(118 days)
Not Found
No
The device description focuses on the hardware components and basic electrical principles of shortwave diathermy, with no mention of AI or ML algorithms for treatment planning, parameter adjustment, or outcome prediction.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is for "applying therapeutic deep heat in body tissues for the treatment of selected medical conditions."
No
Explanation: The device is described as a therapeutic device for applying deep heat to body tissues to treat various medical conditions, not for diagnosing them. It focuses on delivering energy to the patient for treatment purposes, such as pain relief, reducing muscle spasms, and increasing blood flow.
No
The device description clearly outlines hardware components such as a power supply, radio frequency oscillator, power amplifier, output resonant tank, and various electrodes (capacitive and inductive). This indicates it is a hardware device with integrated software for control, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to apply therapeutic deep heat to body tissues for treating various musculoskeletal and inflammatory conditions. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details how it generates and delivers radio frequency energy to the patient for therapeutic heating. It does not describe any process of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic results.
In summary, the device is a therapeutic device used for physical therapy and pain management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffiess, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
- Pain Relief .
- Reduce Muscle Spasm .
- . Decrease Joint Stiffness
- . Contractures
- Increase Blood Flow
- Chronic Inflammatory Conditions .
- . Bursitis
- Tenosynovitis
- Synovitis .
- Chronic Inflammatory Pelvic Disease
Product codes (comma separated list FDA assigned to the subject device)
IMJ
Device Description
The Intelect® SWD 100/ Senior Shortwave Diathermy devices consists of a power supply that provides power to a radio frequency oscillator. This radio frequency oscillator provides stable, drift-free oscillations at the required frequency. The power amplifier generates the power required to drive the different types of electrodes. The output resonant tank tunes in the patient as part of the circuit and allows maximum power to be transferred to the patient.
The output intensity controls the percentage of maximum power transferred to the patient circuit. The tuning control adjusts the output circuit for maximum energy transfer from the radio frequency oscillator. The power output meter monitors only the current that is drawn from the power supply and not the energy being delivered to the patient.
The power output produces sufficient energy to raise the tissue temperature into a therapeutic range. The specific absorption rate (SAR) represents the rate of energy absorbed per unit area of tissue mass.
Patient sensation provides the basis for recommendations of continuous shortwave diathermy dosage and thus varies considerably with different patients. The following are recommended dosage guidelines: Dose I (lowest): No sensation of heat
Dose II (low): Mild heating sensation
Dose III (medium): Moderate (pleasant) heating sensation
Dose IV (heavy): Vigorous heating that is tolerable below the pain threshold
Therapy may be delivered to the patient via either capacitance or induction techniques. The Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy devices use the following accessories:
- Capacitive Electrodes
- Pair of 80mm round
- Pair of 120mm round
- Pair of 165mm round
- 180mm x 120mm flexible rubber electrodes
- 250mm x 145mm flexible rubber electrodes
- Inductive Electrodes
- Monode 14cm
- Diplode 18cm x 39cm
Each of these techniques can affect different biological tissues, therefore selection of the appropriate electrodes is essential for effective treatment.
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.
K042554, K030382, K022458, K973732
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
K083433 510(k)
Page 1 of 3
Chattanooga Group SUBMITTER: 4717 Adams Road Hixson, TN 37343
ESTABLISHMENT 1022819 REGISTRATION:
-
CONTACT: Michael Treas. Director of Regulatory Affairs
DATE PREPARED: November 17, 2008 -
PROPRIETARY NAME: Intelect® SWD 100/ Senior Solutions®
CLASSIFICATION: Class II
PRODUCT CODES: IMJ
21 CFR 890.5290 REGULATION NUMBER Shortwave Diathermy AND COMMON NAMES:
PANEL: Physical Medicine
Indications for Use:
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffness, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
- . Pain Relief
- . Reduce Muscle Spasm
- Decrease Joint Stiffness ●
- Contractures
- Increase Blood Flow .
- Chronic Inflammatory Conditions .
- Bursitis .
- Tenosynovitis .
- Synovitis .
- Chronic Inflammatory Pelvic Disease ●
1
510(k) # K083433
Intended Use:
Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy device for use in applying therapeutic deep heat for selected medical conditions by applying electromagnetic energy in the radio frequency band of 27.12 megahertz 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.
Description :
The Intelect® SWD 100/ Senior Shortwave Diathermy devices consists of a power supply that provides power to a radio frequency oscillator. This radio frequency oscillator provides stable, drift-free oscillations at the required frequency. The power amplifier generates the power required to drive the different types of electrodes. The output resonant tank tunes in the patient as part of the circuit and allows maximum power to be transferred to the patient.
The output intensity controls the percentage of maximum power transferred to the patient circuit. The tuning control adjusts the output circuit for maximum energy transfer from the radio frequency oscillator. The power output meter monitors only the current that is drawn from the power supply and not the energy being delivered to the patient.
The power output produces sufficient energy to raise the tissue temperature into a therapeutic range. The specific absorption rate (SAR) represents the rate of energy absorbed per unit area of tissue mass.
Patient sensation provides the basis for recommendations of continuous shortwave diathermy dosage and thus varies considerably with different patients. The following are recommended dosage guidelines: Dose I (lowest): No sensation of heat
Dose II (low): Mild heating sensation
Dose III (medium): Moderate (pleasant) heating sensation
Dose IV (heavy): Vigorous heating that is tolerable below the pain threshold
Therapy may be delivered to the patient via either capacitance or induction techniques. The Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy devices use the following accessories:
- Capacitive Electrodes
- Pair of 80mm round
- Pair of 120mm round
- Pair of 165mm round
- 180mm x 120mm flexible rubber electrodes
- 250mm x 145mm flexible rubber electrodes
- Inductive Electrodes
- Monode 14cm
- Diplode 18cm x 39cm
Each of these techniques can affect different biological tissues, therefore selection of the appropriate electrodes is essential for effective treatment.
2
510(k) Summary per 21 CFR 807.92(c)
510(k) # K083433
Page 3 of 3
| 510(k) # | Proprietary
Name | Predicate Device
Manufacture's | Device
Classification
Names | Regulation
Numbers | Classification(s)
and Product
Codes |
|----------|---------------------|--------------------------------------|-----------------------------------|-----------------------|-------------------------------------------|
| K042554 | Auto Therm 390 | Mettler Electroinics,
Corporation | Shortwave
Diathermy | 890.5290 | Class II, IMJ |
| K030382 | SeliTherm | Selicor, Inc. | Shortwave
Diathermy | 890.5290 | Class II, IMJ |
| K022458 | Auto Therm 395 | Mettler Electronics,
Corporation | Shortwave
Diathermy | 890.5290 | Class II, IMJ |
| K973732 | Megapulse II | PTI, Inc. | Shortwave
Diathermy | 890.5290 | Class II, IMJ |
Substantially Equivalent Predicate Devices
Declarations of Conformity
The Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy devices comply with the following FDA recognized Consensus Standards:
UL 60601-1: 2003, Standards for Medical Equipment Part 1: General Requirements for Safety, 1* Edition
IEC 60601-1-2: 2001, Medical Electrical Equipment Part 1 - 2: General requirements for Safety -Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition
IEC 60601-2-3: 1991, Medical Electrical Equipment – Part 2: Particular Requirements for the Safety of Short-Wave Therapy Equipment; Amendment 1 – 1998, 2nd Edition (The United States FDA does not recognize IEC 60601-2-3)
IEC 60601-1-4: 2000, Medical Electrical Equipment -- Part 1 -- 4: General Requircments for Safety -Collateral Standard: Programmable Medical Electrical Systems Consolidated with Amendment 1, 1999
Truthful and Accurate Statement
A statement attesting to the truthfulness and accuracy of the information was included in the premarket submission.
Further Information
Contact:
Chattanooga Group 4717 Adams Road Hixson, TN 37343 U.S.A.
Michael Treas, Director of Regulatory Affairs Telephone: (423) 870-2281 ext. 7207 Fax: (423) 870-7404 Email: michael.treas@djoglobal.com
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is facing left and has a sharp beak and talons.
Public Health Service
MAR 1 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chattanooga Group % Mr. Michael Treas Director of Regulatory Affairs 4717 Adams Road Hixson, Tennessee 37343
Re: K083433
Trade/Device Name: Intelect® SWD 100/Senior Solutions® Shortwave Diathermy Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: II Product Code: IMJ Dated: February 17, 2009 Received: February 18, 2009
Dear Mr. Treas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices markcted 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth 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.
4
Page 2 - Mr. Michael Treas
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number:
Device Name: Intelect® SWD 100/ Senior Solutions® Shortwave Diathermy
Indications for Use:
Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as disorders of the musculoskeletal system, muscle spasm, joint stiffiess, contractures, and chronic inflammatory or infective conditions such as tenosynovitis, bursitis, synovitis and chronic inflammatory pelvic diseases.
Generally accepted indications for use:
- Pain Relief .
- Reduce Muscle Spasm .
- . Decrease Joint Stiffness
- . Contractures
- Increase Blood Flow �
- Chronic Inflammatory Conditions .
- . Bursitis
- Tenosynovitis �
- Synovitis .
- Chronic Inflammatory Pelvic Disease
| 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 14083433 |
Submission Page 12 of 905 Page 1 of 1