(210 days)
Not Found
No
The summary describes a device that uses ultrasonic energy for therapeutic heating and does not mention any AI or ML components or functionalities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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." This description clearly delineates a therapeutic purpose.
No
The device is described as an ultrasonic diathermy device used to apply deep heat to tissues for the treatment of various medical conditions, such as pain relief, muscle spasms, and joint contractures. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly details hardware components including a transducer/applicator, cable, driver unit, battery, and charger, indicating it is not a software-only device.
Based on the provided information, the PainShield MD PLUS is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for applying ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description reinforces this by explaining how the device applies deep heat to tissues using a transducer/applicator on the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PainShield MD PLUS does not perform any such analysis of biological specimens.
Therefore, the PainShield MD PLUS is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
PFW
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.
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
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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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 (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)
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)
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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:
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 | |
| (2007) + A1:2012 (3rd Edition), Medical Electrical | |
| Equipment - Part 1: General Requirements for Basic | |
| Safety and Essential Performance | All applicable tests passed. |
| 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. |
| IEC 60601-1-11: 2015 (2nd Edition) General | |
| requirements 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 the
| home healthcare environment. | |
|---|---|
| Biocompatibility Testing | |
| 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 | 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 | ||
| 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. | The PainShield MD diathermy | |
| device 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. | ||
| Classification | Class II | |
| 21 CFR 890.5300 | ||
| Ultrasonic Diathermy | Class II | |
| 21 CFR 890.5300 | ||
| Ultrasonic Diathermy | ||
| Product Code | PFW | PFW |
| Principle of | ||
| Operation | Device applies deep heat to tissues | Device applies deep heat to tissues |
| Major System | ||
| Components | (Ultrasound) Driver | |
| Separate (Ultrasound) Actuator and | ||
| Self-adhesive Patch | ||
| AC Adapter | (Ultrasound) Driver | |
| Actuator and Self-adhesive Patch | ||
| Not Publicly Available | ||
| Performance Specifications | ||
| Energy source | ||
| 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 | ||
| material | Lead Zirconate-Titanate PZT | Not Publicly Available |
| Maximum Beam | ||
| Non-Uniformity | ||
| Ratio | 6.0:1 | Not Publicly Available |
| Effective | ||
| Radiating Area | 6 cm² | 6 cm² |
| Therapy Cycle | For each actuator, alternate between | |
| 30 minutes Active Phase followed by | ||
| 30 minutes of Idle Phase for a total | ||
| duration of 3 hours. Treatment can be | ||
| shut off anytime manually. | Not Publicly Available | |
| Physical Size and Controls | ||
| Height: 113 mm | ||
| Width: 39.4 mm | ||
| Depth: 12.6 mm | Not Publicly Available | |
| Weight | ~227 grams | Not Publicly Available |
| Display: | LED and buzzer status indicators and | |
| digital LCD timer display. | Not Publicly Available | |
| Battery type | ||
| 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 | ||
| operation | 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.).