Dermablate System with its accessories is indicated for coagulation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Device Description

Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The device can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).

AI/ML Overview

This document, a 510(k) Premarket Notification summary for the Dermablate laser system, primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) cannot be extracted directly from this document.

The document outlines that "Dermablate passed all the required testing and is in compliance with all applicable sections of the abovementioned performance standards," which implies that the device did meet acceptance criteria related to these standards, but the specific performance results or acceptance thresholds are not detailed.

Here's an analysis of the information available:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of specific acceptance criteria (e.g., target energy output with an allowable deviation) and the device's reported performance against these criteria. Instead, it lists harmonized standards that the device passed. Compliance with these standards is the reported performance in this context, demonstrating that the device meets safety and electromagnetic compatibility requirements, among others.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described (performance testing, software V&V, biocompatibility) typically involves engineering tests, hardware verification, and software validation rather than patient-level clinical studies with test sets in the context of AI/diagnostic devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The Dermablate is a laser surgical instrument, and its performance evaluation documented here revolves around technical and safety specifications rather than diagnostic accuracy established by expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. As explained in point 3, the evaluation of this device does not involve expert adjudication of a test set in the way a diagnostic AI would.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable here. The Dermablate is a therapeutic laser device, not a diagnostic AI system designed to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to a therapeutic laser device. The device's function is direct treatment, not an algorithmic standalone performance for diagnosis or image analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not detail "ground truth" in the context of clinical outcomes or diagnostic accuracy. For a laser device, "ground truth" would relate to its physical output parameters (wavelength, energy, fluence, etc.) matching specifications, and its safety compliance with international standards. The document states that the device "passed all the required testing and is in compliance with all applicable sections of the above-mentioned performance standards," implying that these standards' requirements serve as the "ground truth" for technical and safety performance.

8. The sample size for the training set

This information is not applicable/provided. The Dermablate is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable/provided. As above, the device does not use a training set.

Summary of available information regarding compliance and efficacy (as per the document):

The document focuses on demonstrating substantial equivalence of the modified Dermablate device (increased max pulse energy to 3J and addition of a "DeepSpot" microbeam handpiece) to its predicate devices (MCL 31 Dermablate and Erise). The "study" proving the device meets acceptance criteria is implied through its successful passage of various harmonized standard tests and software verifications and validations.

The key statement is: "Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards." and "Dermablate passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."

The listed standards that the device passed are:

IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment Part 1: General requirements for safety and essential performance
IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 62304: Medical Device Software – Software life cycle processes
IEC 62366-1:2015: Medical devices – Application of usability engineering to medical devices
IEC 60601-2-22:2019: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60825-1:2014: Safety of laser products - Part 1: Equipment classification, and requirement
ISO 14971: Medical devices - Application of risk management to medical devices
FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for software V&V)
EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation

The "acceptance criteria" are compliance with these standards, and the "reported device performance" is that it did comply. The document does not elaborate on the specific test results or the criteria defined within each standard that the device had to meet (e.g., maximum electromagnetic emissions or specific laser output tolerances).

Summary

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July 3, 2024

Asclepion Laser Technologies GmbH Tom Gruender RA Manager Bruesseler Strasse 10 Jena, 07745 Germany

Re: K241600

Trade/Device Name: Dermablate Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: April 23, 2024 Received: June 4, 2024

Dear Tom Gruender:

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 (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/cdrb/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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/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,

	Digitally signed by
TANISHA	TANISHA L. HITHE -
L. HITHE -S	Date: 2024.07.03

	10:25:21 -04'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & 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) K241600

Device Name Dermablate

Indications for Use (Describe)

Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

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) Summa K2416

Applicant /Manufacturer	Asclepion Laser Technologies GmbH
Name and Address:	Bruesseler Strasse 10, 07745 Jena - Germany
510(k) Contact Person:	Mr. Tom GruenderRegulatory Affairs ManagerTel.: 0049 3641 7700 201E-Mail: tom.gruender@asclepion.com
Date Prepared:	July 2, 2024
Trade Name:	Dermablate
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Main Predicate Device	MCL 31 Dermablate (K210634), Asclepion Laser TechnologiesGmbH
Reference Device	Erise (K202258), El.En SpA

Description of the device:

Description of the modifications:

The laser is a modification to previously cleared MCL 31 Dermablate due the following main technical modifications:

Increase of max pulse energy to 3J.
Adding of a microbeam handpiece named "DeepSpot".

Hardware and software changes were implemented to accommodate the changes mentioned above.

The modified device has the same intended use of the unmodified device. Moreover, the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

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Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.

Intended Use:

Dermablate with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

Dermablate, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

	MainPredicate Device	ReferencePredicate Device	Subject device
	MCL 31 Dermablate	Erise	Dermablate
510k number	K210634	K202258
Device Type	Er:YAG	Er:YAG	Er:YAG
Wavelength	2940 nm	2940 nm	2940 nm
Energy, max	2.5 J	31	3 J
Fluence, max.	Up to 250 J/cm2 (nonmicrobeam mode)Up to 150 J/cm2(microbeam mode withstacking pulses)	Up to 95 J/cm2 (nonmicrobeam mode)Up to 121 J/cm2(microbeam mode withstacking pulses)	Up to 250 J/cm2 (nonmicrobeam mode)Up to 150 J/cm2(microbeam mode withstacking pulses)
Pulse Duration	0.1 to 1ms	0.3 to 1.5ms	0.1 to 1ms
Repetition rate,max	20 Hz	6Hz	20 Hz
Treatment area /Spot size	VarioTEAM Handpieces:from 1 to 12 mm	2/4/9mm	VarioSpot Handpieces:from 1 to 12 mm
	MicroSpot Handpiece:350 µm to 600 µm spotMY JULIET Handpiece:425 µm & 600 µm spot	300-600 µm microdotdiameter	MicroSpot Handpiece:350 um to 600 um spotDeepSpot Handpiece:325 um to 400 um spot
			MY JULIET Handpiece:425 µm & 600 µm spot

Technological Characteristics Comparison

Non clinical Performance Data:

The following performance data were applied in support of the substantial equivalence determination:

IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment Part 1: General requirements for . safety and essential performance

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. IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 62304: Medical Device Software – Software life cycle processes
IEC 62366-1:2015: Medical devices – Application of usability engineering to medical devices
IEC 60601-2-22:2019: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
IEC 60825-1:2014: Safety of laser products - Part 1: Equipment classification, and requirement
ISO 14971: Medical devices - Application of risk management to medical devices
. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing
within a risk management process
. ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin
sensitization
. ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation

Dermablate passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards.

Biocompatibility:

The biocompatibility of Dermablate handpieces is established based on the predicate devices.

Comparison with predicate device:

The subject and predicate devices have intended use and the same fundamental scientific technology. Any minor difference does not raise concern about safety and effectiveness.

Conclusions

The differences in the indications for use and technological characteristics between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.