The NeoGen System is an electro-surgical device intended for use in dermatological applications by trained and duly qualified medical practitioners in hospitals and clinics. Treatment is achieved through controlled heating of 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. Similar biological changes to those from established laser-based dermatological surgical and skin resurfacing technologies are produced. A NeoGen PSR system comprises: NeoGen PSR generator, Footswitch, Handpiece/Cable Assembly, Procedure Pack (disposable nozzles), Nitrogen gas cylinder (not supplied). UHF energy from the Generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin.

AI/ML Overview

The provided text describes the Energist Ltd NeoGen PSR System, an electrosurgical device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the way typically associated with AI/ML device performance studies (e.g., sensitivity, specificity, AUC).

Instead, this document is a 510(k) summary (K132754), which is a premarket notification for a medical device seeking clearance from the FDA. The primary objective of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to perform a rigorous performance study against specific clinical acceptance criteria for a novel algorithm.

The core argument for substantial equivalence is based on:

Identical Intended Use: The NeoGen PSR System has the same intended use as its predicate, the Portrait PSR System (K082197).
Identical Technological Characteristics (with minor modifications): The device's technological characteristics are largely identical to the predicate, with minor modifications to the user interface, software, and outer casing design. The document states these differences "do not result in differences in performance or raise new questions of safety and efficacy."
Equivalent Principles of Operation and Energy Outputs: The device has the same principles of operation, mode of action, and equivalent energy outputs as the predicate device.
Compliance with Safety Standards: The device underwent testing to established international (IEC) and European (EN) safety standards for medical electrical equipment (IEC 60601-1, EN 60601-1, IEC 60601-2-2).
Laboratory Validation & Verification: This was undertaken to ensure design specifications were met and were substantially equivalent to the predicate.

Therefore, many of the requested categories for a typical AI/ML device performance study are not applicable or explicitly mentioned in this 510(k) summary.

Here's an attempt to fill out the table and answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
| :-------------------------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Safety and Efficacy (General) | "minor differences to the systems do not raise additional concerns of safety and efficacy." (This is a conclusion rather than a specific criterion.) | "The NeoGen PSR System is therefore concluded to be substantially equivalent to the above named predicate device and minor differences to the systems do not raise additional concerns of safety and efficacy." |
| Compliance with Standards | Adherence to relevant medical device safety standards. | "IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007)", "EN 60601-1:2006 + A11:2011", "IEC60601-2-2:2009 (Fifth Ed)" were performed. The device is classified as "Class 1 (BS EN 60601-1:2006)" and "Type BF Applied Part". |
| Functional Equivalence to Predicate | Displayed Values Precision (Energy setting): 0.1 Joule. Max Output Energy: 4J. Treatment Pulse Repetition Rate: 1.0 to 2.5 Hz in Repeat Pulse mode; Single Pulse mode selectable. Pulse Width: Varied between 5.2 and 15.4 ms. RF Output Frequency: 2450 to 2480 MHz, typically 2470 MHz. Modulation: Pulsed CW. | The comparison table explicitly states that the NeoGen PSR System matches the predicate (Portrait PSR System) for all these specifications: - Displayed Values Precision (Energy setting): 0.1 Joule.- Max Output Energy: 4J.- Treatment Pulse Repetition Rate: 1.0 to 2.5 Hz in Repeat Pulse mode; Single Pulse mode selectable.- Pulse Width: Output RF pulse width is varied between 5.2 and 15.4 ms according to the energy to be delivered by each RF pulse.- RF Output Frequency: 2450 to 2480 MHz, typically 2470 MHz; No sub-harmonics.- Modulation: Pulsed CW (Carrier Wave). |
| Reproducible Tissue Effects | "The NeoGen System provides a predictable depth of thermal modification so limiting unwanted effects that may result in scarring." (This is a statement of desired outcome, implying it's an unstated criterion.) | "Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects." "Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters." "The range of treatment energies and associated delivery times available has been determined from pre-clinical, clinical studies and expert opinion as being safe and effective for the intended applications..." |
| Clinical Efficacy (implicitly) | The intended uses (treatment of wrinkles/rhytides, superficial skin lesions, actinic keratosis, viral papillomata, seborrheic keratosis, acne scars) are implicitly a clinical acceptance criterion, met by being substantially equivalent to a device already cleared for these indications. | "The treatment is achieved through controlled heating of 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." "Similar biological changes to those from established laser-based dermatological surgical and skin resurfacing technologies are produced." "The range of treatment energies and associated delivery times available has been determined from pre-clinical, clinical studies and expert opinion as being safe and effective for the intended applications when employed by a dermatologist, plastic surgeon or other suitably qualified user." |

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

The document describes "Laboratory Validation & Verification" and refers to "pre-clinical, clinical studies and expert opinion" for determining the range of treatment energies and associated delivery times. However, no specific details on sample sizes for test sets, data provenance (country, retrospective/prospective), or subjects are provided for these studies. The focus is on demonstrating technical equivalence and safety compliance, not a novel clinical efficacy study with a defined test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document mentions "expert opinion" contributed to determining the safe and effective range of treatment energies. No specific number or qualifications of experts are provided. No ground truth in the sense of AI/ML evaluation (e.g., labeling images) is discussed.

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

Not applicable as no AI/ML test set requiring adjudication for ground truth is 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

No MRMC study was done, as this is not an AI/ML device assisting human readers. The device itself performs the treatment.

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

This is not an algorithm-only device. It's an electrosurgical system that is operated by a "trained and duly qualified medical practitioners." The "performance data" refers to the system's ability to produce specific physical outputs (energy, pulse width, frequency) and its compliance with safety standards, not an algorithm's diagnostic or predictive performance.

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

For the technical validation, the "ground truth" would be the expected physical outputs and safety parameters as defined by the design specifications and relevant standards.
For the "pre-clinical, clinical studies and expert opinion" mentioned, the "ground truth" for efficacy would likely be based on clinical observations, histological analysis (pathology, although not explicitly stated), and physician assessment of patient outcomes. However, details are not provided.

8. The sample size for the training set

Not applicable; this is not an AI/ML device that requires a "training set" in the computational sense. The "pre-clinical, clinical studies and expert opinion" inform the device's design and operating parameters, which is analogous to "training" in a broad sense, but specific sample sizes are not given.

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

As per point 8, not applicable in the AI/ML sense. The "ground truth" for the device's design and operational parameters comes from established medical literature, clinical experience, and expert opinion in the field of dermatological treatments using energy-based systems, as implied by the statement: "The User should be familiar with the medical literature, complications and hazards associated with the use of light-based and other energy systems..." and "The range of treatment energies...has been determined from pre-clinical, clinical studies and expert opinion."

Summary

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K132754

Energist Ltd Section 5

NeoGen PSR System

DEC 1 2 2013

Section 5 - 510(k) Summary (21 CFR 807.92)

Applicant Energist Ltd

Manufacturer Address

2 Park Pavilions, Clos Llyn Cwm, Enterprise Park, Swansea SA6 8QY, UK

Contact Person

Darren Thomas, Chief Technical Officer Tel: +44 (0)1792 798768 Fax: +44 (0)1792 790735

Establishment Registration Number 3007353760

3007353760

Device Trade Name NeoGen PSR System

Device Common Name Electrosurgical device

Device Classification

Electrosuraical cutting and coaqulation device and accessories Class II Product code: GEI 21 CFR 878.4400

Legally marketed Predicate Devices

The predicate devices for this Portrait PSR System, K082197

Intended Use

The NeoGen PSR system is an electrosurgical device for the treatment of dermatologic conditions including acne scars, actinic keratosis, superficial skin lesions and the treatment of wrinkles and rhytides. The treatment is achieved through controlled heating of 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.

Indications for Use

The NeoGen PSR System is intended for treatment of the following dermatological conditions:

Treatment of wrinkles and rhytides .
Superficial skin lesions .
Actinic Keratosis .
Viral Papillomata .
Seborrheic Keratosis .
Acne Scars .

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NeoGen PSR System

Device Description & Comparison

The NeoGen System is an electro-surgical device intended for use in dermatological applications by trained and duly qualified medical practitioners in hospitals and clinics. The User should be familiar with the medical literature, complications and hazards associated with the use of light-based and other energy systems in the treatment of facial and non-facial rhytides, acne scars and the removal of skin lesions. It is the responsibility of the user to select appropriate patients, to make a correct diagnosis, to determine the treatment required and the post-operative support required for the patient. It is stressed that some pre- and post-operative treatments for typical laser resurfacing procedures should NOT be applied either in preparation of or following a treatment using NeoGen, as this can lead to increased healing time and increased likelihood of unwanted side effects. Refer to the NeoGen Operators Manual for the Indications for Use and Relative Contraindications.

Treatment is achieved through controlled heating of 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. Similar biological changes to those from established laser-based dermatological surgical and skin resurfacing technologies are produced.

A NeoGen PSR system comprises:

NeoGen PSR generator

A mobile unit powered from a 100-120/230 VAC standard wall socket comprising a trolley and a generator section. During installation the generator section is attached to the trolley but may be subsequently removed by the user for easier transportation to a different site. Care must be taken to avoid damage to the handpiece/cable when the generator section is being transported in this way.

Footswitch

This is a single pedal type for activation of the output.

Handpiece/Cable Assembly

The handpiece has a single button on the top of its body for activation of the output. Disassembly of this from the generator requires a tool and is not described in this manual.

Procedure Pack

Comprising one or more disposable nozzles that is connected to the handpiece and which have an integral 'key' that is used by the generator to ensure the nozzle is not used bevond its operational life.

Nitrogen gas cylinder

This is not supplied as part of the NeoGen PSR system. Only medical grade (99.5% purity) nitrogen gas is to be used.

NEOGEN TECHNOLOGY

UHF energy from the Generator converts Nitrogen gas into plasma within the handpiece. The plasma emerges from the nozzle at the distal end of the handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up enerav to the skin.

Through the combination within the handpiece of precisely controlled energy and Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects. Automatic adjustment of the UHF power level and UHF pulse width to the handpiece

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Energist Ltd	NeoGen PSR System
Section 5

enables control of tissue effects by altering the amount of energy delivered by the plasma to tissue for each pulse. In practice, the energy per pulse is adjustable by the User from 1 to 4 Joules for a standard type nozzle.

The range of treatment energies and associated delivery times available has been determined from pre-clinical, clinical studies and expert opinion as being safe and effective for the intended applications when employed by a dermatologist, plastic surgeon or other suitably qualified user. In particular, the NeoGen System provides a predictable depth of thermal modification so limiting unwanted effects that may result in scarring.

To aid accurate distance from the skin surface, the nozzle is fitted with a 5mm stand-off leg. In practice, no pressure should be applied to the skin when using the stand-off, as this will cause variance of the distance of the nozzle from the skin surface, due to the elasticity of the skin, and could potentially result in an uneven application of energy.

Irrespective of the energy level employed for treatment, the effect is not ablative in that there is not an immediate removal of tissue at the time of application. This retention of the skin surface not only protects against the effects of over treatment but also behaves as a biological dressing to support the healing process over the first 4-5 days following treatment.

Comparison of Technological Characteristics

The NeoGen PSR System has an identical intended use to the predicate system and identical technological characteristics except for modifications to the device user interface and software and outer casing design. These differences do not result in differences in performance or raise new questions of safety and efficacy. The NeoGen PSR System also has the same principles of operation, mode of action and equivalent energy outputs that are used by the Portrait PSR system. Laboratory Validation & Verification utilising calibrated test equipment was undertaken to ensure all design specifications were met and were substantially equivalent to the predicate device. Performance data was provided to demonstrate that the system is capable of providing the outputs necessary to achieve its required treatment parameters.

Performance data was gained through the following tests:

IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) .
. EN 60601-1:2006 + A11:2011
IEC60601-2-2:2009 (Fifth Ed) .
Laboratory Validation & Verification .

The NeoGen PSR System is therefore concluded to be substantially equivalent to the above named predicate device and minor differences to the systems do not raise additional concerns of safety and efficacy.

	NeoGen PSR system	Portrait PSR System
510(k)	This application	K082197
Displayed ValuesPrecisionEnergy setting	0.1 Joule	0.1 Joule
Max Output Energy	4J	4J
Treatment PulseRepetition Rate	1.0 to 2.5 Hz in Repeat Pulse mode.Single Pulse mode selectable by theUser.	1.0 to 2.5 Hz in Repeat Pulsemode. Single Pulse modeselectable by the User.

Pulse Width	Output RF pulse width is variedbetween 5.2 and 15.4 ms accordingto the energy to be delivered byeach RF pulse.	Output RF pulse width isvaried between 5.2 and 15.4ms
SafetyClassification	Class 1 (BS EN 60601-1:2006), the Generator requires connection toa Protective Earth.
Type	Type BF Applied Part	Type BF Applied Part
MDD Class	llb	llb.
FDA Regulation Number	21 CFR 878.4400	21 CFR 878.4400
FDA Regulation Name	Electrosurgical cutting andcoagulation device and accessories.	Electrosurgical cutting andcoagulation device andaccessories.
FDA Product Code	GEI	GEI
	FDA Regulatory Class II	FDA Regulatory Class II
Duty Cycle	The system has a duty cycle of 20 seconds on, 10 seconds off, for amaximum of 50 plasma pulses at 2.5Hz
System OperationAmbient Temperature	10 to 30 °C.	10 to 30 °C.
Relative Humidity	30 to 75%.	30 to 75%.
Atmospheric PressureServices	700 to 1060 hPa.	700 to 1060 hPa.
Power RequirementsVoltage (single phase)Max Current	100 - 120 / 230 Vrms.6.5A	100 - 120 / 230 Vrms.6.5A
AC frequency	50/60 Hz	50/60 Hz
Power Consumption	≤650 VA	≤650 VA
Inlet Fuses	Time Lag 'T' type 250 Vac 20 mm x5mm UL Approved. Current rating6.3A. Breaking Capacity 1500A@250VAC	Time Lag 'T' type 250 Vac 20mm x 5mm UL Approved.Current rating 6.3A. BreakingCapacity 1500A @250VAC
Mains Connection	Detachable power cord to IEC-typeAppliance inlet.Mains switch controlled ON/OFFoperation	Detachable power cord to IEC-type Appliance inlet.Mains switch controlledON/OFF operation
Footswitch	60V 5A DC	60V 5A DC

RF Output Frequency	2450 to 2480 MHz, typically 2470MHz. No sub-harmonics	2450 to 2480 MHz, typically2470 MHz. No sub-harmonics
Modulation	Pulsed CW (Carrier Wave)	Pulsed CW (Carrier Wave)

System Comparison to Predicate device

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Energist Ltd
Section 5

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Energist Ltd Mr. Darren Thomas Chief Technical Officer 2 Park Pavilions, Clos Llyn Cwm Enterprise Park Swansea, UNITED KINGDOM SA6 8QY

Re: K132754.S001

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: November 6, 2013 Received: December 3, 2013

December 12, 2013

Dear Mr. Thomas:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Darren Thomas

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132754 and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi

Device Name: NeoGen PSR System

Indications for Use:

The NeoGen PSR System is intended for treatment of the following dermatological conditions:

Treatment of wrinkles and rhytides .
Superficial skin lesions .
Actinic Keratosis .
Viral Papillomata .
Seborrheic Keratosis .
Acne Scars .

Prescription Use _ × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen	Digitally signed by Long H. Chen ADN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=Long H. Chen - A0.9.2342.19200300.100.1.1=1300369056Date: 2013.12.11 13:46:36 -05'00'
A

for BSA

(Division Sign-off) Division of Surgical Devices 510(k) Number K132754

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.