(29 days)
No
The document describes a software-controlled system for delivering RF energy and muscle activation pulses under direct user control. There is no mention of AI, ML, or any algorithms that learn or adapt based on data. The software is described as providing a user interface and computing outputs based on user input, not performing complex analysis or decision-making using AI/ML techniques.
No
The "Intended Use / Indications for Use" section explicitly states "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."
No
The device description and intended use state that it is for dermatological procedures and muscle conditioning, involving ablation, resurfacing, and non-invasive treatment using RF energy and muscle activation pulses. It explicitly states it is "not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind." These functions describe a therapeutic/treatment device, not a diagnostic one.
No
The device description explicitly states it is a "software-controlled capital equipment system" and includes hardware components such as a console, applicators, and disposable tips. While software is a key component, it controls hardware that delivers energy for treatment.
Based on the provided information, the Legend X Desktop System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for dermatological and general surgical procedures requiring ablation, resurfacing, non-invasive treatment, and muscle conditioning. These are all procedures performed directly on the patient's body.
- Device Description: The device description details a system that applies radiofrequency energy and muscle activation pulses directly to the skin and muscles. This is an external application of energy for therapeutic or cosmetic purposes.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Legend X Desktop System does not involve the analysis of such specimens.
The device is a therapeutic/surgical device used for direct treatment on the patient, not for in vitro analysis of biological samples.
N/A
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).
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, NGX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, Muscles of the face and body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed health care practitioner / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, while the text on the right is written in blue.
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"
1
(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).
2
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
3
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).
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.
| 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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4
510(k) Summary K243217
5.1. General information
| 510(k) Submitter | Pollogen Ltd
6 Kaufman Street Tel
Aviv, IL 6801298 |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| FDA Registration Number | 3008753275 |
| Primary Correspondent | Karen Smith
Vice President, Regulatory & Quality
Lumenis 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 |
5
| 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
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 Device: Legend X Desktop System Page 12.2 - 2 of 8 Attachment 12.2 510(k) Summary
6
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
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.
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).
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.
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
7
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:
| Comparison
Criteria | Proposed Device
Legend X Desktop
System
(K243217) | Predicate Device
Legend X Platform
(K232903) | Comparison
Assessment |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental
Scientific
Technology | Software-Based
system that provides
radiofrequency
electrical current or
pulsed muscle
conditioning to
stimulate healthy
muscles via the
electrodes of the
applicators and
accessories. Operation
is under the continuous
and direct control of
the healthcare
professional. | Software-Based
system that provides
radiofrequency
electrical current and
or pulsed muscle
conditioning to
stimulate healthy
muscles via the
electrodes of the
applicators and
accessories. Operation
is under the
continuous and direct
control of the
healthcare
professional. | Same |
| Primary Mode
of Action | User input to start or
stop application of
radiofrequency or
transcutaneous
electrical muscle
stimulation through
electrodes of
applicators and
accessories | User input to start or
stop application of
radiofrequency or
transcutaneous
electrical muscle
stimulation through
electrodes of
applicators and
accessories | Same |
| Major
Components | Consists of 3 Major
Components and an
optional accessory Legend X
Desktop
Console with
external power
supply 2 Legend X Desktop
Applicators | Consists of 4 Major
Components and an
optional accessory Legend X Console 4 Legend X
Applicators Legend X Foot
Switch Legend X Patient
Manual Controlled
Switch | Similar, predicate
contains additional
major components
and larger capital
equipment |
| 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 / User
Interface | • Connected handheld
applicators designed
to apply RF energy
or pulses
(Applicators
Tripollar and VO)
• USB interface for
software updates | • Connected handheld
applicators designed
to apply RF energy
or pulses
(Applicators 1, 2, 3,
and VO)
• Connected handheld
patient manual
switch designed to
stop operation
• Connected foot
switch designed to
start / continue
operation
• USB interface for
software updates | Similar to
predicate, subject
controls and user
interface are within
range of the
predicate. |
| System Weight | ~5 Kgs/11lbs | ~30 Kgs/66.14lbs | Legend X Desktop
includes a
miniature console
that is lighter in
weight than the
larger Legend X
platform predicate.
However, the
miniature console
does not introduce
any new questions
of safety or
effectiveness as the
technological
specifications are
similar to the
predicate console. |
| System
Dimensions
hxwxd | 32cm x 32cm x 43cm
12.6" x 12.6" x 17" | 110cm x 45cm x 45cm
43.3" x 17.72" x
17.72" | Legend X Desktop
includes a
miniature console
that is smaller in
size than the larger
cleared Legend X
platform predicate
console. |
| Pollogen Ltd | K243217 | Traditional 510(k) Notification | |
| Mode
Application | Stainless steel electrodes
/disposable tips
connected to system
applicator emit
energy/pulses to the skin
while user moves
applicator across
treatment area | Stainless steel
electrodes /disposable
tips connected to
system applicator emit
RF energy/pulses to the
skin while user moves
applicator
across treatment area | Same |
| No. of
Applicators and
Applicator Type | 2 Applicators
• Applicator VO
• Applicator Tripollar | 4 Applicators
• Applicator VO
• Applicator 1
• Applicator 2
• Applicator 3 | Similar, subject
includes two
applicators
(Applicators VO
and Tripollar),
whereas predicate
includes 4
applicators
(Applicators VO an
1-3). However
features of subject
applicators are
within range of the
predicate and
legally marketed
devices. |
| Number and type
of Disposable
Tips | 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 per
pin | up to 62mJ/pin | up to 62mJ/pin | Same as predicate |
| Maximum
number of
pulses per tip | 800 | 800 | Same as predicate |
| Modes of
Operation
(treatment
programs) | Low, Medium, High | Low, Medium, High | Same as predicate |
| Biocompatibility | All parts that are in
contact with patient
comply with
requirements of ISO
10993-1 and FDA
guidance | All parts that are in
contact with patient
comply with
requirements of ISO
10993-1 and FDA
guidance | Same as predicate |
| Pollogen Ltd | | | |
8
9
10
| Pollogen Ltd | K243217 | Traditional 510(k) Notific | |
|---|---|---|---|
| Software | Verified and validated | ||
| according to the FDA | |||
| guidance | Verified and validated | ||
| according to the FDA | |||
| guidance | 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
11
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.