Sonomed IV, Sonomed V
Device Facts
| Record ID | K202788 |
|---|---|
| Device Name | Sonomed IV, Sonomed V |
| Applicant | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto |
| Product Code | IMI · Physical Medicine |
| Decision Date | Dec 23, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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
Device Story
Sonomed IV and Sonomed V are ultrasonic diathermy devices used in clinical settings by therapists. The device generates ultrasound energy via a piezoelectric crystal (PZT) housed in a treatment head (applicator). The therapist applies the head to the patient's body using a contact gel. The device transforms electrical energy into mechanical ultrasonic beams, which are absorbed by tissues and converted into deep heat. This thermal effect increases microcirculation, reduces pain perception, decreases inflammatory activity, and aids tissue recovery. The device operates at 1 MHz or 3.3 MHz frequencies, with higher frequencies targeting more superficial tissues. The therapist controls treatment parameters, including intensity and mode (pulsed or continuous), to achieve therapeutic goals. The device is intended to improve patient outcomes by facilitating joint mobility and reducing musculoskeletal discomfort.
Clinical Evidence
No clinical data were included in this submission. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing for ultrasonic physiotherapy equipment (IEC 60601-2-5).
Technological Characteristics
Class II medical electrical equipment, Type BF. Uses PZT (Zirconia ceramic) piezoelectric crystals for ultrasound generation. Operates at 1 MHz and 3.3 MHz. Features include pulsed/continuous modes, 0.1-3.0 W/cm² intensity, and collimated beam output. Powered by 100-240V AC. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 62304, and ISO 10993-1.
Indications for Use
Indicated for patients requiring therapeutic ultrasound for pain relief, reduction of muscle spasms, localized increase in blood flow, and increased range of motion of contracted joints via heat and stretch techniques.
Regulatory Classification
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.
Predicate Devices
- Sonopulse (K130888)
Submission Summary (Full Text)
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December 23, 2021
Carci Industria E Comercio De Aparelhos Cirurgicos E Orto % Bruno Milhoci Regulatory Affairs Specialist PR Servicos Regulatorios Administrativos Ltda Rua Alice Aem Saadi, 855/ 2404 Ribeirao Preto, SP 14096-570 Brazil
Re: K202788
Trade/Device Name: Sonomed IV, Sonomed V Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: February 19, 2021 Received: February 19, 2021
Dear Bruno Milhoci:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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).
Sincerely.
for Amber Ballard, PhD Assistant Director, Neurodegenerative Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K202788
Device Name Sonomed IV Sonomed V
Indications for Use (Describe)
- 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
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# Sonomed IV / Sonomed V
# 510(k) Summary
## Administrative information
| Sponsor | CARCI Indústria e Comércio de Aparelhos<br>Cirúrgicos e Ortopédicos Ltda.<br>R. Padre Machado, 82–<br>São Paulo – SP – Brazil<br>Telephone: +55 (11) 5621 2791 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Preparer | Bruno Milhoci de Souza<br>Regulatory Affairs Specialist<br>Passarini Regulatory Affairs<br>E-Mail: bruno@rapassarini.com.br<br>Telephone + 55 (16) 3421 8488 |
| Data Prepared | SEPT-15-2020 |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/ Proprietary Name | Sonomed V and Sonomed IV |
| Common Name | Ultrasonic Therapy |
| Primary Classification Name | Ultrasonic Diathermy for Use In Applying<br>Therapeutic Deep Heat |
| Primary Classification regulation | 21 CFR 890.5300 |
| Primary Product Code | IMI |
| Classification Panel | Physical Medicine |
| Reviewing Branch | Physical Medicine |
| PREDICATE DEVICE INFORMATION | |
| Predicate Manufacturer | Ibramed |
| Predicate Trade Name | Sonopulse |
| Predicate 510(k) | K130888 |
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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 stretchtechniques
Subject Device Description
The SONOMED apparatus is ultrasound equipment for therapy, which has been developed in accordance with the safety standards IEC 60601-2 and IEC 60601-2 and IEC 60601-2-5, class II, type BF, which makes it a safe apparatus of high reliability for the therapist and the patient.
SONOMED is medical electric equipment which provides therapeutic ultrasound treatment. Ultrasound is a mechanic stimulus directed to the body through ultrasonic beam emitted by a transducer/applicator, better known as head. This ultrasound is produced in the head through a piezoelectric crystal and is transmitted to the body through the aluminum surface of the head and a contact agent (gel). Depending on how the ultrasound beam passes through the tissues, its energy is gradually and selectively absorbed being transformed into heat, among other effects. This increase in temperature causes biological changes in the tissues as for instance increase in micro circulation, a reduced perception of pain, a reduction in inflammatory activity and an increase in the reestablishing rate of delicate tissues. The higher the ultrasound frequency, the more superficial will be its absorption.
CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.
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### Technological Characteristics
Ultrasound in physiotherapy has successfully and efficiently been used in orthopedics and traumatology for quite a long time.
With this background, Carci developed state-of-the-art ultrasound equipment with multifrequency transducer in 1 MHz and 3 MHz for precise and adequate treatment, in conformity with the type of tissue involved.
| | ﮐ | anic | 5.1 | |
|--|---|------|-----|--|
| | | | | |
| | K number/<br>Manufacturer | Indications for use statement |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Carci | Therapeutic Ultrasound<br>- Pain relief<br>- Reduction of muscle spasms<br>- Localized increase in blood flow<br>- Increase range of motion of contracted<br>joints using heat and stretch techniques |
| Predicate device | K130888<br>Ibramen | Therapeutic Ultrasound<br>- Pain relief<br>- Reduction of muscle spasms<br>- Localized increase in blood flow<br>- Increase range of motion of contracted<br>joints using heat and stretch techniques |
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# Table 5.2 SE comparison
| Trade Name | Subject Device | | Predicate Device | Equivalent discussion |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| information/<br>Manufacturer | Sonomed IV<br>Carci | Sonomed V<br>Carci | K130888/ Sonopulse<br>Ibramed | |
| Regulation Number | 890.5300 | 890.5300 | 890.5300 | Same |
| Indications For Use | Therapeutic<br>Ultrasound<br>- Pain relief<br>- Reduction of muscle<br>spasms<br>- Localized increase in<br>blood flow<br>- Increase range of<br>motion of contracted<br>joints using heat and<br>stretch techniques | Therapeutic<br>Ultrasound<br>- Pain relief<br>- Reduction of muscle<br>spasms<br>- Localized increase in<br>blood flow<br>- Increase range of<br>motion of contracted<br>joints using heat and<br>stretch techniques | Therapeutic Ultrasound<br>- Pain relief<br>- Reduction of muscle<br>spasms<br>- Localized increase in<br>blood flow<br>- Increase range of<br>motion of contracted<br>joints using heat and<br>stretch techniques | Same |
| Product Code | IMI | IMI | IMI | The subject device<br>and the predicate<br>has the same<br>classification of the<br>ultrasound, but the<br>predicate has<br>mode<br>functions |
| Console/Generator<br>Dimensions (L x W x H<br>cm) | 31 x 18 x 6 | 31 x 18 x 6 | Not available | Equivalent |
| Treatment Head<br>Dimensions (L x W x H<br>cm) | 15 cm x 5 cm x 4 cm | 15 cm x 5 cm x 4 cm | Not available | Equivalent |
| Console/Generator<br>Weight (kg) | 1.2 Kg | 1.2 Kg | Not available | Equivalent |
| Treatment Head<br>Weight (kg) | 252 Grams | 252 Grams | Not available | Equivalent |
| Power Supply | 100 - 240V 50/60Hz | 100 - 240V 50/60Hz | (AC Line) 100-240V<br>~50/60Hz | Same |
| Leakage Current | 49 μA (Normal)<br>86 µA (single fault) | 49μA (Normal)<br>86 µA (single fault) | Not available | Equivalent |
| Crystal Material | PZT | PZT | Not available | Equivalent |
| Technology of<br>ultrasound generation | Piezoelectric | Piezoelectric | Piezoelectric | Same |
| Treatment Mode(s) | Pulsed, continuous | Pulsed, continuous | Pulsed, continuous | Same |
| Beam Type (collimated<br>or divergent) | Collimated | Collimated | Pulsed, continuous | Same |
| Transducer Diameter<br>(cm) | 5cm² = 2,52cm | 5cm² = 2,52cm | 7cm² = 2,98 cm | Equivalent |
| Acoustic Working<br>Frequency and<br>Accuracy (MHz) | 1MHZ± 5%<br>3.3MHz± 5% | 1MHZ± 5%<br>3.3MHz± 5% | 1MHZ± 5%<br>3.3MHz± 5% | Frequencies of the<br>devices are similar<br>within the error<br>margin. All the<br>frequencies are<br>covered by the |
| | | | | regulation number<br>890.5300 |
| Effective Radiating<br>Area and Accuracy<br>(cm2) | 3,2 cm² ±10% | 3,2 cm² ±10% | Not available | The effective area<br>of all products are<br>similar |
| Beam Nonuniformity<br>Ratio (not to exceed<br>8*) and Accuracy | 2.8:1 | 2.8:1 | Not available | Similar. |
| Output Mode:<br>(Continuous<br>Wave/Amplitude -<br>Modulated Wave) | Continuous<br>Pulsed | Continuous<br>Pulsed | Continuous<br>Pulsed | Same |
| Maximum Timer<br>Setting and Accuracy<br>(not to exceed 30<br>min*) | 20 minutes | 20 minutes | 30 minutes | The subject device<br>has a lower<br>treatment time. |
| Beam Maximum<br>Intensity and Accuracy<br>(W/cm2) | 0,1 to 2,0 W/cm²<br>(continuous mode)<br>0,1 to 3,0 W/cm²<br>(Pulsed) | 0,1 to 2,0 W/cm²<br>(continuous mode)<br>0,1 to 3,0 W/cm²<br>(Pulsed) | Not available | Similar. |
| Maximum Value of the<br>Output Power (Rated<br>Output Power) and<br>Accuracy (W) | 6,4W ± 20% | 6,4W ± 20% | Not available | The maximum<br>power of the<br>predicate is higher<br>but the Beam<br>maximum<br>intensity is the<br>same 2.0w/cm²<br>for the continuous<br>mode. |
| Maximum Value of the<br>Effective Intensity and<br>Accuracy (Not to<br>exceed 3 W/cm2 *) | 0,1 to 2,0 W/cm²<br>(continuous mode)<br>0,1 to 3,0 W/cm²<br>(Pulsed) | 0,1 to 2,0 W/cm²<br>(continuous mode)<br>0,1 to 3,0 W/cm²<br>(Pulsed) | Not available | Similar. |
| Peak Temperature<br>Rise vs. Time and<br>Tissue Depth to<br>Maximum Treatment<br>Time (for fixed<br>Treatment Head<br>Placement) (deg C) | Head in the air<br>Elevation of<br>temperature raise 18<br>ºC for 20 minutes, 1<br>MHz, 6.4W<br>Elevation of<br>temperature raise 19<br>ºC for 20 minutes, 3.3<br>MHz, 6.4W<br>Effective depth 3cm<br>for 1MHz and 1cm for<br>3MHz | Head in the air<br>Elevation of<br>temperature raise 18<br>ºC for 20 minutes, 1<br>MHz, 6.4W<br>Elevation of<br>temperature raise 19<br>ºC for 20 minutes, 3.3<br>MHz, 6.4W<br>Effective depth 3cm<br>for 1MHz and 1cm for<br>3MHz | Not available | Not available for<br>comparison |
| Maximum Patient<br>Contact Surface<br>Temperature of<br>Treatment Head under<br>Simulated or Actual<br>Use Conditions for all<br>Operating Conditions<br>(Continually operated<br>for maximum | Head in the MMT<br>32 ºC for 1MHz<br>continuous use 6.4W<br>36 ºC for 3.3MHz<br>continuous use 6.4W | Head in the MMT<br>32 ºC for 1MHz<br>continuous use 6.4W<br>36 ºC for 3.3MHz<br>continuous use 6.4W | Not available | Not available for<br>comparison |
| treatment time) (deg<br>C) | | | | |
| Penetration Depth<br>(cm) | 1Mhz 5cm<br>3.3MHz 2cm | 1Mhz 5cm<br>3.3MHz 2cm | 1Mhz 5cm<br>3.3MHz 2cm | Same |
CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.
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CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.
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#### Discussion:
The subject device and the predicate device have similar intended use, principles of operation, and output characteristics. Of note:
- -Treatment time: the predicate has a higher treatment time, if the practitioner needs more than 20 minutes the treatment could be restarted.
- -Piezoelectric Material: They have the same Zirconia ceramic piezoelectric family.
- -Maximum Value of the Output Power: The output power of the predicate is higher, as the ERA is larger, the output density power is equal.
- -Penetration depth: The subject device and the sonopulse has the same penetration depth
### Non-Clinical Performance Data:
The Sonomed was tested in accordance with these standards:
- IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-5 Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
- . IEC 62304 Medical device software – Software life cycle processes
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- . ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Clinical performance Data:
No clinical data were included in this submission.
Conclusion:
The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate device.
