The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.

Device Description

The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles. The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use. The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11.

AI/ML Overview

The provided text is a 510(k) summary for the SkinStylus SteriLock® MicroSystem. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed report of a clinical performance study with specific acceptance criteria and results.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the given text.

The document explicitly states: "A new clinical trial was not conducted to support the additional indications for use and overall safety of the device." (Page 5). This means the 510(k) submission relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a prospective study with human subjects designed to measure a specific level of clinical performance against pre-defined acceptance criteria.

The information provided covers:

Non-Clinical Test Reports: This section lists various tests performed (biocompatibility, sterilization validation, reprocessing validation, fluid ingress validation, shelf-life testing, electrical safety, depth penetration validation, needle reciprocal rate validation, clinician usability study). These are engineering and safety tests, not clinical performance studies with acceptance criteria for device efficacy in improving appearance.
Summary of Substantial Equivalence: This section compares the subject device to a predicate device (Collagen P.I.N. System) and a reference device (SkinStylus SteriLock® MicroSystem). The comparison focuses on technological characteristics like indications for use, mode of action, power source, needle length, geometry, speed, and safety features. The conclusion states that the device "raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device."

Without a clinical trial designed to establish efficacy against specific performance metrics, the other requested details such as sample size, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or cannot be extracted from this document.

Summary

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Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 28, 2023

Esthetic Medical Inc. % Marc Sanchez Regulatory Attorney Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave NW Suite 1025 Washington, District of Columbia 20006

Re: K231073

Trade/Device Name: SkinStylus SteriLock® MicroSystem, Model Number MP1209SL Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: May 12, 2023 Received: May 12, 2023

Dear Marc Sanchez:

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.

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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.

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.07.28
13:54:57 -04'00'

Mark Trumbore, 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

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Indications for Use

510(k) Number (if known)

Device Name SkinStylus SteriLock® MicroSystem

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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5. 510(K) Summary

The following information is provided as required by 21 CFR 807.92 for the SkinStylus SteriLock® MicroSystem 510(k) premarket notification.

Sponsor:	Esthetic Medical Inc.Attention: Lawrence Groop7950 E. Acoma Drive Suite 208Scottsdale, AZ 85260Establishment Registration: 3011338460
Manufacturer:	GUANGZHOU CARAIN BEAUTY EQUIPMENT103 & 601, No. 3 of Xin Liu Mu Road,Zhong Cun StreetGuangzhou Guangdong, CHINA 511495Establishment Registration: 3011568699
Contact:	Marc C. Sanchez, Esq.Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)1717 Pennsylvania Ave NW Suite 1025 Washington D.C. 20006Ph: 202.765.4491E-mail: msanchez@fdaatty.com)
Date of Submission:	July 28, 2023
Proprietary Name:	SkinStylus SteriLock® MicroSystem
Common Name:	Powered Microneedle Device

Regulation Number: 21 CFR 882.4810

Regulatory Class: Class II

Product Code: QAI

Predicate Device(s): Collagen P.I.N. (Percutaneous Induction Microneedling) System (K222199).

Device Description:

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Traditional 510k Submission SkinStylus SteriLock® MicroSystem

The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.

The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.

The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use.

The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge.

The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached.

Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy under report #GM2015012518. Certifications on file with sponsor and available for review.

Intended Use:

The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.

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Summary of Clinical Test Reports

A new clinical trial was not conducted to support the additional indications for use and overall safety of the device.

Non-Clinical Test Reports

The following tests were performed on the SkinStylus SteriLock® MicroSystem device and the test results show that the subject device is substantially equivalent to the predicate Device.

Test Completed	Standard
BiocompatibilityA	Cytotoxity - ISO 10993-5:2009
	Sensitization -ISO 10993-10:2010
	Irritation - Intracutaneous Injection Test GLP - ISO10993-10:2010
	Systemic Toxicity – Systemic Injection GLP - ISO10993-11:2017
	Pyrogenicity ISO 10993
	Metallurgical Analysis – GLP - ASTM E1019-11(Method A)(C/S Analyzer)
Sterilization ValidationB	Sterilization of Health Care Products - Moist heatISO 17665-1:2006
	Sterilization of Medical Devices ISO 11737-1: 2006
	Sterilization of Medical Devices ISO 11737-2: 2009
	Sterility and Bacteriostasis/Fungistasis Tests ISO11737-2: 2009 and USP 71
Reprocessing ValidationB	ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMITIR-12:2004)
Fluid Ingress ValidationB	SkinStylus Sterilock Microsystem LeakTesting Report from MicroChem Laboratories
Shelf-life TestingB	Standard Test Method for Seal Strength of FlexibleBarrier Materials ASTM F88/F88M-15
	Standard Test Method for Detecting Seal Leaks inPorous Medical Packaging by Dye PenetrationASTM F1929-15

Table 1 Summary of Non-Clinical Performance Testing

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	Standard Test Method for Microbial Ranking ofPorous Packaging Materials ASTM F1608-16
Electrical Safety and ElectromagneticCompatibilityC	IEC 60601-1-2 and 60601-1
Depth Penetration ValidationD	Internal Method - Depth Penetration Report
Needle Reciprocal Rate Validation	Internal Method - Needle Reciprocal Rate Report
Clinician Usability Study	Internal Method - Usability Report
A Mitigation measure for adverse tissue reaction.

B Mitigation measure for cross-contamination and infection.

C Mitigation measure for electrical shock or electromagnetic interference with other devices.

D Mitigation measure for Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to exceeding safe penetration depth or mechanical failure. **

**NOTE: The proposed device contains NO software

Summary of Substantial Equivalence

The SkinStylus SteriLock® MicroSystem and the predicate are for similar uses and rely on the same mode of action. Both devices include disposable needle cartridges with design features to mitigate the likelihood of cross-contamination between patients and to prevent needle depth greater than 2.5mm. Both devices also include a redundant safety feature to ensure no fluid enters the motor or housing.

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Table 2
Technological Characteristics

Technological Characteristics
DeviceName/Model	SkinStylus SteriLock®MicroSystemSubject Device	Collagen P.I.N.(Percutaneous InductionMicroneedling) SystemPredicate Device	SkinStylus SteriLock®MicroSystemReference Device	Comments
510(k)Number	K231073	K222199	K200044	N/A
Indication forUse	The SkinStylus SteriLock® MicroSystemis intended to be used as a treatment toimprove the appearance of surgical ortraumatic hypertrophic scars on theabdomen in adults aged 22 years or older.The SkinStylus SteriLock® MicroSystemis a microneedling device and accessoriesintended to be used as a treatment toimprove the appearance of facial acnescars in Fitzpatrick skin types I, II, and IIIin patients aged 22 years and older.	Intended to be used as atreatment to improve theappearance of facial acnescars in Fitzpatrick skintypes I-III in patientsaged 22 years and older	Intended to be used asa treatment to improvethe appearance ofhypertrophicabdominal scarring	Subject devicesame as predicatedevice
Mode ofAction	Microneedling (usingone or more needles tomechanically punctureand injure skin tissue foraesthetic use)	Microneedling (using oneor more needles tomechanically puncture andinjure skin tissue foraesthetic use)	Microneedling (usingone or more needles tomechanically punctureand injure skin tissue foraesthetic use)	Same
Power Source1	5 Volt DC/1 amprechargeablelithium-ion battery	5 Volt DC/1 amprechargeable lithium-ionbattery	5 Volt DC/1 amprechargeable lithium-ionbattery	Same
Power Source2	AC Adapter 5VC+/-, 1A minimum	AC Adapter 5VC +/-,1A minimum	AC Adapter 5VC+/-, 1A minimum	Same
Range ofNeedle Length	0.0-2.5mm	0.0mm-3.0mm	0.0-2.5mm	- Similar topredicate device-Needle penetrationof subject device is.5mm less thanpredicate devicewhich has beencleared to 3.0mm
MaximumPenetration	2.5mm	3.0mm	2.5mm	- Similar topredicate device-Needle penetrationof subject device is.5mm less thanpredicate devicewhich has beencleared to 3.0mm
NeedleGeometry	36 solid needles	36 solid needles	36 solid needles	Same
Speed	6200- 8840 RPM	7000 RPM-9000 RPM	6200- 8840 RPM	Negligibledifference in RPMDoes not impactthe safety orefficacy of thesubject device
CrossContaminationSafety Feature	Cartridge design andintermediate disinfectedhandpiece and noseconewith optional reprocessed(autoclave sterilized)nosecone;	Cartridge design andintermediate disinfectedhandpiece and noseconewith optional reprocessed(autoclave sterilized)nosecone;	Cartridge design andintermediate disinfectedhandpiece and noseconewith optionalreprocessed (autoclavesterilized) nosecone;	Same
Sterility andCleaning	Disposable cartridgeGamma Ray Sterilizedprior to packaging	Disposable cartridgeEthylene Oxide Sterilizedprior to packaging	Disposable cartridgeGamma Ray Sterilizedprior to packaging	Both devices useapproved methodsfor cartridgesterilization.Does not impactthe safety orefficacy of thesubject device

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Traditional 510k Submission

SkinStylus SteriLock® MicroSystem

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Traditional 510k Submission SkinStylus SteriLock® MicroSystem

Conclusion:

Therefore, taking into consideration Table 2 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the SkinStylus SteriLock® MicroSystem raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device. Further, the predicate device has been cleared for 3.0mm needle penetration, whereas the subject device (and already cleared reference device) has a maximum needle penetration of only 2.5mm.

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.