(98 days)
No
The summary describes a standard electrosurgical device using radiofrequency energy and helium gas plasma for cutting and coagulation. There is no mention of any computational processing, algorithms, or learning capabilities that would indicate the presence of AI or ML. The performance studies focus on thermal effects, electrical safety, EMC, and biocompatibility, not algorithmic performance.
Yes
The device is used for electrosurgical cutting and coagulation of soft tissue, which are therapeutic interventions during surgical procedures.
No
Explanation: The device is described as an electrosurgical device used for cutting, coagulation, and ablation of soft tissue, primarily for therapeutic purposes during surgical procedures, not for diagnosing medical conditions.
No
The device description clearly outlines a physical handpiece with an extendable electrode, cable, and introducer, which are hardware components. It also mentions compatibility with and activation by physical generators and footswitches.
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 "electrosurgical cutting, coagulation of soft tissue" during "minimally invasive surgical procedures." This describes a therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details how the device delivers energy and gas plasma to tissue for cutting, coagulation, and ablation. This is a direct interaction with the patient's body for treatment purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on tissue thermal effects, electrical safety, EMC, and biocompatibility – all relevant to a surgical device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.
The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. The compatible Generators operate at an adjustable power of up to 40 W (expressed as 0-100% where 100% is 40 W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.
The J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch.
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
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)
a. Bench Testing
All testing protocols performed on the subject device, J-Plasma Precise® Flex Handpiece, were derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in accordance with Apyx Medical's design and development procedures. Both the predicate and the modified subject device are designed by the same manufacturer, Apyx Medical (formerly Bovie Medical). The test methodology and acceptance criteria were developed from the same standards and following Apyx Medical's Design and Development procedures, in compliance with the Design and Development requirements of 21 CFR 820.30.
b. Tissue Thermal Effect Equivalency Test
An ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney) to compare the tissue thermal effect of the J-Plasma Precise® Flex and the predicate device. The quantitative results of this testing demonstrated that the tissue effects the subject device is equivalent to the predicate device's effect over a range of power and flow settings that are clinically relevant.
c. Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the J-Plasma Precise® Flex. The handpiece complies with the ANSI/AAMI/IEC 60601-1:2005/(R)2012 and A1:2012, and AAMI/ANSI/IEC 60601-2-2:2017 standards for safety and the AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standard for EMC. The J-Plasma Precise® Flex was determined to be in conformance with these standards.
Key Results:
- Mechanical Verification & Functionality: Mechanical functionality requirements were all met.
- Tissue Effect (Plasma Activation): The depth and lateral spread (i.e. average length and width) of thermal tissue effects were demonstrated to be equivalent between the subject device and Predicate device across all tissue types and J-Plasma energy settings.
- Tissue Effect (Monopolar Coagulation): The depth and lateral spread (i.e. average length and width) of thermal tissue effects were demonstrated to be equivalent between the subject device and Predicate device across all tissue types and Monopolar Coagulation energy settings.
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 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 the logos of the Department of Health & Human Services and the U.S. Food & 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 in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".
January 4, 2021
Apyx Medical Corporation (formerly Bovie Medical Corporation) Topaz Kirlew Vice President, Quality Assurance & Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004
Re: K202880
Trade/Device Name: J-Plasma Precise FLEX Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 25, 2020 Received: September 28, 2020
Dear Topaz 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/cdrl/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
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 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 (OS) 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-devices/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 (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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202880
Device Name J-Plasma Precise® FLEX (APYX-500BF)
Indications for Use (Describe)
The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma energy) for electrosurgical cutting, coagulation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.
The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.
| 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/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. A small blue triangle is incorporated into the "A" of "Apyx." Below "Apyx" is the word "MEDICAL" in blue, smaller, block letters.
K202880
| 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 | ||
| Applicant Contact: | Lauren Tiller, Senior Regulatory Affairs Specialist III | ||
| 5115 Ulmerton Road | |||
| Clearwater, Florida 33760-4004 | |||
| United States of America | |||
| Phone: (727) 803-8550 | |||
| Email: Lauren.Tiller@apyxmedical.com | |||
| Correspondent Contact: | Dr. Topaz Kirlew, MBA, Vice President, Quality | ||
| Assurance & Regulatory Affairs | |||
| 5115 Ulmerton Road | |||
| Clearwater, Florida 33760-4004 | |||
| United States of America | |||
| Phone: (727) 803-8617 | |||
| Email: Topaz.Kirlew@apyxmedical.com | |||
| Date Prepared: | December 4, 2020 | ||
| Trade Names (Model Number): | J-Plasma Precise® FLEX Handpiece | ||
| (APYX-500BF) | |||
| Common Name: | Electrosurgical Handpiece | ||
| Classification: | Class II per 21CFR 878.4400 - Electrosurgical | ||
| Cutting and Coagulation Device and Accessories | |||
| Product Code: GEI | |||
| Predicate Device(s): | Predicate Device | ||
| Bovie J-Plasma Precise® Flex (K170777) |
2. Indications for Use
The J-Plasma Precise® FLEX is used for the delivery of radiofrequency energy and/or helium gas plasma (J-Plasma energy) for electrosurgical cutting, coagulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures.
The J-Plasma Precise® FLEX is compatible with Apyx Medical electrosurgical generators.
4
Image /page/4/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. The "A" in "Apyx" has a small, dark blue triangle in the lower-left corner. Below "Apyx" is the word "MEDICAL" in a bold, dark blue font, with a thin, dark blue line underneath.
K202880
3. Device Description
The J-Plasma Precise® Flex Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the delivery of radiofrequency ("RF") energy and/or helium gas plasma for electrosurgical cutting, coaqulation, and ablation of soft tissue. It is intended for use with a grasper during minimally invasive surgical procedures. The handpiece has one configuration, model # APYX-500BF. The compatible Generators operate at an adjustable power of up to 40 W (expressed as 0-100% where 100% is 40 W) and provide an adjustable helium gas flow of 1-5 LPM. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation.
The J-Plasma Precise® Flex Handpiece has an extendable electrode (blade) in the tip to generate helium plasma. The tip is controlled by the user via graspers to actuate (extend and retract) the blade. The handpiece comes with an Introducer that allows for more control of the tip when introducing and removing the distal end to and from the cannula. The handpiece has a flexible, seamless cable that can be advanced with graspers through the cannula during minimally invasive surgical procedures. The handpiece is activated by the footswitch. The J-Plasma Precise® Flex System with all components and accessories is depicted in Figure 1 below:
Image /page/4/Picture/8 description: The image shows a medical device called J-Plasma. The device consists of a generator (ESU), a helium tank with a regulator, a footswitch, a grounding pad, and a handpiece with an introducer and cable. The generator has a display showing the numbers 8, 20, and 40.
Figure 1: J-Plasma Precise® FLEX System
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Image /page/5/Picture/2 description: The image shows the logo for Aryx Medical. The logo features the word "Aryx" in orange, with a small blue triangle replacing the "A". Below the word "Aryx" is the word "MEDICAL" in blue. The logo is simple and modern, and the colors are eye-catching.
K202880
4. Technological Characteristics
The J-Plasma Precise® Flex Handpiece is a modification to the predicate device that was cleared in K170777 (Bovie J-Plasma Precise® Flex Handpiece). There are no changes to intended use, indications for use, operational principles, energy type, tissue treatment effects, performance specifications, electrosurgical modes, output power waveforms, maximum power settings, and plasma settings that change the energy delivered to the tissue.
The J-Plasma Precise® Flex Handpiece, as compared to the predicate device (K170777), has only the following differences in technological characteristics:
- . Blade actuation, extension, and retraction is now in the distal end of the device
- Blade configuration will now extend a maximum of 5 mm .
- Seamless, working length of the cable
- . Addition of the Introducer, as a tip gasping aid/accessory
- . Updated One-Wire Programmability for compatibility with the upgraded APYX-JS3/RS3 (Upgrades cleared under K192867)
The J-Plasma Precise® Flex Handpiece with its components is pictured below in Figures 2 and 3:
Image /page/5/Figure/14 description: The image shows a medical device with several labeled parts. The device includes a cable connected to a plug, which leads to an introducer. At the end of the introducer, there is a blade and a tip with grasping features, indicating its use in surgical or medical procedures.
Figure 2: J-Plasma Precise® FLEX (Subject Device)
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Image /page/6/Picture/0 description: The image shows the logo for Apyx Medical. The logo is comprised of the word "Apyx" in orange, with a blue triangle replacing the "A". Below the word "Apyx" is the word "MEDICAL" in blue. The "TM" symbol is in the upper right corner of the logo.
Image /page/6/Picture/5 description: The image shows a medical device with labels pointing to different parts. The top part of the device is labeled as the "Introducer" and the "Tip". The bottom part of the device is labeled as the "Secondary Grasping Location", "Blade", and "Operative Grasping Location".
Figure 3: J-Plasma Precise® FLEX Introducer, Tip Configuration, and Grasping Features (Subject Device)
Results of verification and validation testing demonstrate that the J-Plasma Precise® Flex Handpiece is equivalent in safety and effectiveness to the predicate device, as described below.
5. Performance Data
a. Bench Testing
All testing protocols performed on the subject device, J-Plasma Precise® Flex Handpiece, were derived from the risk assessment in accordance with ISO 14971 which evaluated the safety and effectiveness of the design modification in accordance with Apyx Medical's design and development procedures. Both the predicate and the modified subject device are designed by the same manufacturer, Apyx Medical (formerly Bovie Medical). The test methodology and acceptance criteria were developed from the same standards and following Apyx Medical's Design and Development procedures, in compliance with the Design and Development requirements of 21 CFR 820.30. The testing performed are summarized in table below.
b. Tissue Thermal Effect Equivalency Test
An ex-vivo study was conducted on several tissue types (i.e., muscle, liver, kidney) to compare the tissue thermal effect of the J-Plasma Precise® Flex and the predicate device. The quantitative results of this testing demonstrated that the tissue effects the subject device is equivalent to the predicate device's effect over a range of power and flow settings that are clinically relevant. This ex-vivo testing is summarized in the table below.
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Image /page/7/Picture/2 description: The image shows the logo for Apyx Medical. The logo is primarily orange, with the word "Apyx" in a stylized font. A small, dark blue triangle is positioned to the left of the "A" in "Apyx." Below "Apyx," the word "MEDICAL" is written in a bold, dark blue font.
K202880
| Test | Objective | Result |
|---|---|---|
| Mechanical | ||
| Verification & | ||
| Functionality | Verify Mechanical functionality of the J- | |
| Plasma Precise® Flex | Mechanical functionality | |
| requirements were all met. | ||
| Tissue Effect | ||
| (Plasma | ||
| Activation) | Verify that the tissue effects for Plasma | |
| Activation are similar between the | ||
| subject device and the Predicate device | ||
| (K170777) using 3 different tissue types | ||
| (Muscle, Kidney & Liver) | The depth and lateral spread | |
| (i.e. average length and width) | ||
| of thermal tissue effects were | ||
| demonstrated to be equivalent | ||
| between the subject device | ||
| and Predicate device across | ||
| all tissue types and J-Plasma | ||
| energy settings. | ||
| Tissue Effect | ||
| (Monopolar | ||
| Coagulation) | Verify that the tissue effects of the | |
| subject device and the Predicate device | ||
| (K170777) are the same for Monopolar | ||
| Coagulation using 3 different tissue | ||
| types (Muscle, Kidney & Liver) | The depth and lateral spread | |
| (i.e. average length and width) | ||
| of thermal tissue effects were | ||
| demonstrated to be equivalent | ||
| between the subject device | ||
| and Predicate device across | ||
| all tissue types and Monopolar | ||
| Coagulation energy settings. |
c. Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the J-Plasma Precise® Flex. The handpiece complies with the ANSI/AAMI/IEC 60601-1:2005/(R)2012 and A1:2012, and AAMI/ANSI/IEC 60601-2-2:2017 standards for safety and the AAMI/ANSI/IEC 60601-1-2:2014 (4th Edition) standard for EMC. The J-Plasma Precise® Flex was determined to be in conformance with these standards.
6. Biocompatibility Testing
The biocompatibility evaluation for the J-Plasma Precise® Flex Handpiece was conducted in accordance with the June 16, 2016 FDA Guidance, "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the ISO 10993-1 Fifth edition 2018-08 standard. "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process".
The J-Plasma Precise® Flex 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.
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Image /page/8/Picture/2 description: The image shows the logo for Apyx Medical. The logo is orange and blue. The word "Apyx" is in orange, with a blue triangle in place of the letter "A". Below the word "Apyx" is the word "MEDICAL" in blue.
K202880
7. Substantial Equivalence
| Feature /
Characteristic | Bovie J-Plasma Precise Flex
(Predicate Device)
K170777 | J-Plasma Precise FLEX
(Subject Device) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Bovie J-Plasma Precise® Flex
Handpiece is used for the delivery
of radiofrequency energy and/or a
helium gas plasma for
electrosurgical cutting, coagulation,
and ablation of soft tissue. It is
intended for use with grasping
instruments during minimally
invasive surgical procedures.
The Bovie J-Plasma Precise Flex
Handpiece is compatible with
Bovie Ultimate Generators BVX- | The J-Plasma Precise® FLEX is
used for the of radiofrequency
energy and/or helium gas
plasma (J-Plasma energy) for
electrosurgical cutting,
coagulation, and ablation of soft
tissue. It is intended for use with
a grasper during minimally
invasive surgical procedures.
The J-Plasma Precise® FLEX is
compatible with Apyx Medical
electrosurgical generators. |
| Procedures | 200H and BVX-200P.
Laparoscopic or minimally invasive
surgical procedures | Same |
| Energy Source | Apyx Generator | Same |
| Energy Type | Monopolar RF energy via Helium
Plasma (helium facilitates the use
of low current RF waveform) | Same |
| Output | Monopolar | Same |
| Plasma settings | Maximum 40 watts, 1-5 lpm gas
flow | Same |
| Plasma Activation
Tissue Effect | Same | Same |
| Monopolar Coagulation
Mode | Yes | Same |
| Monopolar Coagulation
Settings | Maximum 120 watts, 1-5 lpm gas
flow | Same |
| Monopolar Coagulation
Tissue Effect | Same | Same |
| System Components | The Bovie J-Plasma Precise Flex
System consists of:
- Apyx Medical (formerly Bovie
Medical) Generator - Disposable handpiece
- Foot pedal
- Power cord
- Gas regulator
- Gas cylinder | Same |
| User Interface | Footswitch activation and
generator buttons and displays. | Same |
| Connector | Company Proprietary Plug
Connector involving 6 electrical | Same |
| Feature /
Characteristic | Bovie J-Plasma Precise Flex
(Predicate Device)
K170777 | J-Plasma Precise FLEX
(Subject Device) |
| | pins and 1 pneumatic connection
in the center to provide helium gas | |
| Shaft Design | Flexible | Same |
| Shaft Outer Diameter | 8 mm | Same |
| Total Distance from Tip
to Plug | 3,251.2 mm total distance from tip
to the plug | Same |
| Tip Configuration | Extendable Blade or Needle | Extendable Blade |
| Blade Extension | Maximum 10 mm | Maximum 5 mm |
| Blade Width x Thickness | 1.6 mm x 0.4 mm | 1.8 mm x 0.4 mm |
| Tip Protector | Ceramic nozzle | Same |
| Blade Actuation | Proximal Actuation | Distal Actuation |
| Device Activation | Footswitch activation only,
no hand activation | Same |
| Grasping Feature | Yes | Same |
| Tip grasping
aid/accessory | None | Introducer |
| Generator Compatibility | Compatible Bovie Medical
Electrosurgical Generators | Compatible Apyx Medical
(formerly Bovie Medical)
Electrosurgical Generators |
| One-Wire Proximal Chip | ETO Sterilizable | Same |
| Biocompatibility
Materials | All patient contacting materials are
biocompatible | Same |
| Sterility | Single-use disposable sterile
handpieces | Same |
| Electrical Safety | Complies with IEC Electrical Safety
Standards:
IEC 60601-1
IEC 60601-1-2
IEC 60601-2-2 | Same |
9
K202880
The subject device has the same indications for use, operational principle, and technological characteristics as the predicate device. The conclusions drawn from the bench and pre-clinical testing demonstrate that the J-Plasma Precise® Flex Handpiece is substantially equivalent in terms of safety and effectiveness to the legally marketed predicate device for the same indications. Functional and mechanical verification testing demonstrate that the J-Plasma Precise® Flex Handpiece performs as intended in the specified use conditions.
8. Conclusion
The subject device, J-Plasma Precise® FLEX, has the same intended use, indications for use, operational principles, energy type, tissue treatment effects, performance specifications, electrosurgical modes, output power waveforms, maximum power settings, and plasma settings as the originally designed predicate device (Bovie J-Plasma Precise® Flex, K170777).
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Image /page/10/Picture/2 description: The image shows the logo for Apyx Medical. The logo is comprised of 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. There is a thin blue line below the word "MEDICAL".
The technological differences between the subject and predicate device are the transfer of the blade actuation to the tip to create a seamless design of the cable, a reduction of the maximum blade length from 10 mm to 5 mm, the addition of an introducer as a tip grasping aid, and an updated one-wire programmability for compatibility with the upgraded APYX-JS3/RS3 (these generator upgrades were cleared under K192867). The subject device and the predicate device operate in a similar manner with the same range of energy settings; the modifications explained above accommodates the users' preferences and enhances the stability of the device. There are no differences that would raise new or different questions regarding safety or effectiveness, as the subject device and the predicate device operate in a similar manner with the same range of tissue treatment energy parameters.
The subject device's safety and performance have been confirmed by the results of the performance bench testing and the design change has gone through the design controls process and verification and validation testing to demonstrate that the device is as safe and effective as the predicate device (Bovie J-Plasma Precise® Flex, K170777).