRA has 16 skin contact electrodes.
Intended Use: Same
Different questions of Safety and effectiveness? No
Justification of difference:
The difference in number of electrodes do not raise new question of safety or effectiveness. Slim UP® ULTRA use 510k cleared electrode FIAB PG474W (K091163). Apart from this electromagnetic safety of subject device has been established by conducting EMC testing in complies with international EMC standard 60601-1-2 and 60601-2-10. So this difference will not raise any additional questions of safety and efficacy.
Difference-5: Functional parameters like Mode or Program name, Pulse duration, Number of output mode, pulse per burst, burst per second, Burst duration, Duty cycle, RMS current, Number of treatment program Method of channel isolation, Maximum current and power density.
Predicate device:
Buttock muscle stimulator has following different functional parameters: Mode or Program name: WL-2413E Pulse Duration: 720 usec Number of output mode: 04 Pulse per burst: Same for each program Burst per second: Same for each program
15
Burst duration: Same for each program Duty cycle: Same for each program RMS current: 38.644mA (500Ω), 16.907mA (2KΩ), 5.120 mA (10 Ώ) Number of treatment program: N/A Method of Channel isolation: Output coil Maximum Current density: 0.0997 mA/cm2 Maximum Power density: 0.00399 watts/cm2
New Device:
Slim UP® ULTRA has following different functional parameters:
Mode or Program name: 2 TONE (F2 work phase)
Pulse Duration: 400 usec
Number of output mode: N/A
Pulse per burst: 160
Burst per second: 1/8
Burst duration: 4 Sec
Duty cycle: 1/2
RMS current: 100mA during the active phase of the current pulse, square wave with null medium value and period of 600us
Number of treatment program: 7 different programs that should be chosen based on the individual requirements of each case.
Method of channel isolation: Sole transformer on all channels from 12V and the tension that goes to the electrostimulation channels (it is not an insulating transformer). If current goes over 100mA (short output transistor) a safety circuit intervenes by resetting the machine
Maximum current density: 2, 8 mA/cm2 @ 500Ω
Maximum power density: 8, 96 mW/cm² @ 500Ω with electrodes 4x9 cm
Intended Use: Same
Different questions of safety and effectiveness: No Justification of difference:
The minor difference in functional parameter between predicate device and subject device do not raise new questions of safety or efficacy as Electromagnetic safety of Slim UP® ULTRA has been established by conducting EMC testing in complies with international EMC standard 60601-1. 60601-1-2 and 60601-2-10.
Difference-6: Electrical Requirement
Predicate device:
Runs on 3 AAA batteries at 1.5v. New Device: 230VAC, Single-Phase Intended Use: Same Different questions of Safety and effectiveness? No Justification of difference:
16
The difference in Electrical Requirements between predicate device and subject device do not raise new questions of safety or efficacy as Electromagnetic safety of Slim UP® ULTRA has been established by conducting EMC testing in complies with international EMC standard 60601-1, 60601-1-2 and 60601-2-10.
The conclusion of this technical comparison is that Slim UP® ULTRA is substantially equivalent to the Buttock Muscle Stimulator and have been verified by subsequent testing. Any difference between Predicate device and Slim UP® ULTRA do not raise any new questions for safety and efficacy.
PERFORMANCE DATA
The following performance testing was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Patient applied parts of Slim UP® ULTRA are biocompatible as per the International standard ISO 10993-1:2009- Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Electrical safety and electromagnetic compatibility (EMC)
The following standards have been complied within designing, manufacturing and testing of Slim UP® ULTRA:
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Safety.
- IEC 60601-1-2:2007, Medical Electrical Equipment Part 1-2: General ● Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests.
- IEC 60601-2-10:2000: Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
- EN ISO 14121-1:2007- Safety of machinery -- Risk assessment -- Part 1: Principles. o
Software Verification and Validation Testing
Software validation was completed to check the safety requirements implemented by the firmware resident on the Microcontroller used on the Slim Up® Ultra, in order to provide objective evidence that the firmware itself operates as indicated in the user manual and does not cause any risks connected to its use.
17
CONCLUSION I.
The performance data demonstrates that the Slim UP® ULTRA performs as intended and similar to that of predicate devices and exhibits comparable mechanical, functional and technological characteristics to that of the predicate device.
Any technological or engineering differences existing between subject device and predicate devices is insignificant in terms with safety and effectiveness of subject device.
Based on these factors, the Slim UP® ULTRA can be considered substantially equivalent to the predicate device and safe and effective for its intended use.