(115 days)
Not Found
Not Found
No
The document describes a standard shortwave diathermy system and does not mention any AI or ML components or capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that diathermy is used therapeutically to produce desirable therapeutic effects such as increasing tissue temperature, decreasing joint stiffness, relieving pain, and increasing blood flow. The device is indicated for use in various musculoskeletal and chronic inflammatory conditions.
No
Explanation: The provided text describes the device as a "Shortwave Diathermy system" used therapeutically to produce heat and lists various therapeutic effects (e.g., increasing extensibility of collagen, decreasing joint stiffness, relieving pain). Its indications are for "disorders of the musculoskeletal system" and "chronic inflammatory or infective conditions." There is no mention of the device being used to identify or diagnose any medical condition.
No
The device description explicitly states "MEGAPULSE II is a Shortwave Diathermy system," which is a hardware-based therapeutic device. The intended use also describes the therapeutic effects of heat, which is delivered by the hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes therapeutic applications involving increasing tissue temperature to treat musculoskeletal and inflammatory conditions. This is a direct treatment applied to the patient's body.
- Device Description: The device is described as a "Shortwave Diathermy system," which is a type of physical therapy equipment used for applying heat to tissues.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device, on the other hand, is a therapeutic device that applies energy directly to the patient.
N/A
Intended Use / Indications for Use
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:
- Increases the extensibility of collagen tissues 1.
-
- Decreases joint stiffness
-
- Relieves pain
-
- Relieves muscle spasm
-
- Increases blood flow
The Megapulse Shortwave Diathermy system is indicated for use in the following con-Ditions or applications:
-
Disorders of the musculoskeletal system: 1. muscle spasm, joint stiffness, contractures ----------
-
- Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases
Product codes
IMJ
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
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 1998
Mr. Chris Castel CEO PTI. Incorporated 6700 SW Topeka Boulevard Forbes Field, Building 140 Topeka, Kansas 66619
Re: K973732
Trade Name: Megapulse II, Model 3029 Regulatory Class: II Product Code: IMJ Dated: January 7, 1998 Received: January 12, 1998
Dear Mr. Castel:
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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
1
Page 2 - Mr. Castel
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 the 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.
focollf
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K973732
Device Name: MEGAPULSE II
INDICATIONS FOR USE:
Diathermy is used therapeutically to increase the temperature of tissues. It is generally accepted that heat produces the following desirable therapeutic effects:
- Increases the extensibility of collagen tissues 1.
-
- Decreases joint stiffness
-
- Relieves pain
-
- Relieves muscle spasm
- న. Increases blood flow
The Megapulse Shortwave Diathermy system is indicated for use in the following con-Ditions or applications:
-
Disorders of the musculoskeletal system: 1. muscle spasm
joint stiffness, contractures ---------- -
- Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
- Chronic inflammatory or infective conditions: tenosynovitis, bursitis, synovitis chronic inflammatory pelvic diseases
Concurrence of CDRH, Office of Device Evaluation (ODE)
fcollefa
(off)
ral Restorative Devices 2473732
E Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)