(379 days)
Not Found
No
The summary describes a device that uses plasma sublimation for tissue treatment and does not mention any AI or ML components or functionalities.
Yes
The device is used for the removal and destruction of skin lesions and coagulation of tissue, which are therapeutic applications.
No
The device is used for the removal and destruction of skin lesions and coagulation of tissue, which are treatment procedures, not diagnostic ones.
No
The device description explicitly mentions hardware components such as an electrosurgical unit (handpiece), electrodes, and a docking/charging station. The performance studies also include electrical and tissue testing, which are relevant to hardware functionality.
Based on the provided information, the Plexr Plus 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 coagulation of tissue." This is a direct treatment applied to the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a device that generates an electrical arc for plasma sublimation on the skin. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The Plexr Plus is an electrosurgical device used for therapeutic purposes on the skin.
N/A
Intended Use / Indications for Use
Plexr Plus is used in the removal and destruction of skin lesions and coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Plexr Plus utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by high frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A stainless steel straight disposable active sterilized tip is not available with the system and is not supplied by the company. Three cordless handpieces with three fixed powers are charged in a docking/charging station prior to use.
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
professional health care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:
| Test | Objective | Result |
|---|---|---|
| Electrical | Compliance with EN 60601-1 | Pass |
| Compliance with EN 60601-1-2 | Pass | |
| Tissue Testing | Compare thermal spread of devices | Equivalent |
| Packaging | Compliance with EN 22248 | Pass |
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22. 2022
GMV S.r.l. Andrea Cancelli OA Manager Via Roberto Parabeni 37 Rome 00173 Italy
Re: K210693
Trade/Device Name: PLEXR PLUS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 19, 2022 Received: January 25, 2022
Dear Andrea Cancelli:
We have reviewed vour 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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210693
Device Name PLEXR PLUS
Indications for Use (Describe)
Plexr Plus is used in the removal and destruction of skin lesions and coagulation of tissue.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (k) SUMMARY
SUBMITTER INFORMATION
| A. Company Name: | GMV S.r.l. |
|---|---|
| B. Company Address: | Via Roberto Paribeni, 37 |
| 00173 Rome -Italy | |
| C. Company Phone: | |
| Company Fax: | |
| Company e-mail: | +39-06 94315964 |
| +39 06 98380555 | |
| info@gruppogmv.it | |
| D. Contact person: | Andrea Cancelli |
| QA Manager | |
| GMV S.r.l. | |
| E. Date Summary Prepared: | 2nd March 2021 |
| DEVICE IDENTIFICATION | |
| A. Device Name: | PLEXR PLUS |
| B. Common Name: | Electrosurgical, Cutting & Coagulation & |
| Accessories | |
| C. Classification: | Class II |
| D. Product Code: | GEI |
E. Submission Type: 510k (Original Submission)
LEGALLY MARKETED PREDICATE DEVICE
E. Regulation Number:
| Primary predicate device | 510 (k) Holder | 510 (k) No. |
|---|---|---|
| Plasma IQ | Neauvia North America, Inc | K192813 |
878.4400
4
DEVICE DESCRIPTION
Plexr Plus utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by high frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A stainless steel straight disposable active sterilized tip is not available with the system and is not supplied by the company. Three cordless handpieces with three fixed powers are charged in a docking/charging station prior to use.
Performance Testing and data
The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:
| Test | Objective | Result |
|---|---|---|
| Electrical | Compliance with EN 60601-1 | Pass |
| Compliance with EN 60601-1-2 | Pass | |
| Tissue Testing | Compare thermal spread of devices | Equivalent |
| Packaging | Compliance with EN 22248 | Pass |
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
INDICATIONS FOR USE STATEMENT
Plexr Plus is used in the removal and destruction of skin lesions and coagulation of tissue.
SUBSTANTIAL EQUIVALENCE
All information provided with the present submission supports the substantial equivalence for PLEXR PLUS with the predicate device and its accessories that have identical characteristics and intended use and similar indication statement. In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, demonstrate PLEXR PLUS's safety and effectiveness for its intended use.
The following matrix illustrates the equivalencies of PLEXR PLUS, as well as the substantial equivalent predicate device.
5
PREDICATE DEVICES COMPARISON CHART
Table 1
| COMPARISON CHART PLEXR PLUS | | Explanation of
Differences between
the devices | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | GMV S.r.l.
PLEXR PLUS
New Device | Berger & Kraft
PLASMA IQ
Predicate device | |
| "K" NUMBERS | K210693 | K192813 | |
| Proprietary name | PLEXR PLUS | PLASMA IQ | |
| CFR Section | 878.4400 | 878.4400 | none |
| Pro-code | GEI | GEI | none |
| Intended Use | Intended for use during
non-invasive surgery. Is
intended for use only in
professional health care
settings. | Intended for use during non-
invasive surgery. Is intended
for use only in professional
health care settings. | Same intended use |
| Indications for
use | Intended for the removal
and destruction of skin
lesions and coagulation of
tissue | Intended for the removal
and destruction of skin
lesions and coagulation of
tissue | Same indications for use |
| Mode of
operation | Plasma
Radiofrequency energy
ionizes the air creating a
Plasma stream | Plasma
Radiofrequency energy ionizes
the air creating a Plasma
stream | Same mechanism of
action |
| Output | Monopolar | Monopolar | Same kind of output |
| Power Supply | 100-240VAC
50/60Hz | 110-250 VAC
50/60 Hz | Same power input
parameters |
| Frequency | 80 kHz | 40 kHz | The output frequency is
substantially the same in
the electromagnetic
spectrum. The minimal
difference does not
impact the efficacy of
safety at all. |
| Max Output
Power | 2 W | 5 W | The output power is not
linear, and it is
calculated as P=V²/R, so
3 W of difference is not
impacting the efficacy
and the safety of the
device. |
| Output | 60,000 Ω | 54,000 Ω | The output impedance is |
| Impedance | | | substantially the same. |
| Wave form | Image: waveform | Image: waveform | The waveform is sinusoidal for both the devices with similar amplitudes and frequencies. |
| System Components | System consists of a docking station and three handpieces | System consists of a handpiece that incorporates the electrosurgical generator unit, docking station, and an active electrode. | Plasma IQ presents one wireless handpiece with two buttons for choosing the fixed power output.
Plexr Plus has three different wireless handpieces with a fixed power each. The operation is the same, just the configuration is different. |
| Tips | Needle electrode | Needle electrode | Same |
| Raw Materials | Tips: stainless steel
Box and Handpieces: ABS | Tips: stainless steel
Box and Handpieces: ABS | Same |
| Electrical Safety Standards | Complies with IEC60601-1, IEC60601-1-2, IEC60601-2-2 | Complies with IEC60601-1, IEC60601-1-2, IEC60601-2-2 | Same |
6
TECHNICAL CHARACTERISTICS
A comparison of the technological characteristics of PLEXR PLUS and the predicate device has been performed. The results of this comparison demonstrate that the technologic characteristics and the operating principle of PLEXR PLUS are the same or very similar to those of the claimed predicate device. Where any differences arise from the analysis of the predicate device characteristics and those of the device subject of this submission, the clinical data evaluated from scientific publications give scientific evidence of the safety and the effectiveness of PLEXR PLUS. The system was evaluated and found compliant with IEC 60601-1 for electrical safety, IEC 60601-1-2 for IEC60601-1-2, IEC60601-2-2, and 10993-1 for biocompatibility of the treatment tips. Verification and validation data show that the device meets all product specifications.
CONCLUSION
Based on the foregoing, the PLEXR PLUS is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.