(236 days)
The indications for use include the following: a. Therapeutic Massager: Provides temporary relief of minor muscle aches and pains; Relieves muscle spasms; Temporarily improves local blood circulation; Temporarily reduces the appearance of cellulite. b. Ultrasonic Diathermy: Relief of pain; Muscle spasms; Joint contractures; NOT for the treatment of malignancies.
The Dermosonic unit is housed in an injected plastic cabinet. Control panels at the top of the cabinet incorporate all the elements required to operate the unit and control and view the various treatment parameters. Below the control panels are spaces to hold the various accessories. There are wheels at the bottom so the device can be easily moved from place to place. Technical specifications for primary components of the devices are: 1. Therapeutic Massager: The device incorporates a motor powered vacuum suction modality with a maximum suction power of 820 milli-bars (mbar). The airflow is rated at 3.500 liters per hour. The device has two suction modes: Continuous and Pulsed. In the Continuous Mode, the suction is constant. In the Pulsed Mode, the suction is intermittent. The suction therapy is delivered to the body with three different size application heads to treat different parts of the body which utilize stainless steel ball bearings to allow the heads to be easily moved over the body. The head are moved over the body in different patterns and directions to achieve varying treatment objectives. 2. Ultrasonic diathermy (US-6000): The device utilizes a 3 MHz ultrasound head. The applicator crystal is made of AL 6063 (a special type of aluminum commonly used in heat sink material and in CPU cooling fans). Ultrasonic energy can be emitted continuously or intermittently with pulses of limited duration. In the pulse mode, the duration of the pulse (or pulse time) varies from 0.5 milliseconds (msec) to 2 msec. The device allows the operator to select any one of four available ultrasonic emission modes.
This 510(k) submission (K052934), for the S.O.R. Internacional, S.A. Dermosonic device, asserts substantial equivalence to a predicate device rather than conducting a new performance study to establish acceptance criteria and device performance. Therefore, many of the requested details about a new study are not applicable in this context.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim, the "acceptance criteria" are effectively the specifications and intended use of the predicate device, and the "reported device performance" is deemed to be identical to the predicate.
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (Dermosonic) |
|---|---|
| Therapeutic Massager: | Therapeutic Massager: |
| - Provides temporary relief of minor muscle aches and pains | - Provides temporary relief of minor muscle aches and pains |
| - Relieves muscle spasms | - Relieves muscle spasms |
| - Temporarily improves local blood circulation | - Temporarily improves local blood circulation |
| - Temporarily reduces the appearance of cellulite | - Temporarily reduces the appearance of cellulite |
| Ultrasonic Diathermy: | Ultrasonic Diathermy: |
| - Relief of pain | - Relief of pain |
| - Muscle spasms | - Muscle spasms |
| - Joint contractures | - Joint contractures |
| - NOT for the treatment of malignancies | - NOT for the treatment of malignancies |
| Technical Specifications: | Technical Specifications: |
| - Therapeutic Massager: Max suction power 820 mbar, airflow 3.500 liters/hour, Continuous & Pulsed modes, 3 application heads | - Therapeutic Massager: Max suction power 820 mbar, airflow 3.500 liters/hour, Continuous & Pulsed modes, 3 application heads |
| - Ultrasonic Diathermy: 3 MHz ultrasound head, AL 6063 applicator crystal, Continuous or Intermittent emission, 0.5-2 msec pulse duration, 4 emission modes | - Ultrasonic Diathermy: 3 MHz ultrasound head, AL 6063 applicator crystal, Continuous or Intermittent emission, 0.5-2 msec pulse duration, 4 emission modes |
2. Sample Size Used for the Test Set and the Data Provenance
- Not applicable. No new clinical or performance study involving a test set was conducted for this submission. The claim is based on the device being "identical" to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No new clinical or performance study requiring ground truth establishment was conducted.
4. Adjudication Method for the Test Set
- Not applicable. No new clinical or performance study requiring adjudication was conducted.
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
- Not applicable. This device is a therapeutic massager/ultrasound diathermy, not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical therapeutic device, not an algorithm, and no standalone performance study was conducted.
7. The Type of Ground Truth Used
- Not applicable directly. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device as determined by its original clearance (K024307). The current submission relies on the assertion of identical specifications and intended use to that predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning algorithm, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used.
Summary of the Study (or Lack thereof):
The submission argues for substantial equivalence by stating that the S.O.R. Internacional, S.A. Dermosonic is identical to the Sybaritic, Inc. Dermosonic Non-Invasive Subdermal Therapy System (K024307) in terms of specifications, technological characteristics, and intended use. Therefore, no new safety and effectiveness testing (clinical or performance studies) was deemed necessary for this 510(k) submission. The FDA concurred with this assessment, finding the device substantially equivalent.
§ 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.