(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: |
§ 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.