The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

Device Description

The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which generates the ultrasonic energy and provides overall control of the device, and a handpiece with cable. The applicator design allows the simultaneous delivery of ultrasonic energy to tissue at two frequencies, 1 MHz and 45 kHz.

AI/ML Overview

The Orthosonics Duo-Son Ultrasound Diathermy Device is a medical device intended to apply ultrasonic energy to generate deep heat within body tissues. Below is a breakdown of its acceptance criteria and the study performed, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance metrics in a traditional sense. The "acceptance criteria" here implicitly refer to meeting safety and effectiveness standards comparable to the predicate device.

Acceptance Criteria Category/Issue Addressed	Reported Device Performance (Summary)
Electrical Safety	Results supported the safety and effectiveness of the device.
Electromagnetic Compatibility	Results supported the safety and effectiveness of the device.
Temperature Rise in a Phantom (Duo-Son)	Results supported the safety and effectiveness of the device and demonstrated substantial equivalence.
Temperature Rise in a Phantom (Predicate)	Used for comparison to demonstrate substantial equivalence to the predicate device (Mettler Model ME-720, K883228).
Compliance with 21 CFR 1050	Results supported the safety and effectiveness of the device.
Substantial Equivalence to Predicate	Demonstrated through performance tests and comparison of characteristics, the device is substantially equivalent to the Mettler Model ME-720 (K883228).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in terms of human subjects or a clinical dataset. The testing described primarily involved laboratory-based evaluations using a "phantom." Therefore:

Sample size for the test set: Not applicable in the context of human subjects. The tests were performed on a phantom.
Data provenance: Not explicitly stated, but implicitly laboratory-based testing conducted by Orthosonics, Ltd. in the UK. This would be considered prospective, as the tests were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for the device's performance was established through direct physical measurements on a phantom and compliance with regulations, not through expert review of data that required a ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the context of data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is not mentioned or implied in the provided text. The device is a physical therapy device (ultrasound diathermy), not an imaging or diagnostic device that would typically involve MRMC studies.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The testing described focuses on the device's inherent performance characteristics (electrical safety, EMC, temperature rise in a phantom) without human interaction influencing the core performance metrics being evaluated. The "algorithm" here refers to the device's functional operation.

7. The Type of Ground Truth Used:

The ground truth used was based on:

Physical measurements: Directly measuring electrical safety, electromagnetic compatibility, and temperature rise in a phantom.
Regulatory standards: Demonstrating compliance with 21 CFR 1050.
Comparison to a predicate device: The performance observed in the Duo-Son device was compared against the known characteristics and performance of the legally marketed predicate device (Mettler Model ME-720) to establish substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is an ultrasound diathermy device, not an AI/machine learning algorithm that requires a training set. The term "training set" is typically used in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set for an AI model.

Summary

{0}------------------------------------------------

K970131

510(k) Summary

JUN 1 6 1997

orthosonics duo-son ULTRASOUND DIATHERMY DEVICE

Common/Classification Name:	Ultrasonic diathermy
	21 CFR 890.5300

Sponsor:	Orthosonics, Ltd.
	Bremridge Farm
	Ashburton
	Devon TQ137JX
	UK
	+44-1364-652426
	+44-1364-653589

Contact:

Dr. Michael J. R. Young

Prepared: January 14, 1997

LEGALLY MARKETED PREDICATE DEVICES A.

The Orthosonics Duo-Son Ultrasound Diathermy Device is substantially equivalent to the Mettler Model ME-720 (K883228).

DEVICE DESCRIPTION B. ... .......................................................................................................................................................................

C. INTENDED USE

D. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the Duo-Son device are the same as those of the predicate devices.

{1}------------------------------------------------

E. TESTING

Orthosonics carried out testing to address the following issues:

(1) electrical safety,
(2) electromagnetic compatibility,
(3) temperature rise in a phantom during Duo-Son procedures,
(4) temperature rise in a phantom using the predicate device, and
compliance with 21 CFR 1050. (5)

The results from all of these tests supported the safety and effectiveness the Orthosonics Duo-Son Ultrasonic Diathermy Device and of demonstrate that it is substantially equivalent to the predicate devices.

ட் CONCLUSIONS

The Orthosonics Duo-Son device has the same intended use and target population as the predicate devices. Orthosonics has demonstrated through its performance tests on the Duo-Son device and its comparison of Duo-Son characteristics with those of the predicate device that the Duo-Son device is substantially equivalent to the predicate device.

{2}------------------------------------------------

.. . ..

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

T. Whit Athey, Ph.D. JUN 1 6 1997 Senior Consultant C.L. McIntosh & Associates; Inc. r 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

K970131 Orthosonics Duo-Sun Ultrasound Diathermy Device Requlatory Class: II Product Code: IMI Dated: May 14, 1997 May 14, 1997 Received:

Dear Dr. Athey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Che Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Ao coleyo

CeNia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Orthosonics Duo-Son Ultrasound Diathermy Device

Indications For Use:

参

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

GOODS

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.