K Number

Device Name

MicroPen EVO

Manufacturer

Eclipse Medcorp LLC

Date Cleared

2021-11-24

(103 days)

Product Code

QAI OAI

Regulation Number

878.4430

Intended Use

The Eclipse MicroPen® EVO 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.

Device Description

The Eclipse MicroPen EVO™ is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedlingcartridge, a rechargeable battery pack, and a battery charger with power supply. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetrationcan be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by placing the MicroPen EVO battery pack on the Charger base.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K202243

Reference Devices

K203144

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical aspects of the microneedling device and does not mention any AI or ML components or functionalities.

Therapeutic

Yes.
The device is intended to "improve the appearance of wrinkles of the neck" and "improve the appearance of facial acne scars," which are therapeutic benefits aimed at treating or alleviating conditions.

Diagnostic

Explanation: The device is described as a microneedling treatment to improve the appearance of wrinkles and acne scars. Its function is to mechanically create microscopic punctures in the skin for therapeutic purposes, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description explicitly states it is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a rechargeable battery pack, and a battery charger with power supply, indicating it is a hardware device with physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the Eclipse MicroPen® EVO is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is 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 aesthetic purpose, not a diagnostic one.
Device Description: The description details a mechanical microneedling device that creates punctures in the skin. This is a physical intervention, not a method for examining specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in these samples
- Providing information for diagnosis, screening, or monitoring of diseases or conditions.

The device is a therapeutic/aesthetic device used directly on the patient's skin for cosmetic improvement.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

OAI

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neck, facial

Indicated Patient Age Range

adults with all Fitzpatrick skin types aged 22 years and older.

Intended User / Care Setting

Rx Only: Licensed healthcare practitioners or individuals directedby practitioners

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

Puncture rate; needle penetration depth and accuracy; needle retention; battery life; cartridge reliability, and suction prevention testing;
Fluid ingress testing for cross contamination prevention;
Cleaning and disinfection validation for reusable components;
Biocompatibility evaluation conducted in accordance with ISO 10993-1 on the final, finished microneedling cartridge: (1) Cytotoxicity (ISO 10993-5:2009); (2) Sensitization and (3) Irritation/Intracutaneous Reactivity (ISO 10993-10: 2010); (4) Acute Systemic Toxicity (ISO 10993-11:2017); (5) Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test. The results of these tests demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity.
Sterilization, Shelf Life/Package Integrity in accordance with the following standards:
Ethylene oxide sterilization per ISO 11135-2014; ISO 11737-2: 2009; ISO 11737-2: 2009; ISO 10993-7:2008
ASTM-F1980 Std Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM-F1886-2016 Std Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection;
ASTM-F1929-2015 Std Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM-F88 Std Test Method for Seal Strength of Flexible Barrier Materials; ANSI/AAMI/ISO 11607-1: 2006(R) 2010/ A1-2014, Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier System and Packaging Systems
Electrical Safety and Electromagnetic Compatibility: IEC- 60601-1:2005 + A1: 2012 Medical electrical equipment– Part 1: General Requirements for Basic Safety and Essential Performance
EN/IEC 60601-1-2: 2015 /IEC 60601-1-2:2014–Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirement and tests
These tests support substantial equivalence and demonstrate the MicroPen EVO can perform its intended function.

Key Metrics

Not Found

Predicate Device(s)

K202243

Reference Device(s)

K203144

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 24, 2021

Eclipse Medcorp LLC Julie Summerville Senior Director of Product Management 5916 Stone Creek Drive The Colony, Texas 75056

Re: K212558

Trade/Device Name: MicroPen EVO Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: OAI Dated: September 1, 2021 Received: September 2, 2021

Dear Julie Summerville:

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

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,

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

Indications for Use

510(k) Number (if known) K212558

Device Name

MicroPen® EVO

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 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."

| 510(k) Summary
[This 510(k) Summary is submitted in accordance with 21 CFR Part

807.92(c)]
Submitted by:	Eclipse Medcorp, LLC.
5916 Stone Creek Dr.
Suite 120
The Colony, TX
75056	Contact Person:
Julie Summerville
Senior Dir of Product
Management972-380-2911 x
2405
jsummerville@eclipsemed.com
Date Prepared:	November 3, 2021
Trade Name:	MicroPen EVO™
Common Name:	Powered Microneedling Device
Product Code; Regulation Name & No:	QAI
Microneedling device for aesthetic use	21 CFR §878.4430

Device Description:

Indications for Use:

Predicate Device:

The Eclipse MicroPen EVO predicate device is the SkinPen Precision System by Crown Aesthetics (formerly Bellus Medical), K202243.

Reference Device:

The Eclipse MicroPen EVO K203144 is a reference device for the Eclipse MicroPen EVO that is subject to this submission.

| Technological Characteristics Comparison

Chart
	Subject device
Eclipse MicroPen EVO	Predicate
SkinPen Precision
System	Comparison
510(k)	K212558	K202243	NA
Manufacturer	Eclipse MedCorp LLC	Crown
Aesthetics	NA
Trade Name	MicroPen EVO™	SkinPen® Precision System	NA
Product Code	QAI	QAI	Same
Regulation #	21 CFR Part 878.4430	21 CFR Part 878.4430	Same
Reg Name	Microneedling device for
aesthetic use	Microneedling device for
aesthetic use	Same
Device Class	Class II	Class II	Same
Indication for use /
Intended use	The Eclipse MicroPen® EVO 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
Intended Users	Rx Only: Licensed healthcare
practitioners or individuals
directedby practitioners	Rx Only: licensed healthcare
practitioners or individuals
directedby practitioners	Same
Use Location	Face	Face	Same
Power Source
(Pen Body)	Rechargeable Li-ion battery	Rechargeable Li-ion battery	Same
Power Source
(Battery Charger)	AC Powered	AC Powered	Same
Control Mechanism	Microprocessor; embedded
software	Microprocessor; embedded
software	Same
Control Mechanism	Microprocessor; embedded
software	Microprocessor; embedded
software	Same
Operating Principle	Rotary	Rotary	Same
Single Speed(RPM)	6300-7700	6300 - 7700	Same
Puncture Rate	105-128 stamps/second	105-128 stamps/second	Same
Microneedling
Cartridge	Sterile, Single Use	Sterile, Single Use	Same
No. of Needles	14	14	Same
Needle Gauge	32 Ga	32 Ga	Same
Needle Material	Stainless Steel	Stainless Steel	Same
Needle Shape
Geometry	Straight, cylindrical body with a
conical tapered, sharp point	Straight, cylindrical body with
aconical tapered, sharp point	Same
Arrangement	Needles radially arranged	Needles radially arranged	Same
Needle Spacing	2 mm spacing/3.48 mm² per
needle	2 mm spacing/3.54 mm² per
needle	Equivalent:
subject device
has a slightly
smaller total
surface area of
the hub. No
affect to
geometry,
puncture pattern,
needle stamp.
Penetration Depth	1.5 mm (Recommended)	1.5 mm (Recommended)	Same
Max Needle Depth
Setting	2.25 mm	2.5 mm	Different: Not
significant;
treatment depth
is 1.5 mm for
both devices.
Penetration Depth
Selection	9 depth settings; 0 mm to 2.0
mm in 0.25 mm increments	11 depth settings; 0 mm to 2.5mm in 0.25 mm increments	Similar
Sterility
(cartridge)	Ethylene Oxide	Ethylene Oxide	Same
Shelf Life
(Cartridge)	2 years	2 years (min)	Same
Barrier: Cross-
Contamination	MicroSleeve Sheath(Disposable)	BioSheath (Disposable)	Same

Technological Characteristics and Comparison to Predicate:

Performance Data:

In combination with the general controls of the FD&C Act, the Eclipse MicroPen EVO™ microneedling device for aesthetic use has been subjected to performance testing and adheres to the following special controls and standards:

Puncture rate; needle penetration depth and accuracy; needle retention; battery life; cartridge reliability, and suction prevention testing;
Fluid ingress testing for cross contamination prevention;
Cleaning and disinfection validation for reusable components;
Biocompatibility evaluation conducted in accordance with ISO 10993-1 on the final, finished microneedling cartridge: (1) Cytotoxicity (ISO 10993-5:2009); (2) Sensitization and (3) Irritation/Intracutaneous Reactivity (ISO 10993-10: 2010); (4) Acute Systemic Toxicity (ISO 10993-11:2017); (5) Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test. The results of these tests demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity.
Sterilization, Shelf Life/Package Integrity in accordance with the following standards:
- o Ethylene oxide sterilization per ISO 11135-2014; ISO 11737-2: 2009; ISO 11737-2: 2009; ISO 10993-7:2008
- o ASTM-F1980 Std Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM-F1886-2016 Std Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection;
- o ASTM-F1929-2015 Std Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- o ASTM-F88 Std Test Method for Seal Strength of Flexible Barrier Materials; ANSI/AAMI/ISO 11607-1: 2006(R) 2010/ A1-2014, Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier System and Packaging Systems
Electrical Safety and Electromagnetic Compatibility: IEC- 60601-1:2005 + A1: 2012 Medical electrical equipment– Part 1: General Requirements for Basic Safety and Essential Performance
EN/IEC 60601-1-2: 2015 /IEC 60601-1-2:2014–Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirement and tests

Substantial Equivalence:

The MicroPen EVO is substantially equivalent to the Crown Aesthetics SkinPen®Precision System predicate device. The devices are under the same product code (QAI), both have the same intended use/ indication for use, same number of needles, gauge, shape and arrangement, same material, recommended penetration depth, speed, puncture rate and sterilization method. The only technological differencesare the maximum needle depth setting: the MicroPen EVO is 0.5 mm shorter (2.0 mm) than the predicate (2.5 mm); and the penetration depth selection: the MicroPen EVO has 9 depth settings (0-2.0 mm in 0.25 mm increments) and the predicate device has 11 depth settings (0-2.5 mm in 0.25 mm increments). These differencesare minor and are not significant since both devices recommend the same treatment depth (1.5 mm).

There is a small and insignificant difference between the subject and predicate in total surface area of the hub, however theneedle spacing is the same (2 mm) and there is no effect on geometry, puncture pattern, needle stamp. These minor differences do not raise new questions of safety and effectiveness. Further, the results of performance testing support substantial equivalence of the Eclipse MicroPen EVO to the predicate device and demonstrate the MicroPen EVO can perform its intended function.

Conclusion:

The Eclipse MicroPen EVO is considered to be substantially equivalent to the predicate device based on the intended use, technological characteristics, and the results of device testing submitted.