(265 days)
Not Found
No
The device description and performance studies focus on standard therapeutic ultrasound technology and compliance with IEC standards. There is no mention of AI, ML, or any related concepts.
Yes
The "Intended Use / Indications for Use" section explicitly states "Therapeutic Ultrasound" and lists therapeutic applications such as "Pain relief," "Reduction of muscle spasms," and "Localized increase in blood flow." Additionally, the "Device Description" clearly identifies the Sonopulse Compact 1MHz and 3MHz as "therapeutic ultrasound devices."
No
The 'Intended Use / Indications for Use' section lists only therapeutic purposes such as pain relief, reduction of muscle spasms, increase in blood flow, and increased range of motion. There is no mention of diagnosing conditions.
No
The device description explicitly details hardware components like a transducer, membrane panel, and display, and the performance studies reference testing of physical devices according to IEC standards for medical electrical equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all therapeutic applications (pain relief, muscle spasm reduction, increased blood flow, increased range of motion). IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a therapeutic ultrasound device that applies energy to the body. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any aspects typically associated with IVD devices, such as sample types, reagents, analytical methods, or diagnostic results.
Therefore, the Sonopulse Compact 1MHz and 3MHz are therapeutic devices, not in vitro diagnostic devices.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
IMI
Device Description
The Sonopulse Compact 1MHz is a therapeutic ultrasound device with a frequency of 1 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide 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 Compact 3MHz is a therapeutic ultrasound device with a frequency of 3 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
This submission includes testing results of the Sonopulse Compact 1MHz and Sonopulse Compact 3MHz.
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. 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows a logo for IBRAMED. The logo is black and white and features a stylized letter "I" at the top. Below the "I" is the word "IBRAMED" in a bold, sans-serif font. The logo has a slightly distressed or textured appearance.
SECTION 6
510(k) Summary
510 (k) Number: K131309
Date of Submission: June 26, 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: Trade Name:
Classification: Product Code: Classification Panel: Regulation Numbers: Substantial Equivalence: Ultrasonic Diathermy Sonopulse Compact 1MHz; Sonopulse Compact 3MHz Class II IMI Physical Medicine 21 CFR 890.5300 Sonicator Plus 930, ME 930 K013192
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
1
Image /page/1/Picture/0 description: The image shows a logo for IBRAMED. The logo is black and white and features a stylized letter "I" in the center. The word "IBRAMED" is written in bold, sans-serif letters below the symbol. The symbol above the wordmark has a geometric design with horizontal lines.
Device Description
The Sonopulse Compact 1MHz is a therapeutic ultrasound device with a frequency of 1 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide 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 Compact 3MHz is a therapeutic ultrasound device with a frequency of 3 MHz using a 7cm² transducer. The membrane panel provides both tactile and audio feedback when buttons are pressed. A guide provides a through set-up routine for the operator. The display will show which treatment has been chosen and when the output is active.
| Features | Subject Devices | Predicate Device | |
|---|---|---|---|
| Sonopulse Compact | |||
| 1MHz by Ibramed | Sonopulse Compact | ||
| 3MHz by Ibramed | Sonicator Plus 930 by | ||
| Mettler K013192 | |||
| Indications for Use | Therapeutic Ultrasound | Therapeutic Ultrasound | Therapeutic Ultrasound |
| Pain relief | Pain relief | Pain relief | |
| Reduction of muscle | |||
| spasms | Reduction of muscle | ||
| spasms | Reduction of muscle | ||
| spasms | |||
| Localized increase in | |||
| blood | |||
| flow | 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 | Increase range of | ||
| motion of | |||
| contracted joints using | |||
| heat | |||
| and stretch techniques | |||
| Neuromuscular | |||
| Stimulation | |||
| Symptomatic relief of | |||
| chronic intractable pain, | |||
| acute post traumatic | |||
| pain or acute post | |||
| surgical pain | |||
| (interferential and | |||
| premodulated | |||
| waveforms) | |||
| Temporary relaxation of | |||
| muscle spasms (all | |||
| waveforms) | |||
| Prevention of post- | |||
| surgical | |||
| phlebo-thrombosis | |||
| through | |||
| immediate stimulation |
Device Comparison Table
2
Image /page/2/Picture/0 description: The image shows a logo for IBRAMED. The logo consists of a stylized letter "I" with horizontal lines above and below it. The word "IBRAMED" is written in bold letters below the symbol. The logo is black and white.
| of calf muscles (all waveforms) | |
|---|---|
| Increase blood flow in the treatment area (all waveforms) | |
| Prevention or retardation of disuse atrophy in post injury type conditions (all waveforms) | |
| Muscle re-educations (all waveforms) | |
| Maintain or increasing range of motion (all waveforms) | |
| Power Source | (AC Line) 100 - 240V~ 50/60Hz |
| Maximum Treatment Time | 30 minutes |
| Frequency | 1.1 MHz ±10% |
| Modes | Continuous Pulsed-20% and 50% duty cycle |
| Pulse Repetition | 100Hz 16Hz 48Hz |
| Power Source | (AC Line) 100 - 240V~ 50/60Hz |
|---|---|
| Maximum Treatment Time | 30 minutes |
| Frequency | 3.3 MHz ±10% |
| Modes | Continuous Pulsed-20% and 50% duty cycle |
| Pulse Repetition | 100Hz 16Hz 48Hz |
| Power Source | AC Line |
|---|---|
| Maximum Treatment Time | 30 minutes |
| Frequency | 1.1 MHz ±10% 3.2 MHz ±10% |
| Modes | Continuous Pulsed-20% duty cycle |
| Pulse Repetition | 100Hz ±20% |
Substantial Equivalence
The additional duty cycle and pulse repetition frequencies allow the user to choose the optimal setting for treatment. The technological characteristics of the subject device and predicate device are similar. The additional settings on the subject devices does not alter the safety or effectiveness of the technology.
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 Compact 1MHz by Ibramed is a therapeutic ultrasound machine that operates at a 1MHz frequency. The frequency output penetrates to a depth of 5cm.
The Sonopulse Compact 3MHz by Ibramed is a therapeutic ultrasound machine that operates at a 3 MHz frequency. The frequency output penetrates to a depth of 1 to 2cm.
3
Image /page/3/Picture/0 description: The image shows a logo for "IBRAMED Non-Clinical Testing". The logo features a stylized "I" shape above the word "IBRAMED", with the words "Non-Clinical Testing" appearing below. The logo has a slightly distressed or textured appearance.
This submission includes testing results of the Sonopulse Compact 1MHz and Sonopulse Compact 3MHz.
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. 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
4
Image /page/4/Picture/0 description: The image shows a logo with the word "IBRAMED" in bold, black letters. Above the word is a symbol that looks like a stylized "I" with horizontal lines on either side. Below the word "IBRAMED" is the phrase "with this standard" in a smaller font size.
Conclusion
Based on the data and information presented in this submission, the Sonopulse Compact 1MHz and Sonopulse Compact 3MHz 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.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its body, representing the department's commitment to health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2014
IBRAMED - Industria Brazileria de Equipamentos Medicos Ltda c/o Tara Conrad TechLink International Consulting 18851 NE 29th Ave. Suite 720 Aventura, Florida 33180
Re: K131309
Trade/Device Name: Sonopulse Compact 1 MHz and Sonopulse Compact 3 MHz 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Ms. Tara Conrad
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/Resourcesfor You/Industry/default.htm.
for
Sincerely yours,
Joyce
Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K131309
Device Name: Sonopulse Compact 1 MHz and Compact Sonopulse 3 MHz
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)
JoyceMDWang-S
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