(100 days)
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses:
- Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- Temporary reduction in the appearance of cellulite
In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.
The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.
The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient.
The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.
The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes.
The EMS applicator is comprised of two electrodes and a light indicator.
The provided text is a 510(k) summary for the Venus BlissMAX device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and comprehensive study results for efficacy.
However, based on the "Performance Data" subsection, we can infer some aspects of the acceptance criteria and the studies performed to demonstrate compliance.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the device's therapeutic claims (e.g., non-invasive lipolysis, muscle aches/pain, cellulite reduction, muscle conditioning) in a way that suggests a clinical trial with specific endpoints. Instead, it focuses on demonstrating that the device meets safety and performance standards.
The "Performance Bench Testing" implies that the device's outputs were measured against predefined specifications. These specifications would be the acceptance criteria for those particular performance tests.
| Acceptance Criteria (Inferred from Performance Data) | Reported Device Performance (Summary) |
|---|---|
| Compliance with performance standards | "Venus Concept conducted several performance tests to demonstrate that the Venus BlissMAX device complies with performance standards and that it functions as intended." The results demonstrated that differences in technological characteristics do not raise new types of safety or effectiveness concerns. |
| Device output per specifications | "Several performance tests were performed, including software validation and device verification tests in order to evaluate the Venus BlissMAX device's outputs per specifications. The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns." |
| Compliance with applicable electrical safety and electromagnetic compatibility standards (listed IEC standards) | "The device was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing." |
| Software correctly functions as intended | "The software was also subjected to verification and validation testing, and results demonstrated that the system performed as intended." |
| No new types of safety or effectiveness concerns | "These performance tests demonstrated that the device meets the system requirements and do not raise new types of safety or effectiveness concerns." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a "test set" in the context of clinical data for efficacy. The performance tests mentioned (bench testing, electrical safety, software validation) are primarily engineering and quality assurance tests. There is no information regarding sample size, country of origin, or whether it was retrospective or prospective for a clinical test set.
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. The document does not describe a clinical test set requiring expert ground truth establishment for diagnostic or therapeutic outcomes. The performance data discussed pertains to device functionality and safety standards, which are typically evaluated by engineers and regulatory compliance experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical test set requiring expert adjudication for ground truth is described, there is no mention of an adjudication method.
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. The Venus BlissMAX device is not an AI-assisted diagnostic or therapeutic imaging device, and therefore, an MRMC study is not relevant to its assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm. Its operation inherently involves a "trained professional," as stated in the Indications for Use for the FlexMAX applicators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance and safety tests described:
- Performance Bench Testing: The "ground truth" would be the predefined engineering specifications and functional design of the device.
- Electrical Safety and Electromagnetic Compatibility: The "ground truth" is compliance with international standards (e.g., IEC 60601 series).
- Software Testing: The "ground truth" is adherence to software requirements and functionality as per design specifications.
For the claims of efficacy, the document states "The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns." This suggests the efficacy is primarily being demonstrated through substantial equivalence to previously cleared predicate devices, rather than new clinical outcomes data.
8. The sample size for the training set
Not applicable. As this device is not an AI/machine learning product requiring a training set in the conventional sense, this information is not provided.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/machine learning model.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 12, 2022
Venus Concept USA Inc. Nadav Reuben Senior Director RA & OA 1880 N Commerce Pkwy, Suite 2 Weston, Florida 33326
Re: K213308
Trade/Device Name: Venus BlissMAX Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, PKT, NGX Dated: November 14, 2021 Received: November 17, 2021
Dear Nadav Reuben:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213308
Device Name VENUS BlissMAX DEVICE
Indications for Use (Describe)
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- · Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.
The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.
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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510(k) SUMMARY
K213308
VENUS BlissMAX DEVICE
- Applicant Name: Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL33326, USA Tel: +972-524211666
- Nadav Reuben, Contact Person: Senior Director RA & QA Venus Concept Ltd.
- Date Prepared: January 10, 2022
Common/Usual/Trade Name: Venus BlissMAX device
| Regulation Numbers: 21 CFR 878.5400 |
|---|
| 21 CFR 878.4400 |
| 21 CFR 890.5850 |
- Classification Names: Laser For Disruption Of Adipocyte Cells For Aesthetic Use Massager, Vacuum, Radio Frequency Induced Heat Stimulator, Muscle, Powered, For Muscle Conditioning
- Product Codes: PKT, PBX, NGX
- Classification: Class II Medical Device
- Classification Panel: Physical Medicine
- Predicate Devices: Venus Bliss (K190743) Body System (K182440)
- Reference Devices: InMode System with Tone Applicator (K192249)
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Intended Use/Indication for Use:
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses:
- Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- Temporary reduction in the appearance of cellulite ●
In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.
The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.
Device Description:
The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient.
The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.
The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits. The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes.
The EMS applicator is comprised of two electrodes and a light indicator.
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Technological Characteristics:
The Venus BlissMAX device delivers laser energy to the subcutaneous tissue layers via the four diode laser applicators connected to the console utilizes diode laser modules as sources of optical energy and the optical output is fiber-coupled through the applicator to the treatment area. The laser applicators are coupled to the patient's body while using a dedicated belt for the entire treatment. Individual adjustment of the laser output power is provided for each applicator to achieve maximum safety and efficiency for the patient. The laser applicators have an integrated contact skin cooling system to enhance safety and comfort of the treatment.
In addition, the Venus BlissMAX device using the MP2 applicator provides RF treatments combined with emitted magnetic fields and vacuum massaging. The Vacuum is mainly used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage improves the contact surface between electrodes and tissue. The RF currents heat the adipose and muscular tissues to trigger tissue level changes leading to temporary reduction in the appearance, of cellulite and temporary relief of muscle pain and muscle spasm. The RF heating effect also improves local blood circulation in the sub dermal layers. The PEMF assists in achieving treatment effect.
Furthermore, The Venus BlissMAX device using the FlexMAX applicators (EMS applicators) contracts muscles by passing electrical currents through electrodes contacting the affected body area. The transcutaneous electrical current is designed to effect underlying, healthy muscles, causing them to contract. The FlexMAX applicators are coupled to the patient's body while using a dedicated belt during the entire treatment. The belt size and number of EMS applicators is determined by the treatment area and its size. Its use on muscles is in accordance with a class II device Powered Electrical Muscle Stimulator (Product Code NGX), based on the FDA guidance document for powered muscle stimulators for muscle conditioning as a special control1.
Performance Data:
Venus Concept conducted several performance tests to demonstrate that the Venus BlissMAX device complies with performance standards and that it functions as intended.
- Performance Bench Testing: Several performance tests were performed, including software . validation and device verification tests in order to evaluate the Venus BlissMAX device's outputs per specifications. The results demonstrated that the differences in the technological characteristics of the subject and predicate devices do not raise new types of safety or effectiveness concerns.
1 The Guidance for Industry, FDA Reviewers/Staff and Compliance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999
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- . Electrical Safety and Electromagnetic Compatibility: In addition, the device was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.
- . IEC 60601-1:2005+ Amd.1: 2012, Ed.3.1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2 :2017 Ed. 6 Particular requirements for the basic safety and essential . performance of high frequency surgical equipment and high frequency surgical accessories
- . IEC 60601-1-6: 2010+ Amd.1:2013 Ed.3.1, General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-10:2012+Amd.1:2016, Ed. 2.1, Medical electrical equipment Part 2-10: . Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- . IEC 60601-1-2:2014 Ed. 4, General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60825-1:2014 Ed.3, Safety of laser products - Part 1: Equipment classification and requirements
- IEC 60601-2-22:2007+Amd.1:2012 Ed. 3.1 Particular requirements for basic safety and • essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 62304:2006+Amd.1:2015 Ed.1.1, Medical device software Software life cycle . processes
- Software Testing: The software was also subjected to verification and validation testing, and . results demonstrated that the system performed as intended.
These performance tests demonstrated that the device meets the system requirements and do not raise new types of safety or effectiveness concerns.
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Substantial Equivalence:
The following tables compare the Venus BlissMAX device to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
Venus Concept, Ltd.'s Venus BlissMAX Substantial Equivalence Tables
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Venus BlissVenus Concept Ltd.(K190743) | SubstantialEquivalenceDiscussion | |
|---|---|---|---|
| ClassificationProduct Code,Regulation | Class II, PKT, 21 CFR 878.5400 | Class II, PKT, 21 CFR 878.5400 | Same |
| Indications for Use | The Venus BlissMAX device is a diodelaser system intended for non-invasivelipolysis of the abdomen and flanks inindividuals with a Body Mass Index (BMI)of 30 or less. | The Venus Bliss device is a diode lasersystem intended for non-invasive lipolysisof the abdomen and flanks inindividuals with a Body Mass Index(BMI) of 30 or less. | Same |
| Lipolysis Method | Heat-assisted | Heat-assisted | Same |
| Energy Used /Delivered | Diode Laser | Diode Laser | Same |
| Components | System Console(with graphical user interface)4 Applicators- Sapphire light guides- LED contact sensors | System Console(with graphical user interface)4 Applicators- Sapphire light guides- LED contact sensors | Same |
| Wavelength | $1064 \pm 10$ nm (infrared) | $1064 \pm 10$ nm (infrared) | Same |
| Spot Size | 6 x 6 cm2 on each of the Applicator heads | 6 x 6 cm2 on each of the Applicator heads | Same |
| Operation Mode | CW | CW | Same |
Table 1: Substantial Equivalence Table for the Diode Laser Applicators:
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| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Venus BlissVenus Concept Ltd.(K190743) | SubstantialEquivalenceDiscussion | |
|---|---|---|---|
| Power Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² | Same |
| Attachment toPatient | Belt | Belt | Same |
| Electrical Power | 100-240V~50/60 Hz, Single Phase | 100-240V~50/60 Hz, Single Phase | Same |
| Cooling system | Distilled water or Venus Concept ChillerFluid | Distilled water or Venus Concept ChillerFluid | Same |
| Materials | Biocompatible | Biocompatible | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Table 2: Substantial Equivalence Table for the MP2 (RF+ PEMF +Vacuum) Applicators: | |||
|---|---|---|---|
| -- | ------------------------------------------------------------------------------------ | -- | -- |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Venus BlissVenus Concept Ltd.(K190743) | SubstantialEquivalenceDiscussion | ||
|---|---|---|---|---|
| Classification,Product Code,Regulation | Class II, PBX, 21 CFR 878.4400 | Class II, PBX, 21 CFR 878.4400 | Same | |
| Indications for Use | The Venus BlissMAX device isintended for the treatment of thefollowing medical conditions; usingthe MP2 applicator for delivery of RFenergy combined with massage andmagnetic field pulses:Relief of minor muscle achesand pain, relief of musclespasm Temporary improvement oflocal blood circulation Temporary reduction in theappearance of cellulite. | The Venus Bliss device isintended for the treatment of thefollowing medical conditions; usingthe MP2 applicator for delivery of RFenergy combined with massage andmagnetic field pulses:Relief of minor muscle achesand pain, relief of musclespasm Temporary improvement oflocal blood circulation Temporary reduction in theappearance of cellulite. | Same | |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Venus BlissVenus Concept Ltd.(K190743) | SubstantialEquivalenceDiscussion | ||
| Energy Used /Delivered | 1. RF Energy2. Pulsed Electromagnetic Field (PEMF)3. Vacuum | 1. RF Energy2. Pulsed Electromagnetic Field (PEMF)3. Vacuum | Same | |
| Design | Use of RF and PEMF energies delivered through applicator with vacuum and massage of the skin. | Use of RF and PEMF energies delivered through applicator with vacuum and massage of the skin. | Same | |
| Components | Console, including:-Power supply-RF generator-Suction Module-Main CPU-Display panel-PEMF generatorApplicator:-MP2 | Console, including:-Power supply-RF generator-Suction Module-Main CPU-Display panel-PEMF generatorApplicator:-MP2 | Same | |
| Applicators | - MP2 applicator: comprised of 12 RF electrodes (8 peripheral and 4 internal), 8 PEMF coils covering the 8 peripheral RF electrodes, vacuum conduits | - MP2 applicator: comprised of 12 RF electrodes (8 peripheral and 4 internal), 8 PEMF coils covering the 8 peripheral RF electrodes, vacuum conduits | Same | |
| Device Dimensions | 21.7x25.6x53.2 in55x65x135 cm | 21.7x25.6x53.2 in55x65x135 cm | Same | |
| ApplicatorFootprintDimensions | MP2: 38.5 cm2 | MP2: 38.5 cm2 | Same | |
| Performance | Frequency: 1MHzVacuum pressure: -400mbarMaximal RF output power: 100WPEMF Power: 15 Gauss (15Hz) | Frequency: 1MHzVacuum pressure: -400mbarMaximal RF output power: 100WPEMF Power: 15 Gauss (15Hz) | Same | |
| Materials | Biocompatible | Biocompatible | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Powerrequirements | 100-120 VAC / 60Hz220-240 VAC / 50Hz | 100-120 VAC / 60Hz220-240 VAC / 50Hz | Same | |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Body SystemA-1 Engineering(K182440) | Reference Device:InMode System withTone ApplicatorInMode Ltd.(K192249) | Substantial EquivalenceDiscussion | |
| Basic Unit Characteristics | ||||
| ClassificationProduct Code,Regulation | Class II, NGX,21 CFR 890.5850 | Class II, NGX,21 CFR 890.5850 | Class II, IPF & GZJ,21 CFR 890.5850 & 882.5890 | Same as the Predicate device |
| Indications forUse | The Venus BlissMAX deviceusing the FlexMAXapplicators is intended formuscle conditioning tostimulate healthy muscles.The Venus BlissMAX deviceusing the FlexMAXapplicators is not intended tobe used in conjunction withtherapy or treatment ofmedical diseases or medicalconditions of any kind.The Venus BlissMAX deviceusing the FlexMAXapplicators is intended to beoperated by a trainedprofessional. | The Body System is intendedfor muscle conditioning tostimulate healthy muscles.The Body System is notintended to be used inconjunction with therapy ortreatment of medical diseases ormedicalconditions of any kind.The Body System is intended tobe operated by a trainedprofessional who is present tomonitor treatment. | The InMode System with ToneApplicator is used in EMSmode for:- Prevention or retardation ofdisuse atrophy- Maintaining or increasingrange of motion-Muscle re-education- Relaxation of muscle spasms- Increasing local bloodcirculation- Immediate postsurgicalstimulation of calf muscles toprevent venous thrombosisAnd in TENS mode for:- Symptomatic relief andmanagement of chronic,intractable pain- Post-surgical acute pain- Post-traumatic acute pain | Same as the Predicate device |
| Components | The Venus BlissMAX deviceconsists of the followingcomponents:• Console, including a powersupply unit, controller and userinterface including an LCDtouch screen. | The body System is a PoweredMuscle Stimulator with 16channel ports using self-adhesive pad applicatorsattached to the body for muscleconditioning. | The InMode System consistsof the following components:• Console, including a powersupply unit, controller anduser interface including anLCD touch screen. | Similar to the Referencedevice |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Body SystemA-1 Engineering(K182440) | Reference Device:InMode System withTone ApplicatorInMode Ltd.(K192249) | Substantial EquivalenceDiscussion | |
| • Several types of applicatorsfor different indications(Laser, MP2, FlexMAXapplicators) connected to theconsole via a cable. | • Tone Applicator connected tothe console via a cable. | |||
| Mechanism ofAction | Muscle contraction byelectrical pulsing. | Muscle contraction by electricalpulsing. | Muscle contraction byelectrical pulsing. | Same as the Predicate andReference devices |
| Power Source | Main Line Frequency(nominal): 50-60HzInput Voltage (nominal):100-240VAC | Main Line Frequency(nominal): 50-60HzInput Voltage (nominal):110-240VAC | Main Line Frequency(nominal) 50-60HzInput Voltage (nominal)100-240VAC | Similar |
| Method of LineCurrent Isolation | Power Supply isolation | Power Supply isolation | Independent transformerisolated | Same as the Predicate device |
| Patient LeakageCurrent | Normal condition:1 μASingle Fault condition:11 μA | Normal condition:0.05 μASingle Fault condition:0.05 μA | Normal condition:<100 μASingle Fault condition:<300 μA | SimilarComplies with the FDAGuidance on PoweredMuscle Stimulators and IEC60601-2-10 standardNormal condition: <100 μApatient leakageSingle Fault condition: < 500μA line leakage |
| Number of OutputModes | 1 | 5 | 2 | DifferentThe subject, predicate andreference devices have asimilar output mode withsymmetrical biphasic pulsesthat meets the requirementsof the FDA Guidance forPowered Muscle Stimulators. |
| Number of OutputChannels | 4 | 16 | 2 | DifferentAll channels for thesubject, predicate and |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Body SystemA-1 Engineering(K182440) | Reference Device:InMode System withTone ApplicatorInMode Ltd.(K192249) | Substantial EquivalenceDiscussion | |
| Channel Output:Synchronous orAlternating | Synchronous | Synchronous | Not available | Same as the Predicate device |
| Method of channelisolation | Isolation transformer perchannel | Not available | Through transformers andisolators | Similar |
| RegulatedCurrent orRegulated Voltage | Regulated voltage with currentlimit | Both | Regulated voltage on allchannels with current limit | Same as the Predicate andReference devices (voltageregulated devices) |
| Software/Firmware/MicroprocessorControl | Yes | No | Yes | Similar to the Referencedevice |
| AutomaticOverload Trip | No | Yes | Yes | Different |
| Automatic Noload Trip | No | Yes | Yes | Different |
| Automatic EMSShut off | Yes- Automatic EMStreatment shut off | Not available | Yes, On/off switch | Similar to the referencedevice |
| Patient OverrideControl | Yes- Emergency button | Not available | Yes | Similar to the referencedevice |
| Indicator Display:On / Off Status | Yes | Yes | Yes | Same as the Predicate andReference devices |
| Indicator Display:Low Battery | No Battery | Not available | No battery | Similar |
| Indicator Display:Voltage CurrentLevel | Yes | Yes | Yes | Same as the Predicate andReference devices |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Body SystemA-1 Engineering(K182440) | Reference Device:InMode System withTone ApplicatorInMode Ltd.(K192249) | Substantial EquivalenceDiscussion | |
| Timer Range | Selectable 15, 30, 45, 60 min | None | 0-60 [minutes] | Similar to the Referencedevice |
| Compliance withStandards | IEC 60601-1 | Electrical Safety and EMC: | IEC 60601-1 | Similar |
| IEC 60601-1-2 | IEC 60601-1 | IEC 60601-1-2 | ||
| IEC 60601-2-10 | IEC 60601-1-2 | IEC 60601-2-10 | ||
| IEC 60601-1-6 | IEC 60601-2-10 | IEC 60601-1-6 | ||
| IEC 62304 | Biocompatibility: ISO10993-5 | ISO 10993-1 | ||
| ISO 10993-1 | ISO10993-10 | |||
| ISO 14971 | ||||
| Compliance with21 CFR 898 | Yes | Yes | Not available | Similar |
| Weight | 62 Kg / 136.7 lbs | Not available | 20.0 Kg [44 lbs] | Different |
| Dimensions | 21.7 x 25.6 x 53.2 in55 x 65 x 135 cm | Not available | 35cm W x 35cm D x 100cm H[18.2" W x 18.2" D x 40" H] | Different |
| Housing Materialsand Construction | Biocompatible | Biocompatible | Biocompatible | Similar |
| Output Specifications | ||||
| Waveform | Symmetrical Biphasicwaveform | Symmetrical Biphasicwaveform | Symmetrical Biphasicwaveform | Same as the Predicate andReference devices |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Body SystemA-1 Engineering(K182440) | Reference Device:InMode System withTone ApplicatorInMode Ltd.(K192249) | Substantial EquivalenceDiscussion | |
| Shape | Rectangular | Rectangular | Rectangular | Same as the Predicate andReference devices |
| Maximum OutputVoltage | 40V@500Ω105V@2kΩ160V@10kΩ | 58V @ 500 Ω88V @ 2k Ω | 56V @500Ω56V @2 kΩ56V @10kΩ | Similar |
| Maximum OutputCurrent | 80 mA @ 500 Ω52.5 mA @ 2 kΩ16 mA @ 10 kΩ | 108 mA at 500 Ω | 112 mA @ 500 Ω28 mA @ 2 kΩ5.6 mA @ 10 kΩ | Similar |
| Frequency range | 1 Hz to 1000 Hz | 200 to 1200 Hz | 3 to 200 Hz | Similar |
| Pulse width range | 500 to 2500 [μs] | 500 to 2500 [μs] | 20 to 400 [μs] | Same as the Predicate device |
| Net Charge | 0 [μC] @ 500ΩZero net charge is achieved byusing symmetrical biphasicwaveforms | 0 @ 500 ΩZero net charge is achieved byusing symmetrical biphasicwaveforms | 0 [μC] @ 500Ω | Same as the Predicate andReference devices |
| Maximum PhaseCharge | 40 [μC] @ 500Ω @ 1000 Hz | 45 μC @ 500 Ω @ 200 Hz | 44.8 [µC] @ 500Ω | Similar |
| MaximumCurrent Density | 2.5 mA/cm² | 5 mA/cm² | 1 mA/cm² | SimilarThe Venus BlissMAXdevice's maximum currentdensity is encompassedwithin those of the Predicateand Reference devices. |
| Maximum PowerDensity | 55 [mW/cm²] @500Ω | 0.011 W/cm^2 (11 mW/ cm²) | 55 [mW/cm²] @500Ω | Same as the Referencedevice |
| Burst Mode (i.e.,pulse trains)a.Pulses perburst | N/A- No Burst Mode | Not available | Yes:a. 3 - 200b. 1 | Different |
| Proposed Device:Venus BlissMAXVenus Concept Ltd. | Predicate Device:Body SystemA-1 Engineering(K182440) | Reference Device:InMode System withTone ApplicatorInMode Ltd.(K192249) | Substantial EquivalenceDiscussion | |
| b. Bursts persecondc. Burst duration(sec)Duty Cycle[Line(b)xLine (c)] | c. 1-60 secd. Time on / off | |||
| On Time (sec) | N/A- No Burst Mode | Not available | 1 - 60 [sec] | Different |
| Off time (sec) | N/A- No Burst Mode | Not available | 1 - 60 [sec] | Different |
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Table 3: Substantial Equivalence Table for the FlexMAX (EMS) Applicators:
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As described in the comparison tables above, the Venus BlissMAX device has the same intended use and indications for use, similar technological characteristics, and principles of operation as its predicate devices. The technological differences between the Venus BlissMAX device and its predicate and reference devices do not raise any new issues of safety or effectiveness. The Venus BlissMAX device and its predicate devices Venus Concept's Venus Bliss (K190743), A-1 Engineering's Body System (K182440) and its reference device the InMode System with Tone Applicator (K192249) are based on the same core technology of RF along with PEMF and vacuum massaging (as in the Venus Bliss), Diode Laser (as in the Venus Bliss) and EMS (as in the Body System and the InMode System with Tone Applicator), for the same indications for use. The design and components in the Venus BlissMAX device, including the console and the applicators are similar to the design and components found in the predicates and the reference device. The technological differences do not alter the device's core technology or performance.
Furthermore, the Venus BlissMAX device underwent performance testing, including software validation testing, electrical safety and electromagnetic compatibility testing. These performance tests in addition to the bench test demonstrated that the differences in the technological characteristics between the subject's predicate and reference device do not raise new types of safety or effectiveness concerns.
Conclusions:
Therefore, based on the same intended use and indications for use, similar technological characteristics, and principles of operation, the Venus BlissMAX device is substantially equivalent to its predicate devices, the Venus Bliss (K190743) and the Body System (K182440).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.