PainShield MD PLUS

K221210 · Nanovibronix, Inc. · PFW · Nov 23, 2022 · Physical Medicine

Device Facts

• Record ID: K221210
• Device Name: PainShield MD PLUS
• Applicant: Nanovibronix, Inc.
• Product Code: PFW · Physical Medicine
• Decision Date: Nov 23, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

Device Story

PainShield MD PLUS is an ultrasonic diathermy device; generates continuous wave (CW) ultrasound at 90 kHz; utilizes two 6 cm² disk-shaped transducers (Lead Zirconate-Titanate PZT) integrated into self-adhering patches. Driver unit is battery-powered, rechargeable, and portable; intended for home healthcare environment. Device applies deep heat to tissues to treat pain, muscle spasms, and joint contractures. User applies patches to skin; no ultrasound gel typically required, though optional for hairy sites. Therapy cycle involves 30-minute active/idle phases for 3-hour duration. Output monitored via LED/buzzer indicators and digital LCD timer. Benefits include non-invasive pain relief and muscle relaxation; allows treatment of less accessible areas like heel, Achilles tendon, and wrist.

Clinical Evidence

Bench testing only. Device passed IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare environment), and ISO 10993-1 (biocompatibility) standards. Software verification and validation testing also passed.

Technological Characteristics

Ultrasonic diathermy; 90 kHz frequency; 400 mW output power; 2 output channels. Transducer material: Lead Zirconate-Titanate (PZT). Effective radiating area: 6 cm². Beam Non-Uniformity Ratio: 6.0:1. Power: 7.4V rechargeable lithium-ion battery. Dimensions: 113 x 39.4 x 12.6 mm; weight ~227g. Connectivity: Standalone. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-1.

Indications for Use

Indicated for patients requiring deep heat therapy for relief of pain, muscle spasms, and joint contractures.

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

• PainShield MD (K081075)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

November 23, 2022

NanoVibronix, Inc. Hrishikesh Gadagkar Regulatory Affairs 525 Executive Blvd. Elmsford, New York 10523

Re: K221210

Trade/Device Name: PainShield MD PLUS Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: PFW Dated: April 23, 2022 Received: April 27, 2022

Dear Hrishikesh Gadagkar:

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.

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

{1}------------------------------------------------

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 (OS) 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 mediation-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 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) K221210

Device Name PainShield MD PLUS

Indications for Use (Describe)

The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Date of the summary prepared: November 22, 2022

#### Submitter's Information:

510(k) Owner's Name: NanoVibronix, Inc. Address: 525 Executive Blvd., Elmsford, NY 10523 Phone: [phone] Contact Name: Hrishikesh Gadagkar Contact Email: [e-mail]

## Device Information:

Manufacturer: NanoVibronix, Inc. Trade Name: PainShield MD PLUS 510(k) Number: K221210 Product Code: PFW Device Classification: Class II Regulation Number: 21 CFR 890.5300

#### Predicate Device:

Manufacturer: NanoVibronix, Inc. Trade Name: PainShield MD 510(k) Number: K081075 Product Code: PFW Device Classification: Class II Regulation Number: 21 CFR 890.5300

{4}------------------------------------------------

#### Device Description:

The PainShield MD PLUS is an electrically powered ultrasonic diathermy device intended to relieve pain, muscle spasms, and joint contractures. It is used to apply deep heat to tissues in the body with a transducer/applicator that is incorporated into a bandage-like patch that adheres to the skin.

The PainShield MD PLUS is used to generate continuous wave (CW) ultrasound at 90 kHz, through a reusable applicator/transducer that covers an area of about 6 cm². The small applicators allow treatment of less accessible body parts such as, for example, the heel, the Achilles tendon and the wrist. The device includes the above-mentioned transducers with a cable which connects to a small, rechargeable, battery-powered driver unit and self-adhering patch to apply the transducer on to the skin. The unit is also supplied with a charger used for recharging the battery. Ultrasonic gel is typically not required to be used with the PainShield MD PLUS device. However, for treatment over hairy sites where there might not be adequate sonic coupling between the applicator and the skin, users are instructed to apply standard, FDA-cleared ultrasound gel to the site to improve coupling.

#### Indications for Use:

The PainShield MD PLUS is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.

| Test | Summary Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2<br>(2007) + A1:2012 (3rd Edition), Medical Electrical<br>Equipment - Part 1: General Requirements for Basic<br>Safety and Essential Performance | All applicable tests passed. |
| IEC 60601-1-2: 2014, Medical Electrical Equipment -<br>Part 1-2: General Requirements for Basic Safety and<br>Essential Performance, Collateral Standard,<br>Electromagnetic Compatibility | All applicable tests passed. |
| IEC 60601-1-11: 2015 (2nd Edition) General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Requirements for medical electrical | All applicable tests passed. |

#### Test Summary for PainShield MD PLUS:

{5}------------------------------------------------

| equipment and medical electrical systems used in the<br>home healthcare environment. | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Biocompatibility Testing<br>ISO 10993-1: Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk management<br>process. | All applicable tests passed. |
| Software Verification and Validation | All applicable tests passed. |

### Comparison to Predicate Device:

The technological characteristics, features, specifications, materials, mode of operation, and intended use of PainShield MD PLUS System is substantially equivalent to the predicate device (PainShield MD).

The differences between the PainShield MD PLUS and the predicate device do not raise new issues of safety or effectiveness.

| Parameter | PainShield MD PLUS | PainShield MD |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K221210 | K081075 |
| Indications for<br>Use | The PainShield MD PLUS is<br>intended to apply ultrasonic energy<br>to generate deep heat within body<br>tissues for the treatment of selected<br>medical conditions such as relief of<br>pain, muscle spasms, and joint<br>contractures. | The PainShield MD diathermy<br>device is intended to apply<br>ultrasonic energy to generate deep<br>heat within body tissues for the<br>treatment of selected medical<br>conditions such as relief of pain,<br>muscle spasms, and joint<br>contractures. |
| Classification | Class II<br>21 CFR 890.5300<br>Ultrasonic Diathermy | Class II<br>21 CFR 890.5300<br>Ultrasonic Diathermy |
| Product Code | PFW | PFW |
| Principle of<br>Operation | Device applies deep heat to tissues | Device applies deep heat to tissues |
| | | |
| | | |
| Major System<br>Components | (Ultrasound) Driver<br>Separate (Ultrasound) Actuator and<br>Self-adhesive Patch<br>AC Adapter | (Ultrasound) Driver<br>Actuator and Self-adhesive Patch<br>Not Publicly Available |
| Performance Specifications | | |
| Energy source<br>frequency | 90 kHz | 90 kHz |
| Output power: | 400 mW | Not Publicly Available |
| Output modes | CW | Not Publicly Available |
| Output channels | 2 | Not Publicly Available |
| Transducer | Two 6 cm² disk shaped transducers | One 6 cm² disk shaped transducer |
| Transducer<br>material | Lead Zirconate-Titanate PZT | Not Publicly Available |
| Maximum Beam<br>Non-Uniformity<br>Ratio | 6.0:1 | Not Publicly Available |
| Effective<br>Radiating Area | 6 cm² | 6 cm² |
| Therapy Cycle | For each actuator, alternate between<br>30 minutes Active Phase followed by<br>30 minutes of Idle Phase for a total<br>duration of 3 hours. Treatment can be<br>shut off anytime manually. | Not Publicly Available |
| Physical Size and Controls | | |
| | Height: 113 mm<br>Width: 39.4 mm<br>Depth: 12.6 mm | Not Publicly Available |
| Weight | ~227 grams | Not Publicly Available |
| Display: | LED and buzzer status indicators and<br>digital LCD timer display. | Not Publicly Available |
| Battery type<br>recommended: | Rechargeable lithium ion battery | Rechargeable battery |
| Battery Voltage: | 7.4 V | Not Publicly Available |
| Battery Life: | 3 hours continuous operation | Not Publicly Available |
| Mode of<br>operation | Continuous wave | Not Publicly Available |

{6}------------------------------------------------

{7}------------------------------------------------

The technological characteristics, features, specifications, materials, mode of operation, and intended use of PainShield MD PLUS is substantially equivalent to the predicate device (PainShield MD). The differences between the PainShield MD PLUS and the predicate device (such as two actuators, separation of the actuator, and self-adhesive patch) do not raise new issues of safety or effectiveness. The second actuator available with PainShield MD PLUS is intended to increase the physical area over which the therapy is made available. The tandem operation of the two actuators does not introduce new safety concerns for the user. The separation of the actuator and the self-adhesive patch improves the ability to reuse the actuator and replace the self-adhesive patch after each use.

#### Conclusion:

The PainShield MD PLUS is substantially equivalent to the predicate device (PainShield MD manufactured by NanoVibronix, Inc.).