(103 days)
The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:
- Hair removal;
- o Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and
- . Treatment of pseudofolliculitis barbae.
The Venus Velocity consists of a console, a detachable diode laser applicator, and three interchangeable sapphire light quides/tips (small, medium, and large sizes). A water system and pump in the console distribute water to cool the handpiece and tips during device use, decreasing the likelihood of burns, discomfort, or pain during treatment. The system is also provided with a water filling kit.
The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications. The device also comes with goggles and patient eye protectors.
This document is a 510(k) Summary for the Venus Velocity device. It describes the device's technical characteristics, intended use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, this document does not contain a detailed study proving the device meets acceptance criteria in the way typically expected for a clinical performance study. Instead, it relies on demonstrating that the device's technical specifications and safety profile are similar to existing, cleared devices.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of "acceptance criteria" for clinical performance. Instead, it implicitly defines acceptance by demonstrating that the device's technical parameters are within the ranges of predicate devices and that various safety and engineering tests passed.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technical Parameters (Wavelength, Spot Sizes, Pulse Durations, Fluence, Peak Power) | "The key energy parameters are very similar for the devices, where the available wavelength, spot sizes, pulse durations, fluence outputs, and peak power for the Venus Velocity are within the ranges previously cleared for the predicates." |
| Maximum Frequency | "the higher frequency available with the Venus Velocity does not raise different questions of safety or effectiveness because other laser-based devices for similar indications have also been cleared with the same 10 Hz maximum frequency." |
| Electromagnetic Compatibility (EMC) | "Electromagnetic compatibility and electrical safety testing was conducted per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. All results were passing." |
| Electrical Safety | "Electromagnetic compatibility and electrical safety testing was conducted per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. All results were passing." |
| Biocompatibility | "the patient-contacting materials are biocompatible per ISO 10993-1 and ISO 10993-5." |
| Software Verification and Validation | "The Venus Velocity also underwent software verification and validation, with results demonstrating that the software is appropriate for release." |
| System Verification Testing (Performance) | "System verification testing further confirmed that the system performs as intended, and that the energy outputs of the device meet specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with human subjects. The "performance data" refers to engineering, safety, and software verification tests. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as no clinical test set with ground truth established by experts is described in this document. The "tests" described are primarily engineering and technical validations against standards.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring expert adjudication is described in this document.
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
This information is not applicable. The Venus Velocity is a laser surgical instrument, not an AI-assisted diagnostic or interpretative device that would involve human readers or AI assistance in that context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The Venus Velocity is a physical medical device (laser system) and does not involve AI algorithms in the sense of a standalone diagnostic or interpretative tool.
7. The Type of Ground Truth Used
For the engineering and safety tests, the "ground truth" was adherence to established international standards (e.g., IEC 60601 series, ISO 10993 series) and the specified technical parameters of the device. For software, it was "demonstrating that the software is appropriate for release."
8. The Sample Size for the Training Set
This information is not applicable. The Venus Velocity is a physical medical device, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
In summary:
This 510(k) summary focuses on demonstrating "substantial equivalence" to legally marketed predicate devices through a comparison of technological characteristics, intended use, and by showing the device meets relevant engineering, electrical safety, biocompatibility, and software validation standards. It does not present a clinical study with human subjects to establish specific performance metrics like sensitivity, specificity, or permanent hair reduction rates against predefined acceptance criteria for a new clinical claim. Instead, the claim of "permanent hair reduction" is tied to the predicate devices and general understanding of "laser surgical instrument" performance, and the device's technical specifications are verified to be safe and effective within those established ranges.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2017
Venus Concept Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, Pennsylvania 19103
Re: K162765
Trade/Device Name: Venus Velocity Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use In General And Plastic Surgery and In Dermatology Regulatory Class: Class II Product Code: GEX Dated: November 29, 2016 Received: November 29, 2016
Dear Ms. Hogan:
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. 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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
Venus Velocity
Indications for Use (Describe)
The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:
- Hair removal:
- Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when ● measured at 6, 9, and 12 months after the completion of a treatment regimen); and
- Treatment of pseudofolliculitis barbae.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Venus Concept Ltd.'s Venus Velocity
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Venus Concept Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 Phone: 416.907.0115 Facsimile: 954.572.5680
Contact Person: Tal Bresler-Stramer, Ph.D., RAC, Vice President, QA/RA
Date Prepared: November 29, 2016
Name of Device and Classification/Product Code
Trade/Proprietary Name: Venus Velocity
Common or Usual Name: Diode laser system
Classification Name: 21 C.F.R. § 878.4810, Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Code: GEX
Predicate and Reference Devices
Predicate Devices: Palomar Medical Technologies, Inc.'s Palomar Vectus Laser (K120622); Lumenis Ltd. LightSheer® Desire (K151947)
Reference Devices: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms (K112031): Sandstone Medical's Cheveux Diode Laser System (K100893); Milesman's Milesman Premium (K073300); ILOODA Company's Vikini (K151232); Beijing Anchorfree Technology's Diode Laser Hair Removal System (K141973).
Intended Use / Indications for Use
The Venus Velocity is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:
- Hair removal;
- o Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and
- . Treatment of pseudofolliculitis barbae.
Technological Characteristics
The Venus Velocity consists of a console, a detachable diode laser applicator, and three interchangeable sapphire light quides/tips (small, medium, and large sizes). A water system and
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pump in the console distribute water to cool the handpiece and tips during device use, decreasing the likelihood of burns, discomfort, or pain during treatment. The system is also provided with a water filling kit.
The device incorporates several safety features, including an emergency laser stop button, user login and password protection, and other software and hardware settings to mitigate the risk of improper energy release and ensure that system outputs are within specifications. The device also comes with goggles and patient eye protectors.
Performance Data
Performance testing of the subject device supports its safety and effectiveness profile for the proposed indications. Electromagnetic compatibility and electrical safety testing was conducted per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. All results were passing. In addition, the patient-contacting materials are biocompatible per ISO 10993-1 and ISO 10993-5. The Venus Velocity also underwent software verification and validation, with results demonstrating that the software is appropriate for release. System verification testing further confirmed that the system performs as intended, and that the energy outputs of the device meet specifications.
Substantial Equivalence
The Venus Velocity has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices, the Palomar Vectus and Lumenis LightSheer Desire laser systems. The minor technological differences between the Venus Velocity and its predicates raise no new issues of safety or effectiveness. The key energy parameters are very similar for the devices, where the available wavelength, spot sizes, pulse durations, fluence outputs, and peak power for the Venus Velocity are within the ranges previously cleared for the predicates. In addition, the higher frequency available with the Venus Velocity does not raise different questions of safety or effectiveness because other laser-based devices for similar indications have also been cleared with the same 10 Hz maximum frequency. Performance data demonstrate that the Venus Velocity performs as intended, and further support that the device performs as intended. Thus, the Venus Velocity is substantially equivalent to its predicates.
Conclusions
The tests outlined above demonstrate that the device performs as intended. The Venus Velocity has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. Minor differences between the subject and predicate devices do not present any new or different types of safety or effectiveness questions. In sum, the Venus Velocity is substantially equivalent to its predicate devices.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.