(108 days)
None
No
The device description and performance studies focus on electrical and thermal effects, with no mention of AI/ML algorithms or data processing for decision-making.
Yes
The device is intended for the "removal and destruction of skin lesions and coagulation of tissue," which are direct medical interventions to treat a condition.
No
The device's intended use is for the removal and destruction of skin lesions and coagulation of tissue, which are therapeutic and not diagnostic procedures.
No
The device description clearly outlines hardware components including a handpiece, docking station, cables, power bank, and charging block, indicating it is a physical medical device, 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 for 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 description details a physical device that generates an electrical arc to cause controlled skin damage. This is a therapeutic or surgical intervention, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to diagnose diseases or conditions, monitor treatments, or screen for health issues by examining samples.
Therefore, the Plasma MD or Plasma + is a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.
Product codes (comma separated list FDA assigned to the subject device)
OVJ
Device Description
The Plasma Pen utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the disposable tip and the skin is created by a radio frequency generator housed in an electrosurqical unit (handpiece) that ionizes the gas particles in the air. A straight disposable tip is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
The system components include the following:
-
- Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
-
- Docking station for Plasma Pen
-
- Cable for Plasma Pen
-
- Power bank battery
-
- Cable for power bank battery
-
- Charging Block
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical performance testing:
Electrical Safety:
Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device.
Bench / Performance Testing -
Comparative performance testing included:
- Electrical system performance
- Output waveform at the rated load
- Testing for thermal effects on tissue in accordance with FDA Guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery"
The results demonstrated that the device performance was met and was substantially equivalent to the predicate device.
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 2, 2023
Plasma Concepts % Richelle Helman Senior Regulatory Consultant MEDIcept, LLC 200 Homer Avenue Ashland, Massachusetts 01721
Re: K223440
Trade/Device Name: Plasma Pen (Plasma MD); Plasma Pen (Plasma +) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: OVJ Dated: February 6, 2023 Received: February 6, 2023
Dear Richelle Helman:
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 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
1
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 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-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) and -CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-devices/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,
| Mark | Digitally signed by |
|---|---|
| Trumbore - | |
| S | Mark Trumbore -S |
| Date: 2023.03.02 | |
| 13:29:42 -05'00' |
On behalf of 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
2
Indications for Use
510(k) Number (if known) K223440
Device Name Plasma Pen (Plasma MD); Plasma Pen (Plasma +)
Indications for Use (Describe)
The Plasma MD or Plasma + is intended for 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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3
| Date: | 22-February-2023 |
|---|---|
| Company: | Plasma Concepts |
| 800 W Cummings Park | |
| Woburn, MA 01801 | |
| Phone: (617) 519-5570 | |
| Official Contact: | Richelle Helman |
| Senior Regulatory Consultant | |
| Proprietary or Trade Name: | Plasma MD and Plasma + |
| Common/Usual Name: | Electrosurgical cutting and coagulation device and accessories |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation Number: | 21 CFR 878.4400, Class II |
| Classification Product Code: GEI | |
| Predicate Device: | K201738: SubNovii Advanced Plasma Technology |
Device Description:
The Plasma Pen utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the disposable tip and the skin is created by a radio frequency generator housed in an electrosurqical unit (handpiece) that ionizes the gas particles in the air. A straight disposable tip is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.
The system components include the following:
-
- Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
-
- Docking station for Plasma Pen
-
- Cable for Plasma Pen
-
- Power bank battery
-
- Cable for power bank battery
-
- Charging Block
Image /page/3/Picture/12 description: The image shows six different objects, each labeled with a number from 1 to 6. Object 1 is a pen-like device, while object 2 is a stand. Objects 3 and 5 are cables with USB connectors on one end. Object 4 is a rectangular device with four small dots on its surface, and object 6 is a small, rectangular adapter.
4
Indications for Use:
The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.
Substantial Equivalence:
The Plasma Concepts Plasma Pen is substantially equivalent to the predicate device, the SubNovii Advanced Plasma Technology (510(k) K201738). The table below presents the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.
| Characteristic | Subject Device:
Plasma Pen | Predicate Device:
SubNovii Advanced
Plasma Technology
[510(k) K201738] | Substantial
Equivalence |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Prescription or OTC | Prescription | Prescription | SAME |
| Mode of Operation | Plasma
Radiofrequency energy
ionizes the air creating a
plasma stream | Plasma
Radiofrequency energy
ionizes the air creating a
plasma stream | SAME |
| Output | Monopolar | Monopolar | SAME |
| Power Supply | 110-250 VAC 50/60 Hz | 110-250 VAC 50/60 Hz | SAME |
| Frequency | 40 kHz | 40 kHz | SAME |
| Max Power Output | 2W | 5W | DIFFERENT
The subject device has a
lower max power output,
with intended effect still
achievable. Refer to
table SE.2 below for
additional details. |
| System Components | System consists of a
handpiece that
incorporates the
electrosurgical generator
unit, docking station, and
an active electrode. | System consists of a
handpiece that
incorporates the
electrosurgical generator
unit, docking station, and
an active electrode. | SAME |
5
| Characteristic | Subject Device:
Plasma Pen | Predicate Device:
SubNovii Advanced
Plasma Technology
[510(k) K201738] | Substantial
Equivalence |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------------------------------|----------------------------|
| Thermal Effects on 4
porcine tissues (liver,
kidney, muscle and skin)
per FDA Guidance
Premarket Notification
(510(K)) Submission for
Electrosurgical Devices for
General Surgery | Damage depth of