(92 days)
No
The description focuses on the physical mechanism of plasma sublimation and electrical arc generation, with no mention of AI or ML algorithms for control, analysis, or other functions. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as being used for "removal and destruction of skin lesions and coagulation of tissue," which are therapeutic actions.
No
Explanation: The device is described as being used for the removal and destruction of skin lesions and coagulation of tissue, which are therapeutic/treatment functions, not diagnostic ones.
No
The device description explicitly mentions hardware components such as a radio frequency generator, electrosurgical unit (handpiece), electrode, and a docking/charging station.
Based on the provided information, the PLASMA IQ 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 skin.
- Device Description: The device utilizes "plasma sublimation" to cause "controlled skin damage" through an electrical arc. This is a physical intervention on the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The PLASMA IQ does not involve the analysis of any biological specimens.
The PLASMA IQ is a therapeutic device used for a medical procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
Product codes
GEI
Device Description
PLASMA IQ 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 a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance testing data was provided in this submission other than what was provided in the predicate (K212329) to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K212329 – Plasma IQ
Reference Device(s)
K201738 - Subnovii
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.
0
January 17, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neauvia North America, Inc Joy Willard Director of Quality, Regulatory and Clinical Affairs 8480 Honeycutt Road Raleigh, North Carolina 27615
Re: K223222
Trade/Device Name: Plasma IQ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2023 Received: January 11, 2023
Dear Joy Willard:
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, 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
1
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 medical devices and radiation-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.
Colin K. Chen -S
for
Long Chen, Ph.D. Acting 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) K223222
Device Name Plasma IQ
Indications for Use (Describe)
Plasma IQ 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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Date Prepared: October 17, 2022
Sponsor: Neauvia North America
Device Information
| Device Name: | Plasma IQ |
|---|---|
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Class: | II |
| Product Code: | GEI |
| Regulation: | 878.4400 |
| Submission Type: | Traditional 510k (Original Submission) |
| Predicate Information |
| Primary Predicate: | K212329 – Plasma IQ |
|---|---|
| Reference Device: | K201738 - Subnovii |
Contact Information
Joy Willard
Director of Quality, Regulatory and Clinical Affairs
Phone: (984) 777-5296
Email: Joy@neauvia-us.com
1.Intended Use
PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
2. Device Description
PLASMA IQ 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 a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
4
3. Performance Testing
No performance testing data was provided in this submission other than what was provided in the predicate (K212329) to establish substantial equivalence.
| Trade Name | Submission Device | Predicate Device K212329 |
|---|---|---|
| Manufacturer | Berger & Kraft Medical | Berger & Kraft Medical |
| 510(k) # | Pending | K212329 |
| Indications | Used in the removal and | |
| destruction of skin lesions and | ||
| coagulation of tissue. | Used in the removal and destruction of | |
| skin lesions and coagulation of tissue. | ||
| Mode of | ||
| Operation | Plasma | Plasma |
| Output | Monopolar | Monopolar |
| Power | ||
| Supply | 110 - 250 VAC | |
| 50/60 Hz | 110 – 250 VAC | |
| 50/60 Hz | ||
| Frequency | 40 kHz | 40 kHz |
| Max Output | ||
| Power | 5 W | 5 W |
| Output | ||
| Impedance | 54,000 | 54,000 |
| System | ||
| Components | System consists of a handpiece that | |
| incorporates the electrosurgical | ||
| generator unit, Charging Station and | ||
| two active electrode designs | System consists of a handpiece that | |
| incorporates the electrosurgical | ||
| generator unit, Charging Station and two | ||
| active electrode designs | ||
| ElectricalSafety | ||
| Standards | Complies with EN60601-1, EN60601- | |
| 1-2, EN60601-2-2 | Complies with EN60601-1, EN60601-1-2, | |
| EN60601-2-2 |
4. Substantial Equivalence to the Predicate Device
5. Substantial Equivalence to the Reference Device
| Trade Name | Submission Device | SubNovii |
|---|---|---|
| K201738 |
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| 510K number | Pending | K201738 |
|---|---|---|
| Mode of Operation | Plasma | Plasma |
| Output | Monopolar | Monopolar |
| Power Supply | 110 - 250 VAC | |
| 50/60 Hz | 110 - 250 VAC | |
| 50/60 Hz | ||
| Frequency | 40 kHz | 40 kHz |
| Max Output Power | 5 W | 5 W |
| Output Impedance | 54,000 | 54,000 |
| System Components | System consists of a handpiece that incorporates the electrosurgical generator unit, Charging Station and 2 Electrodes | System consists of a handpiece that incorporates the electrosurgical generator unit, Charging Station and 2 Electrodes |
| ElectricalSafety Standards | Complies with EN60601-1, EN60601-1-2, EN60601-2-2 | Complies with EN60601-1, EN60601-1-2, EN60601-2-2 |
6. Conclusion
The Plasma IQ that is subject to this submission is the same device that was cleared in K212329. No changes have been made to this device.
The Plasma IQ is substantially equivalent to the predicate device. The intent of this submission is to amend the labeling to remove a contraindication. There are no new questions regarding safety or effectiveness raised by the change in the labeling.