The Legend X Desktop System and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

It is also intended for use in dermatologic and general surgical procedures for non-invasive treatment when using RF Energy and for muscle conditioning to stimulate healthy muscles (TriPollar Applicator).

Legend X Desktop System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Legend X Desktop System is intended to be operated by a licensed health care practitioner who is present to monitor treatment.

Device Description

The Legend X Desktop System ("Proposed Device") is a software-controlled capital equipment system that enables application of radiofrequency energy onto the skin for ablation, resurfacing, or noninvasive treatment or muscle activation pulses. The application of radiofrequency energy or muscle activation pulses only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the console, applicator indicators and subsequent operation.

The proposed device consists of a console with connected applicators, and applicator accessories (disposable tips) needed to perform some of Legend X Desktop dermatological and general surgical procedures. The summary descriptions of each component are outlined below.

Legend X Desktop Console: The Legend X Desktop Console (also known as the Console or Main Control Unit) contains the graphic display interface for the user that is provided by a touchscreen monitor for viewing and a computer running the Legend X Desktop software. The monitor allows for user input during initial setup and throughout the session. The console also provides power and connectivity for the applicators.

Legend X Desktop Applicators: The Legend X Desktop Applicators (TriPollar and VO) are handheld handpieces which deliver energy to the treatments area. Depending on the applicator and selected user inputs, the user can utilize the applicators to deliver either muscle energy onto the muscles of the face and body or RF energy for ablation and resurfacing or noninvasive treatment onto the skin. Each applicator is connected to the console via an applicator connector cord.

Legend X Desktop Software: The Legend X Desktop software provides the user and patient with the ability to safely commence, drive, and stop the operation of the applicators on the skin or muscle area of interest throughout the face and body. It receives user input from the subject console to compute the appropriate output via the chosen applicator connected to the console. It provides a graphical user interface where the treatment timeline as well as status of operation is shown in real time and displays important system status information.

Legend X Desktop Disposable Tip Accessories: The Legend X Desktop disposable tips set is part of the Legend X Desktop Applicator VO kit. The Disposable Tips Set includes:

. gen12 disposable tip,
gen36 disposable tip,
. gen36L disposable tip,
gen100 disposable tip, and
H7X7 disposable tip

The patient contacting portions of the disposable tips are constructed of stainless steel and gold plating. The disposable tips are connected to handheld Applicator VO for delivery of RF energy via an array of multi-electrode pins onto the skin surface.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the "Legend X Desktop System," a medical device for dermatological and general surgical procedures. My task is to extract information related to acceptance criteria and the study proving the device meets these criteria.

However, the document does not contain information about studies measuring the performance of the device against specific acceptance criteria in a clinical context (e.g., accuracy, sensitivity, specificity, or effects on human readers). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Legend X Platform, K232903) and compliance with various regulatory and performance standards.

The "Performance Data" section (Section 5.4) lists the types of testing performed:

Cleaning and Sterilization Validation: Per AAMI TIR-30, ISO 11135, ISO10993-7, ASTM F1980-16, ASTM F 1929-15, ASTM F88/F88M-15, and ISO 11607.
Biocompatibility Testing: Per ISO 10993-1 and FDA guidance.
Electrical Safety, Performance, and EMC: Per IEC 60601 series standards.
Software Verification and Validation (V&V): Per FDA guidance "Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
V&V Functional Testing: To verify overall functionality, safety features, and adherence to regulatory standards.
Animal Testing: Per "General Considerations for Animal Studies Intended to Evaluate Medical Devices."

These are "performance data" in the context of demonstrating safety and fundamental functional equivalence, not clinical effectiveness studies with specific performance metrics (like sensitivity/specificity for AI, or human reader improvement). The document explicitly states: "The testing identified no new issues of safety or effectiveness." This implies the acceptance criteria are largely based on compliance with existing standards and performance comparable to the predicate device, rather than novel clinical performance endpoints.

Therefore, I cannot populate the requested table or answer most of the specific questions as the document does not contain the type of AI/diagnostic study data implied by the prompt.

Here's what can be extracted based on the provided document, addressing the prompt's implied context as best as possible:

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

Since this is a 510(k) for a physical medical device (electrosurgical and muscle stimulation) and not an AI/diagnostic software, the "acceptance criteria" are primarily related to safety, functionality, and equivalence to a predicate, rather than typical AI performance metrics like accuracy.

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance
Overall Equivalence	Device is substantially equivalent to the predicate (Legend X Platform, K232903) in terms of safety, efficacy, and performance for the requested indications for use, and raises no new questions of safety and effectiveness.	Concluded that the Legend X Desktop System "raises no new questions of safety and effectiveness as compared to the predicate and reference devices and is substantially equivalent to the predicate in terms of safety, efficacy, and performance for the requested indications for use." (Section 5.8)
Functional Performance	Operates as specified by the design input requirements, including applicator and controls, various functional safety features, and other general functionality. Adherence to regulatory standards.	V&V Testing: "Results of verification testing confirm that the proposed device conforms to design specifications and requirements and meets the needs of the intended user." (Section 5.4)
Cleaning & Sterilization	Non-disposable components' cleaning and disinfection instructions validated. Single-use disposable sterile devices and EO residual validated. Shelf life and sterile barrier packaging evaluated.	"The cleaning and disinfection instructions provided in labeling for non-disposable components were validated as per AAMI TIR-30. Single-use disposable sterile (EO) devices and EO residual were validated in accordance with ISO 11135 and ISO10993-7. The shelf life and sterile barrier packaging of the single-use disposable devices were evaluated per ASTM F1980-16, ASTM F 1929-15, ASTM F88/F88M-15, and ISO 11607." (Section 5.4)
Biocompatibility	Patient-contacting components evaluated and validated.	"Biocompatibility for patient contacting components has been evaluated and validated in accordance with the provision of the following FDA Guidance document... and applicable ISO 10993 standards." (Section 5.4)
Electrical Safety / EMC	Complies with relevant electrical safety and electromagnetic compatibility standards.	"The subject device has been fully evaluated for electrical safety and EMC compliance to IEC 60601 series standards." (Section 5.4)
Software	Developed, tested, and verified according to FDA guidance for software in medical devices. Design specifications are met, and needs of intended users are fulfilled.	"Software was developed, tested, and verified per the FDA guidance document: Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and results of verification and validation testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users." (Section 5.4)
Animal Testing	Conducted according to FDA guidance for animal studies.	"Performance testing animal testing was executed according to General Considerations for Animal Studies Intended to Evaluate Medical Devices issued on March 28, 2023." (Section 5.4)
System Specifications	RF energy emission per pin, maximum pulses per tip, and modes of operation (Low, Medium, High) are same as predicate. Applicators and accessories, control/user interface, system weight and dimensions are within acceptable range for substantial equivalence, with differences not introducing new questions of safety or effectiveness. (Implied from Comparison Table, Section 5.6).	Reported values for these parameters are identical or appropriately justified as equivalent to the predicate, as detailed in Section 5.6. The desktop console being "miniature" and lighter is stated not to introduce any new safety/effectiveness questions.

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

This document does not describe a "test set" in the context of a clinical performance study with human subjects (or images/data from them) to measure specific endpoints like accuracy for AI.
The "testing" mentioned pertains to engineering verification and validation (V&V), biocompatibility, electrical safety, etc., which involve laboratory tests, material analysis, and potentially animal studies, not a "test set" of patient data for evaluating a diagnostic or AI algorithm's performance.
No information on country of origin or retrospective/prospective nature of data for such a clinical "test set" is provided because that type of study was not conducted or reported here.

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)

Not applicable. There is no mention of "ground truth" establishment by experts for a clinical performance test set in this 510(k) submission.

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

Not applicable. No "test set" or adjudication process described.

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

Not applicable. This device is an electrosurgical cutting and coagulation device and a powered muscle stimulator. It does not appear to be an AI-driven diagnostic or image analysis tool that would be used by "human readers" to interpret cases.

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

Not applicable. The device is a physical system with user controls, not a standalone algorithm. The software component described manages the device's operation.

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

Not applicable. As noted above, there's no clinical "ground truth" as would be established for an AI or diagnostic device performance study. The "ground truth" for this device's safety and effectiveness is primarily established through compliance with recognized standards, engineering principles, and demonstration of substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. This document does not describe an AI / machine learning component that requires a "training set" of data for learning. The software mentioned is for controlling the device's operation, not for diagnostic or predictive purposes based on learned patterns from large datasets.

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

Not applicable. See point 8.

Summary

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November 1, 2024

Pollogen Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive. Suite 510k Saint Paul, Minnesota 55114

Re: K243217

Trade/Device Name: Legend X Desktop System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, NGX Dated: October 3, 2024 Received: October 3, 2024

Dear Prithul Bom:

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/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.

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"

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(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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.

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).

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Sincerely,

Digitally signed by Long H. Chen Long H. Chen-S Date: 2024.11.01 13:53:12 -04'00'

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

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Indications for Use

510(k) Number (if known) K243217

Device Name Legend X Desktop System

Indications for Use (Describe)

The Legend X Desktop System and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

Legend X Desktop System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Legend X Desktop System is intended to be operated by a licensed health care practitioner who is present to monitor treatment.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K243217

5.1. General information

510(k) Submitter	Pollogen Ltd6 Kaufman Street TelAviv, IL 6801298
FDA Registration Number	3008753275
Primary Correspondent	Karen SmithVice President, Regulatory & QualityLumenis Be, Inc., a Pollogen Ltd Family Company
Contact Information	Email: karen.smith@lumenis.com
Date Prepared	November 22, 2023

5.2. Device Identification

The Legend X Desktop System consists of a Desktop console with connected components including: applicators and applicator accessories (disposable tips) needed to perform some of Legend X Desktop dermatologic procedures. The Legend X Desktop System can be defined as follows:

Proprietary Name	Legend X Desktop System
Device Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Description:	Electrosurgical Cutting and Coagulation Device and Accessories
Regulation Number:	878.4400
Device Class:	Class II
Product Code:	GEI, NGX

5.3 Predicate Device

Proprietary Name	Legend X Platform
Device Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Description:	Electrosurgical Cutting and Coagulation Device and Accessories
510(k) Number:	K232903
Regulation Number:	878.4400
Device Class:	Class II
Product Code:	GEI, NGX

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Pollogen Ltd	K243217	Traditional 510(k) Notification
Reference Device
Proprietary Name	Veinoplus Sport Neuromuscular Stimulator
Device Classification Name:	Stimulator, Muscle, Powered, For Muscle Conditioning
Regulation Description:	Powered muscle stimulator
510(k) Number:	K141919
Regulation Number:	890.5850
Device Class:	Class II
Product Code:	NGX, GXY

5.4. Device Description

Legend X Desktop Disposable Tip Accessories: The Legend X Desktop disposable tips set Device: Legend X Desktop System Page 12.2 - 2 of 8 Attachment 12.2 510(k) Summary

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K243217

is part of the Legend X Desktop Applicator VO kit. The Disposable Tips Set includes:

. gen12 disposable tip,
gen36 disposable tip,
. gen36L disposable tip,
gen100 disposable tip, and
H7X7 disposable tip

5.5. Intended Use/Indications for Use

The Legend X Desktop System and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).

Legend X Desktop System is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.

Legend X Desktop System is intended to be operated by a licensed health care practitioner who is present to monitor treatment.

5.6. Comparison of Technological Characteristics with the Predicate Device

Overall, the proposed and predicate devices are based on the following similar basic technological elements.

. Device contains a central console that connects each of the main components to facilitate dermatologic and general surgical procedures and facilitates the selection of either RF energy or muscle stimulation (pulses) via the graphical user interface
Device contains applicators to allow energy delivery and application of the selected mode on to the treatment area
Device contains similar components between the subject and predicate devices (i.e., desktop console, applicators, and disposable tips)
Device requires continuous direct control by the user to operate the Applicators
Device mode operation is only at the command of the user ●
Device mode operation may be halted at the command of the user

The primary differences between the predicate and the Legend X Desktop System is the smaller desktop console as well as differences in applicator options. In addition to providing equivalent means of ablation and resurfacing of the skin via the applicators and applicator accessories, the Legend X Desktop System includes identical compatible accessories for the VO applicator to facilitate dermatological

Device: Legend X Desktop System Attachment 12.2 510(k) Summary

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Pollogen Ltd

K243217

procedures, gen12, gen36, gen36L, gen100, and H7x7. The Legend X Desktop System is a different configuration of Applicator VO with 5 disposable tips and the tripollar Applicator. For this reason, additional testing for the entire system was performed and is captured as part of this submission. Comparison of the technological characteristics with the Predicate Device for each of the Legend X Desktop System components are described below:

ComparisonCriteria	Proposed DeviceLegend X DesktopSystem(K243217)	Predicate DeviceLegend X Platform(K232903)	ComparisonAssessment
FundamentalScientificTechnology	Software-Basedsystem that providesradiofrequencyelectrical current orpulsed muscleconditioning tostimulate healthymuscles via theelectrodes of theapplicators andaccessories. Operationis under the continuousand direct control ofthe healthcareprofessional.	Software-Basedsystem that providesradiofrequencyelectrical current andor pulsed muscleconditioning tostimulate healthymuscles via theelectrodes of theapplicators andaccessories. Operationis under thecontinuous and directcontrol of thehealthcareprofessional.	Same
Primary Modeof Action	User input to start orstop application ofradiofrequency ortranscutaneouselectrical musclestimulation throughelectrodes ofapplicators andaccessories	User input to start orstop application ofradiofrequency ortranscutaneouselectrical musclestimulation throughelectrodes ofapplicators andaccessories	Same
MajorComponents	Consists of 3 MajorComponents and anoptional accessory Legend XDesktopConsole withexternal powersupply 2 Legend X DesktopApplicators	Consists of 4 MajorComponents and anoptional accessory Legend X Console 4 Legend XApplicators Legend X FootSwitch Legend X PatientManual ControlledSwitch	Similar, predicatecontains additionalmajor componentsand larger capitalequipment
Pollogen Ltd	K243217	Traditional 510(k) Notification
Accessories	6 Disposable tips:• gen12,• gen36,• gen 36L,• gen100,• H7x7	6 Disposable tips:• gen12,• gen36,• gen 36L,• gen100,• H7x7	Same as predicate
Control / UserInterface	• Connected handheldapplicators designedto apply RF energyor pulses(ApplicatorsTripollar and VO)• USB interface forsoftware updates	• Connected handheldapplicators designedto apply RF energyor pulses(Applicators 1, 2, 3,and VO)• Connected handheldpatient manualswitch designed tostop operation• Connected footswitch designed tostart / continueoperation• USB interface forsoftware updates	Similar topredicate, subjectcontrols and userinterface are withinrange of thepredicate.
System Weight	~5 Kgs/11lbs	~30 Kgs/66.14lbs	Legend X Desktopincludes aminiature consolethat is lighter inweight than thelarger Legend Xplatform predicate.However, theminiature consoledoes not introduceany new questionsof safety oreffectiveness as thetechnologicalspecifications aresimilar to thepredicate console.
SystemDimensionshxwxd	32cm x 32cm x 43cm12.6" x 12.6" x 17"	110cm x 45cm x 45cm43.3" x 17.72" x17.72"	Legend X Desktopincludes aminiature consolethat is smaller insize than the largercleared Legend Xplatform predicateconsole.
Pollogen Ltd	K243217	Traditional 510(k) Notification
ModeApplication	Stainless steel electrodes/disposable tipsconnected to systemapplicator emitenergy/pulses to the skinwhile user movesapplicator acrosstreatment area	Stainless steelelectrodes /disposabletips connected tosystem applicator emitRF energy/pulses to theskin while user movesapplicatoracross treatment area	Same
No. ofApplicators andApplicator Type	2 Applicators• Applicator VO• Applicator Tripollar	4 Applicators• Applicator VO• Applicator 1• Applicator 2• Applicator 3	Similar, subjectincludes twoapplicators(Applicators VOand Tripollar),whereas predicateincludes 4applicators(Applicators VO an1-3). Howeverfeatures of subjectapplicators arewithin range of thepredicate andlegally marketeddevices.
Number and typeof DisposableTips	5 Disposable Tips:• gen12,• gen36,• gen36L,• gen 100, and• H7x7	5 Disposable Tips:• gen12,• gen36,• gen36L,• gen 100, and• H7x7	Same as predicate
RF energy perpin	up to 62mJ/pin	up to 62mJ/pin	Same as predicate
Maximumnumber ofpulses per tip	800	800	Same as predicate
Modes ofOperation(treatmentprograms)	Low, Medium, High	Low, Medium, High	Same as predicate
Biocompatibility	All parts that are incontact with patientcomply withrequirements of ISO10993-1 and FDAguidance	All parts that are incontact with patientcomply withrequirements of ISO10993-1 and FDAguidance	Same as predicate
Pollogen Ltd

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Pollogen Ltd	K243217	Traditional 510(k) Notific
Software	Verified and validatedaccording to the FDAguidance	Verified and validatedaccording to the FDAguidance	Same as predicate

5.4. Performance Data

The Legend X Desktop System was assessed for performance in accordance with internal design specification with the applicable performance standards to demonstrate safety and effectiveness. The testing identified no new issues of safety or effectiveness. The testing performed are summarized below:

Cleaning and Sterilization: The cleaning and disinfection instructions provided in labeling for non- disposable components were validated as per AAMI TIR-30. Singleuse disposable sterile (EO) devices and EO residual were validated in accordance with ISO 11135 and ISO10993-7. The shelf life and sterile barrier packaging of the singleuse disposable devices were evaluated per ASTM F1980-16, ASTM F 1929-15, ASTM F88/F88M-15, and ISO 11607.
Biocompatibility: The final finished form of the subject device has been used for the biocompatibility evaluation. Biocompatibility for patient contacting components has been evaluated and validated in accordance with the provision of the following FDA Guidance document, "Guidance for Industry and Food and Drug Administration Staff – Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and applicable ISO 10993 standards.
Electrical Safety, Performance and EMC: The subject device has been fully evaluated for electrical safety and EMC compliance to IEC 60601 series standards.
-Software: Software was developed, tested, and verified per the FDA guidance document: Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and results of verification and validation testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users.
V&V Testing: Performance testing was executed to verify the overall functionality of the proposed device to operate as specified by the design input requirements including applicator and controls, various functional safety features, and other general functionality. Requirements for safety and efficacy of the system, including but not limited to the adherence to regulatory standards were verified. Results of verification testing confirm that the proposed device conforms to design specifications and requirements and meets the needs of the intended user.
Animal Testing: Performance testing animal testing was executed according to General Considerations for Animal Studies Intended to Evaluate Medical Devices issued on March 28, 2023.

Device: Legend X Desktop System Attachment 12.2 510(k) Summary

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5.8 Conclusion

Based on the indication for use, technological characteristic, performance testing and comparison to the predicate devices, the Legend X Desktop System raises no new questions of safety and effectiveness as compared to the predicate and reference devices and is substantially equivalent to the predicate in terms of safety, efficacy, and performance for the requested indications for use.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.