(109 days)
The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.
This document is a 510(k) Summary for the Venus Viva SR Device, indicating that it has been determined to be substantially equivalent to a predicate device. As such, it does not contain the detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way one might expect for a novel device or a clinical trial. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.
However, I can extract information related to performance evaluations and the animal study that supports the device's safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific clinical outcome. Instead, it describes various tests and their "passing" or "as expected" results, demonstrating compliance with recognized standards and expected performance in a pre-clinical setting.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electromagnetic Compatibility (EMC) & Electrical Safety | All results were "passing" per AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
| Biocompatibility | Patient contacting materials (ASTM F899-12b stainless steel, plastic) are biocompatible. |
| Sterilization | Demonstrated that the sterilization cycle achieved a sterility assurance level of 10-6 per ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11138-1, and AAMI/ANSI ST79. |
| Software Validation | Results demonstrated that the software was "appropriate for release." |
| Bench Testing (Radiofrequency Outputs) | Outputs are "substantially equivalent" to those of the predicate device. |
| Animal Study (In Vivo & Gross Necropsy - Erythema, Edema, Microneedle Pattern) | Results were "as expected" at Day 0, Day 4, and Day 14. |
| Animal Study (Histopathology - Healing Profile) | Skin biopsies showed "skin that was healing well." |
| Animal Study (Overall Safety & Performance) | Exhibited a "favorable safety profile and performed as intended in daily observations, adverse events, gross necropsy, wound assessment, and histopathology." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions a "porcine study" (animal study). The specific number of animals or treatment sites is not specified.
- Data Provenance: The study was an animal study (porcine), which is a pre-clinical setting. The country of origin is not specified. It is implicitly a prospective study in the context of controlled experimental animal research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document states "Skin biopsies were submitted for pathologic review to assess the healing profile at sites following treatment."
- Number of experts: Not specified.
- Qualifications of experts: The experts are implicitly pathologists, but their specific qualifications (e.g., years of experience) are not detailed.
4. Adjudication method for the test set
- The document mentions "gross necropsy findings" and "pathologic review." It does not specify an explicit adjudication method like "2+1" or "3+1" for interpreting these findings. It implies a standard pathological review process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This document describes a medical device (Venus Viva SR Device) for dermatological procedures, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable to the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The Venus Viva SR Device is an energy-based medical device, not an algorithm. The performance evaluation focuses on the device's physical and biological effects, not on an algorithm's diagnostic accuracy.
7. The type of ground truth used
- For the animal study:
- Direct observation: For erythema, edema, and microneedle pattern at specified time points (Day 0, Day 4, Day 14).
- Histopathology: For assessing the healing profile of skin biopsies.
- Gross necropsy: For evaluating overall findings.
8. The sample size for the training set
- This document describes a 510(k) submission for a medical device, not a machine learning algorithm. Therefore, there is no concept of a "training set" in this context. The device's design and parameters are based on engineering principles and comparisons to predicate devices, not on training data.
9. How the ground truth for the training set was established
- As there is no "training set" for this type of device, this question is not applicable.
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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 features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird's wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2015
Venus Concept USA Ltd. Tal Bresler-Stramer, Ph.D., RAC Vice President Quality Assurance / Regulatory Affairs 4556 North Hiatus Road Sunrise, Florida 33351
Re: K150161
Trade/Device Name: Venus Viva SR Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: April 16, 2015 Received: April 16, 2015
Dear Dr. Bresler-Stramer:
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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" (21CFR 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 yours.
Jennifer R. Stevenson -S
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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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 on last page
510(k) Number (if known)
Device Name
Venus Viva SR Device
Indications for Use (Describe)
The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
Over-The-Counter Use (21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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K150161 Page 1 of 3
510(k) SUMMARY
Venus Concept's Venus Viva SR Device
Sponsor/Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Venus Concept USA Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 Telephone: 954.572.5585 Fax: 954.572.5680
Contact Person: Tal Bresler-Stramer, PhD, RAC VP QA/RA Venus Concept, Ltd.
Date Prepared: May 11, 2015
Trade Name of Device
Venus Viva SR Device
Classification Name
Electrosurgical cutting and coagulation device and accessories (21 C.F.R. 878.4400; Product Code GEI)
Predicate and Reference Devices
Invasix Ltd.'s Fractora device (K102461) (Primary Predicate) Reference Devices: Primaeva Medical's Miratone System (K082391), Syneron Medical's eMatrix applicator (K101321), Syneron Medical's eTwo Skin Treatment System (K110672), Venus Concept's Venus Freeze (K111670, K100586) and Venus Swan (K140629, K111784)
Intended Use / Indications for Use
The Venus Viva SR system is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Device Description
The Venus Viva SR device is designed for non-invasive dermatological procedures requiring ablation and resurfacing of the skin. The system is designed to deliver RF energy to the skin in a fractional manner. The device is comprised of a console and an applicator. The applicator is connected to the system via a cable. The applicator (hand piece) includes a detachable electrode tip that is comprised of an array of small electrode pins. The radiofrequency energy is delivered from each of the tissue, heating the dermal layers beneath the pin with minimal injury to the epidermis layer.
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Technological Characteristics
The Venus Viva SR Device has similar technological characteristics to the Fractora device, as both are fractional RF devices comprised of a console and applicator. The technological differences between the Venus Viva SR and its predicate are minor, and the key parameter affecting treatment outcomes (i.e., RF enerqy per pin) is identical between the devices. Therefore, the dimensional differences or other technical differences between the Viva SR and its predicate do not present any new issues of safety or effectiveness, as demonstrated by the animal study data submitted in support of this 510(k) notice. Therefore, the Venus Viva SR device presents similar technological characteristics as the predicate, in support of substantial equivalence.
Performance Data and Standards
The performance of the Venus Viva SR has been evaluated in testing per the applicable FDA recognized testing standards below.
Electromagnetic Compatibility and Electrical Safety testing was conducted per AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-2. All results were passing.
In addition, the patient contacting materials (ASTM F899-12b stainless steel, plastic) are biocompatible.
Sterilization parameters were validated per ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11138-1, and AAMI/ANSI ST79. Results demonstrated that the sterilization cycle achieved a sterility assurance level of 10-6.
The Venus Viva SR device also underwent software validation and results demonstrated that the software was appropriate for release.
Bench testing further confirmed the radiofrequency outputs of the Viva SR are substantially equivalent to those of the predicate.
The device was also evaluated in a porcine study to evaluate the device performance. The study included evaluation of the in vivo and gross necropsy findings. Treatment sites were viewed and scored at Day 0, Day 4, and Day 14 for the presence of erythema, edema, and microneedle pattern, and results were as expected. Skin biopsies were submitted for pathologic review to assess the healing profile at sites following treatment; the treated sites showed skin that was healing well. The test data demonstrated that the Viva SR treatment resulted in the desired therapeutic effects. The results of the study indicated that the Venus Viva SR device exhibited a favorable safety profile and performed as intended in daily observations, adverse events, gross necropsy, wound assessment, and histopathology.
Substantial Equivalence
The Venus Viva SR Device has the same intended use and substantially similar indications for use, technological characteristics and principles of operation as its predicate device. The minor technological differences between the Venus Viva SR Device and its predicate device do not raise any new issues of safety or effectiveness, given that the key energy parameter is the same for the two devices. Animal testing data demonstrate that the Venus Viva SR Device is substantially equivalent to the identified predicate device.
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Conclusions
The nonclinical tests outlined above demonstrate that the device performs as intended for dermatological procedures requiring ablation and resurfacing of the skin. Minor differences between the subject and predicate devices do not present any new types of safety or effectiveness questions, as confirmed by device performance. The Venus Viva SR device is substantially equivalent to Invasix Ltd.'s Fractora (K102461).
§ 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.