Sonopuls 190

K230472 · Enraf-Nonius, B.V. · IMI · Oct 24, 2023 · Physical Medicine

Device Facts

• Record ID: K230472
• Device Name: Sonopuls 190
• Applicant: Enraf-Nonius, B.V.
• Product Code: IMI · Physical Medicine
• Decision Date: Oct 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Therapeutic Ultrasound is indicated for: - 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

Multi-frequency ultrasound therapy device; provides 1 and 3 MHz operation via large or small applicators. Operates in continuous or pulsed modes. Features contact control to suspend energy if acoustic contact is insufficient. Used in clinical settings by physicians/trained professionals. Delivers deep heat to tissues; intended for pain relief, muscle spasm reduction, blood flow increase, and joint range of motion improvement. Healthcare providers apply the transducer to the patient's skin; output intensity and duration are adjusted based on clinical need. Benefits include non-invasive therapeutic heating for musculoskeletal conditions.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1), software validation (IEC 62304), electromagnetic compatibility (IEC 60601-1-2), electrical safety (ANSI/AAMI ES60601-1), and ultrasonic physiotherapy performance (IEC 60601-2-5).

Technological Characteristics

Multi-frequency (1/3 MHz) ultrasound therapy equipment. PZT-8 piezoceramic crystal material. Power: 100-240 VAC. Output modes: continuous and pulsed. Applicators: 5 cm² and 0.8 cm² sizes. Contact control mechanism. Connectivity: standalone. Sterilization: not specified. Software: IEC 62304 compliant. Housing: ABS plastic.

Indications for Use

Indicated for patients requiring pain relief, reduction of muscle spasms, localized increase in blood flow, or increased range of motion of contracted joints via heat and stretch techniques. Prescription use only.

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

• Sonomed IV/Sonomed V (K202788)

Reference Devices

• Omniversa Multi-Modality Therapy System (K153559)

Submission Summary (Full Text)

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October 24, 2023

Enraf-Nonius. B.V. % Scott Blood Regulatory Consultant Quality and Regulatory Services 151 Gleasondale Road Stow, Massachusetts 01775

Re: K230472

Trade/Device Name: Sonopuls 190 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: IMI Dated: September 20, 2023 Received: September 22, 2023

#### Dear Scott Blood:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Lauren E. Woodard -S

for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation

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and Rehabilitation 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) K230472

Device Name Sonopuls 190

Indications for Use (Describe)

Therapeutic Ultrasound is indicated for:

- * 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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## 510(k) Summary Sonopuls 190 K230472

- 1. Basic Information-Submitter: 510(k) Owner:
Enraf-Nonius B.V 127, Vareseweg Rotterdam, Zuid-Holland, NL-3047AT THE NETHERLANDS

Official Correspondent:

Scott Blood Principal Consultant Phone: [phone] Fax: [phone] E-Mail: [e-mail]

Date Summary Prepared:

October 23, 2023

- 2. Device Name:
Trade Name: Classification Name:

Requlation Number: Product Code: Classification:

- 3. Predicate Device: Company Name:
Sonopuls 190 Ultrasonic Diathermy for Use in Applying Therapeutic Deep Heat 890.5300 IMI Class II

Sonomed IV/Sonomed V Carci Industria E Comercio De Aparelhos Cirurgicos E Orto K202788

- 4. Reference Device:
Omniversa Multi-Modality Therapy System Accelerated Care Plus (ACP) K153559

#### 5. Device Description:

This device is a multi-frequency ultrasound therapy equipment. The mounted applicators provide both 1 and 3 MHz operation. Depending on the area of treatment, two different types of applicators, large and small, are available. They are suitable for treatment under water.

Contact control suspends the application of ultrasound energy when acoustical contact with the treatment area becomes insufficient. The user can connect two ultrasound applicators. Activation of each applicator can be controlled from the ultrasound menu.

This device is a prescription equipment. Use by any persons other than physicians is prohibited.

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#### 6. Indications for Use Statement:

| Regulatory<br>Characteristics | Subject Device<br>Enraf-Nonius B.V.<br>Sonopuls 190<br>This Submission | Predicate Device<br>CARCI Indústria<br>Sonomed IV/V<br>K202788 | Substantial<br>Equivalence<br>Comments<br>(Subject vs<br>Predicate) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indications for<br>Use | Therapeutic<br>Ultrasound is<br>indicated for:<br>• Pain Relief<br>• Reduction of<br>muscle spasms<br>• Localized increase<br>in blood flow<br>• Increase range of<br>motion of<br>contracted joints<br>using heat and<br>stretch techniques | Therapeutic<br>Ultrasound<br>• Pain Relief<br>• Reduction of muscle<br>spasms<br>• Localized increase<br>in blood flow<br>• Increase range of<br>motion of contracted<br>joints using heat and<br>stretch techniques | Similar |
| Product Code &<br>Regulation | IMI, 890.5300 | IMI, 890.5300 | Identical |

### 7. Technological Characteristics:

Both the subject device and predicate device use the same ultrasound frequencies (1 MHz, 3 MHz) to meet their Indications for Use. The devices are technologically equivalent, however the specific predicate device parameters have not been published in the publicly-available 510(k) statement.

| Technological<br>Characteristics | Subject Device<br>Enraf-Nonius B.V.<br>Sonopuls 190<br>This Submission | Predicate Device<br>CARCI Indústria<br>Sonomed IV/V<br>K202788 | Substantial<br>Equivalence<br>Comments<br>(Subject vs<br>Predicate) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Patient Leakage<br>Current | 1 µA typical<br>(requirements IEC < 10<br>µA) | Not publicly available | Not Available |
| Crystal Material | PZT-8 (lead zirconate<br>titanate) piezoceramic<br>material | PZT | Similar |
| Technological<br>Characteristics | Subject Device<br>Enraf-Nonius B.V.<br>Sonopuls 190<br>This Submission | Predicate Device<br>CARCI Indústria<br>Sonomed IV/V<br>K202788 | Substantial<br>Equivalence<br>Comments<br>(Subject vs<br>Predicate) |
| Technology of<br>ultrasound<br>generation (e.g.,<br>piezoelectric,<br>magnetostrictive) | piezoelectric | piezoelectric | Identical |
| Power source | 100 - 240 VAC +/- 10% | 100 - 240 VAC | Similar |
| Method of Line<br>Current Isolation | Transformer & Opto<br>Isolated | Not Publicly Available | Not available |
| Output Mode | Continuous<br>Pulsed | Continuous<br>Pulsed | Identical |
| Beam Type<br>(collimated or<br>divergent) | 5 cm² applicator:<br>1 MHz: collimating<br>3 MHz: collimating<br>0.8 cm² applicator:<br>1 MHz: collimating<br>3 MHz: diverging | Collimated | Similar |
| Intensity | 0 - 3.0 W/cm² | 0.1 - 2.0 W/cm2 (cont)<br>0.1 - 3.0 W/cm² (pulsed) | Similar |
| Frequency | 1 MHz<br>3 MHz | 1 MHz +/-5%<br>3 MHz +/-5% | Similar |
| Acoustic<br>Working<br>Frequency and<br>Accuracy (MHz) | 5 cm², 0.8 cm² and<br>1 MHz: 0.98 MHz ± 5%<br>3 MHz: 3.1 MHz ± 5% | 1 MHz ± 5%<br>3.3 MHz ± 5% | Similar |
| Effective<br>Radiating Area<br>and Accuracy | 5 cm² applicator:<br>5 cm² ± 20%<br>0.8 cm² applicator:<br>0.8 cm² ± 20% | 3.2cm2 +/- 10% | Different |
| Beam<br>Nonuniformity<br>Ratio and<br>Accuracy | 6:1 maximum | 2.8:1 maximum | Different |
| Pulse Frequency | 16Hz, 48Hz, 100Hz +/-<br>1% | Not publicly available | Not available |
| Technological<br>Characteristics | Subject Device<br>Enraf-Nonius B.V.<br>Sonopuls 190<br>This Submission | Predicate Device<br>CARCI Indústria<br>Sonomed IV/V<br>K202788 | Substantial<br>Equivalence<br>Comments<br>(Subject vs<br>Predicate) |
| Temporal Max<br>Power (W) - [for<br>pulsed] | 5 cm2 applicator:<br>duty cycle 5-50%: 15W<br>duty cycle 80%: 12W<br>0.8 cm2 applicator:<br>duty cycle 5-50% 2.4 W<br>duty cycle 80%: 2 W | Not publicly available | Not available |
| Temporal Max<br>Power (W) - [for<br>continuous] | 5 cm2 applicator:<br>10 W<br>0.8 cm2 applicator:<br>1.6 W | Not publicly available | Not available |
| Maximum Value<br>of the Output<br>Power (Rated<br>Output Power)<br>and Accuracy<br>(W) | 5 cm² applicator:<br>10 W ± 20%<br>0.8 cm² applicator:<br>2 W ± 20% | 6.4 W ± 20% | Different |
| Peak<br>Temperature<br>Rise vs. Time<br>and Tissue<br>Depth to<br>Maximum<br>Treatment Time<br>(for fixed<br>Treatment Head<br>Placement) (deg<br>C) | Elevation of<br>temperature raise 4.8°C<br>for 10 minutes<br>1.0MHz, 2.0W<br>Effective depth 2.5cm<br>Elevation of<br>temperature raise 5.8°C<br>for 3 minutes<br>3.0MHz, 2.0W<br>Effective depth 0.8cm | Head in the air<br>Elevation of<br>temperature raise 18°C<br>for 20 minutes<br>1MHz, 6.4W<br>Elevation of<br>temperature raise 19°C<br>for 20 minutes<br>3.3MHz, 6.4W<br>Effective depth 3cm<br>for 1MHz and 1cm for<br>3MHz | Different |
| Technological<br>Characteristics | Subject Device<br>Enraf-Nonius B.V.<br>Sonopuls 190<br>This Submission | Predicate Device<br>CARCI Indústria<br>Sonomed IV/V<br>K202788 | Substantial<br>Equivalence<br>Comments<br>(Subject vs<br>Predicate) |
| Maximum<br>Patient Contact<br>Surface<br>Temperature of<br>Treatment Head<br>under Simulated<br>fixed Treatment<br>Head<br>Placement) (deg<br>C) or Actual Use<br>Conditions for all<br>Operating<br>Conditions<br>(Continually<br>operated for<br>maximum<br>treatment time)<br>(deg C) | 5 cm2 applicator<br><43 deg C<br>0.8 cm2 applicator<br><34 deg C | Head in the MMT<br>32 °C for 1MHz<br>continuous use 6.4W<br>36 °C for 3.3MHz<br>continuous use 6.4W | Different |
| Penetration<br>Depth | 1Mhz 2.5cm<br>3.0MHz 0.8cm | 1Mhz 5cm<br>3.3MHz 2cm | Different |
| Ultrasound<br>Heads | 0.8 cm²<br>5 cm² | 5 cm² | Similar |
| # of Output<br>Modes | 2 | 2 | Identical |
| Timer Range<br>(minutes) | 0 - 10 | 0 - 20 | Similar |
| Compliance to<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-5<br>IEC 62304<br>ISO 10993-1 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-5 | Similar |
| Weight<br>(Console &<br>Treatment<br>head) | 7 Ibs 2oz | 3 lbs 3 oz | Different |
| Dimensions<br>(W x H x D) | 6.25" x 5.5" x 8" | 12.2" x 2.3" x 7" | Different |
| Housing<br>Materials and<br>Construction | ABS | Not Publicly Available | Not available |

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## 8. Discussion of Differences

| Technological Characteristics | Characteristic differences<br>between Sonopuls 190<br>and predicate device | Discussion on why this difference does not<br>affect the overall safety and effectiveness of<br>the subject device when compared to the<br>predicate device |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Effective Radiating Area<br>and Accuracy | The subject device has an<br>ERA of 5cm2±20% and the<br>predicate device has an<br>ERA of 3.2cm²±10% with<br>the same size (5cm²<br>applicator | The Effective Radiating Area (ERA) of the<br>transducer of the same area as the transducer<br>head for the subject device, and a fraction of the<br>predicate device transducer's area, which is more<br>typical for ultrasound transducers. The accuracy is<br>superior with the predicate device transducer.<br>There are no new questions of safety or<br>performance because the ERA is identical to the<br>Omniversa device (the reference device) which<br>has been cleared as an ultrasound diathermy<br>physical therapeutic device using the same ERA<br>parameters as the subject device. |
| Beam Nonuniformity Ratio and<br>Accuracy | 6.1 maximum versus<br>2.8:1 maximum | Although different between the subject and<br>predicate devices, the differences in Beam<br>Nonuniformity Ratio (BNR) are somewhat similar<br>as compared to values in other cleared ultrasound<br>diathermy devices, which can range between 2<br>and 6:1. There are no new questions of safety or<br>performance because the ERA is identical to the<br>Omniversa device (the reference device) which<br>has been cleared as an ultrasound diathermy<br>physical therapeutic device using the same ERA<br>parameters as the subject device. |
| Maximum Value of the Output<br>Power (Rated Output Power)<br>and Accuracy (W) | 5 cm² applicator:<br>10 W ± 20% and<br>0.8 cm² applicator:<br>2 W ± 20%<br>versus<br>6.4 W ± 20% | Although the maximum output power mean values<br>are different between the subject and predicate<br>devices, the reference device of the subject device<br>was used safely in thermal tissue testing to support<br>this submission. |
| Peak Temperature Rise vs.<br>Time and Tissue Depth to<br>Maximum Treatment Time (for<br>fixed Treatment Head<br>Placement) (deg C) | In summary, the peak<br>temperature rise and tissue<br>depth for the subject device<br>is less over a shorter<br>treatment time than that of<br>the predicate device. | Although the peak temperature rise over treatment<br>time and tissue depth is less for the subject device<br>when compared to the predicate device, there are<br>no new questions of safety as the lower<br>temperature rise over time and tissue depth is<br>lower and slower, and thus safer for the patient. |
| Maximum Patient Contact<br>Surface Temperature of<br>Treatment Head under<br>Simulated fixed Treatment<br>Head Placement) (deq C) or<br>Actual Use Conditions for all<br>Operating Conditions<br>(Continually operated for<br>maximum treatment time) (deg<br>C) | In summary, the subject<br>device maintained a<br>maximum temperature of<br>under 43°C at the<br>maximum output setting<br>where the predicate device<br>maximum temperature<br>operated under 36°C. | The subject device operation resulted in a<br>maximum patient contact temperature of under<br>43°C. The reference device of the subject device<br>was used safely in thermal tissue testing to support<br>this submission. |
| Technological Characteristics | Characteristic differences<br>between Sonopuls 190<br>and predicate device | Discussion on why this difference does not<br>affect the overall safety and effectiveness of<br>the subject device when compared to the<br>predicate device |
| Penetration depth | 1MHz - 2.5cm<br>3.0MHz - 0.8cm<br>Versus<br>1MHz - 5cm<br>3.3MHz - 2cm | The subject device appears to have less<br>penetration depth than the predicate. From a<br>safety standpoint, less penetration is safer for the<br>user. Device performance was established in the<br>thermal tissue test study that support this<br>submission. |
| Timer Range (Treatment Time) | 10 minutes maximum<br>versus 20 minutes<br>maximum | The maximum allowable treatment time is half of<br>what the predicate device allows. Because the<br>exposure of energy during the treatment is less<br>than the predicate, there are no new questions of<br>safety with this difference. Device performance<br>was established in the thermal tissue test study<br>performed using the reference device of the<br>subject device to support this submission, so there<br>are no new question of device performance. |
| Weight and Dimensions | 7lbs 2 oz, 6.25" x 5.5" x 8"<br>versus<br>3 lbs 3oz, 12.2" x 2.3" x 7" | Different weights and dimensions have no<br>influence on the safety or effectiveness of the<br>device |

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#### 9. Summary of Testing:

The technological characteristics of the Sonopuls 190 device has been verified based on assessments of electrical safety, performance, biocompatibility, and software.

The following testing has been conducted with satisfactory results:

- . Biocompatibility: ISO 10993-1:2018 (Edition 5) Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk manaqement process: Samples of the user and patient-contacting were tested for biocompatibility.
- Software Assessment: IEC 62304:2015 Medical devices software -software life cvcle processes: Software features were assessed in accordance with FDA software validation guidelines. Levels of Concern, User & System Requirements, Hazard Analysis, Software Requirements, Architectural Design, Software Validation & Testing were all addressed.
- Electromagnetic compatibility: IEC 60601-1-2:2014 Medical electrical equipment ● Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances – Requirements and tests: EMC testing was done to evaluate emissions and immunity to electromagnetic fields.
- Electrical safety: ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012. . C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance: Full electrical safety testing was completed.
- . Ultrasonic physiotherapy equipment: IEC 60601-2-5 Edition 3.0 2009-07 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and

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essential performance of ultrasonic physiotherapy equipment: Ultrasonic physiotherapy equipment requirements were tested.

The Sonopuls 190 device has been assessed and/or tested for compliance to the following voluntary standards:

| Standards | SUBJECT DEVICE<br>Enraf-Nonius B.V.<br>Sonopuls 190<br>K230472 | Predicate Device<br>CARCI Indústria<br>Sonomed IV/V<br>K202788 |
|---------------|----------------------------------------------------------------|----------------------------------------------------------------|
| ANSI AAMI | X | X |
| ES60601-1 | X | X |
| IEC 60601-1-2 | X | X |
| IEC 60601-2-5 | X | X |
| IEC 62304 | X | X |
| ISO 10993-1 | X | X |

All required performance tests were conducted and show substantial equivalence with the predicate device. Sonopuls 190 has been designed and tested to more contemporary standards, as well as additional standards that are used to support the subject device 510(k) submission. Testing has been performed on final, finished devices and these systems have met the required specifications for the completed tests.

#### 10. Conclusion:

Enraf-Nonius B.V has demonstrated that the Sonopuls 190 device is substantially equivalent to the predicate device.