(259 days)
Yes
The device name "AI.ME System" explicitly includes "AI", strongly suggesting the incorporation of artificial intelligence technology.
Yes
The AI.ME system is indicated for fractional skin resurfacing, which is a medical procedure aimed at improving skin appearance or health. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition or improve a physiological function.
No
The device description, intended use, and performance studies all indicate that the AI.ME system is used for fractional skin resurfacing, which is a treatment, not a diagnostic process. It removes skin, rather than analyzing or identifying a condition.
No
The device description explicitly details hardware components such as a cart, coring mechanism, vacuum assembly, and disposable punch assembly, indicating it is a physical medical device with software control, not a software-only device.
Based on the provided information, the AI.ME™ system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fractional skin resurfacing." This is a procedure performed directly on the patient's skin for therapeutic or cosmetic purposes.
- Device Description: The device is described as a "micro coring device controlled by a robot that removes skin." This is a physical intervention on the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The AI.ME system does not perform any analysis on specimens.
- Anatomical Site: The anatomical site is "skin," indicating direct application to the body.
The AI.ME system is a medical device used for a dermatological procedure, not for diagnostic testing of biological samples.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The AI.ME System is indicated for fractional skin resurfacing.
Product codes
QAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
- 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.
- Accuracy of needle penetration depth and puncture rate: Accuracy of needle penetration depth and puncture rate was tested in a suitable skin substrate model and measured using the Keyence Laser System.
- Safety features built into the device to protect against cross-contamination & fluid ingress protection: The device design prevents cross contamination including fluid ingress protection due to the needle cartridge design. Design elements include serialized disposable assemblies that are entered into the system software prior to use, to prevent needle cartridge re-use and a sealed path to prevent fluid ingress. Testing was performed under worst case scenarios.
- Identification of the max safe needle penetration depth for the device & for the labeled indications for use: Maximum safe needle penetration depth was identified in a suitable skin substrate model. The needle depth is fixed at 3 mm and can not be adjusted thus eliminating the needle depth hazard.
- Sterility of the patient-contacting components of the device: Performance data demonstrates the sterility of the patient-contacting components of the device according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937.
- Shelf life of the device: Disposables are supplied non-sterile and are sterilized per a validated procedure prior to use. Materials are non-degradable and therefore a labeled shelf life is not required.
- Biocompatibility: The patient-contacting components of the device were demonstrated to be biocompatible including evaluation of cytotoxicity, irritation, and sensitization acute systemic toxicity and material-mediated an pyrogenicity per ISO 10993-1.
- Cleaning and disinfection instructions for reusable components of the device: A cleaning and disinfection validation was performed for reusable components of the device per AAMI TIR30.
- Pre-Clinical (Animal) Performance Data: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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.
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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.
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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 significant
differences to the predicate
device |
|-------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
name | Microneedling
Device For
Aesthetic Use | Microneedling Device
For 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 system
is indicated for
fractional skin
resurfacing. | The Cytrellis® Dermal
Micro-Coring™ System
is indicated for use by
medical professionals for
the treatment of
moderate and severe
wrinkles in the mid and
lower face in adults aged
22 years or older with
Fitzpatrick skin types I-
IV. | Similar
Both devices are used in
aesthetic procedures in
dermatology. Both devices
are for the treatment of skin.
The proposed indication
being sought in this 510(K)
is for fractional skin
resurfacing. Animal testing
and performance data
provided demonstrates that
the AI.ME System is safe
and effective for the
indication and intended use
described and does not pose
any undue or additional
risks. |
| Geometry | 6 hollow needles,
hexagon
arrangement | Single (1) needle or three
(3) hollow needles
arranged in a straight
line. Needles are ground
to 10-degree tip angle
resulting in two (2)
cutting services and two
(2) tips | Dissimilar
Animal testing similar to the
predicate device and non-
clinical performance testing
demonstrates that the AI.ME
device does not pose any
undue or additional risks and
is effective. |
| Product | AI.ME System
(Subject) | Ellacor System
(Predicate) | Similarities and significant
differences to the predicate
device |
| Maximum needle
penetration
(maximum needle
length) | Fixed 3 mm core
depth | Up to 4.0mm core
depth setting or 5mm
needle tip depth | Dissimilar
Animal testing similar to the
predicate device and non-
clinical performance testing
demonstrates that the AI.ME
device does not pose any
undue or additional risks and
is effective. |
| Needle protrusion
setting | Fixed 3 mm core
depth | 0-4.0mm core
depth setting or 1-
5mm needle tip
depth | Dissimilar
Animal testing similar to the
predicate device and non-
clinical performance testing
demonstrates that the AI.ME
device does not pose any
undue or additional risks and
is effective. |
| Percentage Tissue
Removal | Up to 10% | Up to 7.9% | Dissimilar
Animal testing similar to the
predicate device and non-
clinical performance testing
demonstrates that the AI.ME
device does not pose any
undue or additional risks and
is effective. |
| Treatment Protocol | At least 2 but no
more
than 3 treatments
spaced 4 weeks apart | At least 2 but no more
than 3 treatments
spaced 4 weeks apart | Identical |
| Delivery System | Robotic Arm with
punch assembly | Handheld instrument | Dissimilar
Animal testing similar to the
predicate device and non-
clinical performance testing
demonstrates that the
AI.ME device does not pose
any undue or additional
risks. |
| Needle Diameter | 0.74 mm |