(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 muscle spasms, the treatment of joint contractures, and the local increase in circulation.
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the ZetrOZ Systems sam 2.0 Long Duration Ultrasound System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device (ZetrOZ Ultrasonic Diathermy Device, K130978) rather than detailing specific, quantified acceptance criteria for novel performance claims. The "comparison" column in the table implicitly indicates where performance is identical or similar to the predicate. Therefore, the acceptance criteria are effectively defined by matching or being similar to the predicate device's established performance specifications.
| Characteristic / Acceptance Criteria (as per predicate) | sam 2.0 Long Duration Ultrasound Device Performance (Subject) | Comparison to Predicate |
|---|---|---|
| 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: Relief of pain, muscle spasms, joint contractures, increase in circulation | The same, with removal of "healthcare practitioner requirement" for home use | Similar (change in use environment) |
| 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 |
| 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 (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: <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 (W/cm2): 0.132 W/cm2 ± 20% | 0.132 W/cm2 ± 20% | Identical |
| Maximum Output Power (Rated Output Power) and Accuracy (W): Single: 0.65W ± 20%, Dual: 1.3W ± 20% | Single: 0.65W ± 20%, Dual: 1.3W ± 20% | Identical |
| Maximum Effective Intensity and Accuracy: 0.264 W/cm2 ± 20% | 0.264 W/cm2 ± 20% | Identical |
| 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 treatment time: 4 hours) | 8°C at 1 cm, 6°C at 3 cm, 3°C at 5 cm (Max treatment time: 4 hours) | Identical |
| Maximum Patient Contact Surface Temperature: 44 °C | 44 °C | Identical |
| Therapeutically Applied: Ultrasound Coupling Patch | Ultrasound Coupling Patch | Identical |
| Applicator Type: Up to two circular Applicators with 3 MHz output | Up to two circular Applicators with 3 MHz output | Identical |
| Applicator Emitting Surface Areas (cm2): One: 5 cm², Two: 10 cm² | 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: Ultem | TPX | Similar |
| 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 | 21 CFR 1050.10 | Identical |
| Sterility: Non Sterile | Non Sterile | Identical |
| Designed to meet Electrical Safety Standards: IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Similar (added 60601-1-11) |
| Biocompatibility: Yes | Yes | Identical |
| Mechanical safety: Yes | Yes | Identical |
| Radiation safety: Not Radioactive | Not Radioactive | Identical |
| Software/Firmware: No | Yes (Firmware for logging usage time, no control function) | Similar |
| Output Channels: Two Independent Power Channels | Two Independent Power Channels | Identical |
2. Sample size used for the test set and data provenance
- Test Set Sample Size: Not explicitly mentioned for specific performance tests.
- Data Provenance:
- Preclinical Testing: "Third party testing of the electronics" and "Third party testing of the device" for electrical safety and home use standards. "Bench testing experiments" for diathermic heating effects on an ex vivo bovine muscle model. This implies lab-based, controlled testing. There is no mention of country of origin, but given the FDA submission, it's likely testing was done in accredited labs that meet international standards.
- Clinical Testing: "Usability data, human factors studies, and literature was provided to support the home use label." This suggests that prospective studies focusing on usability and human factors were conducted, but specific sample sizes and data provenance (e.g., country of origin) are not detailed within this summary. It might also refer to literature reviews of similar devices or general human factors principles. The document is submitted to the US FDA, so any data provided would need to be acceptable to the US regulatory body.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts
Not applicable. The reported studies (bench testing, electrical safety, usability/human factors) do not involve expert interpretation or subjective ground truth establishment in the way, for example, a diagnostic image analysis algorithm would. The "ground truth" for electrical safety and performance standards is defined by the standards themselves and objective measurements. For diathermic heating effects, it would be measured temperature changes. For usability, it would involve direct observation and user feedback rather than expert consensus on a 'truth'.
4. Adjudication method for the test set
Not applicable for the types of studies mentioned. These are objective measures against standards or physical phenomena, not subjective assessments requiring adjudication.
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
No MRMC comparative effectiveness study was done or mentioned. This device is an ultrasound therapy system, not a diagnostic imaging AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance assessment was effectively done for the physical and electrical characteristics of the device through preclinical bench testing and compliance with standards. The device itself operates independently to generate ultrasonic energy. The "home use" indication implies it's designed for use by the patient, meaning it's largely standalone in its therapeutic application, though prescribed by a physician. The firmware is for logging, not for diagnostic or control functions, so there isn't an "AI" component in the traditional sense to evaluate.
7. The type of ground truth used
- Preclinical Testing (Electrical Safety, Performance Standards): The ground truth is defined by the international and national standards (e.g., IEC 60601 series, 21 CFR 1050.10) and objective physical measurements (e.g., temperature, power output) on the device and an ex vivo model.
- Clinical Testing (Usability/Human Factors): The ground truth for usability would be user performance, feedback, and adherence to safety protocols, evaluated against human factors guidelines.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a training set. The firmware mentioned is for logging usage time, not for learning or decision-making.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for an AI/ML component.
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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.
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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
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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) |
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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@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
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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.
| ZetrOZsam 2.0 Long DurationUltrasound Device(Subject) | ZetrOZUltrasonic DiathermyDevice(K130978) | Comparison | |
|---|---|---|---|
| Information | |||
| Classification Name | Ultrasonic DiathermyDevice | Ultrasonic DiathermyDevice | 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 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. | The ZTX UltrasonicDiathermy Device isintended to apply ultrasonicenergy to generate deepheat within body tissues forthe treatment of selectedmedical conditions such asthe relief of pain, the reliefof muscle spasms, thetreatment of jointcontractures, and the localincrease in circulation.The ZTX Device is aprescription use device. TheZTX Device should only beadministered and monitoredby a licensed healthcarepractitioner. | Similar. Removal ofthe healthcarepractitionerrequirement. |
| 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 Head Dimensions(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) | 0.01 kg | 0.01 kg | Identical |
| Treatment Head Weight (kg) | 0.10 kg | 0.10 kg | Identical |
| ZetrOZsam 2.0 Long Duration | ZetrOZUltrasonic Diathermy | ||
| Ultrasound Device(Subject) | Device(K130978) | ||
| Information | Comparison | ||
| Power Supply | 120/240 VAC with 5V DCInput Power Jack andLithium Battery Powered | 120/240 VAC with 5V DCInput Power Jack andLithium Battery 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,magnetoconstructive) | 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 Working Frequencyand Accuracy (MHz) | 3MHz ± 20% | 3MHz ± 20% | Identical |
| Effective Radiating Area andAccuracy (cm2) | One: 6 cm2Two:12 cm2± 20% | One: 6 cm2Two:12 cm2± 20% | Identical |
| Beam Nonuniformity Ratioand Accuracy | BNR: <5:1 ± 20% | BNR: <5:1 ± 20% | Identical |
| Output Mode: (ContinuousWave/Amplitude -Modulated Wave) | Continuous Wave - 100%duty cycle | Continuous Wave - 100%duty cycle | Identical |
| Maximum Timer Setting andAccuracy | 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 Values of the following Powers and Intensities (max settings) | |||
| Maximum Value of theOutput Power (Rated OutputPower) and Accuracy (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 Amplitude ModulatedWaves | Not Amplitude Modulated | Not Amplitude Modulated | Identical |
| Temperature Specifications | |||
| Peak Temperature Rise vs.Time and Tissue Depth toMaximum Treatment Time(for fixed Treatment HeadPlacement) (deg C) | 8°C at 1 cm6°C at 3 cm3°C at 5 cmMax treatment time: 4hours | 8°C at 1 cm6°C at 3 cm3°C at 5 cmMax treatment time: 4hours | Identical |
| Maximum Patient ContactSurface Temperature ofTreatment Head underSimulated or Actual Use | 44 °C | 44 °C | Identical |
| Conditions for all Operating | |||
| ZetrOZsam 2.0 Long DurationUltrasound Device(Subject) | ZetrOZUltrasonic DiathermyDevice(K130978) | Comparison | |
| Information | |||
| Conditions (Continuallyoperated for maximumtreatment time) (deg C) | |||
| Therapeutically Applied | Ultrasound Coupling Patch | Ultrasound Coupling Patch | Identical |
| Applicator Type | Up to two circularApplicators with 3 MHzoutput | Up to two circularApplicators with 3 MHzoutput | Identical |
| Applicator TypeApplicator Emitting SurfaceAreas (cm2) | Up to two circularApplicatorsOne Applicator : 5 cm²Two Applicators :10 cm² | Up to two circularApplicatorsOne Applicator : 5 cm²Two Applicators :10 cm² | Identical |
| Coupling Bandage | ABS Plastic with integratedcoupling medium | ABS Plastic with integratedcoupling medium | Identical |
| Applicator Lens Material | TPX | Ultem | Similar |
| 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 | Non Sterile | Non Sterile | Identical |
| Designed to meet ElectricalSafety Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2 | SimilarAdded 60601-1-11 |
| Biocompatibility | Yes | Yes | Identical |
| Mechanical safety | Yes | Yes | Identical |
| Radiation safety (if notradioactive state as such) | Not Radioactive | Not Radioactive | Identical |
| Software/Firmware | Yes | No | SimilarThe sam 2.0 Long Duration UltrasoundDevice containsfirmware forlogging usage time.There is no controlfunction of thisfirmware. |
| Output Channels | Two Independent PowerChannels | Two Independent PowerChannels | Identical |
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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
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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.
§ 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.