(244 days)
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
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.
This document is a 510(k) Summary for the Sonopuls 190 medical device, which is an ultrasound therapy equipment. It aims to demonstrate substantial equivalence to a predicate device (Sonomed IV/V).
Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets acceptance criteria:
The context of the provided document is a 510(k) submission for a non-AI-powered therapeutic ultrasound device. Therefore, many of the requested elements specifically pertaining to AI/ML device performance and testing (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable or explicitly mentioned in this type of submission. The "acceptance criteria" here primarily refer to meeting regulatory standards and demonstrating substantial equivalence to a predicate device, rather than a specific performance metric for a diagnostic AI model.
However, I will extract what is available and note where the information is not present due to the nature of the device and submission.
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific quantitative "acceptance criteria" for the device's therapeutic performance in a table format with corresponding "reported device performance" in the way one might expect for a diagnostic AI device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with various electrical safety, performance, biocompatibility, and software standards, and showing that any differences from the predicate device do not raise new questions of safety or effectiveness.
The closest equivalent to "performance" for this type of device relates to its physical output parameters (e.g., intensity, frequency, temperature rise, penetration depth) and compliance with safety standards. The "acceptance criteria" are implied by adherence to the listed standards and the conclusion of substantial equivalence.
Here's a table based on the "7. Technological Characteristics" and "8. Discussion of Differences", which details the device's specifications and compares them to the predicate, and serves as an indirect form of "performance" demonstration in this context. The "acceptance criteria" are implied to be "comparable to or not raising new questions of safety/effectiveness compared to the predicate device, and compliant with relevant standards."
| Characteristic / Acceptance Metric | Subject Device Performance (Sonopuls 190) | Predicate Device (Sonomed IV/V) Performance | Discussion/Substantial Equivalence Commentary (Implicit "Acceptance") |
|---|---|---|---|
| Indications for Use | Pain Relief, Reduction of muscle spasms, Localized increase in blood flow, Increase range of motion of contracted joints using heat and stretch techniques | Same as Subject Device | Similar. Formally accepted for substantial equivalence. |
| Product Code & Regulation | IMI, 890.5300 | IMI, 890.5300 | Identical. Formally accepted for substantial equivalence. |
| Crystal Material | PZT-8 (lead zirconate titanate) piezoceramic material | PZT | Similar. Accepted. |
| Technology of ultrasound generation | piezoelectric | piezoelectric | Identical. Accepted. |
| Power source | 100 - 240 VAC +/- 10% | 100 - 240 VAC | Similar. Accepted. |
| Output Mode | Continuous, Pulsed | Continuous, Pulsed | Identical. Accepted. |
| Intensity | 0 - 3.0 W/cm² | 0.1 - 2.0 W/cm² (cont), 0.1 - 3.0 W/cm² (pulsed) | Similar. Accepted. |
| Frequency | 1 MHz, 3 MHz | 1 MHz +/-5%, 3 MHz +/-5% | Similar. Accepted. |
| Acoustic Working Frequency and Accuracy (MHz) | 5 cm², 0.8 cm² and 1 MHz: 0.98 MHz ± 5%; 3 MHz: 3.1 MHz ± 5% | 1 MHz ± 5%, 3.3 MHz ± 5% | Similar. Accepted. |
| Effective Radiating Area (ERA) and Accuracy | 5 cm² applicator: 5 cm² ± 20%; 0.8 cm² applicator: 0.8 cm² ± 20% | 3.2cm² +/- 10% | Different. The ERA for the subject device's 5cm² applicator is larger and less accurate than the predicate's. However, it's deemed acceptable because it's identical to a cleared reference device (Omniversa) which uses the same parameters, thus raising no new safety questions. |
| Beam Nonuniformity Ratio (BNR) and Accuracy | 6:1 maximum | 2.8:1 maximum | Different. Subject device has a higher BNR. Accepted because BNR values in other cleared devices range between 2 and 6:1, and reliance on the thermal tissue testing using the reference device. No new safety/performance questions. |
| Maximum Value of the Output Power (Rated Output Power) and Accuracy (W) | 5 cm² applicator: 10 W ± 20%; 0.8 cm² applicator: 2 W ± 20% | 6.4 W ± 20% | Different. Subject device has higher maximum output power. Accepted because the reference device (Omniversa) was used safely in thermal tissue testing to support the submission, implying safety at these power levels. |
| Peak Temperature Rise vs. Time and Tissue Depth | 1.0MHz, 2.0W: 4.8°C for 10 min, depth 2.5cm; 3.0MHz, 2.0W: 5.8°C for 3 min, depth 0.8cm | 1MHz, 6.4W: 18°C for 20 min, depth 3cm; 3.3MHz, 6.4W: 19°C for 20 min, depth 1cm | Different. Subject device has less temperature rise over shorter time/shallower depth. Accepted as lower/slower temperature rise is "safer for the patient." |
| Maximum Patient Contact Surface Temperature of Treatment Head | 5 cm² applicator: <43 deg C; 0.8 cm² applicator: <34 deg C | 1MHz: 32 °C; 3.3MHz: 36 °C (continuous use 6.4W) | Different. Subject device has higher contact temperature. Accepted because the reference device was used safely in thermal tissue testing to support the submission. |
| Penetration Depth | 1MHz: 2.5cm; 3.0MHz: 0.8cm | 1MHz: 5cm; 3.3MHz: 2cm | Different. Subject device has less penetration depth. Accepted as "less penetration is safer for the user." Device performance was established via thermal tissue test study using the reference device. |
| Timer Range (Treatment Time) | 0 - 10 minutes | 0 - 20 minutes | Different. Subject device has a shorter maximum treatment time. Accepted as less exposure to energy is safer, and performance was established in thermal tissue test study using the reference device. |
| Compliance to Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 62304, ISO 10993-1 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5 | Similar. Subject device shows compliance with additional (more contemporary) standards, further supporting safety and performance. Satisfactory results were reported for all listed tests. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is for a physical medical device (ultrasound therapy equipment), not an AI/ML diagnostic device. Therefore, there isn't a "test set" in the sense of a dataset of medical images or patient data. The "testing" refers to bench testing, electrical safety testing, biocompatibility testing, and software assessment.
- Sample size for test set: Not applicable in the context of a dataset for an AI model. For physical product testing, it would typically relate to the number of devices tested, which isn't specified but typically follows established engineering test protocols (e.g., testing multiple units to confirm reproducibility). The text mentions "final, finished devices" were tested.
- Data provenance (country of origin, retrospective/prospective): Not applicable for this type of device testing. Testing was done on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in this context is established by engineering measurements, compliance with international standards, and verification against known physical parameters. There are no human experts classifying data for ground truth in the way there would be for a diagnostic AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human reader adjudication of data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical therapy device, not an AI-assisted diagnostic tool. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical therapy device, not an AI algorithm. Its "standalone performance" refers to its ability to meet its specifications and safety standards as tested in the lab, which was done as indicated under "9. Summary of Testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Compliance with international standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 62304, ISO 10993-1. These standards define acceptable safety limits, performance parameters, and testing methodologies for medical electrical equipment and specifically ultrasonic physiotherapy equipment.
- Bench testing/Laboratory measurements: Demonstrated electrical safety, electromagnetic compatibility, and ultrasonic physiotherapy equipment requirements.
- Biocompatibility testing: According to ISO 10993-1.
- Software assessment: In accordance with FDA software validation guidelines (IEC 62304).
- Thermal tissue testing: For parameters related to temperature rise and penetration depth, using a "reference device" with identical (or similar and proven safe) parameters to support the submission where direct predicate data was not available (e.g., for maximum output power, contact temperature, penetration depth, timer range). This implicitly serves as the "outcomes data" for thermal effects, demonstrating that the device operates safely within thermal limits.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
-
- Basic Information-Submitter: 510(k) Owner:
Enraf-Nonius B.V 127, Vareseweg Rotterdam, Zuid-Holland, NL-3047AT THE NETHERLANDS
- Basic Information-Submitter: 510(k) Owner:
Official Correspondent:
Scott Blood Principal Consultant Phone: 978.729.5978 Fax: +49 731 9761 118 E-Mail: scottgara@gmail.com
Date Summary Prepared:
October 23, 2023
-
- Device Name:
Trade Name: Classification Name:
- Device Name:
Requlation Number: Product Code: Classification:
-
- Predicate Device: Company Name:
Sonopuls 190 Ultrasonic Diathermy for Use in Applying Therapeutic Deep Heat 890.5300 IMI Class II
- Predicate Device: Company Name:
Sonomed IV/Sonomed V Carci Industria E Comercio De Aparelhos Cirurgicos E Orto K202788
-
- Reference Device:
Omniversa Multi-Modality Therapy System Accelerated Care Plus (ACP) K153559
- Reference Device:
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:
| RegulatoryCharacteristics | Subject DeviceEnraf-Nonius B.V.Sonopuls 190This Submission | Predicate DeviceCARCI IndústriaSonomed IV/VK202788 | SubstantialEquivalenceComments(Subject vsPredicate) |
|---|---|---|---|
| Indications forUse | TherapeuticUltrasound isindicated for:• Pain Relief• Reduction ofmuscle spasms• Localized increasein blood flow• Increase range ofmotion ofcontracted jointsusing heat andstretch techniques | TherapeuticUltrasound• Pain Relief• Reduction of musclespasms• Localized increasein blood flow• Increase range ofmotion of contractedjoints using heat andstretch techniques | Similar |
| Product Code &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.
| TechnologicalCharacteristics | Subject DeviceEnraf-Nonius B.V.Sonopuls 190This Submission | Predicate DeviceCARCI IndústriaSonomed IV/VK202788 | SubstantialEquivalenceComments(Subject vsPredicate) |
|---|---|---|---|
| Patient LeakageCurrent | 1 µA typical(requirements IEC < 10µA) | Not publicly available | Not Available |
| Crystal Material | PZT-8 (lead zirconatetitanate) piezoceramicmaterial | PZT | Similar |
| TechnologicalCharacteristics | Subject DeviceEnraf-Nonius B.V.Sonopuls 190This Submission | Predicate DeviceCARCI IndústriaSonomed IV/VK202788 | SubstantialEquivalenceComments(Subject vsPredicate) |
| Technology ofultrasoundgeneration (e.g.,piezoelectric,magnetostrictive) | piezoelectric | piezoelectric | Identical |
| Power source | 100 - 240 VAC +/- 10% | 100 - 240 VAC | Similar |
| Method of LineCurrent Isolation | Transformer & OptoIsolated | Not Publicly Available | Not available |
| Output Mode | ContinuousPulsed | ContinuousPulsed | Identical |
| Beam Type(collimated ordivergent) | 5 cm² applicator:1 MHz: collimating3 MHz: collimating0.8 cm² applicator:1 MHz: collimating3 MHz: diverging | Collimated | Similar |
| Intensity | 0 - 3.0 W/cm² | 0.1 - 2.0 W/cm2 (cont)0.1 - 3.0 W/cm² (pulsed) | Similar |
| Frequency | 1 MHz3 MHz | 1 MHz +/-5%3 MHz +/-5% | Similar |
| AcousticWorkingFrequency andAccuracy (MHz) | 5 cm², 0.8 cm² and1 MHz: 0.98 MHz ± 5%3 MHz: 3.1 MHz ± 5% | 1 MHz ± 5%3.3 MHz ± 5% | Similar |
| EffectiveRadiating Areaand Accuracy | 5 cm² applicator:5 cm² ± 20%0.8 cm² applicator:0.8 cm² ± 20% | 3.2cm2 +/- 10% | Different |
| BeamNonuniformityRatio andAccuracy | 6:1 maximum | 2.8:1 maximum | Different |
| Pulse Frequency | 16Hz, 48Hz, 100Hz +/-1% | Not publicly available | Not available |
| TechnologicalCharacteristics | Subject DeviceEnraf-Nonius B.V.Sonopuls 190This Submission | Predicate DeviceCARCI IndústriaSonomed IV/VK202788 | SubstantialEquivalenceComments(Subject vsPredicate) |
| Temporal MaxPower (W) - [forpulsed] | 5 cm2 applicator:duty cycle 5-50%: 15Wduty cycle 80%: 12W0.8 cm2 applicator:duty cycle 5-50% 2.4 Wduty cycle 80%: 2 W | Not publicly available | Not available |
| Temporal MaxPower (W) - [forcontinuous] | 5 cm2 applicator:10 W0.8 cm2 applicator:1.6 W | Not publicly available | Not available |
| Maximum Valueof the OutputPower (RatedOutput Power)and Accuracy(W) | 5 cm² applicator:10 W ± 20%0.8 cm² applicator:2 W ± 20% | 6.4 W ± 20% | Different |
| PeakTemperatureRise vs. Timeand TissueDepth toMaximumTreatment Time(for fixedTreatment HeadPlacement) (degC) | Elevation oftemperature raise 4.8°Cfor 10 minutes1.0MHz, 2.0WEffective depth 2.5cmElevation oftemperature raise 5.8°Cfor 3 minutes3.0MHz, 2.0WEffective depth 0.8cm | Head in the airElevation oftemperature raise 18°Cfor 20 minutes1MHz, 6.4WElevation oftemperature raise 19°Cfor 20 minutes3.3MHz, 6.4WEffective depth 3cmfor 1MHz and 1cm for3MHz | Different |
| TechnologicalCharacteristics | Subject DeviceEnraf-Nonius B.V.Sonopuls 190This Submission | Predicate DeviceCARCI IndústriaSonomed IV/VK202788 | SubstantialEquivalenceComments(Subject vsPredicate) |
| MaximumPatient ContactSurfaceTemperature ofTreatment Headunder Simulatedfixed TreatmentHeadPlacement) (degC) or Actual UseConditions for allOperatingConditions(Continuallyoperated formaximumtreatment time)(deg C) | 5 cm2 applicator<43 deg C0.8 cm2 applicator<34 deg C | Head in the MMT32 °C for 1MHzcontinuous use 6.4W36 °C for 3.3MHzcontinuous use 6.4W | Different |
| PenetrationDepth | 1Mhz 2.5cm3.0MHz 0.8cm | 1Mhz 5cm3.3MHz 2cm | Different |
| UltrasoundHeads | 0.8 cm²5 cm² | 5 cm² | Similar |
| # of OutputModes | 2 | 2 | Identical |
| Timer Range(minutes) | 0 - 10 | 0 - 20 | Similar |
| Compliance toStandards | IEC 60601-1IEC 60601-1-2IEC 60601-2-5IEC 62304ISO 10993-1 | IEC 60601-1IEC 60601-1-2IEC 60601-2-5 | Similar |
| Weight(Console &Treatmenthead) | 7 Ibs 2oz | 3 lbs 3 oz | Different |
| Dimensions(W x H x D) | 6.25" x 5.5" x 8" | 12.2" x 2.3" x 7" | Different |
| HousingMaterials andConstruction | ABS | Not Publicly Available | Not available |
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8. Discussion of Differences
| Technological Characteristics | Characteristic differencesbetween Sonopuls 190and predicate device | Discussion on why this difference does notaffect the overall safety and effectiveness ofthe subject device when compared to thepredicate device |
|---|---|---|
| Effective Radiating Areaand Accuracy | The subject device has anERA of 5cm2±20% and thepredicate device has anERA of 3.2cm²±10% withthe same size (5cm²applicator | The Effective Radiating Area (ERA) of thetransducer of the same area as the transducerhead for the subject device, and a fraction of thepredicate device transducer's area, which is moretypical for ultrasound transducers. The accuracy issuperior with the predicate device transducer.There are no new questions of safety orperformance because the ERA is identical to theOmniversa device (the reference device) whichhas been cleared as an ultrasound diathermyphysical therapeutic device using the same ERAparameters as the subject device. |
| Beam Nonuniformity Ratio andAccuracy | 6.1 maximum versus2.8:1 maximum | Although different between the subject andpredicate devices, the differences in BeamNonuniformity Ratio (BNR) are somewhat similaras compared to values in other cleared ultrasounddiathermy devices, which can range between 2and 6:1. There are no new questions of safety orperformance because the ERA is identical to theOmniversa device (the reference device) whichhas been cleared as an ultrasound diathermyphysical therapeutic device using the same ERAparameters as the subject device. |
| Maximum Value of the OutputPower (Rated Output Power)and Accuracy (W) | 5 cm² applicator:10 W ± 20% and0.8 cm² applicator:2 W ± 20%versus6.4 W ± 20% | Although the maximum output power mean valuesare different between the subject and predicatedevices, the reference device of the subject devicewas used safely in thermal tissue testing to supportthis submission. |
| Peak Temperature Rise vs.Time and Tissue Depth toMaximum Treatment Time (forfixed Treatment HeadPlacement) (deg C) | In summary, the peaktemperature rise and tissuedepth for the subject deviceis less over a shortertreatment time than that ofthe predicate device. | Although the peak temperature rise over treatmenttime and tissue depth is less for the subject devicewhen compared to the predicate device, there areno new questions of safety as the lowertemperature rise over time and tissue depth islower and slower, and thus safer for the patient. |
| Maximum Patient ContactSurface Temperature ofTreatment Head underSimulated fixed TreatmentHead Placement) (deq C) orActual Use Conditions for allOperating Conditions(Continually operated formaximum treatment time) (degC) | In summary, the subjectdevice maintained amaximum temperature ofunder 43°C at themaximum output settingwhere the predicate devicemaximum temperatureoperated under 36°C. | The subject device operation resulted in amaximum patient contact temperature of under43°C. The reference device of the subject devicewas used safely in thermal tissue testing to supportthis submission. |
| Technological Characteristics | Characteristic differencesbetween Sonopuls 190and predicate device | Discussion on why this difference does notaffect the overall safety and effectiveness ofthe subject device when compared to thepredicate device |
| Penetration depth | 1MHz - 2.5cm3.0MHz - 0.8cmVersus1MHz - 5cm3.3MHz - 2cm | The subject device appears to have lesspenetration depth than the predicate. From asafety standpoint, less penetration is safer for theuser. Device performance was established in thethermal tissue test study that support thissubmission. |
| Timer Range (Treatment Time) | 10 minutes maximumversus 20 minutesmaximum | The maximum allowable treatment time is half ofwhat the predicate device allows. Because theexposure of energy during the treatment is lessthan the predicate, there are no new questions ofsafety with this difference. Device performancewas established in the thermal tissue test studyperformed using the reference device of thesubject device to support this submission, so thereare no new question of device performance. |
| Weight and Dimensions | 7lbs 2 oz, 6.25" x 5.5" x 8"versus3 lbs 3oz, 12.2" x 2.3" x 7" | Different weights and dimensions have noinfluence on the safety or effectiveness of thedevice |
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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 DEVICEEnraf-Nonius B.V.Sonopuls 190K230472 | Predicate DeviceCARCI IndústriaSonomed IV/VK202788 |
|---|---|---|
| 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.
§ 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.