(57 days)
Not Found
No
The summary describes a computerized system with various energy delivery modalities and a user interface for manual adjustment of parameters. There is no mention of AI, ML, or any features that would suggest automated learning, pattern recognition, or adaptive control based on data. The performance studies focus on equivalence to predicate devices and safety standards, not on the performance of any AI/ML algorithms.
Yes.
The device is intended for the "relief of minor muscle aches and pain, relief of muscle spasm" and "temporary improvement of local blood circulation," which are therapeutic applications. Additionally, it is used for "non-invasive lipolysis" and "muscle conditioning to stimulate healthy muscles," which are also considered therapeutic in nature when addressing a medical or physiological condition.
No
Explanation: The Venus BlissMAX device is intended for non-invasive lipolysis, relief of minor muscle aches and pain, improvement of local blood circulation, temporary reduction in the appearance of cellulite, and muscle conditioning. These are all therapeutic and aesthetic applications, not diagnostic ones.
No
The device description clearly states it 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." This indicates significant hardware components beyond just software.
Based on the provided information, the Venus BlissMAX device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses described for the Venus BlissMAX device are all related to in vivo treatments performed directly on the patient's body (non-invasive lipolysis, relief of muscle aches and pain, improvement of blood circulation, reduction of cellulite, muscle conditioning). IVD devices are intended for the examination of specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a system that delivers energy (laser, RF, EMS) and physical forces (vacuum, magnetic fields) to the patient's body. It does not describe components or processes for analyzing biological specimens.
- Lack of IVD-related information: The document does not mention any aspects related to collecting, preparing, or analyzing biological samples, which are core functions of IVD devices.
Therefore, the Venus BlissMAX device falls under the category of therapeutic or aesthetic medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PBX, PKT, NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, flanks, thighs, back
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professional
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)
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.
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.
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.
Venus Concept Venus BlissMAX (K213308), Cynosure SculpSure (K182741), Venus Concept Venus Legacy Pro (K191528)
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.
Not Found
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
§ 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.
0
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.
1
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
2
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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3
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 § 878.4400 |
| 21 CFR § 878.5400 | |
| 21 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) |
4
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.
5
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
6
| | Venus BlissMAX
(Subject) | Venus BlissMAX
(K213308)
(Primary Predicate) | SculpSure Laser
System
(K182741)
(Co-Secondary
Predicate) | Substantial
Equivalence
Discussion |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Manufacturer | Venus Concept | Venus Concept | Cynosure Inc. | Same as Primary
Predicate Device |
| Classification
Product
Code,
Regulation | Class II, PKT,
21 CFR 878.5400 | Class II, PKT
21 CFR 878.5400 | Class II, PKT,
21 CFR 878.5400 | Same as both |
| 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. | 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. | The SculpSure is
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 device is
intended for non-
invasive lipolysis of the
submental area in
individuals with a BMI
of 49 or less. The device
is intended to affect the
appearance of visible fat
bulges in the abdomen,
flanks, back, thighs and
submental area. When
using the petite mask for
non-invasive lipolysis of
the submental area, the
device can also affect
the appearance of lax
tissue in the submental
area. | Same as Co-
secondary Predicate
and Primary
predicate Devices |
| Lipolysis
Method | Heat-assisted | Heat-assisted | Heat-assisted | Same as both |
| Energy Used /
Delivered | Diode Laser | Diode Laser | Diode Laser | Same as both |
| Components | Console with
GUI
4 Applicators
- Sapphire light guides
- LED contact sensors | Console with GUI
4 Applicators - Sapphire light guides
- LED contact sensors | Console with GUI
4 Applicators - Sapphire light
guides - 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 the
Applicator heads | 6 x 6 cm2 on each of the
Applicator heads | 4 x 6 cm2 on each of the
Applicator heads | Same as Primary
predicate Device |
| Operation
Mode | CW | CW | CW | Same as both |
| | Venus BlissMAX
(Subject) | Venus BlissMAX
(K213308)
(Primary Predicate) | SculpSure Laser
System
(K182741)
(Co-Secondary
Predicate) | Substantial
Equivalence
Discussion |
| Power
Density | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 | Up to 1.4 W/cm2 | Same as both |
| Attachment to
Patient | Belt | Belt | Belt | Same as both |
| Power
Requirements | 100-240V50/60 Hz,50/60 Hz,
Single Phase | 100-240V
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
7
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) | Substantial
Equivalence
Discussion |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Venus Concept | Venus Concept | Venus Concept | Venus Concept | Same as both |
| Classification
Product
Code,
Regulation | Class II, PBX,
21 CFR 878.4400
21 CFR 878.5400 | Class II, PBX,
21 CFR 878.4400
21 CFR 878.5400 | Class II, GEI, PBX
21 CFR 878.4400 | Same as both |
| Indications
for Use | 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. | 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. | When used with the
Octipolar (LB1) or
Diamondpolar (LF1)
applicators, the Venus
Legacy Pro device is
intended for use in
dermatologic and general
surgical procedures for
females for the
noninvasive treatment of
moderate to severe facial
wrinkles and rhytides in
Fitzpatrick skin types I-
IV.
When used with the 4D
Body (LB2) and 4D Face
(LF2) applicators, the
Venus Legacy Pro device
is intended for the delivery
of non-thermal RF
combined with Massage
and magnetic field pulses
for the treatment of the
following medical
conditions:
• Relief of minor
muscles aches and | Same as Primary
predicate Device
and similar to the
Co-Secondary
Predicate. |
8
| | Venus BlissMAX
(Subject) | Venus BlissMAX
(K213308)
(Primary Predicate) | Venus Legacy Pro
(K191528)
(Co-Secondary Predicate) | Substantial
Equivalence
Discussion |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | | | pain, relief of muscle
spasm
• Temporary
improvement of local
blood circulation
• Temporary reduction
in the appearance of
cellulite | |
| Energy Used /
Delivered | 1. RF Energy
2. Pulsed Magnetic Field
(PMF)
3. Vacuum | 1. RF Energy
2. Pulsed Magnetic Field
(PMF)
3. Vacuum | 1. RF Energy
2. Pulsed Magnetic Field
(PMF)
3. Vacuum | Same as Primary
predicate |
| Applicator
Footprint
Dimensions | MP2: 38.5 cm2 | MP2: 38.5 cm2 | LB1: 23.7 cm2
LF1: 2.9 cm2
LB2: 38.5 cm2
LF2: 4.9 cm2 | Same as Primary
predicate |
| Performance | Frequency: 1MHz
Vacuum pressure: -
400mbar
Maximal RF output
power: up to 150W
PMF Power: 15 Gauss
(15Hz) | Frequency: 1MHz
Vacuum pressure: -
400mbar
Maximal RF output
power: up to 100W
PMF Power: 15 Gauss
(15Hz) | Frequency: 1MHz
Vacuum pressure: -
400mbar
Maximal RF output
power: up to 150W
PMF Power: 15 Gauss
(15Hz) | Same as Co-
Secondary
Predicate device |
| Materials | Biocompatible | Biocompatible | Biocompatible | Same as both |
| Power
Requirements | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | 100-240V~50/60 Hz,
Single Phase | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | Same as both |
9
| Table 3: Substantial Equivalence Table for the FlexMAX (EMS) Applicators: |
|---|
| --------------------------------------------------------------------------- |
| | Venus BlissMAX
(Subject) | Venus BlissMAX (K213308)
(Primary Predicate). | Substantial Equivalence
Discussion |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Basic Unit Characteristics | | | |
| Classification Product
Code, Regulation | Class II, NGX,
21 CFR 890.5850, | Class II, NGX,
21 CFR 890.5850 | Same |
| Indications for Use | 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 deviceusing
the FlexMAX applicators is
intended for muscle conditioning to
stimulate healthy muscles.
The Venus BlissMAX deviceusing
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 deviceusing
the FlexMAX applicators is
intended to be operated by a trained
professional. | Same |
| Components | The Venus BlissMAX device
consists of the following
components:
• Console, including a power
supply unit, controller and user
interface including an LCD touch
screen.
• Several types of applicatorsfor
different indications (Laser, MP2,
FlexMAX applicators) connected
to theconsole via a cable. | The Venus BlissMAX device
consists of the following
components:
• Console, including a power
supply unit, controller and user
interface including an LCD touch
screen.
• Several types of applicatorsfor
different indications (Laser, MP2,
FlexMAX applicators) connected
to theconsole via a cable. | Same |
| Mechanism of
Action | Muscle contraction by
electrical pulsing. | Muscle contraction by
electrical pulsing. | Same |
| Power Source | Main Line Frequency
(nominal): 50-60Hz
Input Voltage (nominal): 100-
240VAC | Main Line Frequency
(nominal): 50-60Hz
Input Voltage (nominal): 100-
240VAC | Same |
| Method of Line
Current Isolation | Power Supply isolation | Power Supply isolation | Same |
| Patient Leakage
Current | Normal condition:1 μA
Single Fault condition:11 μA | Normal condition:1 μA
Single Fault condition:11 μA | Same |
| Number of Output
Modes | 1 | 1 | Same |
| Number of Output
Channels | 4 | 4 | Same |
| Channel Output:
Synchronous or
Alternating | Synchronous | Synchronous | Same |
| Method of channel
isolation | Isolation transformer per channel | Isolation transformer per channel | Same |
| Regulated
Current or
Regulated Voltage | Regulated voltage with current
limit | Regulated voltage with current
limit | Same |
| Software/
Firmware/
Microprocessor
Control | Yes | Yes | Same |
| Automatic EMS Shut
off | Yes- Automatic EMStreatment
shut off | Yes- Automatic EMStreatment
shut off | Same |
| Patient Override
Control | Yes- Emergency button | Yes- Emergency button | Same |
| Indicator Display: On /
Off Status | Yes | Yes | Same |
| Indicator Display:
Voltage Current
Level | 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 in
55 x 65 x 135 cm | 21.7 x 25.6 x 53.2 in
55 x 65 x 135 cm | Same |
| Output Specifications | | | |
| Waveform | Symmetrical Biphasicwaveform | Symmetrical Biphasicwaveform | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum Output
Voltage | 40V@500Ω
105V@2kΩ
160V@10kΩ | 40V@500Ω
105V@2kΩ
160V@10kΩ | Same |
| Maximum Output
Current | 80 mA @ 500 Ω
52.5 mA @ 2 kΩ
16 mA @ 10 kΩ | 80 mA @ 500 Ω
52.5 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] @ 500Ω
Zero net charge is achieved by
using symmetrical biphasic
waveforms | 0 [μC] @ 500Ω
Zero net charge is achieved by
using symmetrical biphasic
waveforms | Same |
| Maximum Phase
Charge | 40 [μC] @ 500Ω @ 1000 Hz | 40 [μC] @ 500Ω @ 1000 Hz | Same |
| Maximum Current
Density | 2.5 mA/cm² | 2.5 mA/cm² | Same |
| Maximum Power
Density | 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.