(156 days)
No
The summary describes a device that uses RF energy, PEMF, and massage for therapeutic purposes. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for the treatment of various medical conditions, including relief of minor muscle aches and pain, muscle spasm, improvement of local blood circulation, and temporary reduction in the appearance of cellulite, which are all therapeutic purposes.
No
The device description states its purpose is for treatment, such as relieving muscle aches and pain, improving blood circulation, and reducing cellulite, using RF, PEMF, and massage. It does not mention any diagnostic capabilities.
No
The device description explicitly states it consists of a console (main unit) and three applicators, which are hardware components.
Based on the provided information, the Venus Freedom device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the treatment of medical conditions using physical modalities (RF, massage, magnetic field pulses) applied directly to the patient's body. IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a non-invasive device that delivers energy and manipulation to the skin and underlying tissues. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
The Venus Freedom device is clearly described as a therapeutic device used for physical treatment of the body.
N/A
Intended Use / Indications for Use
The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim 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.
Product codes
PBX
Device Description
The Venus Freedom device, part of the Family of Venus RF devices, is a noninvasive, non-ablative device that delivers Radiofrequency (RF) energy, along with the Pulsed Electro-Magnetic Field (PEMF), into the skin to generate heat through electrical impedance in the epidermis, dermis, subcutaneous layers, and muscular tissue.
The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim).
The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional healthcare facilities (prescription use)
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 test demonstrating that the Venus Freedom device meets the system's technical specification for the max RF power output and max PEMF power density.
- A Bench test which demonstrated the ability of the subject device to maintain a safe treatment temperature on the surface of the human skin with the same protocol that was used for the predicate device, Venus Heal (K182094).
- Electrical Safety and Electromagnetic Compatibility: The Venus Freedom system was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.
- IEC 60601-1: (2005) and A1:2012, Medical Electrical Equipment Part 1-1: General requirements – for basic safety and essential performance
- IEC 60601-1-6: (2010/AMD2013), Medical Electrical Equipment Part 1-6, General requirements for basic safety and essential performance
- IEC 60601-2-2:2017, Medical Electrical Equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-2: 2014, Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 62304: (2006/AMD2015) Medical device software Software life cycle processes -
- Software Testing: Software verification and validation testing has been performed; the device functioned as intended and the results observed were as expected.
- Biocompatibility: Biocompatibility testing was performed on the Venus Freedom's disposable tip's materials according to the FDA Guidance and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization and irritation according to standards set forth in ISO 10993- 5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. All testing passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Venus Heal device (K182094)
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). The logo consists of two parts: on the left is the Department of Health & Human Services logo, and on the right is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 14, 2021
Venus Concept USA Inc. Yoni Iger VP Regulatory, Science & Technology 1880 N Commerce Pkwv. Suite 2 Weston, Florida 33326
Re: K211461
Trade/Device Name: Family of Venus RF Systems - Venus Freedom Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: August 10, 2021 Received: August 17, 2021
Dear Yoni Iger:
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 ffor 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/cfpm/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known) K211461
Device Name
Family of RF Systems - Venus Freedom
Indications for Use (Describe)
The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim 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.
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.
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Page 1 of 1 PSC Publishing Services (301) 443-6740 EF FORM FDA 3881 (7/17)
3
VI. 510(k) SUMMARY
VENUS FREEDOM DEVICE - K211461
- Applicant Name: Venus Concept USA Inc. 1880 N Commerce Pkwy, Ste 2 Weston, FL33326, USA Tel: +1 888 907-0115
- Contact Person: Dr. Yoni Iger VP Regulatory, Science & Technology Venus Concept USA Inc. Yoni@venusconcept.com Tel: +1 888 907-0115
Date Prepared: October 13, 2021
Trade Name: Venus Freedom Device
Classification Name: 21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories
Product Code: PBX
Classification: Class II Medical Device
Classification Panel: General & Plastic Surgery Panel
Predicate Device: Venus Heal device (K182094)
Intended Use/Indication for Use:
The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim 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
4
K211461
Device Description:
The Venus Freedom device, part of the Family of Venus RF devices, is a noninvasive, non-ablative device that delivers Radiofrequency (RF) energy, along with the Pulsed Electro-Magnetic Field (PEMF), into the skin to generate heat through electrical impedance in the epidermis, dermis, subcutaneous layers, and muscular tissue.
The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim).
The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.
Consistent with the previous clearance, the device is intended to be used in professional healthcare facilities (prescription use) just as the predicate.
Comparison of Technological Characteristics:
The following table compares the subject Venus Freedom device to its predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| Parameter | Proposed Device:
Venus Freedom
Venus Concept Inc. | Predicate Device:
Venus Heal
Venus Concept Inc.
(K182094) | Substantial
Equivalence |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Product Class, Code | Class II, PBX | Class II, PBX | Same |
| Indications for Use | The Venus Freedom device is
intended for the treatment of
the following medical
conditions; using the Pearl,
Diamond and Slim
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. | The Venus Heal device
is intended for the treatment
of the following medical
conditions; using the Large
and Small 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. | Same |
| Parameter | Proposed Device:
Venus Freedom
Venus Concept Inc. | Predicate Device:
Venus Heal
Venus Concept Inc.
(K182094) | Substantial
Equivalence |
| Energy Used/
Delivered | RF Energy
Pulsed Electro-Magnetic Field (PEMF) | RF Energy
Pulsed Electro-Magnetic Field (PEMF) | Same |
| Tissue Manipulation
Mechanism | Massage mechanism | Massage mechanism | Same |
| Design | Use of RF and PEMF combined
energies delivered through applicator
and massage of the skin. | Use of RF and PEMF combined
energies delivered through applicator
and massage of the skin. | Same |
| Components | Console, including:
- Power supply
- RF generator
- Main CPU
- Display panel
- PEMF generator
Applicators: - Pearl
- Diamond
- Slim
Footswitch | Console, including: - Power supply
- RF generator
- Main CPU
- Display panel
- PEMF generator
Applicators: - Large
- Small | Same
New
Applicator
Addition of
Footswitch |
| Applicators | Pearl Applicator:
6 electrodes
1 PEMF coil
Diamond Applicator:
4 electrodes
1 PEMF coil
Slim Applicator:
6 electrodes
1 PEMF coil | Large Applicator:
8 electrodes
8 PEMF coils
Small Applicator:
4 electrodes
4 PEMF coils | Same
delivery of
Bipolar RF
and PEMF,
although
different
number of
electrodes
and coils
New
Applicator |
| Applicator's
disposable tip | Single use disposable per applicator: - Pearl disposable tip
- Diamond disposable tip
- Slim disposable tip | None, all applicators are reusable | Different |
| Parameter | Proposed Device:
Venus Freedom
Venus Concept Inc. | Predicate Device:
Venus Heal
Venus Concept Inc.
(K182094) | Substantial
Equivalence |
| Device Dimensions | 16.5x16.5x10.4 in (W × D × H)
42x42x26.5 cm (W × D × H) | 16.5x16.5x10.4 in (W × D × H)
42x42x26.5 cm (W × D × H) | Same |
| Performance | Frequency: 1MHz
Max. RF output power:
80W (Pearl, Diamond and Slim
applicators) | Frequency: 1MHz
Max. RF output power:
100W (Large and Small applicators) | Same |
| | PEMF Power: 15 Gauss (15Hz) | PEMF Power: 15 Gauss (15Hz) | Same |
| | | | Different |
| Power density per
effective treatment
area (Watt/cm²) | Pearl Applicator:
3.75W/cm²
Diamond Applicator:
24.24W/cm²
Slim Applicator:
4.5W/cm² (1 pair of electrodes) | Large Applicator:
2.6W/cm²
Small Applicator:
20.4 W/cm² | Different |
| | | | Different |
| Materials | Biocompatible materials per ISO
10993-1 | Biocompatible materials per ISO
10993-1 | Same |
5
6
Performance Data:
Venus Concept conducted several performance tests to demonstrate that the subject Venus Freedom device complies with performance standards and that it functions as intended per its design.
-
Verification test demonstrating that the Venus Freedom device meets the system's technical specification for the max RF power output and max PEMF power density.
-
A Bench test which demonstrated the ability of the subject device to maintain a safe treatment temperature on the surface of the human skin with the same protocol that was used for the predicate device, Venus Heal (K182094).
7
K211461
Electrical Safety and Electromagnetic Compatibility: The Venus Freedom system was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.
- IEC 60601-1: (2005) and A1:2012, Medical Electrical Equipment Part 1-1: General requirements – for basic safety and essential performance
- IEC 60601-1-6: (2010/AMD2013), Medical Electrical Equipment Part 1-6, General requirements for basic safety and essential performance
- IEC 60601-2-2:2017, Medical Electrical Equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-1-2: 2014, Medical Electrical Equipment, Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 62304: (2006/AMD2015) Medical device software Software life cycle processes -
Software Testing:
Software verification and validation testing has been performed; the device functioned as intended and the results observed were as expected.
Biocompatibility:
Biocompatibility testing was performed on the Venus Freedom's disposable tip's materials according to the FDA Guidance and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization and irritation according to standards set forth in ISO 10993- 5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. All testing passed.
Conclusions:
The Venus Freedom device is as safe and effective as its predicate device, Venus Heal, cleared under K182094 for the same requested intended use. The Venus Freedom device has the same intended use and indications for use, similar technological characteristics, and the same principle of operation as its predicate device. Performance data demonstrated that the technological differences in the Venus Freedom do not raise any issues of safety or effectiveness in comparison to the predicate device. Thus, the Venus Freedom device is substantially equivalent to its predicate, Venus Heal (K182094) for the requested intended use.