(259 days)
The AI.ME System is indicated for fractional skin resurfacing.
The AI.ME system is a micro coring device controlled by a robot that removes skin by using a disposable punch assembly containing six (6), hollow needle punches inserted into the skin with a fixed maximum penetration depth of 3 mm to remove up to 10% of skin in the treatment area to excise and/or resurface skin.
The AI.ME system, which is similar in design and performance as the FDA cleared Venus Concept ARTAS system, consists of a cart, a coring mechanism, single-use vacuum assembly and a sterile single-use disposable punch assembly.
This document describes the FDA's 510(k) clearance for the AI.ME System, a microneedling device for aesthetic use. It details the device's substantial equivalency to predicate devices based on non-clinical performance data.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics like a typical study report might. Instead, it outlines various performance and safety tests conducted and states that they were successfully passed or demonstrated. The acceptance criteria are implicitly linked to compliance with relevant industry standards and guidance documents.
Here's a table constructed from the information provided, outlining the tested aspects and the stated outcome:
| Acceptance Criteria (Stated Test/Requirement) | Reported Device Performance (Outcome) |
|---|---|
| Software Documentation | Prepared and submitted for a moderate level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Electrical Safety | Tested and successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety. |
| Electromagnetic Interference (EMC) | Tested and successfully met all relevant sections (Radiated emissions, Conducted emissions, Harmonic emissions, Flicker emissions, Electrostatic discharge immunity test, radiated radio frequency immunity, Electrical fast transient/burst, lightning surge immunity, conducted RF immunity, electromagnetic field immunity, voltage dips and short interruptions, RFID compatibility, and power frequency magnetic field immunity test) to satisfy compliance with IEC 60601-1-2. |
| Accuracy of needle penetration depth and puncture rate | Tested in a suitable skin substrate model and measured using the Keyence Laser System. (Implicitly passed, as no issues were raised). |
| Safety features against cross-contamination & fluid ingress protection | Device design prevents cross-contamination and includes fluid ingress protection due to needle cartridge design. Design elements include serialized disposable assemblies (to prevent re-use) and a sealed path (to prevent fluid ingress). Testing was performed under worst-case scenarios. (Implicitly passed). |
| Identification of max safe needle penetration depth | Maximum safe needle penetration depth identified in a suitable skin substrate model. The needle depth is fixed at 3 mm and cannot be adjusted, "thus eliminating the needle depth hazard." (Implicitly passed, as control is fixed). |
| Sterility of patient-contacting components | Performance data demonstrates sterility according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937. |
| Shelf life support (sterility, package integrity, device functionality) | Disposables supplied non-sterile and sterilized per validated procedure prior to use. Materials are non-degradable, so a labeled shelf life is not required. (This addresses the concern by stating it's not applicable for this device's components). |
| Biocompatibility of patient-contacting components | Demonstrated to be biocompatible, including evaluation of cytotoxicity, irritation, sensitization, acute systemic toxicity, and material-mediated pyrogenicity per ISO 10993-1. |
| Cleaning and disinfection instructions for reusable components | Cleaning and disinfection validation performed per AAMI TIR30. |
| Software verification, validation, and hazard analysis | Performed for all software components according to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. |
| Labeling content | Includes operational information, device technical parameters, reprocessing instructions for reusable components, disposal instructions, and (where applicable) shelf life. (This is a statement of inclusion, implying compliance). |
| Patient labeling content | Includes device operation information, typical treatment course, probable risks and benefits, and postoperative care instructions. (This is a statement of inclusion, implying compliance). |
| Pre-Clinical (Animal) Performance Data | Study in swine model showed clear time-related progressive healing and full resurfacing of the treated area. Concluded that the system "does not pose any undue or additional risks and is safe and effective for fractional skin resurfacing." |
Study Details
This document describes a 510(k) premarket notification for a medical device that does not involve an AI algorithm for diagnostic or prognostic purposes, but rather a robotic system that incorporates an "AI.ME System" name. The AI aspect, as described, appears to relate to the robotic control for precision, rather than a data-driven AI model that makes clinical assessments or diagnoses. Therefore, many of the requested details about AI model studies (like sample size for test/training sets, ground truth establishment methods, expert adjudication, MRMC studies) are not applicable to the type of device and testing described in this 510(k) summary.
The "AI" in "AI.ME System" seems to refer to Artificial Intelligence in the sense of an intelligent, automated system (robotics), rather than a machine learning algorithm for image analysis or clinical decision support that would require extensive data for training and testing as per the typical questions.
However, based on the provided text, here's what can be inferred about the "performance data" that serves as the "study":
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set (Pre-Clinical Study): A "swine model" was used for the pre-clinical study. The exact number of animals is not specified.
- Data Provenance: The study was "pre-clinical" (animal model), likely conducted in a controlled lab environment by the manufacturer or a contract research organization. The country of origin is not specified. It is a prospective study, as it describes an evaluation over time (7, 14, 28 days post-treatment).
- Other Performance Data: For non-clinical tests like electrical safety, EMC, software validation, sterility, biocompatibility, etc., these are bench tests and lab validations. No patient data or image data sets were mentioned.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- For the swine study, "macroscopical and histopathological analysis" was conducted. This implies expert evaluation (e.g., pathologists).
- However, the number of experts and their specific qualifications are not specified.
- Ground truth regarding the performance characteristics (e.g., accuracy of needle penetration depth) would have been established by engineering measurements using instruments like the Keyence Laser System, not clinical experts.
-
Adjudication Method for the Test Set:
- For the pre-clinical (swine) study, the method of adjudication for macroscopic and histopathological analysis is not specified. It generally implies a consensus or independent review process by qualified personnel, but no details are provided.
- For other performance tests, adjudication methods are not applicable as they involve objective measurements against standards.
-
If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. The AI.ME system is a microneedling device, not a diagnostic imaging AI.
-
If a Standalone (algorithm only without human-in-the-loop performance) was done:
- The document describes device performance characteristics and safety validations. While the "AI.ME System" implies an automated aspect (robotics), the testing detailed is on the physical device's mechanics, safety, and biological interaction. It's not a standalone AI algorithm in the sense of a software-only diagnostic tool being evaluated for its performance. The "performance data" reported is for the system as a whole, including its automated functions, but doesn't isolate an AI algorithm's performance in a way that is typically measured for diagnostic AI.
-
The Type of Ground Truth Used:
- Pre-Clinical Swine Study: Ground truth was established through "macroscopical and histopathological analysis" of tissue from the treated areas at different time points (7, 14, 28 days). This is pathology-based ground truth indicating tissue response and healing.
- Other Tests: Ground truth for other aspects (e.g., electrical safety, EMC, sterility, biocompatibility, accuracy of needle depth) was established through objective measurements against recognized industry standards and validated methods.
-
The Sample Size for the Training Set:
- Not applicable / not specified. The document describes a medical device clearance based on substantial equivalence and non-clinical performance testing validated against standards. It does not describe the development or training of a machine learning model that would require a distinct "training set" of data in the typical AI sense. The "AI" in AI.ME likely refers to robotic automation/control, not a learned model from a dataset.
-
How the Ground Truth for the Training Set was Established:
- Not applicable. As no AI training dataset is explicitly mentioned, the concept of establishing ground truth for a training set does not apply.
Conclusion Summary from Document:
The document concludes that the AI.ME System is safe and effective as the legally marketed predicate and reference devices, and that the performance testing data supports the stated indications for use. It asserts that the AI.ME System did not raise new questions of safety or effectiveness.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
December 20, 2022
Venus Concept USA Inc. William McGrail VP, Global Regulatory Affairs & Quality Assurance 1880 N Commerce Pkwy, Suite 2 Weston. Florida 33326
Re: K221011
Trade/Device Name: AI.ME System Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: November 17, 2022 Received: November 17, 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.
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
{1}------------------------------------------------
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,
Jessica Carr -S
for 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}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name AI.ME System
Indications for Use (Describe)
The AI.ME™system is indicated for fractional skin resurfacing.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V made up of three curved lines, followed by the word "VENUS" in all capital letters. The logo is simple and modern, with a clean design.
510(K) SUMMARY (As Required by 21.CFR.807.92)
| 1. SUBMITTER | |
|---|---|
| Manufacturer: | Venus Concept, Inc. |
| 1800 Bering Drive | |
| San Jose, CA 95112, USA | |
| Contact Person: | William H. McGrail |
| Vice President, Global RA & QA | |
| Venus Concept | |
| Phone: (978) 808-0420 | |
| Email: bmcgrail@venusconcept.com | |
| Date Prepared: | December 19, 2022 |
2. DEVICE INFORMATION
| Trade/Device Name(s): | AI.ME™ System |
|---|---|
| Regulation Number: | 21 CFR § 878.4430 |
| Regulation Name: | Microneedling device for aesthetic use |
| Regulation Class: | Class II |
| Product Code: | QAI |
| Review Panel: | General And Plastic Surgery Devices |
3. PREDICATE DEVICES
| Device Name | 510(k) Number | |
|---|---|---|
| Predicate | Cytrellis Dermal Micro-Coring System (Ellacor) | K202517 |
| Reference #1 | Fraxis DUO System | K160312 |
| Reference #2 | ARTAS IX System | K173358 |
4. INDICATIONS FOR USE
The AI.ME system is indicated for fractional skin resurfacing.
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a bold, sans-serif font.
5. DEVICE DESCRIPTION
The AI.ME system is a micro coring device controlled by a robot that removes skin by using a disposable punch assembly containing six (6), hollow needle punches inserted into the skin with a fixed maximum penetration depth of 3 mm to remove up to 10% of skin in the treatment area to excise and/or resurface skin.
The AI.ME system, which is similar in design and performance as the FDA cleared Venus Concept ARTAsystem, consists of a cart, a coring mechanism, single-use vacuum assembly and a sterile single-use disposable punch assembly.
6. TECHNOLOGICAL CHARACTERISTICS
The AI.ME system consists of a cart, a robotic arm with an integrated imaging system, vacuum assembly, coring mechanism, and punch assembly. The robot arm provides precision skin coring to the treatment area preventing pssibility of retreating an area and causing possible damage to the skin and underlying tissue. The cart consists of a real time controller and an embedded computer for the system software, a touch screen userinterface, power suppliers and circuit controllers. These major components used on the Venus Concept ARTAS (K173358) reference device are the same. The coring mechanism, which is permanently attached to the robot arm, consists of actuation elements to advance, retract, and spin the punch assembly. The disposable punch assembly is connected to the end of the coring mechanism. The disposable vacuum assembly consists of a skin accumulation chamber with the input connected via tubing to the punch assembly used to remove skin from each of the six needles using vacuum prior to the robot inserting thepunches into the skin at the next location in the treatment are. The punch assembly consists of six (6) hollow 0.74 mm in diameter cylindrical shape needles with a sharp conicalcutting tip at the top arranged in a hexagon pattern. The punch assembly and coring mechanism is designed to prevent anythuids from ingress into the coring mechanism to prevent cross contamination. The needles rotate at 4500 RPM while the coring mechanism moves the needle punch assembly in and out of the skin also at 4500 RPM before moving to the next skin treatment location.
7. TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Cytrellis Biosystems, Inc. Ellacor system was chosen as the predicate device since the Ellacor device contains similar micro coring technological characteristics to the AI.ME system. Both the Ellacor and AI.ME perform micro coring of the skin using stainless steel hollow needles to remove 8% to 10% of skin. Both systems have the same product code.
Table 5-1 compares the intended use, key performance and technological features of the AI.ME System with the predicate device.
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom.
The Ilooda Co., Ltd FRAXIS DUO system was chosen as reference #1 device since the AI.ME system indications for use is a subset of the indications for use of the FRAXIX DUO system. Both systems perform fractional skin resurfacing.
The Venus Concept USA, Inc. ARTAX IX system was chosen as reference #2 device since the AI.ME system uses the same major components as the ARTAS IX system which was cleared by the FDA. Both systems use a robotic arm, imaging system, coring mechanism and needle punch assembly to remove skin or hair follicles from the body.
| Product | AI.ME System(Subject) | Ellacor System(Predicate) | Similarities and significantdifferences to the predicatedevice |
|---|---|---|---|
| Device Classificationname | MicroneedlingDevice ForAesthetic Use | Microneedling DeviceFor Aesthetic Use | Identical |
| Device Product Code | QAI | QAI | Identical |
| Device Class | Class II | Class II | Identical |
| Regulation Number | 21 CFR 878.4430 | 21 CFR 878.4430 | Identical |
| Indications for Use | The AI.ME systemis indicated forfractional skinresurfacing. | The Cytrellis® DermalMicro-Coring™ Systemis indicated for use bymedical professionals forthe treatment ofmoderate and severewrinkles in the mid andlower face in adults aged22 years or older withFitzpatrick skin types I-IV. | SimilarBoth devices are used inaesthetic procedures indermatology. Both devicesare for the treatment of skin.The proposed indicationbeing sought in this 510(K)is for fractional skinresurfacing. Animal testingand performance dataprovided demonstrates thatthe AI.ME System is safeand effective for theindication and intended usedescribed and does not poseany undue or additionalrisks. |
| Geometry | 6 hollow needles,hexagonarrangement | Single (1) needle or three(3) hollow needlesarranged in a straightline. Needles are groundto 10-degree tip angleresulting in two (2)cutting services and two(2) tips | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that the AI.MEdevice does not pose anyundue or additional risks andis effective. |
| Product | AI.ME System(Subject) | Ellacor System(Predicate) | Similarities and significantdifferences to the predicatedevice |
| Maximum needlepenetration(maximum needlelength) | Fixed 3 mm coredepth | Up to 4.0mm coredepth setting or 5mmneedle tip depth | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that the AI.MEdevice does not pose anyundue or additional risks andis effective. |
| Needle protrusionsetting | Fixed 3 mm coredepth | 0-4.0mm coredepth setting or 1-5mm needle tipdepth | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that the AI.MEdevice does not pose anyundue or additional risks andis effective. |
| Percentage TissueRemoval | Up to 10% | Up to 7.9% | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that the AI.MEdevice does not pose anyundue or additional risks andis effective. |
| Treatment Protocol | At least 2 but nomorethan 3 treatmentsspaced 4 weeks apart | At least 2 but no morethan 3 treatmentsspaced 4 weeks apart | Identical |
| Delivery System | Robotic Arm withpunch assembly | Handheld instrument | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that theAI.ME device does not poseany undue or additionalrisks. |
| Needle Diameter | 0.74 mm | < 0.50 mm | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that theAI.ME device does not poseany undue or additionalrisks and is effective. |
| Product | AI.ME System(Subject) | Ellacor System(Predicate) | Similarities and significantdifferences to the predicatedevice |
| subject device needlediameter is larger. | |||
| Puncture Rate | 6 punctures/6seconds | 24-36 punctures/second | DissimilarAnimal testing similar to thepredicate device and non-clinical performance testingdemonstrates that theAI.ME device does not poseany undue or additionalrisks and is effective. Thepuncture rate of the subjectdevice is significantly lessthan the predicate. |
Table 5-1 Substantial Equivalence Comparison Table with Predicate Device
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a simple, sans-serif font.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Venus. The logo consists of a stylized "V" made of three curved lines, followed by the word "VENUS" in a simple, sans-serif font. The logo is black and white.
SUBSTANTIAL EQUIVALENCY AND COMPARISON OF TECHNOLOGICAL SIMILARITIES & DIFFERENCES
As described in the comparison tables above, the AI.ME subject device has a similar intended use and indications for use, similar technological characteristics, and principles of operation as its predicate and reference devices. The technological differences between the AI.ME device and its predicate and reference devices do not raise any new issues of safety or effectiveness. The AI.ME device has similar indication for use as Fraxis DUO System (K160312) fractional skin resurfacing and same core technology as ARTAS IX and Cytrellis Dermal Micro-Coring System (Ellacor) (202517). The design and components in the AI.ME device, including the console and the accessories are similar to the design and components found in the predicate and the reference devices ARTAS IX (robotic arm, console and computer items) and Cytrellis Dermal Micro-Coring System (Ellacor) (202517) (coring and punching kits).
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).
Furthermore, the AI.ME device underwent performance testing, including software validation testing, electrical safety and electromagnetic compatibility testing. These performance tests in addition to the bench test demonstrated that the differences in the technological characteristics between the subject's predicate and reference devices do not raise new types of safety or effectiveness concerns.
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for Venus. The logo consists of a stylized letter V made up of three curved lines, followed by the word "VENUS" in a sans-serif font. The logo is black and white. The logo is simple and modern.
8. PERFORMANCE DATA
Summary of Non-Clinical Performance Testing 8.1
The following performance and safety testing has confirmed the proposed device to be substantially equivalent to the predicate device:
- . Software: Documentation was prepared and submitted for a moderate level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Electrical Safety: The AI.ME System has been tested and successfully passed all the ● relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety.
- Electromagnetic Interference (EMC): The AI.ME has been tested and successfully met all of the relevant sections (Radiated emissions, Conducted emissions, Harmonic emissions, Flicker emissions, Electrostatic discharge immunity test, radiated radio frequency immunity, Electrical fast transient/burst, lightning surge immunity, conducted RF immunity, electromagnetic field immunity, voltage dips and short interruptions, RFID compatibility, and power frequency magnetic field immunity test) to satisfy compliance with IEC 60601-1-2.
To demonstrate safety and effectiveness and support substantial equivalence, the AI.ME System has undergone non-clinical performance testing in line with recognized standard: The Guidance for Industry and FDA Administration Staff; Regulatory Considerations for Microneedling Products issued on November 10, 2020.
| (1) The technical specifications and needle characteristics have been identified, including needle | ||
|---|---|---|
| length, geometry, maximum penetration depth, and puncture rate. | ||
| (2) Non-clinical performance data demonstrates that the device performs as intended under | ||
| anticipated conditions of use. The following performance characteristics have | ||
| been tested: | ||
| (i) | Accuracy of needle penetration depthand puncture rate | Accuracy of needle penetration depth and puncturerate was tested in a suitable skin substrate model andmeasured using the Keyence Laser System |
| (ii) | Safety features built into thedevice to protect against cross-contamination & fluid ingressprotection | The device design prevents cross contaminationincluding fluid ingress protection due to the needlecartridge design. Design elements include serializeddisposable assemblies that are entered into the systemsoftware prior to use.to prevent needle cartridge re-use and a sealed path to prevent fluid ingress. Testingwas performed under worst case scenarios. |
| (iii) | Identification of the max safe needlepenetration depth for the device & forthe labeled indications for use | Maximum safe needle penetration depth wasidentified in a suitable skin substrate model. Theneedle depth is fixed at 3 mm and can not be adjustedthus eliminating the needle depth hazard. |
| (3) | Performance data must demonstrate thesterility of the patient-contactingcomponents of the device. | Performance data demonstrates the sterility of thepatient-contacting components of the deviceaccording to ANSI/AAMI/ISO 17665-1 andANSI/AAMI/ISO 14937. |
| (4) | Performance data must support the shelflife of the device by demonstratingcontinued sterility, package integrity,and device functionality over theintended shelf life. | Disposables are supplied non-sterile and are sterilizedper a validated procedure prior to use. Materials arenon-degradable and therefore a labeled shelf life is notrequired. |
| (5) | Performance data must demonstrate theelectrical safety and electromagneticcompatibility (EMC) of all electricalcomponents of the device. | Performance data demonstrates the electrical safetyand electromagnetic compatibility (EMC) of allelectrical components of the device according toIEC 60601-1 and IEC 60601-1-2. |
| (6) | Software verification, validation, andhazard analysis must be performed forall software components of the device. | Software verification, validation, and hazard analysiswere performed for all software components of thedevice according to in accordance with FDA'sGuidance for the Content of Premarket Submissionsfor Software Contained in Medical Devices |
| (7) | The patient-contacting components of thedevice must be demonstrated to bebiocompatible. | The patient-contacting components of the device weredemonstrated to be biocompatible includingevaluation of cytotoxicity, irritation, and sensitizationacute systemic toxicity and material-mediated anpyrogenicity per ISO 10993-1 |
| (8) | Performance data must validate thecleaning and disinfection instructions forreusable components of the device. | A cleaning and disinfection validation wasperformed for reusable components of the device perAAMI TIR30. |
| (9) | Labeling includes the following: | |
| (i) | Information on how to operate the device and its components and the typical course oftreatment; | |
| (ii) | A summary of the device technical parameters, including needle length, needle geometry,maximum penetration depth, and puncture rate; | |
| (iii) | Validated methods and instructions for reprocessing of any reusable components; | |
| (iv) | Disposal instructions; and | |
| (v) | A shelf life | |
| (10) | Patient labeling includes: | |
| (i) | Information on how the device operates and the typical course of treatment; | |
| (ii) | The probable risks and benefits associated with use of the device; |
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a sans-serif font and is all capitalized.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Venus. The logo consists of a stylized letter V on the left and the word "VENUS" on the right. The letter V is made up of three curved lines that converge at the bottom. The word "VENUS" is in a sans-serif font and is all capitalized.
(iii) Postoperative care instructions.
Pre-Clinical (Animal) Performance Data 8.2
A pre-clinical study using swine model was conducted using micro coring of the skin. The evaluation included macroscopic and histopathological analysis of different predetermined parameters of treated area and depth and width of the skin excision areas post treatment; 7 days post treatment; 14 days post treatment and 28 days post treatment. Overall, the macroscopical and the histopathological evaluation of the AI.ME system, showed a clear time-related progressive process of healing, post the skin tissue excision and towards a full resurfacing of the treated area.
Conclusion: The pre-clinical study emphasizing the swine-model, showed that the AI.ME system does not pose any undue or additional risks and is safe and effective for fractional skin resurfacing.
9. CONCLUSION
The performance testing data demonstrates that AI.ME System is as safe and effective as the legally marketed predicate and reference devices. The AI.ME System did not raise new questions of safety or effectiveness. Therefore, based on the information provided in this Premarket Notification, we conclude that Venus AI.ME System has demonstrated substantial equivalence to the predicate and reference devices and the performance testing data support the indications for use.
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.