(174 days)
Ultratherm 808i
Not Found
No
The summary describes a standard shortwave diathermy device and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance metrics typically associated with AI/ML models.
Yes
The device description clearly states its intention to generate deep heat in body tissues for the treatment of medical conditions like pain relief, muscle spasms, and joint contractures, which are therapeutic applications.
No
The device is described as a shortwave diathermy device intended to generate deep heat for treatment, not for diagnosis.
No
The device description explicitly states it is a "shortwave diathermy device intended to generate deep heat in body tissues," which implies a hardware component is necessary to generate the heat.
Based on the provided information, the Ultratherm 908i is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to generate deep heat in body tissues for the treatment of medical conditions. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a shortwave diathermy device, which is a type of physical therapy equipment used for heating tissues. This aligns with a therapeutic purpose.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The Ultratherm 908i's function is to apply heat to the body for therapeutic benefit, which is distinct from the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.
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)
Not Found
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.
Ultratherm 808i
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
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz 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)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
0
APR -3 1997
510(k) Summary for Ultratherm 908i
Date: October 5, 1996
Applicant: SIE-MED Incorporated 991 Aviation Parkway - Suite 100 Morrisville, North Carolina 27560 Contact: Mr. Karl Harbauer, President Phone: (919) 319-8370
Predicate Device: Ultratherm 808i
Device Description: The Ultratherm 908i is a shortwave diathermy device intended to generate deep heat in body tissues for the treatment of medical conditions such as the relief of pain, muscle spasms and joint contractures.
Changes: The labeling for the Ultratherm 908i limits its intended uses to those accepted by FDA for class II shortwave diathermy devices. Operating voltage and leakage are significantly reduced by replacing the tube generator with a compact transistor generator. The maximal effective output does not exceed 200 watts. The selected output is kept constantly in the scope of the patient's coupling conditions and is electronically indicated by the addition of a LED display and luminous band. Safety is enhanced by symmetrical and asymmetrical output sockets for the electrodes, the use of non-flammable silicon rubber field electrodes and sheltered coil field electrodes, and the reduction of impulse peak to 400 watts. Mechanical switches and a small light with a yes/no function have been replaced by touch sensitive contacts with LED control for the selection of operating mode and LED display of output intensity.
The foreign manufacturer of the Ultratherm 908i has independently marketed a similar device in Europe for 4 to 5 years and in Canada for 1 year. The same firm also manufactures the Ultratherm 808i which the present applicant distributes under a premarket notification (K862589) cleared by FDA on August 1, 1986. The safety, effectiveness, and reliability of the Ultratherm 908i have been established by the manufacturer's successful marketing of a similar device without the need for recall or receipt of significant adverse experience reports. The revised indications and changes in technological characteristics described in this present 510(k) submission enhance the safety and effectiveness of this device.