(244 days)
No
The summary describes a standard therapeutic ultrasound device with basic contact control and software validation according to IEC 62304. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, data analysis, or treatment optimization.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "Pain Relief," "Reduction of muscle spasms," and other therapeutic effects.
No
Explanation: The "Intended Use / Indications for Use" section lists therapeutic applications such as "Pain Relief," "Reduction of muscle spasms," and "Increase range of motion of contracted joints," all of which are treatments. The "Device Description" also clearly labels it as "multi-frequency ultrasound therapy equipment." There is no mention of diagnosing conditions or diseases.
No
The device description explicitly states it is "multi-frequency ultrasound therapy equipment" with "mounted applicators" and mentions "contact control" and the ability to connect "two ultrasound applicators." This clearly indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Pain Relief, Reduction of muscle spasms, Localized increase in blood flow, Increase range of motion) are all therapeutic applications performed directly on the patient's body. IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The description details a therapeutic ultrasound device that applies energy to the body. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-specific information: The document does not contain any information typically associated with IVD devices, such as mentions of specimens, assays, reagents, or diagnostic results.
Therefore, this device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes
IMI
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.
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
Physicians
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)
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 essential performance of ultrasonic physiotherapy equipment: Ultrasonic physiotherapy equipment requirements were tested.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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.
1
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
2
and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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.
5
6. Indications for Use Statement:
| Regulatory
Characteristics | Subject Device
Enraf-Nonius B.V.
Sonopuls 190
This Submission | Predicate Device
CARCI Indústria
Sonomed IV/V
K202788 | Substantial
Equivalence
Comments
(Subject vs
Predicate) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indications for
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 | 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 | 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.
| Technological
Characteristics | Subject Device
Enraf-Nonius B.V.
Sonopuls 190
This Submission | Predicate Device
CARCI Indústria
Sonomed IV/V
K202788 | Substantial
Equivalence
Comments
(Subject vs
Predicate) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Patient Leakage
Current | 1 µA typical
(requirements IEC