(128 days)
No
The summary describes a traditional ultrasonic therapy device and lacks any mention of AI, ML, image processing, or performance metrics typically associated with AI/ML-powered devices.
Yes
The device is used for the "treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures," which are therapeutic applications.
No
The device is described as an "Ultrasonic Therapy Appliance" that generates deep heat for the treatment of selected medical conditions, indicating a therapeutic rather than diagnostic purpose.
No
The device is described as an "Ultrasonic Therapy Appliance" which generates "deep heat within body tissues." This strongly implies a hardware component that produces ultrasonic waves, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "generates deep heat within body tissues for the treatment of selected medical conditions". This describes a therapeutic device that acts directly on the body, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: While the description is "Not Found", the intended use is the primary indicator of whether a device is an IVD.
- Mentions image processing, AI, DNN, or ML: These are often associated with IVDs that analyze images or data from specimens. Their absence further supports that this is not an IVD.
- Input Imaging Modality: "Not Applicable" is consistent with a therapeutic device that doesn't rely on imaging.
- Anatomical Site: "body tissues" refers to the site of treatment, not the source of a specimen for testing.
In summary, the function of this device is to apply energy to the body for therapeutic purposes, which is the definition of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
Product codes
IMI
Device Description
Not Found
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
Prescription Use
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or abstract forms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2004
Hwang Sun Enterprise Company, Ltd. C/o Richard C. Lanzillotto NATS Corporation 30 Northport Road Sound Beach, New York 11789
Re: K040798
K040776
Trade/Device Name: HES® Ultrasonic Therapy Appliance Model 3003 and Model 3006 Regulation Number: 21 CFR 890.5300 Regulation Name: Ultrasonic diathermy Regulatory Class: II Product Code: IMI Dated: May 13, 2004 Received: May 17, 2004
Dear Mr. Lanzillotto:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce print to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de rices mat nave been receasined require approval of a premarket approval application (PMA). and Costietle Act (110) that as noves participant to the general controls provisions of the Act. The I ou may, incretere, mains of the Act include requirements for annual registration, listing of general voltable pro receive, 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 If your device is elassinod (600 a00 rols. Existing major regulations affecting your device can may be subject to back as a 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 r least of actived that i Drimination that your device complies with other requirements of the Act that I DA has made a avoid regulations administered by other Federal agencies. You must of any I catal statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It 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.
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Page 2 - Richard C. Lanzillotto
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your he FDA finding of substantial equivalence of your device to a legally premaince hodicate 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 If you desire specific at no 101 - 501) 594-4659. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ു.
Issued: 03-17-04 Revised: 07-20-04
HES® Ultrasonic Therapy Appliance 510K Notification K040798
INDICATIONS FOR USE
| 510(k) Number (if known): | K040798 |
|---|---|
| Device Name: | HES® Ultrasonic Therapy Appliance |
| Indications for Use: | The HES® Ultrasonic Therapy Appliance generates deep heat within body tissues for the treatment of selected medical conditions such as temporary relief of minor pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line-continue on another Page if needed)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Mckinnon
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(Division Sign-on) Restorative, Division of Or of Occal Devices
510(k) Number-