(100 days)
Not Found
No
The device description and performance studies focus on the electro-surgical mechanism and validation against electrical safety standards and predicate device equivalence, with no mention of AI or ML.
Yes
The device is intended for the treatment of various dermatological conditions, which qualifies it as a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the NeoGen PSR System is intended for "treatment of the following dermatological conditions," and the "Device Description" explains it as an "electro-surgical device intended for use in dermatological applications" for "controlled heating of the outer layers of the skin" for treatment purposes. There is no mention of diagnosis or analysis of conditions.
No
The device description explicitly lists multiple hardware components including a generator, footswitch, handpiece/cable assembly, procedure pack, and nitrogen gas cylinder. It is described as an electro-surgical device.
Based on the provided information, the NeoGen PSR System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of dermatological conditions by applying energy to the skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an electro-surgical device that uses plasma to heat the skin for treatment. This aligns with a therapeutic device, not a device used to examine specimens from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The NeoGen PSR System's function is to directly treat the skin.
N/A
Intended Use / Indications for 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 .
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
outer layers of the skin, dermis, facial and non-facial rhytides
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and duly qualified medical practitioners in hospitals and clinics; dermatologist, plastic surgeon or other suitably qualified user.
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)
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.
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.
Not Found
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
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 .
1
Page 2 of 4
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
2
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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 Values | ||
| Precision | ||
| Energy setting | 0.1 Joule | 0.1 Joule |
| Max Output Energy | 4J | 4J |
| Treatment Pulse | ||
| Repetition Rate | 1.0 to 2.5 Hz in Repeat Pulse mode. | |
| Single Pulse mode selectable by the | ||
| User. | 1.0 to 2.5 Hz in Repeat Pulse | |
| mode. Single Pulse mode | ||
| selectable by the User. | ||
| 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. | Output RF pulse width is | |
| varied between 5.2 and 15.4 | ||
| ms | ||
| Safety | ||
| Classification | Class 1 (BS EN 60601-1:2006), the Generator requires connection to | |
| a 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 and | |
| coagulation device and accessories. | Electrosurgical cutting and | |
| coagulation device and | ||
| accessories. | ||
| 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 a | |
| maximum of 50 plasma pulses at 2.5Hz | ||
| System Operation | ||
| Ambient Temperature | 10 to 30 °C. | 10 to 30 °C. |
| Relative Humidity | 30 to 75%. | 30 to 75%. |
| Atmospheric Pressure | ||
| Services | 700 to 1060 hPa. | 700 to 1060 hPa. |
| Power Requirements | ||
| Voltage (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 x | |
| 5mm UL Approved. Current rating | ||
| 6.3A. Breaking Capacity 1500A | ||
| @250VAC | Time Lag 'T' type 250 Vac 20 | |
| mm x 5mm UL Approved. | ||
| Current rating 6.3A. Breaking | ||
| Capacity 1500A @250VAC | ||
| Mains Connection | Detachable power cord to IEC-type | |
| Appliance inlet. | ||
| Mains switch controlled ON/OFF | ||
| operation | Detachable power cord to IEC- | |
| type Appliance inlet. | ||
| Mains switch controlled | ||
| ON/OFF operation | ||
| Footswitch | 60V 5A DC | 60V 5A DC |
| RF Output Frequency | 2450 to 2480 MHz, typically 2470 | |
| MHz. No sub-harmonics | 2450 to 2480 MHz, typically | |
| 2470 MHz. No sub-harmonics | ||
| Modulation | Pulsed CW (Carrier Wave) | Pulsed CW (Carrier Wave) |
System Comparison to Predicate device
3
| Energist Ltd |
|---|
| Section 5 |
Page 4 of 4
4
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
5
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
6
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 A
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Long H. Chen - A
0.9.2342.19200300.100.1.1=1300369056
Date: 2013.12.11 13:46:36 -05'00' |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A | |
for BSA
:
(Division Sign-off) Division of Surgical Devices 510(k) Number K132754