(95 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware components and energy delivery mechanisms.
Yes
The device is intended for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite, all of which are considered therapeutic applications.
No
The Venus Bliss device is described as a diode laser system and an RF energy delivery system intended for non-invasive lipolysis, relief of minor muscle aches and pain, relief of muscle spasm, improvement of local blood circulation, and temporary reduction in the appearance of cellulite. These are all therapeutic treatments, not diagnostic processes.
No
The device description clearly outlines multiple hardware components including a console, RF applicator, diode laser applicators, power supply, controllers, suction module, cooling system, and a touchscreen interface. The performance studies also mention device verification tests, indicating hardware is a significant part of the device.
Based on the provided information, the Venus Bliss device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies energy (laser, RF, magnetic fields) to the body for therapeutic purposes (lipolysis, muscle relief, cellulite reduction, blood circulation). This is a direct treatment of the body, not a test performed on samples taken from the body.
- Device Description: The description details a system with applicators that deliver energy to the skin and underlying tissues. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be characteristic of an in vitro diagnostic test.
In summary, the Venus Bliss device is a therapeutic device used for non-invasive body contouring and treatment of certain medical conditions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Venus Bliss 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 Bliss 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.
Product codes
PBX, PKT
Device Description
The Venus Bliss device consists of a console (main unit), one RF applicator and four Diode Laser applicators. The system delivers laser (Diode Laser Applicators) and bipolar RF energies, vacuum pressure, and pulsed magnetic fields (PMF) to the skin (MP2 applicator) and the underlying tissues of the treatment area. The console of the Venus Bliss device contains a power supply unit, Laser and RF 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen and flanks
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance Bench Testing: Several performance tests were performed, including software validation and device verification tests in order to evaluate the Venus Bliss device outputs per specifications, and as compared to the predicate device's 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.
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 60601-1:2012 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: 2013 Ed.3, General requirements for basic safety and essential performance - Collateral standard: Usability
- 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 Ed. 3 Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 62304 Medical device software Software life cycle processes (2006/AMD2015)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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.
Venus Concept USA Inc. % Elissa Burg Regulatory Consultant BioVision Ltd Had Nes 183 Had Nes, 1295000 Il
June 25, 2019
Re: K190743
Trade/Device Name: Venus Bliss Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX, PKT Dated: March 17, 2019 Received: March 22, 2019
Dear Elissa Burg:
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 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
1
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.
Neil R.P. Ogden, MS Assistant Director, THT4A4 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| ----------------------------------------- |
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K 190743
Device Name: Venus Bliss
Indications for Use (Describe)
The Venus Bliss 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 Bliss device is intended for the treatment of the following medical conditions; using the MPapplicator 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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
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Traditional 510(k) Submission - Venus Bliss - Venus Concept Ltd.
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Attachment 5
Revised 510(k) Summary
Attachment 5 - Additional Information for K190743 - Traditional 510(k) Submission – Venus Bliss System
4
VI. 510(k) SUMMARY
VENUS BLISS DEVICE
| Applicant Name: | Venus Concept USA Inc.
1880 N Commerce Pkwy,
Suite 2 Weston, FL33326, USA
Tel: +972 -549599215 |
|-----------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Yoni Iger, VP QA/RA/CA, Venus Concept USA Inc. |
| Date Prepared: | March 17, 2019 |
| Trade Name: | Venus Bliss device |
| Classification Name: | 21 CFR 878.4400
21 CFR 878.5400 |
| Product Codes: | PBX, PKT |
| Classification: | Class II Medical Device |
| Classification Panel: | General & Plastic Surgery |
| Predicate Devices: | Venus Legacy CX (K143554)
Cynosure's SculpSure (K160470) |
Intended Use/Indication for Use:
The Venus Bliss 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 Bliss 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 .
5
Device Description:
The Venus Bliss device consists of a console (main unit), one RF applicator and four Diode Laser applicators. The system delivers laser (Diode Laser Applicators) and bipolar RF energies, vacuum pressure, and pulsed magnetic fields (PMF) to the skin (MP2 applicator) and the underlying tissues of the treatment area.
The console of the Venus Bliss device contains a power supply unit, Laser and RF 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.
Technological Characteristics:
Venus Bliss delivers laser energy to the subcutaneous tissue layers via the four diode laser applicators connected to the console. 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 Bliss device (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 PMF assists in achieving treatment effect.
Performance Data:
Venus Concept conducted several performance tests to demonstrate that the Venus Bliss 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 Bliss device outputs per specifications, and as compared to the predicate device's 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.
6
- . 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 60601-1:2012 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: 2013 Ed.3, General requirements for basic safety and essential performance - Collateral standard: Usability
- 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 Ed. 3 Particular requirements for basic safety and essential . performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 62304 Medical device software Software life cycle processes (2006/AMD2015) .
- 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 compares the Venus Bliss 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.
Substantial Equivalence Table #1 for the RF Applicators:
| | Venus Bliss
Venus Concept Ltd. | Venus Legacy CX
Venus Concept Ltd.
K143554 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Class, Product
Code,
Regulation | Class II, PBX, 21 CFR 878.4400 | Class II, PBX, 21 CFR 878.4400 |
| Indications for
Use | The Venus Bliss 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 Legacy CX device is intended
the treatment of the following medical
conditions; using the LB2 and LF2
applicators for delivery of non-thermal RF
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. |
| Energy Used /
Delivered | 1. RF Energy
2. Pulsed Magnetic Field (PMF)
3. Vacuum | 1. RF Energy
2. Pulsed Magnetic Field (PMF)
3. Vacuum |
| Applicator
Footprint
Dimensions | MP2:
38.5 cm² | LB2:
38.5 cm2 |
| Performance | Frequency: 1MHz
Vacuum pressure: -400mbar
Maximal RF output power: 100W
(MP2 applicator)
PMF Power: 15 Gauss (15Hz) | Frequency: 1MHz
Vacuum pressure: -400mbar
Maximal RF output power: 50W
(LB2 applicator)
PMF Power: 15 Gauss (15Hz) |
| Materials | Biocompatible | Biocompatible |
| Power
requirements | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | 100-120 VAC / 60Hz
220-240 VAC / 50Hz |
| | Venus Bliss
Venus Concept Ltd. | SculpSure Laser System
Cynosure Inc.
K160470 |
| Class, Product
Code,
Regulation | Class II, PKT, 21 CFR 878.5400 | Class II, PKT, 21 CFR 878.5400 |
| Indications for
Use | The Venus Bliss 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 Cynosure SculpSure 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 device is
intended to affect the appearance of
visible fat bulges in the abdomen and
flanks. |
| Lipolysis Method | Heat-assisted | Heat-assisted |
| Energy Used /
Delivered | Diode Laser | Diode Laser |
| 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 |
| Wavelength | $1064 \pm 10$ nm
(infrared) | $1060 \pm 20$ nm
(infrared) |
| Spot Size | 6 x 6 cm² on each of
the Applicator heads | 4 x 6 cm² on each of
the Applicator heads |
| Pulse Width (laser
ON time) | CW | CW |
| Power
Density | Up to 1.4 W/cm² | Up to 1.4 W/cm² |
| Attachment to
patient | Belt | Belt |
| Electrical
Power | 100-240V50/60 Hz, Single50/60 Hz, Single
Phase | 200-240V
Phase |
| Cooling
system | Yes | Yes |
| Materials | Biocompatible | Biocompatible |
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Substantial Equivalence Table #2 for the Diode Laser Applicators:
9
As described in the comparison tables above, the Venus Bliss 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 Bliss device and its predicate devices do not raise any new issues of safety or effectiveness. The Venus Bliss device and its predicate devices Legacy CX (K143554) and SculpSure (K160470) are based on the same core technology of RF along with PMF and vacuum massaging (as in Legacy CX) and Diode Laser (as in SculpSure), for the same indications for use. The design and components in the Venus Bliss device, including the console and the applicators are similar to the design and components found in the predicates. The technological differences, including the maximum output power for the RF applicator and the spot size of the Laser applicators, do not alter the device's core technology or performance.
Furthermore, the Venus Bliss device underwent performance testing, including software validation testing, electrical safety and electromagnetic compatibility testing. These performance tests in addition to a bench test demonstrated that the differences in the technological characteristics between the subject and predicate devices 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 Bliss device is substantially equivalent to its predicate devices, Legacy CX (K143554) and Cynosure's SculpSure (K160470).