NeoGen PSR System

{0}------------------------------------------------ January 12, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two main elements: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Energist Limited Graham Booth Chief Technical Officer 2 Park Pavilions, Clos Llyn Cwm Enterprise Park Swansea, SA6 8QY United Kingdom Re: K221873 Trade/Device Name: NeoGen PSR System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 08, 2022 Received: December 13, 2022 Dear Graham Booth: 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. 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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 {1}------------------------------------------------ device reporting (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 (QS) 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). 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Chen -S for 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221873 #### Device Name NeoGen PSR Plasma Skin Resurfacing Device #### Indications for Use (Describe) When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions : - · Treatment of wrinkles and rhytids - · Superficial skin lesions - · Actinic Keratosis - Viral Papillomata - · Seborrheic Keratosis - · Acne Scars When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures. **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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K221873: Energist Limited NeoGen PSR 510(k) Application - 510(k) Summary | Revision: | B | Date: | 12 January 2023 | |--------------------------------|-----------------------------------------------------------------------------------------------|-------|-----------------| | Document Title: | 510(k) Summary (Per 21 CFR 807.92) | | | | Subject: | NeoGen PSR System 510(k) Application | | | | 510(k) Number | K221873 | | | | Submitter Name: | Energist Limited | | | | Establishment Registration No: | 3007353760 | | | | Submitter Address: | 2 Park Pavilions, Clos Llyn Cwm, Swansea<br>Enterprise Park, Swansea, SA6 8QY, United Kingdom | | | | Contact Person: | Graham Booth – Chief Technical Officer<br>Email: gbooth@energist.com | | | | Telephone Number: | +44 1792 798768 | | | | Revision Date: | 11 January 2023 | | | | Device Trade Name: | NeoGen PSR System | | | | Common Name: | Electrosurgical Device | | | | Device Classification: | Electrosurgical cutting and coagulation device and<br>accessories Class II | | | | Product Code: | GEI (21 CFR 878.4400) | | | # DEVICE DESCRIPTION ### System Elements The system comprises the following major elements: - . The Energist NeoGen PSR generator. This incorporates a source of Ultra High Frequency (UHF) energy and the gas control system required to support creation of nitrogen plasma; - . A Footswitch – single pedal type for activation of the plasma output. - . A handpiece that connects to the generator via an umbilical, which incorporates electrical and gas connections. The handpiece incorporates a finger-operated button switch that can be used to activate the plasma as an alternative to the footswitch. - . A Procedure Pack, comprising one or more limited life disposable tips (nozzles) through which the plasma is delivered. These are a snap fit to the distal end of the handpiece; - A gas supply system - principally a nitrogen gas cylinder and a regulator assembly; - . A bespoke trolley which provides a secure, mobile platform for the generator, handpiece, gas cylinder (plus a spare cylinder) and gas regulator assembly. {4}------------------------------------------------ # Principle of Operation The NeoGen PSR delivers controlled thermal energy to the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis. The body's natural healing process causes the damaged skin to be replaced with new, fresh, growth – thus resulting in improvement of the appearance and effects of the indicated conditions. The thermal energy emitted by the system is in the form of a nitrogen gas plasma. This is created by subjecting pressurised nitrogen gas to a high level of Ultra High Frequency (UHF) energy. This process takes place in the handpiece of the device, more specifically in a resonator tube, or "nozzle", the distal end of which is directed at the skin surface. The handpiece is connected to the main generator unit via an "umbilical", which incorporates a gas supply tube and a cable capable of conducting the UHF energy. It also incorporates a cable for control signals between the handpiece and the generator unit to support the action of a control button and gas solenoid valve, plus secure identification and "counter" elements in the nozzle and the handpiece itself. The plasma is created in short pulses, approximately 5 to 15 milli-seconds in duration. Automatic adjustment of the UHF power level and pulse duration to the handpiece enables control of tissue effects by altering the amount of energy delivered by the plasma to the skin surface for each pulse. In practice, the energy per pulse can be varied from 1.0 to 4.0 Joules when the system is used with the 5mm nozzle, and from 0.5 to 0.8 Joules when used with the 25mm nozzle. The system can be configured to automatically generate a series of pulses at set intervals to allow the operator to move the handpiece over the surface of the skin at a steady speed to achieve a uniform effect. Alternatively, the pulses can be manually triggered - either by pressing the control button on the handpiece, or by depressing a footswitch, according to operator preference. The nozzles are limited-life components which are a snap-fit onto the distal end of the handpiece and are easily replaced. A stand-off incorporated in the nozzle allows the distance from the skin surface to be accurately determined. The separation distance influences the amount of energy impacting the skin surface. NeoGen PSR systems are capable of supporting the use of nozzles with 5mm standoff, as well as 25mm. This is as per the Rhytec Portrait PSR3, which was the legally marketed predicate device cited when the NeoGen PSR was originally cleared under K132754. Handpiece usage is also monitored and the system limits use to guard against unexpected failure due to degradation with use over time. The handpiece is user replaceable. The generator incorporates a large colour touchscreen display supporting a Graphical User Interface that clearly conveys information to the operator and allows settings to be made readliy and conveniently. {5}------------------------------------------------ ### Intended Use/ Indications For Use When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions: - . Treatment of wrinkles and rhytids - Superficial skin lesions - Actinic Keratosis . - Viral Papillomata - Seborrheic Keratosis . - · Acne Scars When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures. ### Intended Use Environment The system is intended for professional use by trained and duly qualified medical practitioners in hospitals and clinics. It must not be used in domestic, industrial or outdoor locations, or in critical care environments. {6}------------------------------------------------ # TECHNOLOGICAL CHARACTERISTICS The technological characteristics of the current Energist NeoGen PSR system with 25mm nozzle option that is the subject of this K221873 submission and the predicate PSR system originally cleared under K132754 are summarised and compared in the table below: | Parameter | K132754 Predicate NeoGen PSR system | K222873 Subject NeoGen PSR system with 25mm option | |-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Energy setting Displayed Values Precision | 0.1 Joule | 0.1 Joule | | Max Output Energy | 4 Joules | 4 Joules | | Treatment Pulse Repetition Rate | Repeat Pulse mode: 1.0 to 2.5 Hz<br>Single Pulse mode: User determined. | Repeat Pulse mode: 1.0 to 2.5 Hz<br>Single Pulse mode: User determined. | | Output Pulse Width | 5.2 to 15.4 ms | 5.2 to 15.4 ms | | Safety Classification<br>(per EN/ISO 60601-1) | Class 1 (the Generator requires connection to a Protective Earth). | Class 1 (the Generator requires connection to a Protective Earth). | | FDA Regulatory Classification | Class II | Class II | | FDA Regulation Number | 21 CFR 878.4400 | 21 CFR 878.4400 | | FDA Regulation Name | Electrosurgical cutting and coagulation device and accessories. | Electrosurgical cutting and coagulation device and accessories. | | FDA Product Code | GEI | GEI | | EU MDR Classification | Risk Class Ilb | Risk Class Ilb | | Applied Parts | Type BF(not defibrillator proof) | Type BF(not defibrillator proof) | | Duty Cycle | 20 seconds on, 10 seconds off, for a maximum of 50 plasma pulses at the 2.5Hz maximum rate | 20 seconds on, 10 seconds off, for a maximum of 50 plasma pulses at the 2.5Hz maximum rate | | Operational Ambient Temperature Range | 10 to 30 °C. | 10 to 30 °C. | | Operational Humidity | 30 to 75% RH | 30 to 75 RH | | Atmospheric Pressure | 700 to 1060 hPa. | 700 to 1060 hPa. | | Power<br>Requirements | Voltage: 100-230 Vrms, 50-60Hz, 1 ph.<br>Current: 6.5A max.<br>Power Consumption: ≤650 VA | Voltage: 100-230 Vrms, 50-60Hz, 1 ph.<br>Current: 6.5A max.<br>Power Consumption: ≤650 VA | | Inlet Safety<br>Fuses | Quantity, Size: 2x, 20mm x 5mm<br>Type: Time Lag (T) type<br>Rating: 6.3A, 250 VAC<br>Approvals: UL Listed<br>Breaking Capacity: 1500A @250VAC | Quantity, Size: 2x, 20mm x 5mm<br>Type: Time Lag (T) type<br>Rating: 6.3A, 250 VAC<br>Approvals: UL Listed<br>Breaking Capacity: 1500A @250VAC | | Parameter | K132754 Predicate NeoGen PSR system | K222873 Subject NeoGen PSR system with 25mm option | | Mains Connection<br>Inlet type:<br>Power Cord:<br>Mains Switch: | IEC 60320 type C14<br>IEC 60320 type C13 (local plug a/r)<br>Double Pole, integral with inlet | IEC 60320 type C14<br>IEC 60320 type C13 (local plug a/r)<br>Double Pole, integral with inlet | | RF Output Frequency | 2450 to 2480 MHz (2470 MHz typ).<br>No sub-harmonics | 2450 to 2480 MHz (2470 MHz typ).<br>No sub-harmonics | | Modulation | Pulsed CW (Carrier Wave) | Pulsed CW (Carrier Wave) | | Gas System | Commercially available medical<br>grade nitrogen is supplied via a<br>Regulator assembly included with<br>the system to provide a feed to the<br>Generator at 1.7Bar (nom.) | Commercially available medical<br>grade nitrogen is supplied via a<br>Regulator assembly included with<br>the system to provide a feed to the<br>Generator at 1.7Bar (nom.) | | Footswitch | Medical type, rated 60V, 5A DC | Medical type, rated 60V, 5A DC | | Trolley | Custom made 5-wheel trolley with<br>locking wheels accommodates the<br>Generator and 2 gas cylinders<br>(including a spare). Meets stability<br>requirements of IEC 60601-1. | Custom made 5-wheel trolley with<br>locking wheels accommodates the<br>Generator and 2 gas cylinders<br>(including a spare). Meets stability<br>requirements of IEC 60601-1. | | Handpiece | Connecting to the Generator via a<br>flexible umbilical, the Handpiece<br>accommodates the nozzle, which is<br>where the plasma is generated.<br>Total number of shots is limited<br>(electronically) to 250,000 after<br>which the handpiece must be<br>replaced. | Connecting to the Generator via a<br>flexible umbilical, the Handpiece<br>accommodates the nozzle, which is<br>where the plasma is generated.<br>Total number of shots is limited<br>(electronically) to 250,000 after<br>which the handpiece must be<br>replaced. | | Nozzles | 5mm standoff version allows for<br>delivery of plasma energy in the<br>range 1.0 to 4.0 Joules. | 5mm standoff version allows for<br>delivery of plasma energy in the<br>range 1.0 to 4.0 Joules.<br>25mm standoff option allows for<br>delivery of plasma energy in the<br>range 0.5 to 0.8 Joules. | {7}------------------------------------------------ With the exception of the 25mm nozzle option (highlighted in red) – clearance of which is the subject of this 510(k) submission – the technological characteristics of the predicate and subject devices are identical. {8}------------------------------------------------ # TESTS PERFORMED A full description of tests carried out to confirm conformity to applicable standards is given in Energist document no. DD0254 NeoGen PSR Compliance Summary Report [USA], included with this submission. Note that the 25mm nozzle has been included in the scope of the assessments conducted (it has been made available in other markets since 2014). However, the choice of 5mm or 25mm nozzle does not materially impact safety or EMC. A summary is given below. # Basic Safety Representative samples of the NeoGen PSR system have been tested by an accredited thirdparty test organisation to demonstrate compliance with the following medical device safety standards: These tests have included assessment # 60601-1 Basic Safety | Standard | ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 &<br>A2:2010/(R)2012 – Medical electrical equipment Part 1: General<br>requirements for basic safety and essential performance. | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Consensus<br>Standard Recognition<br>Number | 19-4 | | Report Ref. | 071-75945748-000TRF_CE_E (inc. attachment 1) | | Issued By | TÜV SÜD, United Kingdom | ### 60601-2-2 HF Surgical Equipment | Standard | IEC 60601-2-2:2017 - Medical electrical equipment – Part 2-2:<br>Particular requirements for the basic safety and essential performance<br>of high frequency surgical equipment and high frequency surgical<br>accessories | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Consensus<br>Standard Recognition<br>Number | 6-389 | | Report Ref. | 071-75945748-000TRF_CE_E (attachment 2) | | Issued By | TÜV SÜD, United Kingdom | {9}------------------------------------------------ ### Electro-Magnetic Compatibility Representative samples of the NeoGen PSR system have been tested by an accredited thirdparty test organisation to demonstrate compliance with the following medical device EMC standards: | Standard | IEC 60601-1-2 - Medical electrical equipment -- Part 1-2: General<br>requirements for basic safety and essential performance -- Collateral<br>Standard: Electromagnetic disturbances -- Requirements and tests | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Consensus<br>Standard Recognition<br>Number | 19-8 | | Report Ref. | R18-4514A Is. 2 | | Issued By | Kiwa, United Kingdom | # Performance Testing Representative samples of the NeoGen PSR system have been tested by Energist Limited UK to demonstrate compliance with the user and functional performance requirements. Numerous documents are available, the "headline" ones being: DD0133R NeoGen System Validation Report ;Overall System Requirements SD0618R NeoGen System V&V Report :Software determined functionality In respect of the 25mm nozzle specifically, please refer to the following document: DD0246 NeoGen 25mm Nozzle - Safety & Efficacy Review. {10}------------------------------------------------ # TECHNOLOGY COMPARISON This is a review of the differences between the 25mm standoff arrangements as cleared in K072394 for use with the Rhytec PSR3. (the original predicate as cited in the K132754 submission for the NeoGen PSR), and those of the current 25mm nozzle that is the subject of this K221873 submission. # Rhytec 25mm Standoff This took the form of an adapter that could be fitted over the standard nozzle. The below excerpt from Rhytec's instruction sheet for the standoff shows the fitting instructions, and also gives an idea of the physical appearance and characteristics. Image /page/10/Picture/5 description: In the image, a person wearing purple gloves is holding a white nozzle. The top surface of the nozzle is visible. Above the nozzle, there is a handle with a purple design on it. The text in the image labels the top surface of the handle and nozzle. Top surface of Stand-off Orientate Stand-off to the Nozzle noting alignment of top surfaces of each part Image /page/10/Picture/8 description: In this image, a hand wearing a purple glove is holding a white and purple device with two prongs extending from the bottom. The device appears to be some sort of medical or scientific instrument. The prongs are translucent and have a yellowish tint. The hand is gripping the device firmly, and the background is a plain, light-colored surface. Engage the Stand-off onto the Nozzle Image /page/10/Picture/10 description: In the image, a gloved hand is holding a white plastic device with yellow tubes extending from the bottom. The device appears to be some sort of medical or laboratory instrument. The hand is holding the device near the top, and the tubes are pointing downwards. A black arrow is pointing to the top of the white plastic device. Stand-off correctly fitted onto the Nozzle Align protrusion on the Stand-off in relation to the joint between the Handpiece and Nozzle Essential characteristics of the Rhytec 25mm standoff are as follows: | Standoff Distance: | 25mm | |------------------------------|------------------------------------------| | Service Life: | To be replaced after use with 10 nozzles | | Energy Reduction Factor: | 0.65 | | Patient Contacting Material: | Ultem | | Spot Separation: | 12mm | | Energy Range: | 0.65 to 1.0 Joule* | * The lower limit is determined by the minimum output level of the Portrait PSR3 (1 Joule) and the Energy Reduction Factor (0.65). The maximum is that recommended in the IFU to prevent overheating of the tips, which could result in patient discomfort and damage to the standoff. The Rhytec Portrait PSR was a relatively basic device and was not able to detect the presence or absence of the adapter. It was therefore necessary for the operator to perform their own calculation of the effective energy reaching the skin surface, based on the reading on the numeric display. {11}------------------------------------------------ The range of energy outputs available were: | PSR3 Energy Setting (J): | 1.0 | 1.1 | 1.2 | 1.3 | 1.4 | 1.5 | |-----------------------------|------|-----|-----|------|-----|-----| | Energy at Skin Surface (J): | 0.65 | 0.7 | 0.8 | 0.85 | 0.9 | 1 | #### NeoGen 25mm Nozzle On the NeoGen device, the standoff is an integral part of the nozzle. It attaches to the distal end of the handpiece in the same manner as the 5mm nozzle. A picture of the device is shown below. Image /page/11/Picture/5 description: The image shows a black electrical plug with three prongs. The plug has a clear glass tube extending from one side, with a visible filament inside. The prongs are a light tan color and appear to be made of a flexible material. The plug is resting on a light-colored surface. Essential characteristics of the NeoGen 25mm nozzle are as follows: | Standoff Distance: | 25mm | |------------------------------|----------------------------------| | Service Life: | 9000 shots | | Energy Reduction Factor: | N/A | | Patient Contacting Material: | Ultem | | Spot Separation: | 12mm | | Energy Range: | 0.5 to 0.8 Joule (in 0.1J steps) | The main practical differences between the NeoGen 25mm nozzle and the Rhytec solution are: - . The NeoGen PSR automatically detects the presence of the 25mm nozzle and adjusts the on-screen energy settings to reflect the actual energy delivered to the skin surface. This reduces the burden on the operator, and the possibility of errors; - It is not possible to exceed the maximum ratings of the nozzle in respect of enerqy level or ● rated lifetime; - The possibility of the standoff being incorrectly fitted, or becoming detached, is reduced; - Available energy levels differ. At such low levels the clinical differences are minimal however. The main similarities are: - Same spot size treatment techniques therefore remain the same; ● - Same material used for standoff biocompatibility and thermal stability considerations ● therefore remain the same. {12}------------------------------------------------ # CONCLUSION The comparison of Technological Characteristics and the results of the performance and compliance testing conducted demonstrate that the subject device is Substantially Equivalent to the predicate device as cleared in K132754, and that the 25mm nozzle is Substantially Equivalent to that of the Rhytec nozzle/25mm standoff combination as cleared under K072394.