(157 days)
Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.
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.
I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML device, as the document describes a 510(k) submission for a non-AI medical device called "Plasma IQ" for electrosurgical cutting and coagulation.
The document discusses performance testing for electrical safety, tissue testing (thermal spread comparison), and packaging, but not for an AI/ML component. Therefore, there is no information in the provided text to address the following points:
- Acceptance criteria and reported device performance for an AI/ML device.
- Sample size for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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March 6, 2020
Neauvia North America, Inc Misty Williams Executive VP Regulatory & Clinical Affairs 8480 Honeycutt Rd Raleigh, North Carolina 27615
Re: K192813
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: February 3, 2020 Received: February 4, 2020
Dear Misty Williams:
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
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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 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.
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) K192813
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary - Plasma IQ
As required by 807.92(c)
Date Prepared: March 5, 2020
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: | K161134 - Bovie Derm 941, Electrosurgical GeneratorBovie Medical Corporation, Clearwater, FL |
Contact Information
Misty Williams Executive Vice President of Regulatory and Clinical Affairs Phone: (984) 777-5292 Email: misty(@neauvia-us.com
1. Intended Use
PLASMA IQ is used in the removal and destruction of skin lesions and the 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.
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3. Performance Testing
The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:
| Test | Objective | Results |
|---|---|---|
| Electrical | Compliance with EN 60601-1 | Pass |
| Electrical | Compliance with EN 60601-1-2 | Pass |
| Tissue Testing | Compare thermal spread ofdevices | Equivalent |
| Packaging | Compliance with EN 22248 | Pass |
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4. Substantial Equivalence
| Trade Name | Submission Device | Predicate Device - Bovie DERM 941Electrosurgical Generator |
|---|---|---|
| Manufacturer | Berger & Kraft | Bovie Medical Corporation |
| 510(k) # | K192813 | K161134 |
| Indications | Intended for the removal anddestruction of skin lesions andcoagulation of tissue | Intended for the removal and destruction of skinlesions and coagulation of tissue |
| Mode ofOperation | PlasmaRadiofrequency energy ionizesthe air creating a Plasma stream | Radiofrequency |
| Output | Monopolar | Monopolar |
| PowerSupply | 110-250 VAC50/60 Hz | 100-240 VAC50-60 Hz |
| Frequency | 40 kHz | 368 kHz |
| Max OutputPower | 5 W | 40 W |
| OutputImpedance | $54,000 \Omega$ | $200 \Omega$ |
| Waveform | Image: waveform | Image: waveform |
| SystemComponents | System consists of a handpiecethat incorporates theelectrosurgical generator unit,docking station, and an activeelectrode. | System consists of an electrosurgical generator unit,a handpiece, and dermal tips. |
| ElectricalSafetyStandards | Complies with IEC60601-1,IEC60601-1-2, IEC60601-2-2 | Complies with IEC60601-1, IEC60601-2*, andEN60529 |
*As listed in K170188 510(k) Summary
5. Conclusion
The predicate Bovie Derm 941 and the PLASMA IQ both produce RF energy to remove and destroy skin lesions and coagulate the tissue. The maximum output power of the Plasma IQ device is less than that of the Bovie Derm 941; however, the Plasma IQ and Bovie Derm 941 are substantially equivalent. There are no different questions of safety and effectiveness. Therefore, the subject device and predicate device are
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substantially equivalent. Tissue testing, electrical testing (EMC testing) and packaging testing meet the current standards.
§ 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.