The Legend X Applicator VO and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (tips gen12, gen100, gen 36, gen36L, H7x7). The Legend X Applicator VO with genXL tip is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Applicator VO with genXL tip is limited to Skin Types I-IV.

Device Description

The Legend X Applicator VO ("Proposed Device") is connected to the Legend X softwarecontrolled capital equipment platform to enable application of radiofrequency onto the skin for ablation and resurfacing or electrocoagulation and hemostasis. The proposed device applicator and applicator accessories are identical to the recently cleared Legend X Platform (K232903), with the exception of the new optional Applicator VO genXL disposable tip. The application of radiofrequency with the Applicator VO Disposable Tip only occurs under the continuous and direct control of a user with direct visualization, via the user inputs into the Legend X Console and Applicator indicators.

The proposed device consists of applicators and applicator accessories (disposable tips) needed to perform some of Legend X dermatological procedures. The summary descriptions of the proposed device are outlined below.

Legend X Applicator VO: The Legend X Applicator VO is a handheld handpiece which delivers energy to the treatment area. Depending on the selected user inputs, the user can utilize the applicator to deliver fractional RF energy for ablation and resurfacing, or electrocoagulation and hemostasis, as a means for noninvasive skin treatment throughout the face and body. The Applicator VO is connected to the cleared Legend X Console via an Applicator Connector cord.

Legend X Software: The Legend X Software provides the user and patient with the ability to safely commence, drive, and stop the operation of the Applicator on the skin area of interest throughout the face and body. It receives user input from the Legend X Console and computes the appropriate output to the Applicator VO connected to the Console. It provides a graphical user interface where the treatment parameters are adjusted as well as status of operation is shown in real time and displays important system status information.

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

1. gen12 disposable tip
1. gen36 disposable tip
1. gen36L disposable tip
1. gen100 disposable tip
1. H7X7 disposable tip
1. genXL 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 radiofrequency electrical current via an array of micro-electrode pins onto the skin surface.

AI/ML Overview

The provided text describes the regulatory clearance for the "Legend X Applicator VO" and its accessories, not an AI or software-based medical device. Therefore, much of the requested information regarding acceptance criteria and studies for AI/software devices (such as sample size for test/training sets, expert qualifications, HR/AI assistance effect size, etc.) is not applicable and not present in the document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (an electrosurgical cutting and coagulation device and accessories) based on similar technological characteristics and performance data related to biocompatibility, electrical safety, electromagnetic compatibility, and software V&V for controlling the device.

Here's a breakdown of the relevant information from the document:

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

The document does not provide a specific table of acceptance criteria with corresponding performance metrics in the format typically seen for, for example, diagnostic accuracy of an AI model. Instead, it states that the device was assessed for performance in accordance with internal design specifications and applicable performance standards to demonstrate safety and effectiveness.

Acceptance Criteria (General themes inferred from "Summary of Performance Testing"):
- No new issues of safety or effectiveness identified.
- Reprocessing, sterilization, and shelf life are identical to the primary predicate.
- Biocompatibility compliance with specified ISO standards (10993-1, -5, -10, -11, -23) and FDA guidance.
- Electrical Safety and EMC compliance with IEC 60601-1 standards.
- Software development, testing, and verification per FDA guidance for software in medical devices.
- Overall functionality conforms to design specifications and meets intended user needs.
- Adherence to regulatory standards.
Reported Device Performance (as stated in the document):
- "The testing identified no new issues of safety or effectiveness."
- "The reprocessing, sterilization, and shelf life for the subject device are identical to those evaluated for the primary predicate."
- "Biocompatibility for patient-contacting components has been evaluated and validated in accordance with the provisions of the following guidance document and standards..." (lists ISO standards and FDA guidance)
- "The subject device has been fully evaluated for electrical safety and EMC compliance and is compliant with IEC 60601-1 standards."
- "Software was developed, tested, and verified per Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- "Results of verification and validation (V&V) testing confirm that the proposed device conforms to design specifications and meets the needs of the intended users."
- "Results of verification testing confirm that the subject device conforms to design specifications and requirements and meets the needs of the intended users."

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 applicable and therefore not provided, as the submission concerns a physical medical device, not an AI/software diagnostic or predictive tool requiring a test set of patient data. The "testing" mentioned refers to engineering performance testing, biocompatibility, electrical safety, and software verification/validation against specifications.

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 and therefore not provided, as there is no "test set" in the context of patient data requiring expert ground truth for this type of device submission.

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

This information is not applicable and therefore not provided for the reasons stated above.

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 such study was conducted or reported, as the device is not an AI assistance tool for human readers.

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

This is not applicable as the device is an electrosurgical device that requires continuous human control and direct visualization. The software mentioned controls the device's operation based on user input, it's not a standalone diagnostic algorithm.

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

This is not applicable. The "ground truth" for this device would be its adherence to design specifications and relevant safety and performance standards, established through engineering testing and regulatory compliance checks, not clinical outcomes or expert labels on patient data.

8. The sample size for the training set

This is not applicable as there is no AI/ML model being trained on a dataset. The software mentioned is a control system.

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

This is not applicable for the reasons stated above.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

May 8, 2024

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

RE: K240999

Trade/Device Name: Legend X Applicator VO Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 11, 2024 Received: April 11, 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 (the 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.

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).

Sincerely.

Digitally signed by Long H. Chen -S Lona H. Chen-Date: 2024.05.08 13:39:12 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices

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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) K240999

DeviceName Legend X Applicator VO

Indications for Use (Describe)

The Legend X Applicator VO and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (tips gen12, gen361, H7x7). The Legend X Applicator VO with genXL tip is intended for use in dermatological procedures for electrocoagulation and hemostass. At higher energy levels greater than 62 m.J/pin, use of the Applicator VO with genXL tip is limited to Skin Types I-IV.

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) Summary K240999

1. General information

510(k) Submitter	Pollogen Ltd6 Kaufman StreetTel Aviv, 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
Secondary Correspondent	Lola FajinmiRegulatory Affairs ConsultantMedTeCheck
Contact Information	Email: lola@MedTeCheck.com
Date Prepared	April 11, 2024

2. Device Identification

The Legend X Applicator VO consists of an applicator accessories (disposable tips) needed to perform some of Legend X dermatological procedures. The Legend X Applicator VO can be defined as follows:

Proprietary Name	Legend X Applicator VO
Device Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Description:	Electrosurgical Cutting and Coagulation Device andAccessories
Regulation Number:	878.4400
Device Class:	Class II
Product Code:	GEI

3. Predicate Devices

Primary Predicate:

Proprietary Name	Legend X Platform
Device Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Description:	Electrosurgical Cutting and Coagulation Device andAccessories
510(k) Number:	K232903
Regulation Number:	878.4400

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Device Class:	Class II
Product Code:	GEI, NGX

Secondary Predicate:

Proprietary Name	InMode System with the Morpheus8 Applicators
Device Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Description:	Electrosurgical Cutting and Coagulation Device andAccessories
510(k) Number:	K200947
Regulation Number:	878.4400
Device Class:	Class II
Product Code:	GEI

4. Device Description

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

1. gen12 disposable tip
1. gen36 disposable tip
1. gen36L disposable tip
1. gen100 disposable tip
1. H7X7 disposable tip
1. genXL disposable tip

5. Intended Use/Indications for Use

6. Comparison of Technological Characteristics with the Predicate Devices

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

1. Device contains a central console that connects each of the main components to facilitate dermatologic procedures and facilitates the selection of fractional RF treatment modes via the graphic user interface
1. Device contains an applicator to allow energy delivery and application on to the area of interest on the skin
1. Device contains similar components between the subject and predicate devices (i.e., Applicator VO and disposable tips)
1. Device requires continuous direct control by the user to operate the Applicator
1. Device mode operation is only at the command of the user

Comparison of the technological characteristics with the predicate devices for each of the Legend X Applicator VO disposable tip components are described below:

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Proposed Device	Primary Predicate	Secondary Predicate	Technological CharacteristicsComparison
Legend XApplicator VO	Legend X Platform(K232903)	InMode System(K200947)
Components:- Applicator VO(connected to acleared Legend XConsole) withaccessories	System Components:- Console- Patient-controlledmanual switch- Applicators (1, 2, 3,and VO)- Footswitch	System Components:- Console- Applicator- Footswitch	Identical Characteristics:- The Legend X ApplicatorVO is identical to theprimary predicate LegendX Platform infunctionality, design, andspecifications.
			Differences- The subject Legend XApplicator VO iscompatible with sixdisposable tip accessories,whereas the primarypredicate is compatiblewith five disposable tipaccessories.
Applicator VODisposable Tips:- gen12- gen36- gen36L- gen100- H7x7- genXL	Applicator VODisposable Tips:- gen12- gen36- gen36L- H7x7- gen100	Accessories- T tip head- 12-pin tip head- 24-pin tip head- 40-pin tip head	Identical Characteristics:- Functionality: To providedelivery of fractional RFenergy- Similar materials,specifications, and intendedfunctionalityDifferences- The Applicator VO genXLdisposable tip is anadditional disposable tipwith insertion depthoptions of up to 4 mm,which is within the rangeof the secondarypredicate's disposable tipsthat are up to 7 mm.

7. Performance Data

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The Legend X Applicator VO 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:

Summary of Performance Testing:

The reprocessing, sterilization, and shelf life for the subject device are identical to those evaluated for the primary predicate. The Legend X. Applicator VO disposable tips are EO sterilized for single use, and the Legend X Applicator VO is reusable.

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 provisions of the following guidance document and standards:

. FDA 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."
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 ● cvtotoxicitv
ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation . and skin sensitization
. ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-23 Biological evaluation of medical devices Part 23: Tests for irritation ●

Electrical Safety and Electromagnetic Compatibility: The subject device has been fully evaluated for electrical safety and EMC compliance and is compliant with IEC 60601-1 standards.

Software: Software was developed, tested, and verified per Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Results of verification and validation (V&V) 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

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for safety and effectiveness of the device, including the adherence to regulatory standards, were verified. Results of verification testing confirm that the subject device conforms to design specifications and requirements and meets the needs of the intended users.

8. Conclusion

Based on the same Indications for Use and similar technological characteristics as the secondary predicate and performance testing, the Legend X Applicator VO with genXL tip raises no new questions of safety and effectiveness and is substantially equivalent to the secondary predicate device in terms of safety, effectiveness, and performance.

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.