The Wolf Diode Lasers are a family of products with a laser diode as the beam source. Dependent on the chosen diode the laser system can radiate one wavelength with either 445nm, 980nm or 1470nm. This submission refers to and includes only one model, the Wolf 445nm.

The Wolf 445nm is a compact diode laser with a high resolution color touchscreen for user control. The laser utilizes a green (532nm) aiming beam diode to indicate the area to be irradiated by the laser beam.

AI/ML Overview

The provided document describes the FDA 510(k) summary for the "Wolf 445nm" diode laser system. This device is a laser surgical instrument, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices, not on proving new clinical effectiveness or diagnostic accuracy through AI performance studies.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and AI-specific metrics are not applicable to this type of regulatory submission. This document describes a medical device, but it is not an AI/ML medical device.

However, I can extract the information that is relevant to the device's performance demonstration.

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

For this type of device (a surgical laser), acceptance criteria are primarily related to safety and performance characteristics in comparison to established predicate devices. The "reported device performance" is demonstrated through non-clinical bench testing.

Acceptance Criterion (Implicit)	Reported Device Performance
Electrical Safety (Compliance with standards)	Wolf 445nm tested according to IEC 60601-1:2005 A1:2012 and /or EN 60601-1:2006/A1:2013.
Laser Safety (Compliance with standards)	Wolf 445nm tested according to IEC 60825-1: 2014 (edition 3.0) and IEC 60601-2-22:2007/A1:2012.
Usability (Compliance with standards)	Wolf 445nm tested according to IEC 60601-1-6:2010/A1:2013 and IEC 62366:20017, AMD1:2014.
Electromagnetic Compatibility (EMC) (Compliance with standards)	Wolf 445nm tested according to IEC 60601-1-2:2014, (edition 4.0).
Software Verification & Validation (Compliance with FDA Guidance)	Software verification and validation testing conducted, and documentation provided as recommended by FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate level of concern."
Tissue Interaction Equivalence (Safety & Effectiveness)	Comparison bench test between 445nm and 532nm laser devices demonstrated that the Wolf 445nm provides "as safe & effective performance data as a KTP Laser (532 nm) in terms of tissue interaction processes."
Cut Depth (Effectiveness)	Evaluated in histological samples. The document states the purpose was to demonstrate "as safe & effective performance data" in comparison to the predicate. Specific quantitative acceptance values are not provided, but the conclusion implies they were met.
Thermal Damage (Safety)	Evaluated in histological samples. The document states the purpose was to demonstrate "as safe & effective performance data" in comparison to the predicate. Specific quantitative acceptance values are not provided, but the conclusion implies they were met.

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

Sample Size for Test Set: Not explicitly stated in terms of number of tissue samples or specific test parameters. The document mentions "histological samples" were evaluated but does not provide details on the quantity. This was a bench test, not a clinical study involving human patients.
Data Provenance: The testing was "non-clinical" and involved "histological samples." No country of origin for the biological samples is provided. Given the manufacturer is German, it is likely the testing was conducted in Germany or a contracted lab. The testing is presumed prospective as part of the device development and submission process.

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)

The document does not specify the number or qualifications of experts who evaluated the histological samples. This is common for non-clinical bench testing where expert histological analysis is implied rather than formalized as a "ground truth" establishment for a clinical accuracy claim.

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

Not applicable/Not described. The non-clinical bench testing involved evaluating histological samples; there's no indication of a multi-reader or adjudication process as would be seen in a diagnostic imaging study.

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

No MRMC study was done. This is a laser surgical instrument, not an AI-powered diagnostic tool. The submission is for substantial equivalence to predicates for soft tissue applications.

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

Not applicable. This device is a physical laser system, not an algorithm.

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

For the non-clinical tissue interaction testing, the "ground truth" was established by histological evaluation of "areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage." This represents a form of pathology/histology-based assessment.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

Not applicable. As there is no training set mentioned, this question does not apply.

Summary

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March 17, 2020

A.R.C. Laser GmbH Angela Thyzel General Manager Bessemer St. 14 Nurnberg, 90411 De

Re: K192272 Trade/Device Name: Wolf 445nm 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: February 3, 2020 Received: February 10, 2020

Dear Angela Thyzel:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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,

Jessica Mavadia-Shukla, Ph.D. Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192272

Device Name Wolf 445nm

Indications for Use (Describe)

The Wolf 445nm is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters. Below that, the word "LASER" is in a white box. Underneath the box, the phrase "enlighten your surgery." is written in a cursive font.

510(k) Summary - K192272

Submitter:	A.R.C. Laser GmbHBessemer St. 1490411, NurnbergGermany
Contact person :PhoneFaxE-Mail:	Angela Thyzel, General Manager0911-21779-00911-21779-99a.thyzel@arclaser.de
DatePrepared:	March 6, 2020
Device TradeName:	Wolf 445nm
CommonName:	Diode Laser System
ClassificationName:	Laser surgical instrument for use in general and plastic surgery and indermatology
Device productcode:	GEX
DeviceClassification	21 CFR 878.4810
PredicateDevices:	Aura Laser System, K951034, Primary PredicateSiroLaser Blue, K180044, Reference Predicate

Device Description:

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Image /page/4/Picture/1 description: The image shows the logo for A.R.C. Laser. The logo is in a blue box with the text "A.R.C." in large, bold, white letters. Below that is the word "LASER" in smaller, white letters. Underneath the word laser is the company's slogan, "enlighten your surgery" in a cursive font.

510(k) Summary – K192272

Indications for Use: The Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Comparison of Technological Characteristics with the Predicate Devices

The primary predicate device is the Aura laser system (K951034), a KTP laser with a wavelength of 532nm with same intended use as the subject device.

The SiroLaser Blue, K180044, is a reference device, with the same intended use although is used for dental applications, shares the same wavelength, the same product code GEX, same device class and same classification name and number.

Specification	Subject DeviceWolf 445nm	Primary Predicate DeviceAura Laser System	Reference PredicateDevice SIROLaserBlue
510(k) #	K192272	K951034	K180044
Regulation #	878.4810	878.4810	878.4810
Class Code	GEX	GEX	GEX & ILY
Class	II	II	II
Indications forUse	The Wolf 445nm is intended for usein incision/excision, vaporization,ablation, hemostasis and coagulationof soft tissue	Aura XP is intended for use in inincision/excision, vaporization,ablation, hemostasis andcoagulation of soft tissue	SIROLaserBlue is intendedfor intra and extra oralsurgery including incision,excision, hemostasis,coagulation & vaporizationof soft tissue
Use of device	RX only	RX only	RX only
Laser type	Diode Laser	Flash Lamp Pulsed KTP Laser	Diode Laser
Laser power	0.5 W to 10 W	0.5 W to 15 W	0.2 W - 3.0 W
Wavelength	445 nm	532 nm	445 nm, 660 nm, 970 nm
Laser Class	4	4	4
Operationmode	Pulsed, Continuous Wave (CW) orSingle Pulse (SP)	Pulsed, Quasi continuous wave	Continuous wave (CW) orPulsed
Pulse length/duration	< 4 Watt: 1 ms to 45 sec and CW> 4 Watt: 1 ms to 60 ms	1 to 50 milliseconds in 1 msincrements, then .1 to 1 sec in0.1 increment, then .5 secincrements to continuous	10 µs to 0.99 sec.
Pulsefrequency	< 4 Watt: 0.01 Hz to 500 Hz and SP> 4 Watt: 0.02 Hz to 6.6 Hz and SP	0.5 Hz to 5 Hz	1 Hz to 10 kHz
Aiming beamwavelength	532 nm	635 nm	660 ± 5 nm
Aiming beampower	< 5 mW	5 mW	max. 1 mW

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Image /page/5/Picture/1 description: The image features the logo of A.R.C. Laser, set against a solid blue background. The acronym "A.R.C." is prominently displayed in large, bold white letters, positioned above the word "LASER," which is enclosed in a white box. Below the boxed word, the tagline "enlighten your surgery." is written in a cursive font, completing the logo's design.

Page 2 of 4 510(k) Summary - K192272

Specification	Subject DeviceWolf 445nm	Primary Predicate DeviceAura Laser System	Reference PredicateDeviceSIROLaserBlue
Use incombination	Delivery devicesoptical fibers 300 µm, 400 µm and600 µm with or without handpieces	Delivery devices - MultipleAura Fibers and accessoriesfor various applications	Delivery devices, fibers200 µm, 320 µm
Cooling	Air	Air	Air
Display	Touch screen	Buttons and regulators	Touch screen
Main powerSupply	100-240 V~, 47-63 Hz, 1.06-0.45 A	120 V AC/ 15 AMPS230 V AC/ 10 AMPS	15 V DC 6.66 A max.100 VA MPU101-106
Dimensionsof system	H 10.06 cm (3.9 inches)W 20.3 cm (7.9 inches)L 23.9 cm (9.4 inches)	H 41 cm (16 inches)W 30.5 cm (12 inches)L 58 cm (23 inches)	H 18.2 cm (7.1 inches)W 19.7 cm (7.7 inches)L 18.9 cm (7.4 inches)
Weight	2.8 kg (6.17 pounds)	27 kg (60 pounds)	1.3 kg (2.86 pounds)

Comparison of Technological Characteristics with the Predicate Devices (continuation)

Performance Data

The safety and effectiveness determination of the 445nm subject device compared to the primary predicate with wavelength 532nm is supported by the Electrical Safety, EMC, Software, and non-clinical comparison bench tests provided in the submission.

Non clinical testing :

A comparison bench test between 445 nm and 532 nm laser devices was conducted with the purpose of demonstrating that the Wolf 445 nm provides as safe & effective performance data as a KTP Laser (532 nm) in terms of tissue interaction processes.

The cut depth (effectiveness) and thermal damage (safety) zones of the 445nm laser device were used for the purpose of comparison.

Following the tests, histological samples were evaluated for areas of visible alteration of depth and width of the incision as well as zones of thermal and mechanical damage created by the tests.

Electrical Safety and EMC testing:

Electrical safety and EMC testing were conducted on the Wolf 445nm, consisting of Diode laser console and optical fibers.

The Wolf 445nm system has been tested for Electrical Safety according to IEC 60601-1:2005 A1:2012 and /or EN 60601-1:2006/A1:2013, for Laser Safety according to IEC 60825-1: 2014 (edition 3.0), for Safety of laser according to IEC 60825-1:2014 and IEC 60601-2-22:2007/A1:2012, for Usability with IEC 60601-1-6:2010/A1:2013 and IEC 62366:20017, AMD1:2014.

Electromagnetic Compatibility was tested according to IEC 60601-1-2:2014, (edition 4.0).

Software Verification and Validation Testing

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."

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Image /page/6/Picture/1 description: The image is a logo for A.R.C. Laser. The logo is set against a blue background. The text "A.R.C." is in large, bold, white letters, stacked above the word "LASER", which is also in white. Below "LASER" is the tagline "enlighten your surgery.", written in a smaller, italicized font.

Page 3 of 4

510(k) Summary - K192272

The software is considered as a moderate level of concern and the documentation was provided accordingly.

Summary

Based on the clinical performance, technological characteristics and performance data as documented in this submission, the Wolf 445nm was found to have a safety and effectiveness profile that is similar to the predicate devices.

Conclusion

The safety and effectiveness determination between the subject and the predicate devices is supported by the performance data provided in the submission, the electrical and EMC testing, the software verification and validation testing and the non-clinical bench test demonstrating that the Wolf 445nm performs comparably to the predicate device that is currently marketed for the same intended use.

Animal or clinical studies: None

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.