The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

Device Description

Ultrasonic equipment generates high frequency sound waves that are transferred to a specific body area via a round-headed probe. The sound waves travel deep into tissue and create gentle heat. As the probe glides over the skin's surface, sound waves penetrate the skin's surface causing soft tissues to creating deep heat. In turn, the heat induces vasodilatation: drawing blood into the target tissues. The generated deep heat is found to help relieve pain and reduce muscle spasms.

AI/ML Overview

The provided text is a 510(k) summary for the SUN-RAIN Ultrasonic Therapy devices (SU-300 to SU-900). It focuses on establishing substantial equivalence to a predicate device (SUN-RAIN Ultrasonic Therapy, SU-100 K024013) based on shared indications for use and power input, as well as compliance with electrical safety and electromagnetic compatibility standards.

Crucially, this document does not describe acceptance criteria relating to device performance for the purpose of a study, nor does it detail a study proving the device meets performance criteria.

Instead, it outlines the regulatory pathway for a medical device seeking market clearance in the US, primarily by demonstrating that the new devices are substantially equivalent to an already legally marketed predicate device. The information provided is primarily about safety and technical standards compliance, rather than a clinical performance study with acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Here's why each specific requested point cannot be answered:

A table of acceptance criteria and the reported device performance: Not provided. The document lists safety and electrical standards the device was tested against (e.g., IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 60601-2-5, IEC 61689), but not performance acceptance criteria or specific performance results.
Sample size used for the test set and the data provenance: Not applicable. There was no clinical performance test described with a test set. The non-clinical tests relate to electrical and safety standards compliance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical performance test requiring expert ground truth was described.
Adjudication method for the test set: Not applicable. No clinical performance test requiring adjudication was described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ultrasonic therapy device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device in the context of AI.
The type of ground truth used: Not applicable. No clinical performance study requiring ground truth was described. The "ground truth" here would relate to compliance with electrical and safety standards.
The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory submission for an ultrasonic therapy device, emphasizing its substantial equivalence to a predicate device and compliance with relevant safety and electrical standards. It does not contain information about clinical performance studies, acceptance criteria for such studies, or data related to AI/machine learning device development.

Summary

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KO90542

OCT 2 8 2009

5. 510(K) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS for SUN-RAIN Ultrasonic Therapy

DATE OF SUBMISSION:	February 23, 2009
SUBMITTER:	SUN-RAIN System Corp.8F, No.125, Lane 235, Paochiao Road,Sindian City, Taiwan, ROC, 23145TEL: 886-2-89191180FAX: 886-2-89191190

ESTABLISHMENT REGISTRATION NO: 9616346

OFFICIAL Dr. JEN, KE-MIN CONTACT: No. 58, Fu-Chiun Street. Hsin-Chu City, TAIWAN, ROC, 30067 TEL: 886-3-5208829 FAX:886-3-5209783

TRADE NAME: SUN-RAIN Ultrasonic Therapy, SU-300, SU-400. SU-500, SU-600, SU-700, SU-800, SU-900

COMMON/USUAL Ultrasonic Therapy

NAME:

IMI, Class II

CLASSIFICATION CODE:

REGULATION 890.5300 NUMBER:

PREDICATED DEVICE:

SUN-RAIN Ultrasonic Therapy, SU-100 K024013

INTENDED USE: The SUN-RAIN Ultrasonic Therapy generates deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.

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Description of Ultrasonic equipment generates high frequency Device: sound waves that are transferred to a specific body area via a round-headed probe. The sound waves travel deep into tissue and create gentle heat. As the probe glides over the skin's surface, sound waves penetrate the skin's surface causing soft tissues to creating deep heat. In turn, the heat induces vasodilatation: drawing blood into the target tissues. The generated deep heat is found to help relieve pain and reduce muscle spasms.

Non-Clinical Tests Submitted:

The Ultrasonic Therapy equipment has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for safety of ultrasonic physiotherapy equipment.

The relevant standards including:

1. IEC/EN 60601-1 : Medical electrical equipment Part 1. General requirements for safety, 1996.
1. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2. Electromagnetic compatibility -Requirements and tests, 2004.
1. IEC 60601-2-5 : Safety particular requirements for ultrasonic physiotherapy equipment, 2005.

None

1. IEC 61689 : Ultrasonics Physiotherapy systems -Field specifications and methods of measurement in the frequency range.
- 1. Reliability Test report.

The subject new devices and the predicate device have the same indications for use and same power input. The major difference is new device of SU-400/SU-600/SU-800 is with 3MHz of frequency. Besides, the size and the dimension for the subject new devices are different. This is due to the different design and choice for the clients. Although the appearance and probe size are different but we use the same PCB and the specification is almost the This is not related to the safety same. or effectiveness.

Thus the new device is substantially equivalent to the predicate devices in this aspect.

Clinical Tests Submitted:
Performance Tests Submitted:

Conclusion:

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three overlapping, curved lines that resemble a bird in flight or a stylized human figure. The overall design is simple and conveys a sense of movement and progress.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

OCT 2 3 2009

SUN-RAIN System Corporation % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen No. 58, Fu Chiun Street Hsin Chu City, Taiwan, ROC 30067

Re: K090542

Trade/Device Name: SUN-RAIN Ultrasonic Therapy, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: September 30, 2009 Received: October 6, 2009

Dear Dr. Jen:

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. 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.

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.

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Page 2 - Dr. Ke-Min Jen

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CcntersOffices/CDRHOffices/ucm1117801cc11ccm11178001.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Preu 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M Millham

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K_____________________________________________________________________________________________________________________________________________________________________________ 510(k) Number:

Device Name:

...

.... ..

SUN-RAIN Ultrasonic Therapy, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900

Indications for Use :

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

KATHLEEN M. HOGAN FOR M.MEKERSON

(Division Sign of Surgical, Orthopedic, Divisionative Devices

Page I of 1

510(k) Number

Regulation Number and Section

§ 890.5300 Ultrasonic diathermy.

(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.