(27 days)
Not Found
No
The device description explicitly states the firmware has no control function, and there are no mentions of AI, DNN, or ML.
Yes
The device is intended to treat conditions by applying ultrasonic energy to generate deep heat and increase local circulation within body tissues, which are therapeutic effects.
No
Explanation: The device is described as applying ultrasonic energy to generate deep heat and increase local circulation, which are therapeutic functions, not diagnostic ones. Its "Intended Use / Indications for Use" section focuses on treatment rather than diagnosis.
No
The device description explicitly lists hardware components such as a "Rechargeable Power Controller and Timer" and "Ultrasound Generating Applicators," indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply ultrasonic energy to generate deep heat and increase local circulation within body tissues. This is a therapeutic application, not a diagnostic one.
- Device Description: The device generates ultrasonic energy and applies it to the body. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely therapeutic.
N/A
Intended Use / Indications for Use
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
Product codes
PFW
Device Description
The sam CS 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 CS 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.
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
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)
Non-Clinical Performance Data:
The sam CS Long Duration Ultrasound Device is in accordance with these recognized consensus standards:
IEC 60601-1 Ed. 3.1 2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Ed. 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-11 Ed. 2.0 2015-01 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment ISO 10993 Biological evaluation of medical devices - Part 1-Ed. 5-2018: Evaluation and testing within a risk management process; Part 5 Ed. 3-2009: Tests for in vitro cytotoxicity; Part 10 Ed. 3-2010: Tests for irritation and skin sensitization
Clinical Performance Data:
Clinical testing was not necessary to support substantial equivalence of the sam CS device.
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 25, 2023
ZetrOZ Systems, LLC Sabrina Lewis OAR Director 56 Quarry Road Trumbull, Connecticut 06611
Re: K233210
Trade/Device Name: sam CS Long Duration Ultrasound Device Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Code: PFW Dated: September 28, 2023 Received: September 28, 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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Rehabilitation Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233210
Device Name sam CS Long Duration Ultrasound Device
Indications for Use (Describe)
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local 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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4
510(K) SUMMARY - K233210
| Device Trade Name: | sam CS 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: | October 24, 2023 |
| Classification: | 21 CFR 890.5300; Ultrasonic diathermy. |
| Class: | II |
| Product Code: | PFW |
| Predicate Devices: | sam X1 Long Duration Ultrasound Device (K211513) |
Indications for Use:
The sam CS Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues and to increase local circulation.
Device Description:
The sam CS 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 CS 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.
5
The system is intended for prescription home use to apply ultrasonic energy for a long duration (1 hour) to generate deep heat within body tissues and to increase local circulation.
| Table 1: Substantial Equivalence Summary | ||||
|---|---|---|---|---|
| Information | ZetrOZ sam CS Long | |||
| Duration Ultrasound | ||||
| Device | ||||
| (Subject) | ZetrOZ sam X1 Long | |||
| Duration Ultrasound | ||||
| Device | ||||
| (K211513) | Comparison | |||
| (to sam X1) | ||||
| 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 CS Long | |||
| Duration Ultrasound | ||||
| Device is intended for | ||||
| home use to apply | ||||
| ultrasonic energy to | ||||
| generate deep heat within | ||||
| body tissues and to | ||||
| increase local circulation. | 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. | Similar. The | |||
| indication statement is | ||||
| a subset of the | ||||
| previous indication for | ||||
| use. The intended use | ||||
| remains the same. | ||||
| Manufacturer | ZetrOZ | ZetrOZ | Identical | |
| Console/Generator | ||||
| Dimensions (L x W x H | ||||
| cm) | 3.4 cm x 3.4 cm x 1.4 cm | 3.4 cm x 3.4 cm x 1.4 cm | Identical | |
| 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 | 0.02 kg | Identical | |
| 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 | |
| Information | ZetrOZ sam CS Long | |||
| Duration Ultrasound | ||||
| Device | ||||
| (Subject) | ZetrOZ sam X1 Long | |||
| Duration Ultrasound | ||||
| Device | ||||
| (K211513) | Comparison | |||
| (to sam X1) | ||||
| 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: |