(200 days)
Not Found
No
The summary describes a device using radiofrequency and ultrasound for therapeutic purposes. There is no mention of AI, ML, image processing, or any data-driven decision-making processes that would indicate the use of these technologies. The performance studies focus on bench testing and ex vivo models, not on training or testing AI/ML models.
Yes
The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, and increasing range of motion, which are therapeutic applications. Additionally, it is used for the removal and destruction of skin lesions and coagulation of tissue, which are also therapeutic interventions.
No
The device is intended for the removal and destruction of skin lesions, coagulation of tissue, pain relief, reduction of muscle spasms, localized increase in blood flow, and increase in range of motion. These are all therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of a main unit, two handpieces, foot switch, LCD touchscreen, and power cable, which are all hardware components. The summary also mentions hardware and software documentation and hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for the removal and destruction of skin lesions, coagulation of tissue, pain relief, reduction of muscle spasms, localized increase in blood flow, and increasing range of motion. These are all therapeutic procedures performed directly on the patient's body.
- Device Description: The device is described as an instrument used for tissue coagulation by means of high-frequency current and delivering therapeutic ultrasound waves. These are physical interventions applied to the patient.
- IVD Definition: In Vitro Diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
The device is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.
The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.
Product codes
GEI, IMI
Device Description
The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable.
The PLASONIC has two systems (two handpieces) :
-
- Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.
-
- Ultrasound (SONOPASS Handpiece)
The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin lesions for radiofrequency; not specified for ultrasound (targets muscle spasms, blood flow, joint range of motion).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professionals in a clinical setting
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 tests submitted:
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-2-2:2017/AMD1:2023 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
- IEC 60601-2-5:2009 for use with IEC 60601-1:2005. COR1:2006 COR2:2007. AMD1:2012 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment:
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests is evaluated in accordance with the FDA-recognized consensus standard
- IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability is evaluated in accordance with the FDA-recognized consensus standard
- IEC 62304:2006 Medical device software Software life cycle processes is evaluated according to the FDA-recognized consensus standard
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices is evaluated in accordance with the FDA-recognized consensus standard
- ISO 14971:2019 Medical devices Application of risk management to medical devices
- In the ex vivo model, the handpieces were applied in the same way as applied to the actual human body and the temperature change of the application site was analyzed through a thermal imaging camera. In addition, the length, width and depth of tissue coagulation at the application site were analyzed through photography and histological evaluation.
Clinical tests submitted:
No clinical test was performed.
Key results:
The non-clinical data for proposed device, including biocompatibility, bench testing, hardware and software documentation shows that the device should perform as intended in the specified use. In addition, the Electromagnetic Compatibility and Electrical Safety test shows that the device is safe to use and meets required standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
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, 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.
November 8, 2024
Hironic Co., Ltd. Gwijin Lee Assistant Manager 19F, U-TOWER, 767, Sinsu-ro, Suji-gu Yongin-si, Gyeonggi-do 16827 Korea, South
Re: K241099
Trade/Device Name: Plasonic (Plasonic) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, IMI Dated: October 11, 2024 Received: October 11, 2024
Dear Gwijin Lee:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Long H. Chen - S" in a large, clear font. To the right of the name, there is a statement indicating that the name was digitally signed by Long H. Chen - S. The date of the signature is provided as 2024.11.08 at 07:34:22, with a time zone offset of -05'00'.
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
3
Indications for Use
Submission Number (if known)
Device Name
PLASONIC (PLASONIC)
Indications for Use (Describe)
The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.
The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.
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/4/Picture/1 description: The image shows the logo for HIRONIC. The logo consists of a red square with a white arrow pointing to the right, followed by the word "HIRONIC" in black, block letters. The logo is simple and modern, and the colors are eye-catching.
510(k) Summary
This summary of 510(k) Safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
- Submitter Information - 807.92(a)(1)
| Applicant | Hironic Co., Ltd. |
|---|---|
| Address | 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do, |
| 16827, Republic of Korea | |
| Phone Number | +82-31-525-7000 |
| Fax Number | +82-31-525-7010 |
| Contact Person | Gwijin Lee |
| Contact Information | 19F, U-TOWER, 767, Sinsu-ro, Suji-gu, Yongin-si, Gyeonggi-do, |
| 16827, Republic of Korea | |
| t. +82-31-525-7000, m. +82-10-5049-2959, e. ra@hironic.com | |
| Preparation Date | Oct. 11th, 2024 |
Date 510(k) summary prepared: Oct. 11th, 2024
| Trade/Device Name | PLASONIC |
|---|---|
| Common Name | Electrosurgical System |
| Classification Name | Electrosurgical cutting and coagulation device and accessories |
| Product Code | GEI, IMI |
| Regulation Number | 21 CFR 878.4400 |
| Regulatory Class | II |
| Review Panel | General & Plastic Surgery (ODE) |
2. Device Name and Code - 807.92(a)(2)
- Legally marketed device(s) to which equivalence is claimed - 807.92(a)(3)
| Predicate Device - 1 | K223222
Applicant: Neauvia North America, Inc
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 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device - 2 | K230472
Applicant: Enraf-Nonius, B.V.
Trade/Device Name: Sonopuls 190
Regulation Number: 21 CFR 890.5300
Regulation Name: Ultrasonic Diathermy
Regulatory Class: Class II
Product Code: IMI |
| Predicate Device - 3 | K161628
Applicant: Bonutti Research, Inc.
Trade/Device Name: JAS Pulse™ Ultrasonic Therapy
Regulation Number: 21 CFR 890.5300
Regulation Name: Ultrasonic Diathermy
Regulatory Class: Class II
Product Code: IMI |
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Image /page/5/Picture/1 description: The image shows the word "HIRONIC" in a stylized font. The first letter, "H", is red and has a unique design with a square and an arrow-like shape. The rest of the letters, "IRONIC", are in black and have a rounded, sans-serif appearance. The logo is simple and modern.
4. Device Description - 807.92(a)(4)
The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable.
The PLASONIC has two systems (two handpieces) :
-
- Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.
-
- Ultrasound (SONOPASS Handpiece)
The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being
- Indication for Use - 807.92(a)(5)
-
Radiofrequency (Handpiece - PLAPASS) - Used in the removal and destruction of skin lesions and coagulation of tissue.
-
Ultrasound (Handpiece - SONOPASS)
- Indicated for Pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.
- Summary of the Technological Characteristics of the Device Compared to the Predicate - 807.92(a)(6)
| Characteristics | Proposed Device | Predicate Device - 1 | Comparison
Comment |
|-------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------|
| 510(k) Number | Pending K241099 | K223222 | - |
| Manufacturer | Hironic Co., Ltd. | Neauvia North
America, Inc | - |
| Trade/Device Name | PLASONIC | Plasma IQ | - |
| Product Code
(Regulation Number) | GEI (878.4400),
IMI (890.5300) | GEI (878.4400) | - |
| Indication for use | 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. | Identical |
| Mode of Operation | Radio Frequency
(Plasma) | Radio Frequency
(Plasma) | Identical |
| Output | Monopolar | Monopolar | Identical |
| Power Supply | 100-240VAC,
50/60Hz | 110-250VAC,
50/60Hz | Similar |
| Frequency | 41kHz | 40kHz | Similar |
-
- Predicate Device 1
6
аніяОпіс
| Max Output Power | 0.35W | 5W | Different, but the
safety of the product
has been proven by
the Safety Standard
Test Report, its
performance has
been proven by the
Performance Test
Report, and its
effectiveness for its
intended use has
been proven by the
Animal Test Report. |
|--------------------------------|------------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Output Impedance | $500 \Omega$ | $54,000 \Omega$ | Different, but the
safety of the product
has been proven by
the Safety Standard
Test Report, its
performance has
been proven by the
Performance Test
Report, and its
effectiveness for its
intended use has
been proven by the
Animal Test Report. |
| Electrical Safety
Standards | Complies with IEC
60601-1, IEC
60601-1-2, IEC
60601-2-2 | Complies with EN
60601-1, EN 60601-
1-2, EN 60601-2-2 | Identical |
7
Image /page/7/Picture/1 description: The image shows the word "HIRONIC" in a stylized font. The letters are black, except for a red square to the left of the word. The square has a white shape inside it.
2) Predicate Device – 2, 3
| Characteristics | Proposed Device | Predicate Device - 2 | Predicate Device - 3 | Comparison Comment |
|---|---|---|---|---|
| 510(k) Number | Pending K241099 | K230472 | K161628 | |
| Manufacturer | Hironic Co., Ltd. | Enraf-Nonius, B.V. | Bonutti Research, Inc. | |
| Trade/Device Name | PLASONIC | Sonopuls 190 | JAS Pulse™ Ultrasonic | |
| Therapy | ||||
| Product Code | ||||
| (Regulation Number) | GEI (878.4400), | |||
| IMI (890.5300) | IMI (890.5300) | IMI (890.5300) | ||
| Indications for Use | Indicated for Pain relief, | |||
| reduction of muscle | ||||
| spasms, localized increase | ||||
| in blood flow, increase | ||||
| range of motion of | ||||
| contracted jointed using | ||||
| heat and stretch techniques | Indicated for pain relief, | |||
| reduction of muscle | ||||
| spasms, localized increase | ||||
| in blood flow, increase | ||||
| range of motion of | ||||
| contracted jointed using | ||||
| heat and stretch techniques | Application of therapeutic | |||
| ultrasound for: | ||||
| Pain. | ||||
| Pain relief, muscle | ||||
| spasms, and joint | ||||
| contractures. | ||||
| Relief of pain, muscle | ||||
| spasms, and joint | ||||
| contractures that may be | ||||
| associated with: | ||||
| o Adhesive capsulitis, | ||||
| o Bursitis with slight | ||||
| calcification, | ||||
| o Myositis, | ||||
| o Soft tissue injuries, | ||||
| and | ||||
| o Shortened tendons due to | ||||
| past injuries and scar | ||||
| tissues. | ||||
| Relief of pain, muscle | ||||
| spasms, and joint | ||||
| contractures resulting | ||||
| from: | ||||
| o Capsular tightness, | ||||
| and | ||||
| o Capsular scarring | Identical to Predicate device |
Identical to Predicate device
- 3.
Pain relief, muscle
spasms, and joint
contractures
Localized increase in
blood flow.
Increased range of
motion of contracted joints
using heat and stretch
techniques. |
| | | | Localized increase in
blood flow.
Increased range of
motion of contracted joints
using heat and stretch
techniques. | |
| Weight
(Console & Treatment head) | 8.1 kg | 7 lbs 2oz | 0.151 kg
(with transducer) | Different, but does not
adversely affect safety and
effectiveness of the
proposed device. |
| Dimension
(W x H x D) | 410.8 x 214 x 418.4 mm | 6.25 x 5.5 x 8" | 10.5 x 6.7 x 2.5cm | Different, but does not
adversely affect safety and
effectiveness of the
proposed device. |
| Power Supply | 100-240VAC, 50/60Hz | 100-240 VAC +/- 10% | AC Line 100-240V 50/60 Hz | Identical. |
| Patient Leakage Current | 1 $ μ $ A typical
(requirements IEC