(57 days)
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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.
This document is a 510(k) summary for the Venus BlissMAX device, a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. Critically, there is no acceptance criteria table or formal study data presented in the provided text in the manner one might see for an AI/ML medical device where specific performance metrics (e.g., sensitivity, specificity) are tested against predefined thresholds.
Instead, this submission leverages the concept of "substantial equivalence" to predicate devices already cleared by the FDA. The "study" proving the device meets its acceptance criteria is primarily a comparison of its technological characteristics and safety testing to these predicate devices. The acceptance criteria are implicit in demonstrating that the new device is as safe and effective as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
As mentioned, a formal acceptance criteria table with quantifiable performance metrics (like sensitivity, specificity, accuracy) akin to an AI/ML device is not present in this document. The device's performance is "accepted" if it is determined to be substantially equivalent to the predicate devices. The "reported device performance" is the demonstration through non-clinical testing that the device functions according to specifications and conforms to applicable safety standards, which are shared with the predicates.
Implicit Acceptance Criteria (based on Substantial Equivalence):
| Acceptance Criteria Category | Device Performance (How Criterion is Met) |
|---|---|
| Intended Use | Identical or highly similar to predicate devices. |
| Indications for Use | Identical or highly similar to predicate devices, with broader coverage for some areas (e.g., "back" for lipolysis) aligning with other predicate devices. |
| Technological Characteristics | Similar principles of operation (Diode Laser, RF, PEMF, Vacuum, EMS). Differences do not raise new safety/effectiveness concerns. |
| Safety (Electrical & EMC) | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, EN 60601-2-22, IEC 60601-2-10, IEC 60825-1, IEC 60601-1-6. |
| Software Performance | Software verification testing conducted, results acceptable, in accordance with FDA guidance. |
| Biocompatibility | Patient-contacting components demonstrated biocompatibility per ISO 10993-1 guidance. |
| Clinical Performance | No clinical testing was deemed necessary as the device is substantially equivalent to predicates for which clinical data already existed or was not required for initial clearance. Bench testing for MP2 applicator (up to 150W) demonstrated safety, aligning with previous predicate data. |
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of human clinical data for this 510(k). The "test set" primarily refers to individual devices or components undergoing engineering and safety testing.
- Data Provenance: The data provenance for the safety and engineering tests (Electrical, EMC, Biocompatibility) would be internal lab testing or testing conducted by independent third-party laboratories. No specific country of origin for this testing data is provided, but it's typically performed in a controlled, accredited environment. The document states these are "non-clinical performance testing" and "Verification and Validation tests." There is no patient data involved in this submission for the Venus BlissMAX.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of expert evaluation for establishing ground truth (e.g., for image interpretation in AI/ML) is not applicable to this device's 510(k) submission. The ground truth for device safety and performance here comes from engineering and quality system standards (e.g., IEC standards, ISO 10993-1).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where human expert consensus is needed to establish ground truth for patient outcomes or interpretations. This 510(k) relies on non-clinical engineering and safety performance testing against established standards.
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
- No, an MRMC study was NOT done or reported. This device is not an AI-assisted diagnostic tool for which an MRMC study would be relevant. Its clearance is based on substantial equivalence for physical therapeutic/aesthetic functionalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" performance study. The device contains software and firmware (page 9), but these are for controlling the hardware functionality (e.g., power levels, timers, safety shutdowns), not for performing analytical tasks or diagnoses independently. The software testing mentioned is for verification of its control functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is established by international and national consensus standards for medical device safety and performance (e.g., IEC standards, ISO standards for biocompatibility), as well as internal engineering specifications and functional requirements. For example, the "ground truth" that the device is electrically safe is compliance with IEC 60601-1.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML-based device that undergoes a "training set" for an algorithm. Its functionality is based on established physical principles (laser, RF, EMS, vacuum).
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for a training set.
Summary of the "Study" Proving Compliance:
The "study" proving the Venus BlissMAX meets its acceptance criteria (i.e., is safe and effective and substantially equivalent) is a comprehensive set of non-clinical tests and comparisons:
- Direct Comparison to Predicate Devices: The core of the submission is a detailed comparison of the Venus BlissMAX to its primary predicate (Venus BlissMAX K213308) and co-secondary predicates (Cynosure SculpSure K182741, Venus Legacy Pro K191528) across various technical specifications (wavelength, power density, components, indications for use, energy type, etc.). The acceptance criterion here is that the new device's characteristics are either identical, very similar, or that any differences do not introduce new safety or effectiveness concerns compared to the already cleared predicate devices.
- Safety Testing Conformity: The device underwent rigorous testing to ensure compliance with a multitude of international safety and performance standards relevant to medical electrical equipment, lasers, high-frequency surgical equipment, and muscle stimulators. These include:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (EMC – Requirements and Tests)
- IEC 60601-2-2 (High frequency surgical equipment)
- EN 60601-2-22 (Laser equipment)
- IEC 60601-2-10 (Nerve and muscle stimulator)
- IEC 60825-1 (Safety of laser products)
- IEC 60601-1-6 (Usability)
- Software verification testing per FDA guidance.
- Biocompatibility testing per ISO 10993-1 guidance.
The acceptance of the device is based on the satisfactory results of these non-clinical tests and the successful demonstration of substantial equivalence without raising new safety or effectiveness questions.
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
April 27, 2022
Venus Concept USA Inc. William Mcgrail VP, Global Regulatory Affairs & Quality Assurance 1880 N Commerce Pkwy, Suite 2 Weston, Florida 33326
Re: K220592
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: February 24, 2022 Received: March 1, 2022
Dear William McGrail:
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.
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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Purva Pandya, D.Eng. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K220592
Device Name Venus BlissMAX
Indications for Use (Describe)
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus BlissMAX device is intended for 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ] Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (As Required by 21.CFR.807.92)
| 1. SUBMITTER | ||
|---|---|---|
| Manufacturer: | Venus Concept USA, Inc. | |
| 1880 N Commerce Pkwy, Suite 2 | ||
| Weston, FL 33326, USA | ||
| Contact Person: | William H. McGrail | |
| Vice President, Global RA & QA | ||
| Venus Concept | ||
| Phone: (978) 808-0420 | ||
| Email: bmcgrail@venusconcept.com | ||
| Date Prepared: | April 27, 2022 |
2. DEVICE INFORMATION
| Trade/Device Name(s): | Venus BlissMAX System |
|---|---|
| Common or Unusual Name: | Venus BlissMAX System |
| Regulation Number: | 21 CFR § 878.440021 CFR § 878.540021 CFR § 890.5850 |
| Classification Name: | Electrosurgical Cutting And Coagulation Device And Accessories |
| Regulation Class: | Class II |
| Product Code: | PKT, PBX, NGX, |
| Review Panel: | General & Plastic Surgery |
3. PREDICATE DEVICES
| Primary Predicate: | Venus Concept Venus BlissMAX (K213308) |
|---|---|
| Co-Secondary Predicate: | Cynosure SculpSure (K182741) |
| Co-Secondary Predicate: | Venus Concept Venus Legacy Pro (K191528) |
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4. INDICATIONS FOR USE
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs 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
5. 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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6. 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.
7. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The following tables compare the Venus BlissMAX (Subject) device to the primary predicate: Venus BlissMAX (K213308) and co-secondary predicate: Cynosure SculpSure Laser System (K182741) and co-secondary predicate: Venus Legacy Pro (K191528) devices with respect to intended use, technological characteristics, and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
1 The Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999
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| Venus BlissMAX(Subject) | Venus BlissMAX(K213308)(Primary Predicate) | SculpSure LaserSystem(K182741)(Co-SecondaryPredicate) | SubstantialEquivalenceDiscussion | |
|---|---|---|---|---|
| Manufacturer | Venus Concept | Venus Concept | Cynosure Inc. | Same as PrimaryPredicate Device |
| ClassificationProductCode,Regulation | Class II, PKT,21 CFR 878.5400 | Class II, PKT21 CFR 878.5400 | Class II, PKT,21 CFR 878.5400 | Same as both |
| Indicationsfor Use | The Venus BlissMAXdevice is a diode lasersystem intended for non-invasive lipolysis of theabdomen, flanks, back,and thighs in individualswith a Body Mass Index(BMI) of 30 or less. | The Venus BlissMAXdevice is a diode laser systemintended for non-invasivelipolysis of the abdomen andflanks inindividuals with a BodyMass Index (BMI) of 30 orless. | The SculpSure isintended for non-invasive lipolysis of theabdomen, flanks, back,and thighs inindividuals with a BodyMass Index (BMI) of 30or less.In addition, the device isintended for non-invasive lipolysis of thesubmental area inindividuals with a BMIof 49 or less. The deviceis intended to affect theappearance of visible fatbulges in the abdomen,flanks, back, thighs andsubmental area. Whenusing the petite mask fornon-invasive lipolysis ofthe submental area, thedevice can also affectthe appearance of laxtissue in the submentalarea. | Same as Co-secondary Predicateand Primarypredicate Devices |
| LipolysisMethod | Heat-assisted | Heat-assisted | Heat-assisted | Same as both |
| Energy Used /Delivered | Diode Laser | Diode Laser | Diode Laser | Same as both |
| Components | Console withGUI4 Applicators- Sapphire light guides- LED contact sensors | Console with GUI4 Applicators- Sapphire light guides- LED contact sensors | Console with GUI4 Applicators- Sapphire lightguides- LED contact sensors | Same as both |
| Wavelength | 1064 ± 10nm (infrared) | 1064 ± 10nm (infrared) | 1060 ± 20nm (infrared) | Same as both |
| Spot Size | 6 x 6 cm2 on each of theApplicator heads | 6 x 6 cm2 on each of theApplicator heads | 4 x 6 cm2 on each of theApplicator heads | Same as Primarypredicate Device |
| OperationMode | CW | CW | CW | Same as both |
| Venus BlissMAX(Subject) | Venus BlissMAX(K213308)(Primary Predicate) | SculpSure LaserSystem(K182741)(Co-SecondaryPredicate) | SubstantialEquivalenceDiscussion | |
| PowerDensity | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 | Same as both |
| Attachment toPatient | Belt | Belt | Belt | Same as both |
| PowerRequirements | 100-240V~50/60 Hz,Single Phase | 100-240V~50/60 Hz,Single Phase | 100-240V~50/60 Hz,Single Phase | Same as both |
| Materials | Biocompatible | Biocompatible | Biocompatible | Same as both |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same as both |
Table 1: Substantial Equivalence Table for the Diode Laser Applicators
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Table 2: Substantial Equivalence Table for the MP2 (RF+ PEMF +Vacuum) Applicators
| Manufacturer | Venus BlissMAX(Subject) | Venus BlissMAX(K213308)(Primary Predicate) | Venus Legacy Pro(K191528)(Co-Secondary Predicate) | SubstantialEquivalenceDiscussion |
|---|---|---|---|---|
| Venus Concept | Venus Concept | Venus Concept | Venus Concept | Same as both |
| ClassificationProductCode,Regulation | Class II, PBX,21 CFR 878.440021 CFR 878.5400 | Class II, PBX,21 CFR 878.440021 CFR 878.5400 | Class II, GEI, PBX21 CFR 878.4400 | Same as both |
| Indicationsfor Use | The Venus BlissMAXdevice is intended for thetreatment of the followingmedical conditions; usingthe MP2 applicator fordelivery of RF energycombined with massageand magnetic field pulses:• Relief of minor muscleaches and pain, relief ofmuscle spasm• Temporaryimprovement of localblood circulation• Temporary reduction inthe appearance ofcellulite. | The Venus BlissMAXdevice is intended for thetreatment of thefollowing medicalconditions; using theMP2 applicator fordelivery of RF energycombined with massageand magnetic fieldpulses:• Relief of minor muscleaches and pain, relief ofmuscle spasm• Temporaryimprovement of localblood circulation• Temporary reduction inthe appearance ofcellulite. | When used with theOctipolar (LB1) orDiamondpolar (LF1)applicators, the VenusLegacy Pro device isintended for use indermatologic and generalsurgical procedures forfemales for thenoninvasive treatment ofmoderate to severe facialwrinkles and rhytides inFitzpatrick skin types I-IV.When used with the 4DBody (LB2) and 4D Face(LF2) applicators, theVenus Legacy Pro deviceis intended for the deliveryof non-thermal RFcombined with Massageand magnetic field pulsesfor the treatment of thefollowing medicalconditions:• Relief of minormuscles aches and | Same as Primarypredicate Deviceand similar to theCo-SecondaryPredicate. |
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| Venus BlissMAX(Subject) | Venus BlissMAX(K213308)(Primary Predicate) | Venus Legacy Pro(K191528)(Co-Secondary Predicate) | SubstantialEquivalenceDiscussion | |
|---|---|---|---|---|
| pain, relief of musclespasm• Temporaryimprovement of localblood circulation• Temporary reductionin the appearance ofcellulite | ||||
| Energy Used /Delivered | 1. RF Energy2. Pulsed Magnetic Field(PMF)3. Vacuum | 1. RF Energy2. Pulsed Magnetic Field(PMF)3. Vacuum | 1. RF Energy2. Pulsed Magnetic Field(PMF)3. Vacuum | Same as Primarypredicate |
| ApplicatorFootprintDimensions | MP2: 38.5 cm2 | MP2: 38.5 cm2 | LB1: 23.7 cm2LF1: 2.9 cm2LB2: 38.5 cm2LF2: 4.9 cm2 | Same as Primarypredicate |
| Performance | Frequency: 1MHzVacuum pressure: -400mbarMaximal RF outputpower: up to 150WPMF Power: 15 Gauss(15Hz) | Frequency: 1MHzVacuum pressure: -400mbarMaximal RF outputpower: up to 100WPMF Power: 15 Gauss(15Hz) | Frequency: 1MHzVacuum pressure: -400mbarMaximal RF outputpower: up to 150WPMF Power: 15 Gauss(15Hz) | Same as Co-SecondaryPredicate device |
| Materials | Biocompatible | Biocompatible | Biocompatible | Same as both |
| PowerRequirements | 100-120 VAC / 60Hz220-240 VAC / 50Hz | 100-240V~50/60 Hz,Single Phase | 100-120 VAC / 60Hz220-240 VAC / 50Hz | Same as both |
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| Table 3: Substantial Equivalence Table for the FlexMAX (EMS) Applicators: |
|---|
| --------------------------------------------------------------------------- |
| Venus BlissMAX(Subject) | Venus BlissMAX (K213308)(Primary Predicate). | Substantial EquivalenceDiscussion | |
|---|---|---|---|
| Basic Unit Characteristics | |||
| Classification ProductCode, Regulation | Class II, NGX,21 CFR 890.5850, | Class II, NGX,21 CFR 890.5850 | Same |
| Indications for Use | The Venus BlissMAX device usingthe FlexMAX applicators isintended for muscle conditioning tostimulate healthy muscles.The Venus BlissMAX device usingthe FlexMAX applicators is notintended to be used in conjunctionwith therapy or treatment ofmedical diseases or medicalconditions of any kind.The Venus BlissMAX device usingthe FlexMAX applicators isintended to be operated by a trainedprofessional. | The Venus BlissMAX deviceusingthe FlexMAX applicators isintended for muscle conditioning tostimulate healthy muscles.The Venus BlissMAX deviceusingthe FlexMAX applicators is notintended to be used in conjunctionwith therapy or treatment ofmedical diseases or medicalconditions of any kind.The Venus BlissMAX deviceusingthe FlexMAX applicators isintended to be operated by a trainedprofessional. | Same |
| Components | The Venus BlissMAX deviceconsists of the followingcomponents:• Console, including a powersupply unit, controller and userinterface including an LCD touchscreen.• Several types of applicatorsfordifferent indications (Laser, MP2,FlexMAX applicators) connectedto theconsole via a cable. | The Venus BlissMAX deviceconsists of the followingcomponents:• Console, including a powersupply unit, controller and userinterface including an LCD touchscreen.• Several types of applicatorsfordifferent indications (Laser, MP2,FlexMAX applicators) connectedto theconsole via a cable. | Same |
| Mechanism ofAction | Muscle contraction byelectrical pulsing. | Muscle contraction byelectrical pulsing. | Same |
| Power Source | Main Line Frequency(nominal): 50-60HzInput Voltage (nominal): 100-240VAC | Main Line Frequency(nominal): 50-60HzInput Voltage (nominal): 100-240VAC | Same |
| Method of LineCurrent Isolation | Power Supply isolation | Power Supply isolation | Same |
| Patient LeakageCurrent | Normal condition:1 μASingle Fault condition:11 μA | Normal condition:1 μASingle Fault condition:11 μA | Same |
| Number of OutputModes | 1 | 1 | Same |
| Number of OutputChannels | 4 | 4 | Same |
| Channel Output:Synchronous orAlternating | Synchronous | Synchronous | Same |
| Method of channelisolation | Isolation transformer per channel | Isolation transformer per channel | Same |
| RegulatedCurrent orRegulated Voltage | Regulated voltage with currentlimit | Regulated voltage with currentlimit | Same |
| Software/Firmware/MicroprocessorControl | Yes | Yes | Same |
| Automatic EMS Shutoff | Yes- Automatic EMStreatmentshut off | Yes- Automatic EMStreatmentshut off | Same |
| Patient OverrideControl | Yes- Emergency button | Yes- Emergency button | Same |
| Indicator Display: On /Off Status | Yes | Yes | Same |
| Indicator Display:Voltage CurrentLevel | Yes | Yes | Same |
| Timer Range | Selectable 15, 30, 45, 60 min | Selectable 15, 30, 45, 60 min | Same |
| Weight | 62 Kg / 136.7 lbs | 62 Kg / 136.7 lbs | Same |
| Dimensions | 21.7 x 25.6 x 53.2 in55 x 65 x 135 cm | 21.7 x 25.6 x 53.2 in55 x 65 x 135 cm | Same |
| Output Specifications | |||
| Waveform | Symmetrical Biphasicwaveform | Symmetrical Biphasicwaveform | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum OutputVoltage | 40V@500Ω105V@2kΩ160V@10kΩ | 40V@500Ω105V@2kΩ160V@10kΩ | Same |
| Maximum OutputCurrent | 80 mA @ 500 Ω52.5 mA @ 2 kΩ16 mA @ 10 kΩ | 80 mA @ 500 Ω52.5 mA @ 2 kΩ16 mA @ 10 kΩ | Same |
| Frequency range | 1 Hz to 1000 Hz | 1 Hz to 1000 Hz | Same |
| Pulse width range | 500 to 2500 [μs] | 500 to 2500 [μs] | Same |
| Net Charge | 0 [μC] @ 500ΩZero net charge is achieved byusing symmetrical biphasicwaveforms | 0 [μC] @ 500ΩZero net charge is achieved byusing symmetrical biphasicwaveforms | Same |
| Maximum PhaseCharge | 40 [μC] @ 500Ω @ 1000 Hz | 40 [μC] @ 500Ω @ 1000 Hz | Same |
| Maximum CurrentDensity | 2.5 mA/cm² | 2.5 mA/cm² | Same |
| Maximum PowerDensity | 55 [mW/cm²] @500Ω | 55 [mW/cm²] @500Ω | Same |
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8. SUBSTANTIAL EQUIVALENCY AND COMPARISON OF TECHNOLOGICAL SIMILARITIES & DIFFERENCES
As described in the comparison tables above, the Venus BlissMAX subject device has the same intended use and indications for use, similar technological characteristics, and principles of operation as its primary predicate and co-secondary predicate devices. The technological differences between the Venus BlissMAX device and its primary predicate and co-secondary devices do not raise any new issues of safety or effectiveness. The Venus BlissMAX device and its primary predicate device Venus Concept's Venus BlissMAX (K213308) and its co-secondary predicate devices the Venus Concept Venus Legacy Pro (K191528) and Cynosure SculpSure (K182741) are based on the same core technologies of Diode Laser (as in the Venus BlissMAX and Cynosure SculpSure), RF along with PEMF and vacuum massaging (as in the Venus BlissMAX and the Venus Legacy Pro), and EMS technology (as in the Venus BlissMAX) 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 primary predicate and the co-secondary predicate devices.
The technological differences do not alter the device's core technology or performance and have been addressed by the manufacturer through the applicable safety standards (General controls and mitigation measures) and through non-clinical performance testing (Special controls).
9. PERFORMANCE DATA
Verification and Validation tests have been performed to show that the performance specifications of Venus BlissMAX system is the same as the primary predicate and co-secondary predicate devices. As MP2 applicator is identical to the primary predicate and co-secondary predicate devices, the Bench test that was conducted in Legacy demonstrates that the use of 150W is considered to be safe. Testing to IEC 60601-1 and IEC 60601-1-2 has been conducted on the Venus BlissMAX System. All performance testing demonstrated that the Venus BlissMAX System performs according to specifications and functions as intended.
The following non-clinical testing was performed on the Venus BlissMAX System. These tests verified that the Venus BlissMAX System was identical to the primary predicate and co-secondary predicate devices.
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Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic
compatibility (EMC) testing for the Venus BlissMAX System was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and with IEC 60601-1-2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
The Venus BlissMAX System was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1 and IEC 60601-1-2).
The Venus BlissMax was also determined to be in conformance with the following electrical and safety testing:
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.
EN 60601-2-22:2007+A1:2012 Particular requirements for basic safety and essential performance of laser equipment.
IEC 60601-2-10:2012+A1:2016 Particular requirements for the basic safety and essential performance of nerve and muscle stimulator.
IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-6: 2013 ed 3 General requirements for basic safety and essential performance -Collateral standard: Usability.
Software: Software verification testing was conducted, and results demonstrated that testing results were found acceptable for software release. Software testing was performed per FDA's guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Biocompatibility
The patient-contacting components of the device were demonstrated to be biocompatible including evaluation of cytotoxicity, irritation, and sensitization, acute systemic toxicity and materialmediated pyrogenicity per the FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Clinical Testing
No Clinical testing was performed.
10. SUBSTANTIAL EQUIVALENCE SUMMARY
The Venus BlissMAX System is the same device and has the same technological characteristics as the primary device: Venus BlissMAX (K213308) and co-secondary predicate: Venus Legacy Pro Legacy Pro (K191528) and has the same intended use and indications as the co-secondary
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predicate device: Cynosure SculpSure (K182741). Thus, the Venus BlissMAX System is Substantially equivalent to its predicate devices.
11. CONCLUSION
The performance testing data demonstrates that Venus BlissMAX System is as safe and effective as the legally marketed primary predicate and co-secondary predicate devices. The Venus BlissMAX System did not raise new questions of safety or effectiveness. Therefore, based on the information provided in this Premarket Notification, we conclude that Venus BlissMAX System has demonstrated substantial equivalence to the predicate devices and the performance testing data support the indications for use.
§ 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.