(96 days)
No
The device description and performance studies focus on basic electronic controls, power output, and safety, with no mention of AI or ML capabilities. The firmware is described as controlling timing and power buttons, not complex functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the 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." This description clearly indicates a therapeutic purpose.
No
The device description clearly states that the device is intended for therapeutic purposes (applying ultrasonic energy to generate deep heat for treatment of pain, muscle spasms, joint contractures, and increased circulation), not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a Rechargeable Power Controller, Ultrasound Generating Applicators, and single-use disposable accessories, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 body for therapeutic purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The sam X1 device does not perform any such tests on biological samples.
- Device Description: The description details a system that delivers ultrasonic energy externally to the body.
- Lack of IVD-related information: There is no mention of analyzing biological samples, performing diagnostic tests, or providing diagnostic information.
Therefore, the sam X1 Long Duration Ultrasound Device is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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 muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Product codes
PFW
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 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.
- Ultrasonic Coupling Patch
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
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
1
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
2
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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3
510(K) SUMMARY
| Device Trade Name: | sam X1 Long Duration Ultrasound Device |
|---|---|
| Manufacturer: | ZetrOZ Systems, LLC |
| 56 Quarry Road | |
| Trumbull, CT 06611 | |
| Contact: | Ms. Sabrina Lewis |
| QAR Director | |
| Phone: 888-202-9831 | |
| Email: 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
4
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 Long
Duration Ultrasound
Device
(Subject) | ZetrOZ
sam 2.0 Long Duration
Ultrasound Device
(K191568) | Comparison
(to sam 2.0) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Classification Name | Ultrasonic Diathermy
Device | Ultrasonic Diathermy
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 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. | 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. | Identical |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/Generator
Dimensions (L x W x H
cm) | 3.4 cm x 3.4 cm x 1.4 cm | 6.10 cm L x 7.09 cm H x
1.88cm W | Similar
Console/generator
sized to accommodate
smaller
rechargeable
battery. |
| Information | ZetrOZ sam X1 Long
Duration Ultrasound
Device
(Subject) | ZetrOZ
sam 2.0 Long Duration
Ultrasound Device
(K191568) | Comparison
(to sam 2.0) |
| Treatment Head
Dimensions (L x W x H
cm) | 3.81 cm L x 3.30 cm W x
1.14 cm H | 3.81 cm L x 3.30 cm W x
1.14 cm H | Identical |
| Console/Generator Weight
(kg) | 0.02 kg | 0.10 kg | Similar
Lesser weight
primarily driven by
use of smaller
rechargeable battery. |
| Treatment Head Weight
(kg) | 0.01 kg | 0.01 kg | Identical |
| Power Supply | 120/240 VAC with 5V DC
Input Power Jack and
Lithium Battery Powered | 120/240 VAC with 5V DC
Input Power Jack and
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
generation (e.g.,
piezoelectric.
magnetoconstructive) | Piezoelectric | Piezoelectric | Identical |
| Treatment Mode(s) | Two discrete settings of
power at same Frequency | Two discrete settings of
power at same Frequency | Identical |
| Beam Type (collimated or
divergent) | Divergent | Divergent | Identical |
| Transducer Diameter (cm) | 5 cm | 5 cm | Identical |
| Acoustic Working
Frequency and Accuracy
(MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area
and Accuracy (cm2) | One: 6 cm2
Two:12 cm2
± 20% | One: 6 cm2
Two:12 cm2
± 20% | Identical |
| Beam Nonuniformity Ratio
and Accuracy | BNR: