(616 days)
None
No
The description focuses on radiofrequency and thermal energy delivery, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as removing and destroying skin lesions and coagulating skin tissue, which are therapeutic actions.
No
The device description states its purpose is for "Removal and destruction of skin lesions and the coagulation of skin tissue," which describes a therapeutic function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a console, handpiece, electrodes, and foot pedal, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Removal and destruction of skin lesions and the coagulation of skin tissue." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a radiofrequency-based system that applies thermal energy to the skin. This is a physical intervention, not a test performed on a sample taken from the body.
- IVD Definition: In Vitro Diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform such tests.
The device is a therapeutic device used for dermatological procedures.
N/A
Intended Use / Indications for Use
Removal and destruction of skin lesions and the coagulation of skin tissue.
Product codes
GEI
Device Description
The Plasmage system is a radiofrequency based professional device exciting an electrical plasma discharge between a metal tip and the patient skin. The discharge deposit thermal energy in the skin and results in removal and destruction of skin lesions and the coagulation of skin tissue. The device is operating in monopolar mode only.
The device consists of a console with touch LCD screen and graphic user interface, handpiece with integrated cable, single use electrodes, and foot pedal. The main technical parameters are shown in a comparison table in section G.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
As recommended by the FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", revised in 2020, a histology study has been performed to evaluate shape and size of thermal damage profile at 3 power settings - minimum, recommended for intended use and maximum power, on ex vivo porcine skin. The tissue damage was evaluated with Nitro Blue Tetra Chlorine (NBTC) histological evaluation.
The study demonstrated that treatment by predicate and subject devices similar histological and thermal effect on skin tissue, supporting substantial equivalence of the devices.
Key Metrics
Not Found
Predicate Device(s)
Bovie Derm 941/942, K161134
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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April 6, 2022
Brera Medical Inc. Paul Dunleavy President 19 Kramas Lane Northwood, New Hampshire 03261
Re: K202106
Trade/Device Name: Plasmage System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 16, 2021 Received: August 23, 2021
Dear Paul Dunleavy:
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. 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,
1
including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical 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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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Indications for Use
510(k) Number (if known) K202106
Device Name Plasmage System
| Indications for Use (Describe) | Removal and destruction of skin lesions and the coagulation of skin tissue. |
|---|---|
| -------------------------------- | ----------------------------------------------------------------------------- |
| 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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Traditional 510(k) Summary - Plasmage system as required by 21 CFR 807.92
| A) Sponsor: | Brera Medical Inc. |
|---|---|
| Official Contact: | Paul Dunleavy |
| President | |
| Brera Medical Inc. | |
| 19 Kramas Lane, Northwood NH 03261 | |
| Phone 888 5801233 ext 101 | |
| B) Device Name: | |
| Common Name: | |
| Device Class: | |
| Regulation: | |
| Product Code: | |
| Classification panel: | |
| Submission Type: | Plasmage System |
| Electrosurgical Cutting and Coagulation Device and Accessories | |
| Class II | |
| 878.4400 | |
| GEI | |
| General & Plastic Surgery | |
| Traditional 510(k) (Original Submission) | |
| C) Predicate: | Bovie Derm 941/942, K161134 |
| Bovie Medical Corporation, Clearwater FL | |
| D) Date Prepared: | September 17, 2021 |
- E) Device Description:
The Plasmage system is a radiofrequency based professional device exciting an electrical plasma discharge between a metal tip and the patient skin. The discharge deposit thermal energy in the skin and results in removal and destruction of skin lesions and the coagulation of skin tissue. The device is operating in monopolar mode only.
The device consists of a console with touch LCD screen and graphic user interface, handpiece with integrated cable, single use electrodes, and foot pedal. The main technical parameters are shown in a comparison table in section G.
F) Intended Use/Indications For Use:
Removal and destruction of skin lesions and the coagulation of skin tissue.
G) Technology Comparison and Substantial Equivalence Discussions
The product code for the subject device is GEI (Electrosurgical Cutting and Coagulation Device and Accessories), regulation number 21 CFR 878.4400, The predicate device is Bovie Derm 941/942 (K103654), product code GEI, regulation number
21 CFR 878.4400.
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The K103654 clearance covers two devices – Derm 941 (capable of only monopolar mode) and Derm 942 (capable of operating in monopolar and bipolar mode). Both devices have identical performance when operated in monopolar mode. Subject device is only capable of monopolar mode.
The following table contains comparison of technological characteristics of subject and predicate devices
| | Brera USA
K202106 | Bovie Derm 941/942
K161134 | |
|----------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Predicate | Subject | Primary | |
| Product code | GEI | GEI | |
| Indications for Use | Removal and destruction of
skin lesions and the
coagulation of skin tissue | The intended use for the DERM 941 and DERM 942
is for removal and destruction of skin lesions and the
coagulation of tissue | |
| OTC
Specifications | No | No | |
| | Plasmage | Derm 941/942 | Comparison |
| Applicator/electrode | Metal tip | Metal tip | Different shape
and size |
| Electrode material | Stainless steel 316L | Stainless steel 316L | Same |
| Energy source | Radiofrequency | Radiofrequency | Same |
| RF Application | Monopolar | 941 is monopolar only, 942 is
monopolar and bipolar | Same for
monopolar mode |
| RF frequency | 100 kHz | 368 kHz bipolar, 410 kHz monopolar | SE |
| RF voltage | Up to 3000 peak to peak | Up to 6300 peak Monopolar | SE |
| RF power | Up to 5.5 W | Up to 40 W | Different |
| Energy applied to tissue | Plasma discharge | Plasma discharge | Same |
| Tissue type | Skin | Multiple tissues types including skin | Same |
| Treatment duration | Selected by operator | Selected by operator | Same |
| Weight | 1.5 kg | 2.3 kg | SE |
| Size | 27 x 25 x 9 cm | 22.8 x 18.8 x 10.5 cm | SE |
| Electrical safety,
EMC requirements | Yes | Yes | Same |
Discussions
Similarities
The Plasmage suggested indications for use are a subset of the predicate device indication for use. Both Plasmage and predicate device create a small size area of thermal damage used to coagulate or evaporate tissue. Such thermal damage could be used in surgery for hemostasis or to facilitate skin remodeling. Both treatment tips should be manually held at a small distance from the tissue (less than 1 mm) during treatment, while treatment energy is enables by operator using a foot pedal.
The exposure level in both devices is controlled by an operator by selecting power and then controlling exposure duration by visually observing tissue effect and/or training the operator to maintain the combination of power and tip movement speed appropriate for selected clinical
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procedure. Subject and predicate devices are using RF energy, such as plasma discharge initiated by radiofrequency waves, at 100 kHz sinusoidal voltage in the subject device and short pulses with central frequency of 410 kHz for monopolar mode of operation in the predicate device. The action of both devices on tissue is predominantly thermal and related to absorption of the energy provided and heating the tissue in the area of energy application. The provided histologies with viability staining show similar size and shape of thermal damage profile created by these devices.
See more information about specific evaluation of the thermal damage profile for Plasmage and comparison with the predicate device in the Discussion of Substantial Equivalence section of the submission.
Like the predicate devices, the Plasmage meets appropriate electrical safety and EMC testing requirements per FDA recognized consensus standards.
Differences
The subject has different output power, RF frequency and applicators. However, these differences do not raise additional safety or effectiveness concerns. Performance tests as listed in the following section Hand I demonstrated the subject device has equivalent performance as the predicate device for the proposed indications for use.
Conclusion
The Plasmage and the predicate device have same indication for use, Technology, mechanism of actions, operational principles and performance for the proposed indications for use. The differences between the Plasmage and the predicate devices do not raise additional safety or effectiveness concerns.
H) Performance Testing – bench.
As recommended by the FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", revised in 2020, a histology study has been performed to evaluate shape and size of thermal damage profile at 3 power settings - minimum, recommended for intended use and maximum power, on ex vivo porcine skin. The tissue damage was evaluated with Nitro Blue Tetra Chlorine (NBTC) histological evaluation.
The study demonstrated that treatment by predicate and subject devices similar histological and thermal effect on skin tissue, supporting substantial equivalence of the devices.
I) Consensus Standards
The Plasmage System complies with the following FDA recognized consensus standards:
- AAMI ANSI ES 60601-1:2005(R)2012 and A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (FDA recognition #19-4)
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA recognition #19-8)
- ANSI AAMI ISO 10993-1:2018 (Fifth edition) Biological evaluation of medical devices -● Part 1 : Evaluation and testing within a risk management process (FDA recognition #2-258)
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- ANSI AAMI IEC 62304:2016 Medical device software Software life cycle processes . [Including Amendment 1 (2016)] (FDA recognition #13-79)
- ISO 14971:2007 (Second edition) Medical devices Application of risk management to . medical devices ) (FDA recognition #5-40)
J). Conclusion
The Plasmage is substantially equivalent to the predicate device.