sam 2.0 Long Ultrasound Device

K223019 · ZetrOZ Systems, LLC · PFW · Jun 23, 2023 · Physical Medicine

Device Facts

• Record ID: K223019
• Device Name: sam 2.0 Long Ultrasound Device
• Applicant: ZetrOZ Systems, LLC
• Product Code: PFW · Physical Medicine
• Decision Date: Jun 23, 2023
• 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, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).

Device Story

Device is a stationary, long-duration ultrasound system for home use; prescribed by healthcare professionals. Inputs: electrical power from lithium battery or AC adapter. Transformation: piezoelectric crystal converts electrical energy into 3 MHz ultrasonic energy; delivered via applicators and coupling patches to generate deep heat in tissues. Output: continuous wave ultrasound (0.65 W single applicator; 1.3 W dual). Operation: patient applies applicators to skin for up to 4 hours. Clinical use: relief of pain, muscle spasms, joint contractures, increased circulation, and improved mobility in soft tissue injuries. Benefit: sustained deep heat therapy for chronic musculoskeletal conditions.

Clinical Evidence

Systematic literature review and meta-analysis using PubMed, EBSCOhost, Academic Search Complete, Google Scholar, and ClinicalTrials.gov. Evaluated Sustained Acoustic Medicine (SAM) effects on musculoskeletal functional outcomes (strength, range of motion), quality of life, pain reduction, and safety. Evidence supports efficacy for deep heat generation, pain relief, and treatment of knee osteoarthritis, tendinopathy, and chronic myofascial pain.

Technological Characteristics

Piezoelectric ultrasound generator; 3 MHz frequency; 0.65 W/applicator power; 100% duty cycle. Lead Zirconate-Titanate crystal; TPX lens; ABS plastic coupling bandage. Battery/AC powered. Dimensions: 6.10x7.09x1.88 cm (console). Standards: 21 CFR 1050.10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11. Non-sterile.

Indications for Use

Indicated for home use in patients requiring deep heat therapy for pain relief, muscle spasms, joint contractures, increased local circulation, and pain associated with limited mobility/function from soft tissue injuries including knee osteoarthritis, chronic myofascial pain, and shoulder, elbow, or ankle tendinopathy.

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

• sam 2.0 Long Duration Ultrasound Device (K191568)

Submission Summary (Full Text)

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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 the FDA logo, which 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.

June 23, 2023

ZetrOZ Systems, LLC Sabrina Lewis QAR Director 56 Quarry Road Trumbull, Connecticut 06611

Re: K223019

Trade/Device Name: sam 2.0 Long Ultrasound Device Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: Class II Product Code: PFW Dated: May 17, 2023 Received: May 17, 2023

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.

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

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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,

# Amber T. Ballard -S

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223019

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 pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></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: | June 23, 2023 |
| 510(k) Number: | K223019 |
| Classifications: | 21 CFR §890.5300; Ultrasonic diathermy. |
| Class: | II |
| Product Code: | PFW |
| Predicate Device: | sam 2.0 Long Duration Ultrasound Device (K191568) |

#### 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, the local increase in circulation, and the relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy).

#### Device Description:

The device was previously cleared in K191568. The sam 2.0 Long Duration Ultrasound Device consists of ultrasound:

- Power Controller ●
- Cables ●
- Applicators ●
- 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 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

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Applicator. In single Applicator mode, the patient can receive 0.65 W at 3 MHz. In dual Applicator mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with a onetime use Coupling Patches.

The system is intended to apply ultrasonic energy for a long duration (4 hours) to generate deep heat within body tissues. The system is intended for prescription home use after proper instruction from a healthcare professional.

## Predicate Device:

ZetrOZ submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the sam 2.0 Long Duration Ultrasound Device is substantially equivalent in intended use, design principles, and performance to the following predicate device:

Primary Predicate: sam 2.0 Long Duration Ultrasound Device (K191568)

## Performance Testing Summary:

Clinical performance testing was utilized to support the substantial equivalence of this device. A systematic literature review was conducted using PubMed, EBSCOhost, Academic Search Complete, Google Scholar and ClinicalTrials.gov to identify studies evaluating the effects of the subject device, Sustained Acoustic Medicine (SAM), on the musculoskeletal system of humans. This systematic review and meta-analysis aim to summarize the clinical effects of SAM treatment on musculoskeletal injuries functional outcomes (strength and range of motion), quality of life, pain reduction, and safety profile of the intervention. Cumulatively, these studies demonstrate the efficacy of SAM therapy 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. As evidenced by the study data summarized above, the relief of pain associated with limited mobility and function related to the soft tissue injuries that have been clinically validated include knee osteoarthritis, shoulder, elbow and ankle tendinopathy, and chronic myofascial pain.

No non-clinical performance testing was performed to support the expansion of indications.

## Substantial Equivalence:

Overall, the subject device is nearly identical in design and intended use to the primary predicate K191568. The notable difference is in that of the indications. The subject device presents an expansion of indications to better align with the clinical literature on SAM. The SAM is a stationary ultrasound device that is capable of creating (>4℃) into the tissue. The subject device and predicate K191568 are identical with respect to design, technology, and application.

| | ZetrOZ sam 2.0<br>Long Duration<br>Ultrasound Device<br>(Subject Device) | ZetrOZ sam 2.0 Long<br>Duration Ultrasound<br>Device (K191568)<br>(Primary<br>Predicate) | Comparison |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information | | | |
| Classification Name | Ultrasonic<br>Diathermy Device | Ultrasonic<br>Diathermy Device | Identical |
| Service Type | Physical<br>Medicine | Physical<br>Medicine | Identical |
| Classification | 21 CFR<br>890.5300 | 21 CFR<br>890.5300 | Identical |
| Class | II | II | Identical |
| Product Code | PFW | PFW | 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, the local<br>increase in circulation, and<br>the relief of pain associated<br>with limited mobility and<br>function related to soft<br>tissue injuries (e.g., knee<br>osteoarthritis, chronic<br>myofascial pain, and<br>shoulder, elbow and ankle<br>tendinopathy). | 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. | Similar to the Primary<br>Predicate.<br>The device is intended to<br>treat medical conditions<br>such as the relief of pain,<br>the relief of muscle spasms,<br>the treatment of joint<br>contractures, and the local<br>increase in<br>circulation. It also includes<br>medical<br>conditions relief of pain<br>associated with limited<br>mobility and function<br>related to soft tissue<br>injuries including knee<br>osteoarthritis, shoulder,<br>elbow and ankle<br>tendinopathy, and chronic<br>myofascial pain as<br>supported by clinical<br>evidence. |
| 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<br>Dimensions (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) | 0.10 kg | 0.10 kg | Identical |
| Treatment Head Weight<br>(kg) | 0.01 kg | 0.01 kg | Identical |
| Power Supply | 120/240 VAC with 5V<br>DC Input Power Jack and<br>LithiumBattery Powered | 120/240 VAC with 5V<br>DC Input Power Jack and<br>Lithium<br>Battery Powered | Identical |
| Leakage Current | 0.3 mA | 0.3 mA | Identical |
| Crystal Material | Lead Zirconate-<br>Titanate | Lead Zirconate-<br>Titanate | Identical |
| Technology of ultrasound<br>generation (e.g., | 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<br>(cm) | 5 cm | 5 cm | Identical |
| Acoustic Working<br>Frequency and<br>Accuracy (MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area | One: 6 cm² | One: 6 cm² | Identical |

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| | ± 20% | ± 20% | | | | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------|-------------|------------------------------|-----------|-----------|
| Beam Nonuniformity<br>Ratio and Accuracy | BNR: <5:1 ±<br>20% | BNR: <5:1 ±<br>20% | Identical | | | | |
| Output Mode:<br>(Continuous<br>Wave/Amplitude -<br>Modulated Wave) | Continuous<br>Wave - 100%<br>duty cycle | Continuous<br>Wave - 100%<br>duty cycle | Identical | | | | |
| Maximum Timer Setting<br>and 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 Value of the<br>Output Power (Rated<br>Output Power) and<br>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<br>Modulated Waves | Not Amplitude Modulated | Not Amplitude Modulated | identical | | | | |
| Peak Temperature Rise<br>vs. Time and Tissue<br>Depth to Maximum<br>Treatment Time (for<br>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 hours | 8°C at 1 cm<br>6°C at 3 cm<br>3°C at 5 cm<br>Max treatment time: 4 hours | Identical | | | | |
| Maximum Patient Contact<br>Surface Temperature of<br>Treatment Head under<br>Simulated or Actual Use<br>Conditions for all Operating<br>Conditions (Continually<br>operated for maximum<br>treatment time) (deg C)<br>Therapeutically Applied | 44 °C | 44 °C | Identical | | | | |
| Applicator Type | Ultrasound Coupling Patch<br>Up to two circular<br>Applicators with 3 MHz<br>output | Ultrasound Coupling Patch<br>Up to two circular<br>Applicators with 3 MHz<br>output | identical | | | | |
| Applicator Type Applicator<br>Emitting Surface Areas<br>(cm2) | Up to two circular<br>Applicators<br>One Applicator : 5 cm²<br>Two Applicators :10<br>cm² | Up to two circular<br>Applicators<br>One Applicator : 5<br>cm²<br>Two Applicators :10<br>cm² | Identical | | | | |
| Coupling Bandage | ABS Plastic with<br>integrated coupling<br>medium | ABS Plastic with<br>integrated coupling<br>medium | Identical | | | | |
| Applicator Lens Material | TPX | TPX | identical | | | | |
| 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 | Designed to meet Electrical<br>Safety Standards | Non Sterile | IEC 60601-1<br>IEC 60601-1-2 | Non Sterile | IEC 60601-1<br>IEC 60601-1-2 | identical | Identical |

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| | IEC 60601-1-11 | IEC 60601-1-11 | |
|--------------------------------------------------------|-----------------------------------|-----------------------------------|-----------|
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety (if<br>not radioactive state as such) | Not Radioactive | Not Radioactive | identical |
| Software/Firmware | Yes | Yes | Identical |
| Output Channels | Two Independent Power<br>Channels | Two Independent Power<br>Channels | Identical |

#### Conclusion:

The subject device and the predicate device have the same intended use, technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials. The data included in this submission demonstrate substantial equivalence to the predicate device listed above. The sam 2.0 Long Duration Ultrasound Device is as safe, as effective, and performs as well as the predicate device.