(267 days)
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 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.
This document is a 510(k) Premarket Notification from ZetrOZ Systems, LLC for their sam 2.0 Long Duration Ultrasound Device. It seeks to demonstrate substantial equivalence to a previously cleared predicate device, K191568. The key aspect of this submission is an expansion of indications for use for an identical device design.
The document states that the substantial equivalence is supported by clinical performance testing which involved a systematic literature review and meta-analysis rather than a new clinical study. This means there is no traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way one would analyze a new AI medical device's performance.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria in the way one would for a new AI or diagnostic device (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to the predicate device and by providing clinical evidence from published literature supporting the expanded indications.
The 'performance' is described qualitatively as "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." For the expanded indications, it is stated: "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."
Given that this is a K-submission for an ultrasound device with expanded indications and not a novel AI/diagnostic device, the table structure won't fit perfectly with typical AI acceptance criteria. The most relevant 'performance' is the equivalency of the device's technical specifications and the clinical efficacy of ultrasound therapy as demonstrated by the literature review.
Table of Device Comparison (as presented in the document to demonstrate equivalence):
| Feature/Parameter | Subject Device: sam 2.0 Long Duration Ultrasound Device | Predicate Device: sam 2.0 Long Duration Ultrasound Device (K191568) | Comparison (Acceptance Criteria implicitly met by "Identical" or "Similar") |
|---|---|---|---|
| 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 For Use | Extended (see document for full text) | Original (see document for full text) | Similar (expanded indications supported by clinical evidence) |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/Generator Dimensions | 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 | 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 | 0.10 kg | 0.10 kg | Identical |
| Treatment Head Weight | 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 | 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 | Divergent | Divergent | Identical |
| Transducer Diameter | 5 cm | 5 cm | Identical |
| Acoustic Working Frequency and Accuracy | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area | One: 6 cm² ± 20% (Two: 10 cm²) | One: 6 cm² ± 20% (Two: 10 cm²) | Identical |
| Beam Nonuniformity Ratio and Accuracy | BNR: <5:1 ± 20% | BNR: <5:1 ± 20% | Identical |
| Output Mode | Continuous Wave - 100% duty cycle | Continuous Wave - 100% duty cycle | Identical |
| Maximum Timer Setting and Accuracy | 4 Hours +/- 1 minute | 4 Hours +/- 1 minute | Identical |
| Beam Maximum Intensity and Accuracy | 0.132 W/cm² ± 20% | 0.132 W/cm² ± 20% | Identical |
| Max Output Power and Accuracy | Single: 0.65W ± 20%, Dual: 1.3W ± 20% | Single: 0.65W ± 20%, Dual: 1.3W ± 20% | Identical |
| Max Effective Intensity and Accuracy | 0.264 W/cm² ± 20% | 0.264 W/cm² ± 20% | Identical |
| For Amplitude Modulated Waves | Not Amplitude Modulated | Not Amplitude Modulated | Identical |
| Peak Temperature Rise vs. Time and Tissue Depth | 8°C at 1 cm, 6°C at 3 cm, 3°C at 5 cm (Max 4 hrs) | 8°C at 1 cm, 6°C at 3 cm, 3°C at 5 cm (Max 4 hrs) | Identical |
| Maximum Patient Contact Surface Temperature | 44 °C | 44 °C | Identical |
| Applicator Type | Ultrasound Coupling Patch, Up to two circular Applicators with 3 MHz output | Ultrasound Coupling Patch, Up to two circular Applicators with 3 MHz output | Identical |
| Applicator Emitting Surface Areas | Up to two circular Applicators: One: 5 cm², Two: 10 cm² | Up to two circular Applicators: One: 5 cm², Two: 10 cm² | Identical |
| Coupling Bandage | ABS Plastic with integrated coupling medium | ABS Plastic with integrated coupling medium | Identical |
| Applicator Lens Material | TPX | TPX | Identical |
| Environmental - Operating Temperature 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, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | 21 CFR 1050.10, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Identical |
| Sterility | Non Sterile | Non Sterile | Identical |
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety | Not Radioactive | Not Radioactive | Identical |
| Software/Firmware | Yes (firmware for logging usage time, no control function) | Yes (firmware for logging usage time, no control function) | Identical |
| Output Channels | Two Independent Power Channels | Two Independent Power Channels | Identical |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission relies on a systematic literature review and meta-analysis to support the expanded indications, not a new clinical trial with a defined "test set" sample size. Therefore, there isn't a single "sample size" for a test set in the traditional sense.
- Sample Size: Not applicable as a new test set was not generated. The evidence comes from accumulated studies in the literature.
- Data Provenance: The systematic literature review was conducted using databases such as PubMed, EBSCOhost, Academic Search Complete, Google Scholar, and ClinicalTrials.gov. This implies global data sources, reflecting a diverse range of studies published in scientific literature. The studies themselves would have their own provenance (e.g., country of origin, retrospective/prospective design), but these details are not provided for the individual studies included in the review. The review itself is retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable as this submission is for an ultrasound therapy device and relies on clinical efficacy from published literature, not on expert adjudication of diagnostic images or interpretations to establish ground truth for a test set. There's no mention of experts involved in reviewing the literature for the purpose of establishing a "ground truth" for a device performance test. The "ground truth" is implied by the clinical outcomes reported in the accumulated scientific literature on SAM treatment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as there was no new "test set" and no image-based diagnostic task requiring adjudication. The evidence comes from a systematic literature review and meta-analysis of clinical studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This question is not applicable. The device is an ultrasound therapy device, not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a therapeutic ultrasound device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the expanded indications for this therapeutic device is based on outcomes data from various clinical studies summarized in the systematic literature review. These outcomes relate to "the relief of pain, the relief of muscle spasms, the treatment of joint contractures, the local increase in circulation," and specifically for the expanded indications, "relief of pain associated with limited mobility and function related to soft tissue injuries (e.g., knee osteoarthritis, chronic myofafascial pain, and shoulder, elbow and ankle tendinopathy)." The efficacy is based on the therapeutic effect reported in the aggregated clinical literature.
8. The sample size for the training set
- This question is not applicable. The device is not an AI algorithm requiring a training set. The clinical evidence is derived from existing scientific literature.
9. How the ground truth for the training set was established
- This question is not applicable. The device is not an AI algorithm.
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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 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
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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
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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, LLC56 Quarry RoadTrumbull, CT 06611 |
| Contact: | Ms. Sabrina LewisQAR DirectorPhone: 888-202-9831Email: 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
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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 2.0Long DurationUltrasound Device(Subject Device) | ZetrOZ sam 2.0 LongDuration UltrasoundDevice (K191568)(PrimaryPredicate) | Comparison | |
|---|---|---|---|
| Information | |||
| Classification Name | UltrasonicDiathermy Device | UltrasonicDiathermy Device | Identical |
| Service Type | PhysicalMedicine | PhysicalMedicine | Identical |
| Classification | 21 CFR890.5300 | 21 CFR890.5300 | Identical |
| Class | II | II | Identical |
| Product Code | PFW | PFW | Identical |
| Indications | The sam 2.0 Long DurationUltrasound Device isintended for home use toapply ultrasonic energy togenerate deep heat withinbody tissues for thetreatment of selectedmedical conditions such asthe relief of pain, the reliefof muscle spasms, thetreatment of jointcontractures, the localincrease in circulation, andthe relief of pain associatedwith limited mobility andfunction related to softtissue injuries (e.g., kneeosteoarthritis, chronicmyofascial pain, andshoulder, elbow and ankletendinopathy). | The sam 2.0 Long DurationUltrasound Device isintended for home use toapply ultrasonic 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. | Similar to the PrimaryPredicate.The device is intended totreat medical conditionssuch as the relief of pain,the relief of muscle spasms,the treatment of jointcontractures, and the localincrease incirculation. It also includesmedicalconditions relief of painassociated with limitedmobility and functionrelated to soft tissueinjuries including kneeosteoarthritis, shoulder,elbow and ankletendinopathy, and chronicmyofascial pain assupported by clinicalevidence. |
| Manufacturer | ZetrOZ | ZetrOZ | Identical |
| Console/GeneratorDimensions (L x W x H cm) | 6.10 cm L x 7.09 cm H x1.88cm W | 6.10 cm L x 7.09 cm H x1.88cm W | Identical |
| Treatment HeadDimensions (L x W x H cm) | 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) | 0.10 kg | 0.10 kg | Identical |
| Treatment Head Weight(kg) | 0.01 kg | 0.01 kg | Identical |
| Power Supply | 120/240 VAC with 5VDC Input Power Jack andLithiumBattery Powered | 120/240 VAC with 5VDC Input Power Jack andLithiumBattery 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 | 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 andAccuracy (MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area | One: 6 cm² | One: 6 cm² | Identical |
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| ± 20% | ± 20% | ||||||
|---|---|---|---|---|---|---|---|
| Beam NonuniformityRatio and Accuracy | BNR: <5:1 ±20% | BNR: <5:1 ±20% | Identical | ||||
| Output Mode:(ContinuousWave/Amplitude -Modulated Wave) | ContinuousWave - 100%duty cycle | ContinuousWave - 100%duty cycle | Identical | ||||
| Maximum Timer Settingand Accuracy | 4 Hours +/- 1 minute | 4 Hours +/- 1 minute | identical | ||||
| 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 | ||||
| For AmplitudeModulated Waves | Not Amplitude Modulated | Not Amplitude Modulated | identical | ||||
| Peak Temperature Risevs. Time and TissueDepth to MaximumTreatment Time (forfixed Treatment HeadPlacement) (deg C) | 8°C at 1 cm6°C at 3 cm3°C at 5 cmMax treatment time: 4 hours | 8°C at 1 cm6°C at 3 cm3°C at 5 cmMax treatment time: 4 hours | Identical | ||||
| Maximum Patient ContactSurface Temperature ofTreatment Head underSimulated or Actual UseConditions for all OperatingConditions (Continuallyoperated for maximumtreatment time) (deg C)Therapeutically Applied | 44 °C | 44 °C | Identical | ||||
| Applicator Type | Ultrasound Coupling PatchUp to two circularApplicators with 3 MHzoutput | Ultrasound Coupling PatchUp to two circularApplicators with 3 MHzoutput | identical | ||||
| Applicator Type ApplicatorEmitting Surface Areas(cm2) | Up to two circularApplicatorsOne Applicator : 5 cm²Two Applicators :10cm² | Up to two circularApplicatorsOne Applicator : 5cm²Two Applicators :10cm² | 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 | Designed to meet ElectricalSafety Standards | Non Sterile | IEC 60601-1IEC 60601-1-2 | Non Sterile | IEC 60601-1IEC 60601-1-2 | identical | Identical |
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| IEC 60601-1-11 | IEC 60601-1-11 | ||
|---|---|---|---|
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety (ifnot radioactive state as such) | Not Radioactive | Not Radioactive | identical |
| Software/Firmware | Yes | Yes | Identical |
| Output Channels | Two Independent PowerChannels | Two Independent PowerChannels | Identical |
Conclusion:
The subject device and the predicate device have the same intended use, technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials. The data included in this submission demonstrate substantial equivalence to the predicate device listed above. The sam 2.0 Long Duration Ultrasound Device is as safe, as effective, and performs as well as 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.