(267 days)
No
The device description and summary of performance studies do not mention any AI or ML capabilities. The firmware is described as only for logging usage time with no control function.
Yes
The device is intended for the treatment of selected medical conditions such as pain relief, muscle spasms, and joint contractures, which are therapeutic medical purposes.
No
The device description clearly states its purpose is to "apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions," such as pain relief and aiding in joint and muscle conditions. There is no mention of it being used to diagnose conditions.
No
The device description explicitly lists hardware components: Power Controller, Cables, Applicators, and Coupling Patches. While it mentions firmware, the core functionality relies on physical hardware to generate ultrasonic energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The sam 2.0 Long Duration Ultrasound Device applies ultrasonic energy to the body to generate deep heat for therapeutic purposes (pain relief, muscle spasms, etc.). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic application of energy to the body, not the analysis of biological samples.
- Device Description: The description details components for generating and applying ultrasound energy externally.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with IVD devices.
Therefore, the sam 2.0 Long Duration Ultrasound Device is a therapeutic device, not an In Vitro Diagnostic device.
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 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).
Product codes
PFW
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body tissues, knee, shoulder, elbow, ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use, prescription. After proper instruction from a healthcare professional.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
sam 2.0 Long Duration Ultrasound Device (K191568)
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). 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
1
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,
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
2
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) | |
|---|---|
| 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 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@zertoz.com | |
| 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
4
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
Long Duration
Ultrasound Device
(Subject Device) | ZetrOZ sam 2.0 Long
Duration Ultrasound
Device (K191568)
(Primary
Predicate) | 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 |
| Product Code | PFW | PFW | 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, 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). | 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. | Similar to the Primary
Predicate.
The device is intended to
treat medical conditions
such as the relief of pain,
the relief of muscle spasms,
the treatment of joint
contractures, and the local
increase in
circulation. It also includes
medical
conditions relief of pain
associated with limited
mobility and function
related to soft tissue
injuries including knee
osteoarthritis, shoulder,
elbow and ankle
tendinopathy, and chronic
myofascial pain as
supported by clinical
evidence. |
| 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) | 0.10 kg | 0.10 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
LithiumBattery 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 | 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 | One: 6 cm² | One: 6 cm² | Identical |
5
6
| ± 20% | ± 20% | ||||||
|---|---|---|---|---|---|---|---|
| Beam Nonuniformity | |||||||
| Ratio and Accuracy | BNR: |