(104 days)
K220506 SkinPen Precision System
Not Found
No
The summary describes a mechanical microneedling device and its accessories, with no mention of AI, ML, image processing, or data-driven algorithms.
No
Therapeutic devices are primarily used to treat a disease, injury, or condition to restore health or improve function. While the appearance of wrinkles and acne scars can be improved with this device, these are cosmetic concerns rather than medical conditions that need to be "treated" in the traditional therapeutic sense.
No
The device is described as a microneedling system intended for cosmetic treatments to improve the appearance of wrinkles and acne scars, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a microneedling pen handpiece, a sterile needle cartridge, a charging base, and a BioSheath, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck... and to improve the appearance of facial acne scars". This describes a therapeutic or cosmetic treatment applied directly to the patient's skin.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. The SkinPen Precision Elite System does not involve testing samples from the body.
- Device Description: The description details a microneedling pen, needle cartridge, charging base, and sheath. These are all components of a device used for a physical procedure on the body, not for analyzing biological samples.
Therefore, the SkinPen Precision Elite System falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SkinPen® Precision Elite system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 vears and older.
Product codes (comma separated list FDA assigned to the subject device)
QAI
Device Description
The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neck and facial
Indicated Patient Age Range
adults with all Fitzpatrick skin types aged 22 years and older.
Intended User / Care Setting
Healthcare professionals trained in use of the device / Clinical
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)
No Clinical testing was conducted as part of this submission.
Performance testing was conducted on the cartridge's reciprocating rate to ensure that it operates as intended. Testing was also conducted to verify puncture depth of the needle.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K220506 SkinPen Precision System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 29, 2024
Crown Aesthetics Marie Fogartie Sr. Director of Regulatory Affairs 5005 Lyndon B. Johnson Frwy. Suite 370 Dallas, Texas 75244
Re: K241400
Trade/Device Name: SkinPen Precision Elite System Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: August 1, 2024 Received: August 1, 2024
Dear Marie Fogartie:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/7 description: The image shows the name "Julie A. Morabito -S" in a simple, sans-serif font. The name is arranged vertically, with "Julie A." on the top line and "Morabito -S" on the bottom line. The text is black against a white background, making it easily readable.
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
SkinPen Precision Elite System
Indications for Use (Describe)
The SkinPen® Precision Elite system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 vears and older.
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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4
510(K) SUMMARY
Date Prepared: May 1, 2024
1. Submitter and Owner:
Bellus Medical LLC, dba Crown Aesthetics 5005 Lyndon B. Johnson Freeway, Suite 370 Dallas, Texas 75244, USA
-
- Official Correspondent: Marie Fogartie, Sr. Director of Regulatory Affairs Phone: 423-630-2296 Email: mfogartie@crownlaboratories.com
-
- Submission Type: Traditional 510(k)
-
- Proprietary Name: SkinPen® Precision Elite System
5. Device Classification Information:
Classification Name: Microneedling Device for Aesthetic Use Regulation Number: 878.4430 Product Code: QAI Device Class: 2
6. Predicate Device: K220506 SkinPen Precision System
7. Device Description
The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.
8. Indications/Intended use:
The SkinPen® Precision Elite System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.
9. Indications for Use Comparison:
| | Subject Device | Predicate Device
K220506 | Comparison |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The SkinPen® Precision Elite System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. | The SkinPen® Precision System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older. | Same. |
| Characteristic | Subject Device | Predicate Device
K220506 | Comparison |
| Trade Name | SkinPen® Precision
Elite System | SkinPen® Precision
System | Same |
| Classification Name | Microneedling device
for aesthetic use | Microneedling device
for aesthetic use | Same |
| Classification | 2 | 2 | Same |
| Product Code | QAI | QAI | Same |
| Regulation No. | 878.4430 | 878.4430 | Same |
| Prescription Use | Yes | Yes | Same |
| Target Population | Adults age 22 and
over | Adults age 22 and
over | Same |
| Target User | Healthcare
professionals trained
in use of the device | Healthcare
professionals trained
in use of the device | Same |
| Environment | Clinical | Clinical | Same |
| Treatment Area | Face and Neck | Face and neck | Same |
| Shape of needle cartridge | Round | Round | Same |
| Use of needle cartridge | Sterile, single use | Sterile, single use | Same |
| Needles | 14 total | 14 total | Same |
| Needle Protrusion settings | 0–2.5 mm | 0–2.5 mm | Same |
| Max. Needle Length used
in the clinical study | 2.5mm | 2.5mm | Same |
| Frequency | 105-128.3 Hz | 105-128.3 Hz | Same |
| Puncture rate | 1470-1797
punctures/sec | 1470-1797
punctures/sec | Same |
| User Interface | LCD screen and
On/Off button | On/Off button | Different. The new
LCD screen allows
users to see whether
the cartridge is
correctly installed
and verify that the
cartridge is not being
re-used. Software
Verification and
Validation was
performed for this
software change. This
function does not
impact safety or
efficacy of the device. |
| Cartridge
authentication/verification | NFC Chip | Manual lock out | Different. Cartridges
now can be
authenticated with an
NFC chip. This
function does not
impact safety or
efficacy of the device. |
5
10. Technological characteristics comparison:
6
510(K) SUMMARY
11. Non-clinical performance testing
Performance testing was conducted on the cartridge's reciprocating rate to ensure that it operates as intended. Testing was also conducted to verify puncture depth of the needle.
12. Clinical Testing Summary
No Clinical testing was conducted as part of this submission.
13. Electrical Safety, Risk Management, Sterility and Software
The SkinPen® Precision Elite System was developed and tested according to the following standards:
IEC 60601-1 Edition 3.2 2020-08 IEC 60601-1-2 Edition 4.1 2020-09 ISO 10993-1 Fifth edition 2018-08 IEC 62304 Edition 1.1 2015-06 ISO 11135 Second edition 2014-07-15 IEC 60601-1-6 Edition 3.2 2020-07
14. Biocompatibility
All patient contacting components of the SkinPen® Precision Elite System have been tested according to ISO 10993-1:2018 and are considered biocompatible.
15. Statement of Substantial Equivalence
The SkinPen® Precision Elite System, the subject device for this submission, is very similar to the predicate device, the SkinPen® Precision System. Changes to the user interface, cartridge connection points, and the addition of an NFC chip for cartridge verification do not impact the device effectiveness, and safety is increased with the use of the NFC chip. There are no changes to the general technology, mechanism of action, or indications for use. Changes to the device are supported through software verification and validation, IEC, biocompatibility, and usability testing, Therefore, the two devices can be considered substantially equivalent.