(153 days)
No
The summary describes a device that generates ultrasonic energy for therapeutic heating and does not mention any AI/ML components or functions.
Yes
The device is described as treating "selected medical conditions such as relief of pain, muscle spasms, and joint contractures," which indicates a therapeutic purpose.
No
The device is described as an Ultrasound Diathermy Device intended to apply ultrasonic energy to generate deep heat for treatment, not for diagnosis.
No
The device description explicitly states it consists of a "two-channel power module" and a "handpiece with cable," which are hardware components. The performance studies also focus on hardware-related testing like electrical safety, electromagnetic compatibility, and temperature rise.
Based on the provided information, the Orthosonics Duo-Son Ultrasound Diathermy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply ultrasonic energy to generate deep heat within body tissues for therapeutic purposes (pain relief, muscle spasms, joint contractures). This is a therapeutic application, not a diagnostic one.
- Device Description: The device generates and delivers energy to the body. It does not analyze samples of human origin (like blood, urine, tissue) outside of the body, which is the core function of an IVD.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of diseases or conditions through in vitro testing, or any of the typical components or processes associated with IVDs.
Therefore, the Orthosonics Duo-Son Ultrasound Diathermy Device is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
Product codes
IMI
Device Description
The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which generates the ultrasonic energy and provides overall control of the device, and a handpiece with cable. The applicator design allows the simultaneous delivery of ultrasonic energy to tissue at two frequencies, 1 MHz and 45 kHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body tissues
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)
Orthosonics carried out testing to address the following issues:
- (1) electrical safety,
- (2) electromagnetic compatibility,
- (3) temperature rise in a phantom during Duo-Son procedures, and
- (4) temperature rise in a phantom using the predicate device, and
- compliance with 21 CFR 1050. (5)
The results from all of these tests supported the safety and effectiveness the Orthosonics Duo-Son Ultrasonic Diathermy Device and of demonstrate that it is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
JUN 1 6 1997
orthosonics duo-son ULTRASOUND DIATHERMY DEVICE
| Common/Classification Name: | Ultrasonic diathermy |
|---|---|
| 21 CFR 890.5300 |
| Sponsor: | Orthosonics, Ltd. |
|---|---|
| Bremridge Farm | |
| Ashburton | |
| Devon TQ137JX | |
| UK | |
| +44-1364-652426 | |
| +44-1364-653589 |
Contact:
Dr. Michael J. R. Young
Prepared: January 14, 1997
LEGALLY MARKETED PREDICATE DEVICES A.
The Orthosonics Duo-Son Ultrasound Diathermy Device is substantially equivalent to the Mettler Model ME-720 (K883228).
DEVICE DESCRIPTION B. ... .......................................................................................................................................................................
The Orthosonics Duo-Son Ultrasound Diathermy Device consists of a two-channel power module which generates the ultrasonic energy and provides overall control of the device, and a handpiece with cable. The applicator design allows the simultaneous delivery of ultrasonic energy to tissue at two frequencies, 1 MHz and 45 kHz.
C. INTENDED USE
The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
D. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the Duo-Son device are the same as those of the predicate devices.
1
E. TESTING
P
Orthosonics carried out testing to address the following issues:
- (1) electrical safety,
- (2) electromagnetic compatibility,
- (3) temperature rise in a phantom during Duo-Son procedures,
- (4) temperature rise in a phantom using the predicate device, and
- compliance with 21 CFR 1050. (5)
The results from all of these tests supported the safety and effectiveness the Orthosonics Duo-Son Ultrasonic Diathermy Device and of demonstrate that it is substantially equivalent to the predicate devices.
ட் CONCLUSIONS
The Orthosonics Duo-Son device has the same intended use and target population as the predicate devices. Orthosonics has demonstrated through its performance tests on the Duo-Son device and its comparison of Duo-Son characteristics with those of the predicate device that the Duo-Son device is substantially equivalent to the predicate device.
2
.. . ..
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
T. Whit Athey, Ph.D. JUN 1 6 1997 Senior Consultant C.L. McIntosh & Associates; Inc. r 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
K970131 Orthosonics Duo-Sun Ultrasound Diathermy Device Requlatory Class: II Product Code: IMI Dated: May 14, 1997 May 14, 1997 Received:
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - T. Whit Athey, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Che Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Ao coleyo
CeNia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Orthosonics Duo-Son Ultrasound Diathermy Device
Indications For Use:
参
The Orthosonics Duo-Son Ultrasound Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
GOODS