(457 days)
Not Found
No
The summary describes a standard therapeutic ultrasound device and does not mention any AI or ML components or capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states "Therapeutic Ultrasound" for purposes like "Pain relief," "Reduction of muscle spasms," and "Localized increase in blood flow," all of which are therapeutic effects. The "Device Description" further elaborates on how the ultrasound provides "therapeutic ultrasound treatment" and causes "biological changes in the tissues" for medical benefits.
No
The device is described as "Therapeutic Ultrasound" equipment, with its intended uses focused on pain relief, reduction of muscle spasms, increasing blood flow, and improving range of motion. These are all therapeutic applications, not diagnostic ones. The device description consistently refers to its function in providing "therapeutic ultrasound treatment" and causing "biological changes in the tissues." There is no mention of using ultrasound for imaging, assessment, or diagnosis of conditions.
No
The device description explicitly details hardware components like a transducer/applicator (head) with a piezoelectric crystal and an aluminum surface, which are essential for generating and transmitting the therapeutic ultrasound. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are therapeutic: pain relief, reduction of muscle spasms, increased blood flow, and increased range of motion. These are all related to treating conditions within the body, not diagnosing them.
- Device Description: The description clearly states it's "ultrasound equipment for therapy" and describes how it delivers mechanical stimulus and heat to tissues for therapeutic effects.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening.
Therefore, the SONOMED apparatus, as described, is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes
IMI
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.
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)
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
- . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
1
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
2
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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3
Sonomed IV / Sonomed V
510(k) Summary
Administrative information
| Sponsor | CARCI Indústria e Comércio de Aparelhos
Cirúrgicos e Ortopédicos Ltda.
R. Padre Machado, 82–
São Paulo – SP – Brazil
Telephone: +55 (11) 5621 2791 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Preparer | Bruno Milhoci de Souza
Regulatory Affairs Specialist
Passarini Regulatory Affairs
E-Mail: bruno@rapassarini.com.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
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 |
4
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.
5
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/
Manufacturer | Indications for use statement |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Carci | 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 |
| Predicate device | K130888
Ibramen | 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 |
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Table 5.2 SE comparison
| Trade Name | Subject Device | Predicate Device | Equivalent discussion | |
|---|---|---|---|---|
| information/ | ||||
| Manufacturer | Sonomed IV | |||
| Carci | Sonomed V | |||
| Carci | K130888/ Sonopulse | |||
| Ibramed | ||||
| Regulation Number | 890.5300 | 890.5300 | 890.5300 | Same |
| 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 | 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 | 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 | Same |
| Product Code | IMI | IMI | IMI | The subject device
and the predicate
has the same
classification of the
ultrasound, but the
predicate has
mode
functions |
| Console/Generator
Dimensions (L x W x H
cm) | 31 x 18 x 6 | 31 x 18 x 6 | Not available | Equivalent |
| Treatment Head
Dimensions (L x W x H
cm) | 15 cm x 5 cm x 4 cm | 15 cm x 5 cm x 4 cm | Not available | Equivalent |
| Console/Generator
Weight (kg) | 1.2 Kg | 1.2 Kg | Not available | Equivalent |
| Treatment Head
Weight (kg) | 252 Grams | 252 Grams | Not available | Equivalent |
| Power Supply | 100 - 240V 50/60Hz | 100 - 240V 50/60Hz | (AC Line) 100-240V
~50/60Hz | Same |
| Leakage Current | 49 μA (Normal)
86 µA (single fault) | 49μA (Normal)
86 µA (single fault) | Not available | Equivalent |
| Crystal Material | PZT | PZT | Not available | Equivalent |
| Technology of
ultrasound generation | Piezoelectric | Piezoelectric | Piezoelectric | Same |
| Treatment Mode(s) | Pulsed, continuous | Pulsed, continuous | Pulsed, continuous | Same |
| Beam Type (collimated
or divergent) | Collimated | Collimated | Pulsed, continuous | Same |
| Transducer Diameter
(cm) | 5cm² = 2,52cm | 5cm² = 2,52cm | 7cm² = 2,98 cm | Equivalent |
| Acoustic Working
Frequency and
Accuracy (MHz) | 1MHZ± 5%
3.3MHz± 5% | 1MHZ± 5%
3.3MHz± 5% | 1MHZ± 5%
3.3MHz± 5% | Frequencies of the
devices are similar
within the error
margin. All the
frequencies are
covered by the |
| | | | | regulation number
890.5300 |
| Effective Radiating
Area and Accuracy
(cm2) | 3,2 cm² ±10% | 3,2 cm² ±10% | Not available | The effective area
of all products are
similar |
| Beam Nonuniformity
Ratio (not to exceed
8*) and Accuracy | 2.8:1 | 2.8:1 | Not available | Similar. |
| Output Mode:
(Continuous
Wave/Amplitude -
Modulated Wave) | Continuous
Pulsed | Continuous
Pulsed | Continuous
Pulsed | Same |
| Maximum Timer
Setting and Accuracy
(not to exceed 30
min*) | 20 minutes | 20 minutes | 30 minutes | The subject device
has a lower
treatment time. |
| Beam Maximum
Intensity and Accuracy
(W/cm2) | 0,1 to 2,0 W/cm²
(continuous mode)
0,1 to 3,0 W/cm²
(Pulsed) | 0,1 to 2,0 W/cm²
(continuous mode)
0,1 to 3,0 W/cm²
(Pulsed) | Not available | Similar. |
| Maximum Value of the
Output Power (Rated
Output Power) and
Accuracy (W) | 6,4W ± 20% | 6,4W ± 20% | Not available | The maximum
power of the
predicate is higher
but the Beam
maximum
intensity is the
same 2.0w/cm²
for the continuous
mode. |
| Maximum Value of the
Effective Intensity and
Accuracy (Not to
exceed 3 W/cm2 *) | 0,1 to 2,0 W/cm²
(continuous mode)
0,1 to 3,0 W/cm²
(Pulsed) | 0,1 to 2,0 W/cm²
(continuous mode)
0,1 to 3,0 W/cm²
(Pulsed) | Not available | Similar. |
| Peak Temperature
Rise vs. Time and
Tissue Depth to
Maximum Treatment
Time (for fixed
Treatment Head
Placement) (deg C) | Head in the air
Elevation of
temperature raise 18
ºC for 20 minutes, 1
MHz, 6.4W
Elevation of
temperature raise 19
ºC for 20 minutes, 3.3
MHz, 6.4W
Effective depth 3cm
for 1MHz and 1cm for
3MHz | Head in the air
Elevation of
temperature raise 18
ºC for 20 minutes, 1
MHz, 6.4W
Elevation of
temperature raise 19
ºC for 20 minutes, 3.3
MHz, 6.4W
Effective depth 3cm
for 1MHz and 1cm for
3MHz | Not available | Not available for
comparison |
| Maximum Patient
Contact Surface
Temperature of
Treatment Head under
Simulated or Actual
Use Conditions for all
Operating Conditions
(Continually operated
for maximum | Head in the MMT
32 ºC for 1MHz
continuous use 6.4W
36 ºC for 3.3MHz
continuous use 6.4W | Head in the MMT
32 ºC for 1MHz
continuous use 6.4W
36 ºC for 3.3MHz
continuous use 6.4W | Not available | Not available for
comparison |
| treatment time) (deg
C) | | | | |
| Penetration Depth
(cm) | 1Mhz 5cm
3.3MHz 2cm | 1Mhz 5cm
3.3MHz 2cm | 1Mhz 5cm
3.3MHz 2cm | Same |
CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.
7
CARCI Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos Ltda.
8
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
9
- . 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.