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.

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) :

1. 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.
1. 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

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "PLASONIC." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Therefore, I cannot provide the requested table or answer questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given text.

The text does state the following regarding studies:

Non-clinical tests:
- Compliance with several IEC and ISO standards for electrical safety, electromagnetic compatibility, usability, software lifecycle processes, and risk management (listed in section 7).
- An ex vivo model study where handpieces were applied to analyze temperature change via thermal imaging, and tissue coagulation length, width, and depth via photography and histological evaluation.
Clinical tests: "No clinical test was performed."

Summary

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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, 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"

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(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).

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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

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Indications for Use

Submission Number (if known)

K241099

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.

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 Koreat. +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	K223222Applicant: Neauvia North America, IncTrade/Device Name: Plasma IQRegulation Number: 21 CFR 878.4400Regulation Name: Electrosurgical Cutting and Coagulation Deviceand AccessoriesRegulatory Class: Class IIProduct Code: GEI
Predicate Device - 2	K230472Applicant: Enraf-Nonius, B.V.Trade/Device Name: Sonopuls 190Regulation Number: 21 CFR 890.5300Regulation Name: Ultrasonic DiathermyRegulatory Class: Class IIProduct Code: IMI
Predicate Device - 3	K161628Applicant: Bonutti Research, Inc.Trade/Device Name: JAS Pulse™ Ultrasonic TherapyRegulation Number: 21 CFR 890.5300Regulation Name: Ultrasonic DiathermyRegulatory Class: Class IIProduct 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) :

1. 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.
1. Ultrasound (SONOPASS Handpiece)

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	ComparisonComment
510(k) Number	Pending K241099	K223222	-
Manufacturer	Hironic Co., Ltd.	Neauvia NorthAmerica, 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 theremoval anddestruction of skinlesions andcoagulation oftissue.	Used in the removaland destruction ofskin lesions andcoagulation 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

1. Predicate Device 1

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аніяОпіс

Max Output Power	0.35W	5W	Different, but thesafety of the producthas been proven bythe Safety StandardTest Report, itsperformance hasbeen proven by thePerformance TestReport, and itseffectiveness for itsintended use hasbeen proven by theAnimal Test Report.
Output Impedance	$500 \Omega$	$54,000 \Omega$	Different, but thesafety of the producthas been proven bythe Safety StandardTest Report, itsperformance hasbeen proven by thePerformance TestReport, and itseffectiveness for itsintended use hasbeen proven by theAnimal Test Report.
Electrical SafetyStandards	Complies with IEC60601-1, IEC60601-1-2, IEC60601-2-2	Complies with EN60601-1, EN 60601-1-2, EN 60601-2-2	Identical

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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™ UltrasonicTherapy
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 musclespasms, localized increasein blood flow, increaserange of motion ofcontracted jointed usingheat and stretch techniques	Indicated for pain relief,reduction of musclespasms, localized increasein blood flow, increaserange of motion ofcontracted jointed usingheat and stretch techniques	Application of therapeuticultrasound for:Pain.Pain relief, musclespasms, and jointcontractures.Relief of pain, musclespasms, and jointcontractures that may beassociated with:o Adhesive capsulitis,o Bursitis with slightcalcification,o Myositis,o Soft tissue injuries,ando Shortened tendons due topast injuries and scartissues.Relief of pain, musclespasms, and jointcontractures resultingfrom:o Capsular tightness,ando Capsular scarring	Identical to Predicate device- 2.Identical to Predicate device- 3.Pain relief, musclespasms, and jointcontracturesLocalized increase inblood flow.Increased range ofmotion of contracted jointsusing heat and stretchtechniques.
			Localized increase inblood flow.Increased range ofmotion of contracted jointsusing heat and stretchtechniques.
Weight(Console & Treatment head)	8.1 kg	7 lbs 2oz	0.151 kg(with transducer)	Different, but does notadversely affect safety andeffectiveness of theproposed 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 notadversely affect safety andeffectiveness of theproposed 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 < 10 $ μ $ A)	1 $ μ $ A typical(requirements IEC < 10 $ μ $ A)	- Normal Condition3uAMeets IEC 60601-1, section8.7LEAKAGE CURRENTSandPATIENT AUXILIARYCURRENTS- Single Fault condition5uAMeets IEC 60601-1, section8.7LEAKAGE CURRENTSandPATIENT AUXILIARYCURRENTS	Identical to Predicate device- 2.Different to Predicate device- 3, but does not adverselyaffect safety andeffectiveness of theproposed device.
Crystal material	PZT	PZT-8 (lead zirconatetitanate) piezoceramicmaterial	PZT	Identical.
Housing Materials andConstruction	ABS	ABS	ABS	Identical.

Technology of ultrasoundgeneration	Piezoelectric	Piezoelectric	Piezoelectric	Identical.
Treatment Modes	ContinuousPulsed	ContinuousPulsed	Pulsed & Continuous	Identical.
Beam Type(collimated or divergent)	Divergent	5 cm2 applicator:1 MHz: collimating3 MHz: collimating0.8 cm2 applicator:1 MHz: collimating3 MHz: diverging	Collimated	Similar to Predicate device- 2.Different to Predicate device- 3, but does not adverselyaffect safety andeffectiveness of theproposed device.
Transducer Diameter (cm)	2.5cm²	0.8 cm²5cm²	Diameter: 2.56 cmArea: 5.15 cm²	Different to each device butdoes not adversely impactsafety and effectiveness ofthe proposed device.
Frequency	3MHz	1MHz3MHz	1MHz	Similar to Predicate device- 2.Different to Predicate device- 3, but does not adverselyaffect safety andeffectiveness of theproposed device.
Acoustic WorkingFrequency and Accuracy(MHz)	3MHz± 10%	5 cm², 0.8 cm² and1 MHz: 0.98 MHz ± 5%3 MHz: 3.1 MHz ± 5%	1.0 MHz ± 10%	Similar to Predicate device- 2.Different to Predicate device- 3, but does not adverselyaffect safety andeffectiveness of theproposed device.
Effective Radiating Area	1.485 cm²	5 cm² applicator:5 cm²	1.133 cm2 ± 20%	Similar to Predicate device -3.
		0.8 cm² applicator:0.8 cm²
Beam Non-uniformity Ratio	3.9367:1 maximum	6:1 maximum	2.5 ± 30%	Different, but does notadversely impact safety andeffectiveness of theproposed device andcomplies with IEC 60601-2-5.
Output Mode of UltrasoundHead	Continuous mode: 1Pulsed Mode: 4	2	2	Similar to each device.
Maximum Timer Setting	10 minutes	10 minutes	15 minutes	Identical to Predicate device- 2.
Output power(Intensity)	0 - 0.18W/cm²	0 - 3.0W/cm²	Continuous (High): 1.4 W/cm2Pulsed (Low): 0.7 W/ cm2(all values ± 20%)	Different but does notadversely impact safety andeffectiveness of theproposed device andcomplies with IEC 60601-2-5.
Pulse Frequency	2Hz± 10%	16Hz, 48Hz, 100Hz +/- 1%	-	Different to each device, butdoes not adversely affectsafety and effectiveness ofthe proposed device.
Temporal Max Power (W) -[for pulsed]	Duty cycle 25%: 0.12WDuty cycle 50%: 0.14WDuty cycle 62.5%: 0.21WDuty cycle 75%: 0.20W	5 cm² applicator:duty cycle 5-50%: 15Wduty cycle 80%: 12W0.8 cm² applicator:duty cycle 5-50% 2.4 Wduty cycle 80%: 2 W	0.79W	Different to each device butdoes not adversely impactsafety and effectiveness ofthe proposed device andcomplies with IEC 60601-2-5.
Temporal Max Power (W) -[for continuous]	0.21W	5 cm² applicator: 10 W0.8 cm² applicator: 1.6 W	1.59W	Different but does notadversely impact safety andeffectiveness of theproposed device andcomplies with IEC 60601-2-5.
Maximum Value of theOutput Power (RatedOutput Power) andAccuracy (W)	$0.21W \pm 20%$	5 cm² applicator: $10 W \pm$20%0.8 cm² applicator: $2 W \pm$20%	Continuous (High): 1.59WPulsed (Low): 0.79W(all values $\pm$ 20%)	Different but does notadversely impact safety andeffectiveness of theproposed device andcomplies with IEC 60601-2-5.
Peak Temperature Risevs. Time and Tissue Depthto Maximum TreatmentTime (for fixed TreatmentHead Placement) (deg C)	Elevation of temperatureraise 10.5 °C for 10minutes 3.0 MHz, 0.21 WEffective depth 0.5 cm	Elevation of temperatureraise 4.8°C for 10 minutes1.0MHz, 2.0W Effectivedepth 2.5cmElevation of temperatureraise 5.8°C for 3 minutes3.0MHz, 2.0W Effectivedepth 0.8cm		Different to each device, butdoes not adversely affectsafety and effectiveness ofthe proposed device.
Maximum Patient ContactSurface Temperature ofTreatment Head underSimulated fixed TreatmentHead Placement) (degC) orActual Use Conditions for allOperating Conditions	1.485 cm² applicator < 45deg C	5 cm² applicator <43 deg C0.8 cm² applicator <34 degC	Transducer surface doesnot exceed 43 °C whenmeasured under testconditions 201.11.1.3.101.1as stated in IEC 60601-2-5.	Different to each device, butdoes not adversely affectsafety and effectiveness ofthe proposed device.
(Continually operated formaximum treatment time)(deg C)
Penetration Depth	3 MHz: 1.1 cm	1MHz: 2.5cm3MHz: 0.8cm		Similar to Predicate device -2.
Electrical Safety Standards	Complies with IEC 60601-1,IEC 60601-1-2, IEC60601-2-5	Complies with IEC 60601-1,IEC 60601-1-2, IEC 60601-2-5	Complies with IEC 60601-1,IEC 60601-1-2, IEC 60601-2-5	Identical.

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аніяопіс

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аніяопіс

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анікопіс

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Image /page/11/Picture/1 description: The image shows the logo for HIRONIC. The logo consists of a red square with a white shape inside, followed by the word "HIRONIC" in black, block letters. The letters are stylized and have a modern look.

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аніяопіс

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Image /page/13/Picture/1 description: The image shows the word "HIRONIC" in a bold, sans-serif font. The letters are black, except for a red square-like shape to the left of the word. The red shape has a white, stylized "H" inside it.

Non-clinical tests submitted - 807.92(b)(1)

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.

8. Clinical tests submitted - 807.92(b)(2)

No clinical test was performed.

Conclusions drawn from clinical and non-clinical tests submitted

The PLASONIC is substantially equivalent to its predicate device and reference device with same indication for use and technological characteristics. 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.

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device.

Regulation Number and Section

§ 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.