(96 days)
The sam X I 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
The sam X1 Long Duration Ultrasound Device consists of:
- Rechargeable Power Controller and Timer
- Ultrasound Generating Applicators
- Single use disposable accessories
- Ultrasonic Coupling Patch
The Power Controller can be used to power the Applicator 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 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 X1 Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 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.
This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam X1 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a predicate device (sam 2.0 Long Duration Ultrasound System, K191568).
The document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Instead, it details a physical medical device (an ultrasonic diathermy device) used for therapeutic purposes (deep heat generation for pain relief, muscle spasms, joint contractures, and circulation increase).
Therefore, I cannot provide the information requested in the prompt, as the prompt's questions pertain to acceptance criteria and studies for AI/ML diagnostic devices, such as those that might involve:
- A table of acceptance criteria and reported device performance (for AI metrics like sensitivity, specificity, AUC).
- Sample sizes and data provenance for test sets (relevant to AI model validation).
- Number and qualifications of experts for ground truth establishment (critical for AI imaging diagnostics).
- Adjudication methods for test sets (common in AI imaging studies).
- MRMC comparative effectiveness studies (specifically for AI assistance to human readers).
- Standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data - often used in AI validation).
- Training set sample size and ground truth establishment (fundamental to AI development).
The provided text focuses on the physical and functional equivalence of the sam X1 device to its predecessor, particularly noting a smaller battery and a maximum 1-hour treatment duration compared to the predicate's 4 hours. The testing mentioned (power output, treatment time, battery conformance, electrical safety, usability, software, cybersecurity) are standard for medical device hardware and firmware safety and performance, not for AI model validation.
In summary, as the provided document is for a non-AI medical device, the requested information regarding AI acceptance criteria and study design is not applicable and cannot be extracted from the text.
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August 18, 2021
ZetrOZ Systems, LLC Sabrina Lewis QAR Director 56 Quarry Road Trumbull, Connecticut 06611
Re: K211513
Trade/Device Name: sam X1 Long Duration Ultrasound Device Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: PFW Dated: August 5, 2021 Received: August 6, 2021
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 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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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)
K211513
Device Name sam X1 Long Duration Ultrasound Device
Indications for Use (Describe)
The sam X I 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Device Trade Name: | sam X1 Long Duration Ultrasound Device |
|---|---|
| Manufacturer: | ZetrOZ Systems, LLC56 Quarry RoadTrumbull, CT 06611 |
| Contact: | Ms. Sabrina LewisQAR DirectorPhone: 888-202-9831Email: sabrina@zetroz.com |
| Date Prepared: | 5/13/2021 |
| Regulation Number: | 21 CFR 890.5300 |
| Regulation Name: | Ultrasonic diathermy |
| Regulation Class: | Class II |
| Product Code: | PFW |
| Predicate Device: | sam 2.0 Long Duration Ultrasound System (K191568) |
Indications for Use:
The sam X1 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 X1 Long Duration Ultrasound Device consists of:
- Rechargeable Power Controller and Timer
- Ultrasound Generating Applicators ●
Single use disposable accessories
- . Ultrasonic Coupling Patch
The Power Controller can be used to power the Applicator to generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per Applicator. In single Applicator mode, the
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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 onetime use Ultrasonic Coupling Patches.
The sam X1 Long Duration Ultrasound Device contains firmware that controls the timing display and inputs from the power button to activate/deactivate the device. There is no control function of this firmware.
The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 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 X1 Long Duration Ultrasound Device is substantially equivalent to the predicate devices cited on the previous page with respect to indications, design, function, and performance. The purpose of this special 510(k) is to allow a smaller battery back to be used. The output and strength of the signal are identical to the predicate. The only difference in the max duration of the subject device is 1 hour where the predicate device can be used for 1 to 4 hours. However, this change does not create a new intended use or different questions of safety or effectiveness as the timeframe of use is within the use of the predicate device.
| Information | ZetrOZ sam X1 LongDuration UltrasoundDevice(Subject) | ZetrOZsam 2.0 Long DurationUltrasound Device(K191568) | Comparison(to sam 2.0) |
|---|---|---|---|
| Classification Name | Ultrasonic DiathermyDevice | Ultrasonic DiathermyDevice | 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 X1 LongDuration UltrasoundDevice is intended forhome use to applyultrasonic energy togenerate deep heat withinbody tissues for thetreatment of selectedmedical conditions such asthe relief of pain, the reliefof muscle spasms, thetreatment of jointcontractures, and the localincrease in circulation. | The sam 2.0 LongDuration UltrasoundDevice is intended forhome use to applyultrasonic energy togenerate deep heat withinbody tissues for thetreatment of selectedmedical conditions such asthe relief of pain, the reliefof muscle spasms, thetreatment of jointcontractures, and the localincrease in circulation. | Identical |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/GeneratorDimensions (L x W x Hcm) | 3.4 cm x 3.4 cm x 1.4 cm | 6.10 cm L x 7.09 cm H x1.88cm W | SimilarConsole/generatorsized to accommodatesmallerrechargeablebattery. |
| Information | ZetrOZ sam X1 LongDuration UltrasoundDevice(Subject) | ZetrOZsam 2.0 Long DurationUltrasound Device(K191568) | Comparison(to sam 2.0) |
| Treatment HeadDimensions (L x W x Hcm) | 3.81 cm L x 3.30 cm W x1.14 cm H | 3.81 cm L x 3.30 cm W x1.14 cm H | Identical |
| Console/Generator Weight(kg) | 0.02 kg | 0.10 kg | SimilarLesser weightprimarily driven byuse of smallerrechargeable battery. |
| Treatment Head Weight(kg) | 0.01 kg | 0.01 kg | Identical |
| Power Supply | 120/240 VAC with 5V DCInput Power Jack andLithium Battery Powered | 120/240 VAC with 5V DCInput Power Jack andLithium Battery Powered | Identical |
| Leakage Current | 0.3 mA | 0.3 mA | Identical |
| Crystal Material | Lead Zirconate-Titanate | Lead Zirconate-Titanate | Identical |
| Technology of ultrasoundgeneration (e.g.,piezoelectric.magnetoconstructive) | Piezoelectric | Piezoelectric | Identical |
| Treatment Mode(s) | Two discrete settings ofpower at same Frequency | Two discrete settings ofpower at same Frequency | Identical |
| Beam Type (collimated ordivergent) | Divergent | Divergent | Identical |
| Transducer Diameter (cm) | 5 cm | 5 cm | Identical |
| Acoustic WorkingFrequency and Accuracy(MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Areaand Accuracy (cm2) | One: 6 cm2Two:12 cm2± 20% | One: 6 cm2Two:12 cm2± 20% | Identical |
| Beam Nonuniformity Ratioand Accuracy | BNR: <5:1 ± 20% | BNR: <5:1 ± 20% | Identical |
| Output Mode: (ContinuousWave/Amplitude -Modulated Wave) | Continuous Wave - 100%duty cycle | Continuous Wave - 100%duty cycle | Identical |
| Maximum Timer Settingand Accuracy | 1 Hour +/- 1 minute | 4 Hours +/- 1 minute | SimilarPredicate devicepermits treatmentdurations of 1, 2, 3, or4 hours. |
| Beam Maximum Intensityand Accuracy (W/cm2) | 0.132 W/cm² ± 20% | 0.132 W/cm² ± 20% | Identical |
| Maximum Value of theOutput Power (RatedOutput Power) andAccuracy (W) | Single Applicator:0.65W ± 20%Dual Applicator:1.3W ± 20% | Single Applicator:0.65W ± 20%Dual Applicator:1.3W ± 20% | Identical |
| Maximum Value of theEffective Intensity andAccuracy (Not to exceed 3W/cm2 *) | 0.264 W/cm² ± 20% | 0.264 W/cm² ± 20% | Identical |
| Information | ZetrOZ sam X1 LongDuration UltrasoundDevice(Subject) | ZetrOZsam 2.0 Long DurationUltrasound Device(K191568) | Comparison(to sam 2.0) |
| For Amplitude ModulatedWaves | Not Amplitude Modulated | Not Amplitude Modulated | Identical |
| Peak Temperature Rise vs.Time and Tissue Depth toMaximum Treatment Time(for fixed Treatment HeadPlacement) (deg C) | 7°C at 1 cm4°C at 3 cm2°C at 5 cmTreatment time: 1 hour | 7°C at 1 cm4°C at 3 cm2°C at 5 cmTreatment time: 1 hour | Identical |
| Maximum Patient ContactSurface Temperature ofTreatment Head underSimulated or Actual UseConditions for allOperating Conditions(Continually operated formaximum treatment time)(deg C) | 44 °C | 44 °C | Identical |
| Therapeutically Applied | Ultrasound Coupling Patch | Ultrasound Coupling Patch | Identical |
| Applicator Type | Up to two circularApplicators with 3 MHzoutput | Up to two circularApplicators with 3 MHzoutput | Identical |
| Applicator TypeApplicator EmittingSurface Areas (cm2) | Up to two circularApplicatorsOne Applicator : 5 cm2Two Applicators :10 cm2 | Up to two circularApplicatorsOne Applicator : 5 cm2Two Applicators :10 cm2 | Identical |
| Coupling Bandage | ABS Plastic withintegrated couplingmedium | ABS Plastic withintegrated couplingmedium | Identical |
| Applicator Lens Material | TPX | TPX | Identical |
| Environmental - OperatingTemperature Range | 0°C to +50°C (32°F to+122°F) | 0°C to +50°C (32°F to+122°F) | Identical |
| Performance Standards | 21 CFR 1050.10 | 21 CFR 1050.10 | Identical |
| Sterility | Non Sterile | Non Sterile | Identical |
| Designed to meet ElectricalSafety Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | Identical |
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety (if notradioactive state as such) | Not Radioactive | Not Radioactive | Identical |
| Software/Firmware | Yes - For measurement ofbattery level | Yes - For measurement ofbattery level | Identical |
| Output Channels | Two Independent PowerChannels | Two Independent PowerChannels | Identical |
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Preclinical Testing:
The sam X1 Long Duration Ultrasound Device was evaluated to ensure the smaller power control can still deliver the appropriate treatment for the duration of treatment (1 hour). Testing included:
- Power Output Evaluation .
- Evaluation of Total Treatment Time .
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- Battery Conformance Evaluation .
- Electrical Safety and EMC Evaluation
- Device Operation Validation ●
- Powering On/Off .
- Evaluation of Usability ●
- Software Evaluation
- Cybersecurity Evaluation .
Clinical Testing:
Clinical data was not necessary to support substantial equivalence.
Conclusion:
The sam X1 Long Duration Ultrasound Device possesses the same intended use and similar technological characteristics as the predicate devices. The sam X1 Long Duration Ultrasound Device is substantially equivalent to the predicate device.
§ 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.