The Sonopulse III offers 1.1 and 3.3MHz ultrasound using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.

The Sonopulse offers 1.1 and 3.3MHz ultrasound using a 7cm² or 3cm² transducer. The membrane panel provides both tactile and audio feedback when the buttons are pressed. A provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.

AI/ML Overview

A. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Sonopulse and Sonopulse III therapeutic ultrasound devices are based on substantial equivalence to a legally marketed predicate device, the Sonicator Plus 930. The device performance is assessed through compliance with specific IEC standards, demonstrating basic safety and essential performance.

Feature	Acceptance Criteria (Predicate Device: Sonicator Plus 930)	Reported Device Performance (Sonopulse / Sonopulse III)
Indications for Use	Therapeutic Ultrasound:	Therapeutic Ultrasound:
	- Pain relief	- Pain relief
	- Reduction of muscle spasms	- Reduction of muscle spasms
	- Localized increase in blood flow	- Localized increase in blood flow
	- Increase range of motion of contracted joints using heat and stretch techniques	- Increase range of motion of contracted joints using heat and stretch techniques
Maximum Treatment Time	30 minutes	30 minutes
Frequency	1.1 MHz ±10%	1.1 MHz ±10%
	3.2 MHz ±10%	3.2 MHz ±10%
Modes	Continuous	Continuous
	Pulsed - 20% duty cycle	Pulsed - 20% and 50% duty cycle
Pulse Repetition	100Hz ±20%	100Hz, 16Hz, 48Hz (Note: The subject devices offer more pulse repetition frequencies, but 100Hz is covered, which aligns with the predicate.)
Safety and Performance Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5 (compliance)	Both the subject (Sonopulse and Sonopulse III) and predicate devices comply with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic compatibility), and IEC 60601-2-5 (Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment).

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical testing program focused on demonstrating substantial equivalence to a predicate device. This is a common approach for 510(k) submissions where the new device is compared to a legally marketed device rather than undergoing extensive clinical trials for efficacy.

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or clinical samples for evaluating the device's therapeutic effect. Instead, the "test set" refers to the devices themselves (Sonopulse and Sonopulse III) undergoing engineering and performance testing.
- Data provenance: The testing was performed in accordance with IEC (International Electrotechnical Commission) standards. The country of origin for the data is implied to be where these engineering tests were conducted, likely Brazil, given the submitter's location (IBRAMED - Industria Brazileria de EQUIPAMENTOS MEDICOS). This is a retrospective application of standards to existing device designs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to compliance with established engineering and safety standards (IEC 60601 series). The "experts" involved would be the testing engineers and regulatory bodies (like those certifying compliance to IEC standards), not medical experts establishing ground truth for clinical outcomes or diagnoses.
Adjudication method for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data (e.g., image readings). Here, the "adjudication" is through verification against objective engineering test parameters outlined in the IEC standards.
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:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is a key component. This submission is for a therapeutic ultrasound device, not a diagnostic or AI-enabled device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device is a physical therapeutic device, not a software algorithm. Its operation relies on direct human application and interaction.
The type of ground truth used:
- The "ground truth" for this submission is compliance with international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5) and demonstration of substantial equivalence to a legally marketed predicate device (Sonicator Plus 930) in terms of indications for use, technological characteristics, and performance parameters.
- It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather engineering and regulatory compliance.
The sample size for the training set:
- This is not applicable. The device is a hardware therapeutic device, not a machine learning algorithm, so there is no "training set" in the computational sense. The "training" for the device design would be iterative engineering and adherence to established design principles for medical devices.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the device's design and manufacturing is established through adherence to quality management systems (e.g., ISO 13485) and medical device regulations during its development and production.

Summary

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SECTION 6

510(k) Summary

510 (k) Number: K130888 Date of Submission: June 20, 2013

Submitter: IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil

TEL - 5519-3817-9633 FAX - 5519-7816-7980

Official Contact:

Tara Conrad TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180

TEL - (305) 377-0077

Common Name: Ultrasonic Diathermy Trade Name: Sonopulse; Sonopulse III Class II Classification: Product Code: IMI Classification Panel: Physical Medicine Regulation Numbers: 21 CFR 890.5300 Sonicator Plus 930, ME 930 K013192 Substantial Equivalence:

Indications for Use

Therapeutic Ultrasound

Pain relief .
Reduction of muscle spams
Localized increase in blood flow ●
Increase range of motion of contracted joints using heat and stretch . techniques

Device Description

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Features	Subject Devices		Predicate Device
	Sonopulse by Ibramed	Sonopulse III byIbramed	Sonicator Plus 930 byMettler K013192
Indications for Use	Therapeutic Ultrasound	Therapeutic Ultrasound	Therapeutic Ultrasound
	Pain relief	Pain relief	Pain relief
	Reduction of musclespams	Reduction of musclespams	Reduction of musclespams
	Localized increase inbloodflow	Localized increase inbloodflow	Localized increase inbloodflow
	Increase range ofmotion ofcontracted joints usingheatand stretch techniques	Increase range ofmotion ofcontracted joints usingheatand stretch techniques	Increase range ofmotion ofcontracted joints usingheatand stretch techniques
			NeuromuscularStimulation
			Symptomatic relief ofchronic intractable pain,acute post traumaticpain or acute postsurgical pain(interferential andpremodulatedwaveforms)
			Temporary relaxation ofmuscle spasms (allwaveforms)
			Prevention of post-surgicalphlebo-thrombisisthroughimmediate stimulationof calf muscles (allwaveforms)
			Increase blood flow inthe treatment area (allwaveforms)
			Prevention orretardation ofdisuse atrophy in post

Device Comparison Table

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			(all waveforms)
			Muscle re-educations(all waveforms)
			Maintain or increasingrange of motion (allwaveforms)
			Power Source
Maximum TreatmentTime	30 minutes	30 minutes	30 minutes
Frequency	1.1 MHz ±10%3.2 MHz ±10%	1.1 MHz ±10%3.2 MHz ±10%	1.1 MHz ±10%3.2 MHz ±10%
Modes	ContinuousPulsed-20% and 50%duty cycle	ContinuousPulsed-20% and 50%duty cycle	ContinuousPulsed-20% duty cycle
Pulse Repetition	100Hz16Hz48Hz	100Hz16Hz48Hz	100Hz ±20%

Substantial Equivalence

The subject and the predicate devices have the same intended use, the same operating principle, and are similar in their hardware configuration.

Technology

The Sonopulse III by Ibramed is a therapeutic ultrasound machine that operates at a 1.1 or 3.3 MHz frequency. The two frequency outputs penetrate to a depth of 5cm and 1 or 2cm respectively.

The Sonopulse by Ibramed is a therapeutic ultrasound machine that operates at a 1.1 or 3.3 MHz frequency. The two frequency outputs penetrate to a depth of 5cm and 1 or 2cm respectively.

Non-Clinical Testing

This submission includes testing results of the Sonopulse and Sonopulse III. Testing was performed in accordance with the IEC tests submitted in the Declaration of Conformity. The subject and predicate devices have all been tested in accordance with the following IEC tests:

IEC 60601-1: The general standard IEC 60601-1 - Medical equipment|medical electrical equipment - Part 1: General requirements for basic safety and essential performance - gives general requirements of the series of standards. It is used as a bench mark for many electrical medical devices. Both the subject and predicate devices comply with this standard.

The standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment.

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For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility - Requirements and tests

This collateral standard applies to electromagnetic compatibility of medical electrical equipment and medical electrical systems. The object of this collateral standard is to specify general requirements and tests for electromagnetic compatibility of medical electrical equipment and medical electrical systems. They are in addition to the requirements of the general standard and serve as the basis for particular standards. Both the subject and predicate devices comply with this standard.

IEC 60601-2-5: Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment

IEC 60601-2-5 applies to the basic safety and essential performance of ultrasonic physiotherapy equipment employing a single plane unfocused circular transducer per treatment head, producing static beams perpendicular to the face of the treatment head. This standard can also be applied to ultrasonic physiotherapy equipment used for compensation or alleviation of disease, injury or disability. Both the subject and predicate devices comply with this standard.

Conclusion

Based on the data and information presented in this submission, the Sonopulse and Sonopulse III are substantially equivalent to the currently legally marketed Sonicator Plus 930. The differences between the subject and predicate devices do not affect the safety or effectiveness of the proposed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 9, 2014

IBRAMED - Industria Brazileria de EQUIPAMENTOS MEDICOS Ltda c/o Tara Conrad TechLink International Consulting 18851 NE 29th Ave. Suite 720 Aventura, Florida 33180 USA

Re: K130888

Trade/Device Name: Sonopulse and Sonopulse III Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: December 17, 2013 Received: December 19, 2013

Dear Ms. Conrad:

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. 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.

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

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Page 2 - Ms. Tara Conrad

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S

Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130888

Device Name: Sonopulse and Sonopulse III

Indications For Use:

Therapeutic Ultrasound:

Pain relief ●
Reduction of muscle spasms .
Localized increase in blood flow .
Increase range of motion of contracted joints using heat and stretch techniques

Prescription Use × (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 Center for Devices and Radiological Health (CDRH)

Carlos L. Pena -S

Page 1 of __ 1

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.