(56 days)
No
The summary describes a standard electrosurgical handpiece that delivers helium plasma. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is intended for cutting, coagulation, and ablation of soft tissue during surgical procedures, which are therapeutic actions.
No
The device is described as an electrosurgical accessory intended for cutting, coagulation, and ablation of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device is a physical handpiece with a retractable blade, designed for use with electrosurgical generators. The description details its mechanical components and physical interactions with tissue, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures." This describes a surgical tool used directly on a patient's tissue in vivo.
- Device Description: The description details a handpiece that delivers helium plasma for surgical procedures. It mentions a retractable cutting blade and activation trigger, all consistent with a surgical instrument used on a living organism.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any analysis of specimens or diagnostic purposes.
Therefore, the Renuvion®/J-Plasma® Precise Handpiece is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Renuvion®/J-Plasma® Precise Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Precise Handpiece is available with a retractable cutting tip blade for excising tissue. The blade tip serves as an electrode to generate helium plasma.
The blade can be extended in 2mm increments from 0 to 10mm from the distal tip of the shaft via a ratcheted slider and retracted via a release latch. The device is activated via pressing the purple activation trigger. The handpiece is to be used with compatible electrosurgical generators, BVX-200H or BVX-200P, manufactured by Apyx Medical.
The Renuvion®/J-Plasma® Precise Handpiece is available in a 33 cm length for use in laparoscopic or open surgical procedures. The 33 cm is a standard length for laparoscopic instruments and are compatible with standard 5 mm trocars.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Bench Testing:
- Mechanical Performance & Functionality: Verify Mechanical functionality of the Renuvion®/J-Plasma® Precise Handpiece. Result: Mechanical functionality requirements met.
- Tissue Effect (Plasma Activation): Verify that the tissue effects are the similar between the subject device and the Primary Predicate device (K183610 & K151325). Result: Tissue effects are equivalent between the subject device and Primary Predicate device.
- Tissue Effect (Monopolar Coagulation): Verify that the tissue effects are the similar between the subject device and the Reference device (K183610 & K170188). Result: Tissue effects are equivalent between the subject device and Reference device.
Electrical Safety and Electromagnetic Compatibility (EMC):
- Tested in accordance with IEC 60601-1, and IEC 60601-2-2 standards for safety and IEC 60601-1-2 standard for EMC.
- Result: The subject device was determined to be in conformance with these standards.
Biocompatibility Testing:
- Conducted in accordance with the FDA guidance; "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process."
- Battery of evaluations included: Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Hemolysis, Material Mediated Pyrogen/Pyrogenicity.
- Result: Biocompatibility has been established per ISO 10993 guidelines for this category. Biocompatibility verification testing was satisfactorily conducted for the subject 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.
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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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30, 2019
Apyx Medical Corporation (formerly Bovie Medical) Dr. Topaz Kirlew Vice President OA & RA 5115 Ulmerton Road Clearwater, Florida 33760
Re: K191484
Trade/Device Name: Renuvion/J-Plasma Precise Handpiece (Model # BVX-330 BPS) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 4, 2019 Received: June 4, 2019
Dear Dr. Kirlew:
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.
1
542 of the Act); 21 CFR 1000-1050.
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 and Part 809: 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-
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191484
Device Name
Renuvion®/J-Plasma® Precise Handpiece (BVX-330 BPS)
Indications for Use (Describe)
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium plasma for cutting, coagulation of soft tissue during open and laparoscopic surgical procedures. The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.
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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Image /page/3/Picture/0 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange with a blue triangle in the upper left corner of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The TM symbol is in the upper right corner of the logo.
1. General Information:
| Submitted by: | Apyx Medical Corporation (formerly Bovie Medical)
5115 Ulmerton Road
Clearwater, Florida 33760 -4004
United States of America |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration #: | 3007593903 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Dr. Topaz Kirlew, Vice President, QA & RA
5115 Ulmerton Road
Clearwater, Florida 33760 -4004
United States of America
Phone: (727) 803-8617
Email: topaz.kirlew@apyxmedical.com |
| Date Prepared: | July 30, 2019 |
| Trade Names (Model Number): | Renuvion®/J-Plasma® Precise Handpiece
(BVX-330 BPS) |
| Common Name: | Electrosurgical Handpiece |
| Classification: | Class II per 21CFR 878.4400 - Electrosurgical
Cutting and Coagulation Device and Accessories
Product Code GEI |
| Predicate Devices: | Primary Predicate Device
Renuvion®/ J-Plasma® Precise Handpiece (K183610 &
K151325) |
| | Reference Device
Renuvion®/ J-Plasma® Precise Open Handpiece
(K183610 & K170188) |
2. Intended Use / Indications for Use:
The Renuvion®/J-Plasma® Precise Handpiece is intended to be used with compatible electrosurgical generators for the delivery of helium plasma for cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.
The Renuvion®/J-Plasma® Precise Handpiece is compatible with the Electrosurgical Generators BVX-200H and BVX-200P manufactured by Apyx Medical.
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Image /page/4/Picture/0 description: The image shows the logo for Apyx Medical. The logo consists of the word "Apyx" in orange, with a blue triangle in the upper left corner of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are bright and eye-catching.
3. Device Description Renuvion/J-Plasma Precise Handpiece:
The Renuvion®/J-Plasma® Precise Handpiece is a sterile, single use electrosurgical accessory intended to be used in conjunction with compatible electrosurgical generators for the delivery of helium gas plasma for cutting, coagulating, and ablating soft tissue. The compatible Generators operate at an adjustable power of up to 40W (expressed as 0-100% where 100% is 40W) and provide an adjustable helium gas flow of 1-5 LPM. The Renuvion/J-Plasma Precise Handpiece is available with a retractable cutting tip blade for excising tissue. The blade tip serves as an electrode to generate helium plasma.
The blade can be extended in 2mm increments from 0 to 10mm from the distal tip of the shaft via a ratcheted slider and retracted via a release latch. The device is activated via pressing the purple activation trigger. The handpiece is to be used with compatible electrosurgical generators, BVX-200H or BVX-200P, manufactured by Apyx Medical.
The Renuvion®/J-Plasma® Precise Handpiece is available in a 33 cm length for use in laparoscopic or open surgical procedures. The 33 cm is a standard length for laparoscopic instruments and are compatible with standard 5 mm trocars.
4. Technological Characteristics:
The subject device, Renuvion®J-Plasma® Precise Handpiece (without the transformer) is a modification to the legally marketed Primary Predicate Device (K183610 & K151325) with the same name. The modification consists of a design change to remove the transformer from the base of this pistol shaped handpiece (HP) and the addition of the Monopolar Coagulation mode. This removal of the transformer from the handpiece is being implemented to improve manufacturability and device ergonomics. There is no change to the handpiece geometry or shaft length, no change to materials and no technology or performance change other than changes in product specifications. There is no change to the Indications for Use or operational principles.
The Subject, Primary Predicate and Reference devices all use the same basic technology, deliver the same J-Plasma helium plasma energy and are compatible only with the Electrosurgical Generators (BVX-200H and BVX-200P) manufactured by Apyx Medical.
The removal of the transformer from the subject device handpiece improves ergonomics since it is 39% lighter than the Primary Predicate device (K183610 & K151325) and improves manufacturability (efficiency, cost and speed).
The removal of the transformer from the handpiece does not affect the functionality of the handpiece because the compatible electrosurgical generators (BVX-200H and BVX-200P) have transformers already built into them and are capable of supporting the subject device without any changes to these generators. The Reference Device (Renuvion/J-Plasma Precise Open Handpiece, K183610 & K170188) also functions by using the transformer in the
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Image /page/5/Picture/0 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a small blue triangle replacing the "A". Below "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, with a focus on the company name.
electrosurgical generator resulting in the following identical characteristics being shared with the subject device:
- . The internal transformer located at the base of the handpiece has been removed.
- 트 Availability of the Monopolar Coagulation feature (via optional foot pedal) for enhanced coagulation - gives the user the ability to use the Monopolar Coagulation mode on the compatible electrosurgical generator without having to switch to a secondary electrode handpiece.
- . Can access 'Contact J-Plasma' by double clicking the button or foot pedal which tells the compatible electrosurgical generator that the intention is to cut (this feature on the compatible electrosurgical generators was cleared in K170188).
Bench testing has demonstrated that the tissue effect of the subject device and the Primary Predicate device (Renuvion/J-Plasma Precise Handpiece, K183610 & K151325) using the J-Plasma mode are equivalent and bench testing has also demonstrated that the tissue effect of the subject device and the Reference device (Renuvion/J-Plasma Precise Open Handpiece, K183610 & K170188) using the Monopolar Coagulation mode are equivalent. The results of design validation demonstrate that the tissue effect meets the user needs for cutting, coagulation and ablation of soft tissue.
The Apyx J-Plasma Precise Handpiece is pictured below with the circled area depicting the location at the base of the handpiece where the transformer has been removed.
Image /page/5/Figure/9 description: The image shows a medical device with several labeled parts. The device has a long, thin shaft extending from a handle. The handle features an advance slider, an activation button, and a slider release. The image also points out that the device has no transformer and a connector cable.
5. Performance Data:
a) Bench Testing
All testing performed on the subject device, Renuvion®/J-Plasma® Precise Handpiece (without transformer), was derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in
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Image /page/6/Picture/0 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle replacing the left side of the "A". Below "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, with a focus on the company name.
accordance with Apyx Medical's design and development procedures. The test methodology and acceptance criteria were developed from the same standards and internal Design and Development procedures used for clearance of the Primary Predicate and Reference devices.
Performance testing to assure that the subject device met performance requirements was conducted in accordance with protocols to verify design specifications. The testing performed is summarized in the following table:
| Test | Objective | Result |
|---|---|---|
| Mechanical | ||
| Performance & | ||
| Functionality | Verify Mechanical functionality of the | |
| Renuvion®/J-Plasma® Precise Handpiece | Mechanical functionality | |
| requirements met | ||
| Tissue Effect | ||
| (Plasma | ||
| Activation) | Verify that the tissue effects are the similar | |
| between the subject device and the Primary | ||
| Predicate device (K183610 & K151325) | Tissue effects are equivalent | |
| between the subject device | ||
| and Primary Predicate | ||
| device | ||
| Tissue Effect | ||
| (Monopolar | ||
| Coaqulation) | Verify that the tissue effects are the similar | |
| between the subject device and the Reference | ||
| device (K183610 & K170188) | Tissue effects are equivalent | |
| between the subject device | ||
| and Reference device |
b) Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device. Renuvion/J-Plasma Precise Handpiece (without transformer). The handpiece complies with the IEC 60601-1, and IEC 60601-2-2 standards for safety and the IEC 60601-1-2 standard for EMC. The subject device, Renuvion/J-Plasma Precise Handpiece (without transformer), was determined to be in conformance with these standards.
c) Biocompatibility Testing
The biocompatibility evaluation for the subject device, Renuvion/J-Plasma Precise Handpiece (without transformer), was conducted in accordance with the FDA guidance; "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process." The Biocompatibility testing for the patient and user contacting materials for the subject device, Renuvion/J-Plasma Precise Handpiece (without transformer), was either conducted or was previously submitted to the FDA in 510(k)s cleared under the Primary Predicate and Reference devices (K183610, K151325 & K170188). The battery of evaluations included the following testing:
- Cytotoxicity ■
- Sensitization
- 트 Irritation
- 트 Systemic toxicity
- Hemolysis ■
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Image /page/7/Picture/1 description: The image shows the logo for Apyx Medical. The logo features the word "Apyx" in orange, with a blue triangle in place of the letter "A". Below the word "Apyx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are bright and eye-catching.
- Material Mediated Pyrogen/Pyrogenicity
The Renuvion/J-Plasma Precise Handpiece (subject device) is an external communicating device with an indirect blood path contact for a duration of less than 24 hours. Biocompatibility has been established per ISO 10993 guidelines for this category. Biocompatibility verification testing was satisfactorily conducted for the subject device.
6. Substantial Equivalence:
| Subject Device | 1º Predicate Device | Reference Device | |
|---|---|---|---|
| Feature/ | |||
| Characteristic | Renuvion®/J-Plasma | ||
| Precise HP | |||
| (without transformer) | Renuvion®/J-Plasma | ||
| Precise HP | |||
| (K138610 & K151325) | Renuvion®/J-Plasma | ||
| Precise Open HP | |||
| (K138610 & K170188) | |||
| Intended Use | Same | Same | Similar |
| Energy Source | RF Generator; Only with | ||
| Bovie/Apyx J-Plasma | |||
| Generators | Same | Same | |
| Location of | |||
| Transformer | Electrosurgical | ||
| Generator | Handpiece | Electrosurgical | |
| Generator | |||
| Handpiece weight | 221.3 g | 362.8 g | N/A |
| Energy Type | Helium gas plasma; | ||
| Monopolar coagulation | Helium gas plasma | Helium gas plasma; | |
| Monopolar coagulation | |||
| Output | Monopolar | Same | Same |
| Plasma settings | Maximum 40 watts, 1-5 | ||
| LPM gas flow | Same | Same | |
| Monopolar | |||
| Coagulation Mode | |||
| & Settings | Yes; Maximum 120 | ||
| watts, 1-5 lpm gas flow | No - feature not | ||
| available | Yes; Maximum 120 | ||
| watts, 1-5 lpm gas flow | |||
| Monopolar | |||
| Coagulation Tissue | |||
| Effect | Same | N/A - feature not | |
| available | Same | ||
| Plasma Activation | |||
| Tissue Effect | Same | Same | N/A |
| Device Activation | Hand Activation with 1 | ||
| button (J-Plasma) or | |||
| optional Foot Activation | |||
| with 2-foot pedals (J- | |||
| Plasma, monopolar | |||
| coagulation) | Hand Activation with 1 | ||
| button (J-Plasma) | Hand Activation with 2 | ||
| buttons (J-Plasma, | |||
| monopolar coagulation) | |||
| or optional Foot | |||
| Activation with 2-foot | |||
| pedals (J-Plasma, | |||
| monopolar coagulation) | |||
| System | |||
| Components | Same | Same | Same |
| User Interface | Straight | Same | Same |
| Connector | Company Proprietary - | ||
| per design change | |||
| reflected in K183610 | |||
| that establishes both | Same | Same |
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Image /page/8/Picture/0 description: The image shows the logo for Apyx Medical. The logo consists of the word "Apyx" in orange, with a blue triangle in the negative space of the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The "TM" symbol is in the upper right corner of the logo.
| Feature/
| Characteristic | Subject Device | 1° Predicate Device | Reference Device |
|---|---|---|---|
| Renuvion®/J-Plasma | |||
| Precise HP | |||
| (without transformer) | Renuvion®/J-Plasma | ||
| Precise HP | |||
| (K138610 & K151325) | Renuvion®/J-Plasma | ||
| Precise Open HP | |||
| (K138610 & K170188) | |||
| pneumatic seal and | |||
| electrical connection |
7. Conclusion:
The subject device, Renuvion® / J-Plasma® Precise Handpiece (without the transformer), has the same intended use, indications for use, operational principles, device ergonomics, handle geometry, handpiece geometry, and shaft length as the originally designed Primary Predicate device (Renuvion/J-Plasma Precise Handpiece, K183610 & K151325) of the same name.
The technological difference between the subject and Primary Predicate devices is the physical location of the transformer (moved from the handpiece to the electrosurgical generator) to reduce weight for easier handling as well as improve manufacturability, and availability of the Monopolar Coagulation feature (via optional foot pedal) to give the user the ability to use the Monopolar Coagulation mode on the compatible electrosurgical generator without having to switch to a secondary electrode handpiece. Bench testing has demonstrated that the tissue effects of the subject device are equivalent to the tissue effects of the Primary Predicate device (Renuvion/J-Plasma Precise Handpiece, K183610 & K151325) in the J-Plasma mode and the tissue effects of the subject device are also equivalent to the Reference device (Renuvion/J-Plasma Precise Open Handpiece, K183610 & K170188) in the Monopolar Coagulation mode.
The subject device's safety and performance have been confirmed by results of the performance bench testing and the design change has gone through the design controls process and the proper verification and validation demonstrate that the device performs as intended. Therefore, there are no differences that would raise new or different questions regarding safety or effectiveness as the subject device, Primary Predicate device and the Reference device all operate in a similar manner with an equivalent range of tissue treatment parameters.