sam 2.0 Long Duration Ultrasound System

K191568 · ZetrOZ Systems, LLC · PFW · Mar 6, 2020 · Physical Medicine

Device Facts

• Record ID: K191568
• Device Name: sam 2.0 Long Duration Ultrasound System
• Applicant: ZetrOZ Systems, LLC
• Product Code: PFW · Physical Medicine
• Decision Date: Mar 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Device Story

Device applies ultrasonic energy to generate deep heat in body tissues; used for pain relief, muscle spasms, joint contractures, and circulation increase. System comprises rechargeable power controller/timer, ultrasound applicators, applicator cables, and disposable ultrasonic coupling patches. Operates at 3 MHz frequency; delivers 0.65 W (single applicator) or 1.3 W (dual applicator) in continuous wave mode. Intended for home use by patients; prescription required. Firmware logs usage time without controlling therapy. Healthcare providers use output to manage musculoskeletal conditions; patients benefit from long-duration (4-hour) therapeutic heat application.

Clinical Evidence

No clinical trials performed. Evidence includes usability data, human factors studies, and literature supporting home-use labeling. Bench testing demonstrated diathermic heating effects on an ex vivo bovine muscle model and compliance with 21 CFR 1050.10, IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11.

Technological Characteristics

Piezoelectric ultrasound generation using Lead Zirconate-Titanate crystals. 3 MHz frequency; continuous wave output. ABS plastic coupling bandage; TPX applicator lens. Powered by 120/240 VAC or lithium battery. Dimensions: 6.10 cm x 7.09 cm x 1.88 cm (console). Non-sterile. Compliance: 21 CFR 1050.10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.

Indications for Use

Indicated for home use in patients requiring deep heat therapy for pain relief, muscle spasms, joint contractures, and local circulation increase.

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

• ZetrOZ Ultrasonic Diathermy Device (K130978)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

March 6, 2020

ZetrOZ Systems, LLC Sabrina Lewis Director, Quality Assurance & Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW Suite 1000 Washington, DC 20001

Re: K191568

Trade/Device Name: sam 2.0 Long Duration Ultrasound System Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: PFW Dated: February 4, 2020 Received: February 4, 2020

Dear Sabrina Lewis:

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.

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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 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 (QS) 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.

For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K191568

Device Name

sam 2.0 Long Duration Ultrasound Device

#### Indications for Use (Describe)

The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">❌</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

| Device Trade Name: | sam 2.0 Long Duration Ultrasound Device |
|--------------------|---------------------------------------------------------------------------------------|
| Manufacturer: | ZetrOZ Systems, LLC<br>56 Quarry Road<br>Trumbull, CT 06611 |
| Contact: | Ms. Sabrina Lewis<br>QAR Director<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 4, 2020 |
| Classification: | 21 CFR §890.5300; Ultrasonic diathermy. |
| Class: | II |
| Product Code: | PFW |
| Predicate Devices: | ZetrOZ Ultrasonic Diathermy Device (K130978) |

## Indications for Use:

The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

### Device Description:

The sam 2.0 Long Duration Ultrasound Device consists of:

- Rechargeable Power Controller and Timer ●
- Ultrasound Generating Applicators
- Applicator Adaptor Cables

Single use disposable accessories

- Ultrasonic Coupling Patch ●
The Power Controller and cables can be used to power one or two Applicators simultaneously to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator

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mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with onetime use Ultrasonic Coupling Patches.

The sam 2.0 Long Duration Ultrasound Device contains firmware for logging usage time. There is no control function of this firmware.

The system is intended for prescription home use to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues and treat selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

### Substantial Equivalence:

The sam 2.0 Long Duration Ultrasound Device is substantially equivalent to the predicate device cited on the previous page with respect to indications, design, function, and performance.

| | ZetrOZ<br>sam 2.0 Long Duration<br>Ultrasound Device<br>(Subject) | ZetrOZ<br>Ultrasonic Diathermy<br>Device<br>(K130978) | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information | | | |
| Classification Name | Ultrasonic Diathermy<br>Device | Ultrasonic Diathermy<br>Device | Identical |
| Service Type | Physical Medicine | Physical Medicine | Identical |
| Classification | 21 CFR 890.5300 | 21 CFR 890.5300 | Identical |
| Class | II | II | Identical |
| Indications | The sam 2.0 Long Duration<br>Ultrasound Device is<br>intended for home use to<br>apply ultrasonic energy to<br>generate deep heat within<br>body tissues for the<br>treatment of selected<br>medical conditions such as<br>the relief of pain, the relief<br>of muscle spasms, the<br>treatment of joint<br>contractures, and the local<br>increase in circulation. | The ZTX Ultrasonic<br>Diathermy Device is<br>intended to apply ultrasonic<br>energy to generate deep<br>heat within body tissues for<br>the treatment of selected<br>medical conditions such as<br>the relief of pain, the relief<br>of muscle spasms, the<br>treatment of joint<br>contractures, and the local<br>increase in circulation.<br>The ZTX Device is a<br>prescription use device. The<br>ZTX Device should only be<br>administered and monitored<br>by a licensed healthcare<br>practitioner. | Similar. Removal of<br>the healthcare<br>practitioner<br>requirement. |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/Generator<br>Dimensions (L x W x H cm) | 6.10 cm L x 7.09 cm H x<br>1.88cm W | 6.10 cm L x 7.09 cm H x<br>1.88cm W | Identical |
| Treatment Head Dimensions<br>(L x W x H cm) | 3.81 cm L x 3.30 cm W x<br>1.14 cm H | 3.81 cm L x 3.30 cm W x<br>1.14 cm H | Identical |
| Console/Generator Weight<br>(kg) | 0.01 kg | 0.01 kg | Identical |
| Treatment Head Weight (kg) | 0.10 kg | 0.10 kg | Identical |
| | ZetrOZ<br>sam 2.0 Long Duration | ZetrOZ<br>Ultrasonic Diathermy | |
| | Ultrasound Device<br>(Subject) | Device<br>(K130978) | |
| Information | | | Comparison |
| Power Supply | 120/240 VAC with 5V DC<br>Input Power Jack and<br>Lithium Battery Powered | 120/240 VAC with 5V DC<br>Input Power Jack and<br>Lithium Battery Powered | Identical |
| Leakage Current | 0.3 mA | 0.3 mA | Identical |
| Crystal Material | Lead Zirconate-Titanate | Lead Zirconate-Titanate | Identical |
| Technology of ultrasound<br>generation (e.g.,<br>piezoelectric,<br>magnetoconstructive) | Piezoelectric | Piezoelectric | Identical |
| Treatment Mode(s) | Two discrete settings of<br>power at same Frequency | Two discrete settings of<br>power at same Frequency | Identical |
| Beam Type (collimated or<br>divergent) | Divergent | Divergent | Identical |
| Transducer Diameter (cm) | 5 cm | 5 cm | Identical |
| Acoustic Working Frequency<br>and Accuracy (MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area and<br>Accuracy (cm2) | One: 6 cm2<br>Two:12 cm2<br>± 20% | One: 6 cm2<br>Two:12 cm2<br>± 20% | Identical |
| Beam Nonuniformity Ratio<br>and Accuracy | BNR: <5:1 ± 20% | BNR: <5:1 ± 20% | Identical |
| Output Mode: (Continuous<br>Wave/Amplitude -<br>Modulated Wave) | Continuous Wave - 100%<br>duty cycle | Continuous Wave - 100%<br>duty cycle | Identical |
| Maximum Timer Setting and<br>Accuracy | 4 Hours +/- 1 minute | 4 Hours +/- 1 minute | Identical |
| Beam Maximum Intensity<br>and Accuracy (W/cm2) | 0.132 W/cm2 ± 20% | 0.132 W/cm2 ± 20% | Identical |
| Maximum Values of the following Powers and Intensities (max settings) | | | |
| Maximum Value of the<br>Output Power (Rated Output<br>Power) and Accuracy (W) | Single Applicator:<br>0.65W ± 20%<br><br>Dual Applicator:<br>1.3W ± 20% | Single Applicator:<br>0.65W ± 20%<br><br>Dual Applicator:<br>1.3W ± 20% | Identical |
| Maximum Value of the<br>Effective Intensity and<br>Accuracy (Not to exceed 3<br>W/cm2 *) | 0.264 W/cm2 ± 20% | 0.264 W/cm2 ± 20% | Identical |
| For Amplitude Modulated<br>Waves | Not Amplitude Modulated | Not Amplitude Modulated | Identical |
| Temperature Specifications | | | |
| Peak Temperature Rise vs.<br>Time and Tissue Depth to<br>Maximum Treatment Time<br>(for fixed Treatment Head<br>Placement) (deg C) | 8°C at 1 cm<br>6°C at 3 cm<br>3°C at 5 cm<br>Max treatment time: 4<br>hours | 8°C at 1 cm<br>6°C at 3 cm<br>3°C at 5 cm<br>Max treatment time: 4<br>hours | Identical |
| Maximum Patient Contact<br>Surface Temperature of<br>Treatment Head under<br>Simulated or Actual Use | 44 °C | 44 °C | Identical |
| Conditions for all Operating | | | |
| | ZetrOZ<br>sam 2.0 Long Duration<br>Ultrasound Device<br>(Subject) | ZetrOZ<br>Ultrasonic Diathermy<br>Device<br>(K130978) | Comparison |
| Information | | | |
| Conditions (Continually<br>operated for maximum<br>treatment time) (deg C) | | | |
| Therapeutically Applied | Ultrasound Coupling Patch | Ultrasound Coupling Patch | Identical |
| Applicator Type | Up to two circular<br>Applicators with 3 MHz<br>output | Up to two circular<br>Applicators with 3 MHz<br>output | Identical |
| Applicator Type<br>Applicator Emitting Surface<br>Areas (cm2) | Up to two circular<br>Applicators<br>One Applicator : 5 cm²<br>Two Applicators :10 cm² | Up to two circular<br>Applicators<br>One Applicator : 5 cm²<br>Two Applicators :10 cm² | Identical |
| Coupling Bandage | ABS Plastic with integrated<br>coupling medium | ABS Plastic with integrated<br>coupling medium | Identical |
| Applicator Lens Material | TPX | Ultem | Similar |
| Environmental - Operating<br>Temperature Range | 0°C to +50°C (32°F to<br>+122°F) | 0°C to +50°C (32°F to<br>+122°F) | Identical |
| Performance Standards | 21 CFR 1050.10 | 21 CFR 1050.10 | Identical |
| Sterility | Non Sterile | Non Sterile | Identical |
| Designed to meet Electrical<br>Safety Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2 | Similar<br>Added 60601-1-11 |
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety (if not<br>radioactive state as such) | Not Radioactive | Not Radioactive | Identical |
| Software/Firmware | Yes | No | Similar<br>The sam 2.0 Long Duration Ultrasound<br>Device contains<br>firmware for<br>logging usage time.<br>There is no control<br>function of this<br>firmware. |
| Output Channels | Two Independent Power<br>Channels | Two Independent Power<br>Channels | Identical |

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## Preclinical Testing:

The sam 2.0 Long Duration Ultrasound device was tested to the performance standards set forth under 21 CFR 1050.10 (April 1, 2012). Third party testing of the electronics was performed to demonstrate compliance to IEC 60601-1:2005+AMD1:2012 (Edition 3.1) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2014 (Edition 4.0) General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests. Third party testing of the device was performed to demonstrate compliance for home use under IEC 60601-1-11:2015 (Edition 2) General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home

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healthcare environment. Bench testing experiments demonstrated substantially equivalent diathermic heating effects on an ex vivo bovine muscle model.

#### Clinical Testing:

Usability data, human factors studies, and literature was provided to support the home use label.

#### Conclusion:

The purpose of the 510(k) is to receive regulatory clearance to introduce the sam 2.0 Long Duration Ultrasound Device to interstate commerce. Substantial equivalence has been demonstrated to the cited predicate device.