(236 days)
Not Found
No
The device description details standard mechanical and ultrasonic components and functionalities without mentioning any AI or ML algorithms for control, analysis, or treatment optimization.
Yes
The device is described as a "Therapeutic Massager" and "Ultrasonic Diathermy" with indications for use that include temporary relief of minor muscle aches and pains, relief of pain, muscle spasms, and joint contractures. These functions are therapeutic in nature.
No.
The provided text describes a therapeutic device used for massage and ultrasonic diathermy, aimed at providing temporary relief and pain reduction, improving circulation, and reducing cellulite. It does not gather data or perform tests to diagnose conditions.
No
The device description clearly outlines physical hardware components including an injected plastic cabinet, control panels, wheels, a motor-powered vacuum suction modality, and an ultrasonic diathermy head with a crystal made of AL 6063. This indicates it is a hardware device with integrated software for control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The description clearly states the device's functions are related to therapeutic massage and ultrasonic diathermy, applied externally to the body. These are physical therapies, not tests performed on samples in vitro (outside the body).
- Intended Use: The intended uses listed are for temporary relief of muscle aches, spasms, improving circulation, reducing cellulite, and pain relief. These are all therapeutic applications, not diagnostic ones.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic outputs.
Therefore, the Dermosonic unit described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use include the following: a. Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains I.
- Relieves muscle spasms ii .
- Temporarily improves local blood circulation iii.
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy:
- Relief of pain i.
- ii. Muscle spasms
- Joint contractures iii.
- NOT for the treatment of malignancies iv.
Product codes (comma separated list FDA assigned to the subject device)
89-ISA, 90-IMI
Device Description
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:
-
- 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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Safety and performance testing has been completed on the S.O.R. Internacional, S.A. Dermosonic. The S.O.R. Internacional, S.A. Dermosonic is identical to the Sybaritic, Inc. Dermosonic Non-Invasive Subdermal Therapy System, 510(k) K024307. There are no differences between the S.O.R. Internacional, S.A. Dermosonic specifications and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
S.O.R. Internacional, S.A. 510(k) Premarket Submission Dermosonic
JUN 1 2 2006
SECTION 5 - 510(k) SUMMARY
| Submission Correspondent:
Address: | Emergo Group, Inc.
2454 McMullen Booth Road
Suite 427 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Phone:
Fax: | Clearwater, FL 33759
(727) 797-4727
(727) 797-4757 |
| Contact: | Mr. Ian Gordon |
| Submission Sponsor: | S.O.R. Internacional, S.A.
Moines, 13-Pol. Ind. C'an Cassablancas
08192 Sant Quirze del Valles (Barcelona) Spain |
| Date Prepared: | October 17, 2005, Revised April 4, 2006 |
| Trade Name: | Dermosonic |
| Common Name: | Therapeutic Massager/Ultrasound Diathermy |
| Classification: | Regulation # | Product Code |
|---|---|---|
| Massager, Therapeutic | 890.5660 | 89-ISA |
| Diathermy, Ultrasonic | 890.5300 | 90-IMI |
Class II device
Description: 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:
-
- 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
1
S.O.R. Internacional, S.A. 510(k) Premarket Submission Dermosonic
moved over the body in different patterns and directions to achieve varying treatment objectives.
-
- 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.
Intended Use:
- 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.
The indications for use include the following: a. Therapeutic Massager:
- Provides temporary relief of minor muscle aches and pains I.
- Relieves muscle spasms ii .
- Temporarily improves local blood circulation iii.
- Temporarily reduces the appearance of cellulite iv.
- b. Ultrasonic Diathermy:
- Relief of pain i.
- ii. Muscle spasms
- Joint contractures iii.
- NOT for the treatment of malignancies iv.
Predicate Devices: The predicate device referenced in this submission is:
Sybaritic. Inc.
Dermosonic Non- Invasive Subdermal Therapy System 510(k) K024307
Safety and Effectiveness:
Safety and performance testing has been completed on the S.O.R. Internacional, S.A. Dermosonic.
The S.O.R. Internacional, S.A. Dermosonic is identical to the Sybaritic, Inc. Dermosonic Non-Invasive Subdermal Therapy System, 510(k) K024307.
There are no differences between the S.O.R. Internacional, S.A. Dermosonic specifications and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness.
2
Summary and Conclusion Regarding Substantial Equivalence:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
There are no differences between the S.O.R. Internacional, S.A. Dermosonic specifications and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness. There are no differences in the technological characteristics or in the intended use of these devices.
The S.O.R. Internacional, S.A. Dermosonic device is identical to the predicate device, and therefore we have determined this device to be substantially equivalent to the referenced predicate device.
3
Public Health Service
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is a stylized image of three lines that appear to be flowing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2006
S.O.R. Internacional, S.A. c/o Mr. Ian Gordon Emergo Group, Inc. 2454 McMullen Booth Road, Suite 427 Clearwater, FL 33759
Re: K052934
Trade/Device Name: Dermosonic Regulation Number: 21 CFR 890.5300(a) Regulation Name: Ultrasonic Diathermy Regulatory Class: Class II Product Codes: IMI, ISA Dated: April 7, 2006 Received: April 10, 2006
Dear Mr. Gordon:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Ian Gordon
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hebert Lermerino
Mark N. Mellion
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
K052934 510(k) Number (if known): __
Device Name: Dermosonic
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.
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Hubert Henning
(Division Sign-Off) (Division of General, Restorative,
Division of General, Revices Division of Gent
and Neurological Devices
and Neurological Devices
510(k) Number Ko 52934