(267 days)
Not Found
No
The device description explicitly states that the firmware is only for logging usage time and has no control function. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to treat selected medical conditions such as the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation by applying ultrasonic energy to generate deep heat within body tissues.
No
Explanation: The device is intended to treat medical conditions by applying ultrasonic energy to generate deep heat. It does not perform any diagnostic functions like identifying or classifying diseases or conditions.
No
The device description explicitly lists hardware components such as a Rechargeable Power Controller and Timer, Ultrasound Generating Applicators, Applicator Adaptor Cables, and single-use disposable accessories. While it mentions firmware, 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 therapeutic purposes (relief of muscle spasms, treatment of joint contractures, local increase in circulation). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details how the device generates and applies ultrasonic energy to the body. There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not include any components or functions related to analyzing biological samples or providing diagnostic results.
- Performance Studies: The performance studies focus on safety, electrical standards, and the diathermic heating effects on tissue, which are relevant to a therapeutic device. There are no studies related to diagnostic accuracy or performance on biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the body for therapeutic effect.
N/A
Intended Use / 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 muscle spasms, the treatment of joint contractures, and the local increase in circulation.
Product codes (comma separated list FDA assigned to the subject device)
PFW
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 mode, the patient can receive 1.3 W at 3 MHz. The Applicators are applied to the skin with one time 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.
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ZetrOZ Ultrasonic Diathermy Device (K130978)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| ❌ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
| Device Trade Name: | sam 2.0 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: | 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
4
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
sam 2.0 Long Duration
Ultrasound Device
(Subject) | ZetrOZ
Ultrasonic Diathermy
Device
(K130978) | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Information | | | |
| 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 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. | The ZTX Ultrasonic
Diathermy Device is
intended 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 ZTX Device is a
prescription use device. The
ZTX Device should only be
administered and monitored
by a licensed healthcare
practitioner. | Similar. Removal of
the healthcare
practitioner
requirement. |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/Generator
Dimensions (L x W x H cm) | 6.10 cm L x 7.09 cm H x
1.88cm W | 6.10 cm L x 7.09 cm H x
1.88cm W | 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) | 0.01 kg | 0.01 kg | Identical |
| Treatment Head Weight (kg) | 0.10 kg | 0.10 kg | Identical |
| | ZetrOZ
sam 2.0 Long Duration | ZetrOZ
Ultrasonic Diathermy | |
| | Ultrasound Device
(Subject) | Device
(K130978) | |
| Information | | | Comparison |
| 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: