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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the SkinPen® Precision Elite System. It details the device, its intended use, and comparison to a predicate device. However, it explicitly states "No Clinical testing was conducted as part of this submission" (Section 12, page 6).

Therefore, there is no information within this document to address the requested points regarding acceptance criteria and a study proving the device meets those criteria, as no clinical study was performed for this submission. The device's substantial equivalence was based on non-clinical performance testing (reciprocating rate, puncture depth), electrical safety, risk management, sterility, software verification and validation, and biocompatibility, along with a direct comparison to a predicate device.

To answer your request, if a clinical study had been performed and described in the document, here's what the response would look like if the information were present:

Based on the provided 510(k) summary, no clinical performance study was conducted to demonstrate the device meets specific acceptance criteria based on human subject data. The submission relies on substantial equivalence to a predicate device and non-clinical testing.

Therefore, I cannot provide the detailed information requested in points 1 through 9.

Explanation from the document:

Section 12 "Clinical Testing Summary" (Page 6): "No Clinical testing was conducted as part of this submission."

The acceptance criteria and study detailed in your request typically refer to clinical performance studies, which were not performed for this device's submission as stated. The changes made to the device (user interface, cartridge connection points, NFC chip for verification) were supported by:

Non-clinical performance testing (reciprocating rate, puncture depth).
Software verification and validation.
Electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6).
Biocompatibility testing (ISO 10993-1).
Sterility standards (ISO 11135).
Risk Management (IEC 62304).

The submission argues that these changes "do not impact the device effectiveness, and safety is increased with the use of the NFC chip," and that "There are no changes to the general technology, mechanism of action, or indications for use." This forms the basis for demonstrating substantial equivalence without a new clinical study.

Summary

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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.

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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

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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241400

Device Name

SkinPen Precision Elite System

Indications for Use (Describe)

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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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

1. Official Correspondent: Marie Fogartie, Sr. Director of Regulatory Affairs Phone: 423-630-2296 Email: mfogartie@crownlaboratories.com
1. Submission Type: Traditional 510(k)
1. 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

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 DeviceK220506	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 DeviceK220506	Comparison
Trade Name	SkinPen® PrecisionElite System	SkinPen® PrecisionSystem	Same
Classification Name	Microneedling devicefor aesthetic use	Microneedling devicefor 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 andover	Adults age 22 andover	Same
Target User	Healthcareprofessionals trainedin use of the device	Healthcareprofessionals trainedin 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 usedin the clinical study	2.5mm	2.5mm	Same
Frequency	105-128.3 Hz	105-128.3 Hz	Same
Puncture rate	1470-1797punctures/sec	1470-1797punctures/sec	Same
User Interface	LCD screen andOn/Off button	On/Off button	Different. The newLCD screen allowsusers to see whetherthe cartridge iscorrectly installedand verify that thecartridge is not beingre-used. SoftwareVerification andValidation wasperformed for thissoftware change. Thisfunction does notimpact safety orefficacy of the device.
Cartridgeauthentication/verification	NFC Chip	Manual lock out	Different. Cartridgesnow can beauthenticated with anNFC chip. Thisfunction does notimpact safety orefficacy of the device.

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10. Technological characteristics comparison:

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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.

Regulation Number and Section

§ 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.