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 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.

AI/ML Overview

The provided text describes the PainShield MD PLUS device and its substantial equivalence to a predicate device, PainShield MD, but it does not contain information about studies proving the device meets acceptance criteria related to clinical performance or effectiveness.

The document focuses on regulatory compliance through non-clinical testing (electrical safety, EMC, biocompatibility, and software validation) and a comparison of technological characteristics with its predicate device. This type of information is typical for a 510(k) submission where the goal is to demonstrate substantial equivalence, rather than provide new clinical effectiveness data.

Therefore, many of the requested details about acceptance criteria for clinical performance, sample size, ground truth, expert qualifications, and MRMC studies are not available in the provided text.

Here's a breakdown of the information that is available:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Category)	Reported Device Performance
Electrical Safety (compliance with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + A1:2012 (3rd Edition) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance)	All applicable tests passed.
Electromagnetic Compatibility (EMC) (compliance with IEC 60601-1-2: 2014 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance, Collateral Standard, Electromagnetic Compatibility)	All applicable tests passed.
Home Healthcare Environment Safety (compliance with IEC 60601-1-11: 2015 (2nd Edition) - General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)	All applicable tests passed.
Biocompatibility (compliance with ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)	All applicable tests passed.
Software Verification and Validation (ensuring software functions as intended and meets design specifications)	All applicable tests passed.
Substantial Equivalence (technological characteristics, features, specifications, materials, mode of operation, and intended use are equivalent to the predicate device, and differences do not raise new issues of safety or effectiveness)	Concluded to be substantially equivalent to the predicate device, PainShield MD (K081075). Differences (two actuators, separate actuator/patch) do not raise new safety or effectiveness concerns.

Missing Information (Not found in the provided text)

Sample size used for the test set and the data provenance: Not applicable as no clinical test set data is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth data is provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set data is provided.
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 device is an ultrasonic diathermy device, not an AI-powered diagnostic tool. No human-in-the-loop performance or AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, but a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical effectiveness, as no such studies are described. For the non-clinical tests (electrical safety, EMC, etc.), the "ground truth" is adherence to the specified international standards.
The sample size for the training set: Not applicable as no machine learning/AI model training is described.
How the ground truth for the training set was established: Not applicable as no machine learning/AI model training is described.

Summary

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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

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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 (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 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

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Indications for Use

510(k) Number (if known) K221210

Device Name PainShield MD PLUS

Indications for Use (Describe)

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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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: (410) 245-0501 Contact Name: Hrishikesh Gadagkar Contact Email: gadagkar@idonea-solutions.com

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

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Device Description:

Indications for Use:

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

Test Summary for PainShield MD PLUS:

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equipment and medical electrical systems used in thehome healthcare environment.
Biocompatibility TestingISO 10993-1: Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk managementprocess.	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 forUse	The PainShield MD PLUS isintended to apply ultrasonic energyto generate deep heat within bodytissues for the treatment of selectedmedical conditions such as relief ofpain, muscle spasms, and jointcontractures.	The PainShield MD diathermydevice is intended to applyultrasonic energy to generate deepheat within body tissues for thetreatment of selected medicalconditions such as relief of pain,muscle spasms, and jointcontractures.
Classification	Class II21 CFR 890.5300Ultrasonic Diathermy	Class II21 CFR 890.5300Ultrasonic Diathermy
Product Code	PFW	PFW
Principle ofOperation	Device applies deep heat to tissues	Device applies deep heat to tissues


Major SystemComponents	(Ultrasound) DriverSeparate (Ultrasound) Actuator andSelf-adhesive PatchAC Adapter	(Ultrasound) DriverActuator and Self-adhesive PatchNot Publicly Available
Performance Specifications
Energy sourcefrequency	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
Transducermaterial	Lead Zirconate-Titanate PZT	Not Publicly Available
Maximum BeamNon-UniformityRatio	6.0:1	Not Publicly Available
EffectiveRadiating Area	6 cm²	6 cm²
Therapy Cycle	For each actuator, alternate between30 minutes Active Phase followed by30 minutes of Idle Phase for a totalduration of 3 hours. Treatment can beshut off anytime manually.	Not Publicly Available
Physical Size and Controls
	Height: 113 mmWidth: 39.4 mmDepth: 12.6 mm	Not Publicly Available
Weight	~227 grams	Not Publicly Available
Display:	LED and buzzer status indicators anddigital LCD timer display.	Not Publicly Available
Battery typerecommended:	Rechargeable lithium ion battery	Rechargeable battery
Battery Voltage:	7.4 V	Not Publicly Available
Battery Life:	3 hours continuous operation	Not Publicly Available
Mode ofoperation	Continuous wave	Not Publicly Available

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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.).

Regulation Number and Section

§ 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.