(18 days)
KXXXXXX
KXXXXXX
No
The device description focuses on the physical components and operational modes of a shortwave diathermy device, with no mention of AI or ML capabilities.
Yes
The device delivers deep heating therapeutic effects to body tissues to treat conditions such as relieving pain, reducing muscle spasms, increasing range of motion, and increasing blood flow, which are all therapeutic uses.
No
This device is described as providing "deep heating therapeutic effects to body tissues" and is used for "treatment of many conditions" like "relieving pain" and "reducing muscle spasm," indicating a therapeutic rather than a diagnostic purpose.
No
The device description clearly details physical hardware components such as a control panel, intensity control knob, power switch, sockets for cables, and a ripcord for an emergency-OFF switch, indicating it is a hardware device with integrated controls, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the Auto*Therm 390 delivers energy to the body for therapeutic effects like pain relief, muscle spasm reduction, and increasing blood flow. This is a form of physical therapy or medical treatment applied to the patient, not a diagnostic test performed on a sample from the patient.
- Intended Use: The intended use describes treating conditions in the body using heat.
- Device Description: The description details a device that applies energy externally to the patient.
The device is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
Indications for use:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase in blood flow
-
- Increase range of motion of contracted joints.
Shortwave diathermy delivers energy in the radio band of 27.12.
The success blockers heating therapeutic effects to body tissues. Shortwave diathermy delivers encryy in offects to body tissues.
MHz to provide deep heating therapeutic the body at intensities Miz to provide deep neating cherapease othe body at intensities When shortwave diathermy is deirverod cature increase, it can
capable of generating a deep tissue temperature increase, it can
capable of generating a deep tissue tuch as capable of generating a deep creat of the many as:
- Relieving pain 1 .
- Reducing muscle spasm 2.
- Reducing muscie spasm
Increasing range of motion of contracted joints using heat , ' and stretch techniques. - and stretch techniques.
Increasing blood flow to tissues in the treatment area. 4 .
Product codes
IMJ
Device Description
The Auto*Therm 390 is a shortwave diathermy device that operates at 27.12 MHz. It provides shortwave diathermy therapy using condenser and electromagnetic inductive coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and medical practice.
The ME 390 is portable and easily transportable between treatment rooms. A four-wheel cart is provided when the optional induction electrode and arm are used. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on the top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 390.
The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting cables for the condenser and inductive coil applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Auto*Therm 395, Model 395 (KXXXXXX)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUTO*THERM® 390, MODEL ME 390 510(K) SUMMARY STATEMENT (KXXXXXX)
Mettler Electronics Corp. Submitter's Name: 1333 South Claudina Street Address: Anaheim, CA 92805
714-533-2221 Telephone:
Contact: Robert E. Fleming Director, QA/RA
August 31, 2003 Date Prepared:
Proposed Device Name:
| a. TRADE NAME: | Auto*Therm® 390, Model ME 390 |
|---|---|
| b. CLASSIFICATION NAME: | Shortwave Diathermy |
| c. COMMON NAME: | Shortwave Diathermy |
Predicate Device:
- Auto*Therm 395, Model 395 a. TRADE NAME:
- b. 510(k) Number: K
Description of Proposed Device:
The Auto*Therm 390 is a shortwave diathermy device that operates at 27.12 MHz. It provides shortwave diathermy therapy using condenser and electromagnetic inductive coil fields in both continuous and pulsed modes of operation. It is suited for all diathermy treatments in both the clinic and medical practice.
The ME 390 is portable and easily transportable between treatment rooms. A four-wheel cart is provided when the optional induction electrode and arm are used. Two of these wheels have brakes that can be locked to prevent movement during use. The membrane control panel is mounted on the top of the unit. It is easily cleaned and contains all the controls and displays for operating the Auto*Therm 390.
The intensity control knob adjusts the output power via an encoder. The power switch is on the upper left side of the unit. Screw holes for attaching the arms are located on the rear of the unit. The sockets for connecting cables for the condenser and inductive coil applicators and the detachable mains power supply cable including fuses are also located on the back of the unit. The ripcord for the patient emergency-OFF switch passes through a bushing mounted on the back of the unit so that it can be pulled from all directions.
1
AUTO*THERM® 390, MODEL ME 390 510(K) SUMMARY STATEMENT (KXXXXXX)
Proposed Device Intended Use Statement:
510(k) Number: TBD
Device Name: Auto*Therm® 390, Model ME 390
Indications for use:
-
- Pain relief
-
- Reduction of muscle spasm
-
- Localized increase in blood flow
-
- Increase range of motion of contracted joints.
Comparison of Technological Characteristics Between Proposed and Predicate Devices: (see following page)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
OCT 7 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert E. Fleming Regulatory Compliance Manager Mettler Electronics Corporation 1333 South Claudina Street Anaheim, California 92805
Re: K042554
R042934
Trade/Device Name: Auto* Therm 390 (ME390) Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Device Regulatory Class: II Product Code: IMJ Dated: September 17, 2004 Received: September 21, 2004
Dear Mr. Fleming:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device started in interstate referenced above and nave decemblied the actived predicate devices marketed in interstate for use stated in the encrosule) to tegally manced profital Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the classified in accordance with Federal Food, Drug, devices that have been recrassified in accordance what approval application (PMA).).
and Cosmetic Act (Act) that do not require approval of a premarket approval ions of the A and Cosmetic Act (Act) that to not require upproval controls provisions of the Act. The You may, merelore, market the device, subject to the general registration, listing of
general controls provisions of the Act include requirements for annual registeredire and general controls provisions of the free here. In the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), , If your device is classified (35c above) into e. Existing major regulations affecting your device in the it may be subject to such additional controlly. Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Peacha. Regulations ,
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 Please be advised that FDA s issualles of a business with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a decierimation administered by other Federal agencies. You must of any Pederal Statutes and regulations and limited to: registration and listing (21 comply with an the Act stequirements, n.c. and manufacturing practice requirements as set CFK Part 607), labeling (21 CFR Part 807), good if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Robert E. Fleming
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin makemig your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA Intellig of substantal organ 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
rs the last the comments of 2010 - Alancelone on to the ragulation entitled If you desire specific advice for your ac vice of an aconomic the regulation entitled, the may obtain contact the Office of Colliphance at (210) 216 - 10 - 12 - 1 - 1 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 - 1 - 1 - 1 - 1 - 1 - 1 - "Misbranding by reference to premarkst nothleanon" (the Act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638–200 other general information on your 16300mer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at themamain html Manufacturers, International and Consumer Absounts and Consumer of Childsmardsmamain.html
Sincerely yours,
Mark N. 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
4
Indications for Use
510(k) Number (if known): K042554
Device Name: Auto*Therm 390 (ME390)
Indications For Use:
Shortwave diathermy delivers energy in the radio band of 27.12.
The success blockers heating therapeutic effects to body tissues. Shortwave diathermy delivers encryy in offects to body tissues.
MHz to provide deep heating therapeutic the body at intensities Miz to provide deep neating cherapease othe body at intensities When shortwave diathermy is deirverod cature increase, it can
capable of generating a deep tissue temperature increase, it can
capable of generating a deep tissue tuch as capable of generating a deep creat of the many as:
- Relieving pain 1 .
- Reducing muscle spasm 2.
- Reducing muscie spasm
Increasing range of motion of contracted joints using heat , ' and stretch techniques. - and stretch techniques.
Increasing blood flow to tissues in the treatment area. 4 .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Device Evaluation (ODE) Concurrence of CD
Mark A. Milliken
- TRANSCRIPT
estorative,
Page 1 of 1
510(k) Number