(267 days)
Not Found
No
The description focuses on standard microprocessor control, manual parameter setting, and safety features, with no mention of AI or ML capabilities for analysis, adaptation, or decision-making.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for the treatment of selected medical conditions" and lists therapeutic applications such as "Relieving pain," "Reducing muscle spasm," and "Increasing range of motion."
No
The device is described as a therapeutic device for applying deep heat for the treatment of various medical conditions, not for diagnosis.
No
The device description clearly details hardware components such as a control unit, electronic system for electromagnetic field generation, a touch screen, a control knob, a neon check light, and various capacitive and inductive applicators. It is a physical medical device that utilizes software for control, but it is not solely software.
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 is for applying therapeutic deep heat to body tissues for treating conditions like pain, muscle spasm, limited range of motion, and increasing blood flow. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a shortwave diathermy system that generates electromagnetic fields to heat tissues. This is a physical therapy modality, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for therapeutic treatment of patients, not for diagnosing diseases or conditions by testing samples outside the body.
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: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
Product codes
IMJ
Device Description
The BTL Elite is a shortwave diathermy system intended for the therapeutic application of deep heating. The control unit consists of the control system and the electronic system. The control system contains the main microprocessor and software for control of the entire equipment; the electronic system contains the complete electronics for electromagnetic field generation. The device is operated via a 5.7 inch color touch screen and graphic user interface that allows for maximum operator comfort. A large control knob is provided to increase and decrease output power.
A neon check light is provided to verify that radiofrequency energy is being transmitted between the capacitive applicators. If such energy is transmitted, the indicator illuminates. If the initial energy is set too low, the check light will not illuminate. The check light is not designed for the use with inductive applicators.
For therapeutic procedures, various capacitive and inductive applicators are available. Applicators of various size are available to accommodate different size treatment areas. Applicators are connected to the rear of the main unit using the connector cable and are affixed to the adjustable arm.
With the capacitive field method, the treated body part is located in the highfrequency electric field between two insulated electrodes. The body and the applicators together form a capacitor. The transformation of electromagnetic energy into heat occurs in tissues of low blood circulation. Thus, the major amount of heat is generated in areas near the surface. While contact application causes intensive warming of superficial tissues, contactless application causes deeper warming. The inductive field method produces high-frequency electric currents within the body tissue by means of induction. These currents increase with increasing electric conductivity of the corresponding tissue region. The danger of excessive heating of the outer layers of tissue is therefore significantly reduced.
Individual treatment parameters can be manually set and adjusted by the operator. All treatment parameters can be set and saved as a reference for future therapy sessions.
The BTL Elite control unit continuously monitors the output of the system for safe operation. In addition, output can be terminated at any time during a treatment session by the patient pulling the safety switch. If the therapy is stopped by pulling the safety switch, the applicator immediately stops emitting electromagnetic energy and the unit switches to a pause mode. Patient safety is assured through a number of ways including proper maintenance of the system, operator training, and adherence to the general safety precautions and instructions provided in the user manual.
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
The review of the technical characteristics, indications for use, and verification and validation information provided in the 510(k) Premarket Notification demonstrates that the BTL Elite system is substantially equivalent to its predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
As required by section 807.92(c)
Oct 5 2012
ترت ે
I. General Information
| Submitter: | BTL Industries, Inc.
47 Loring Drive
Framingham, MA 01702
Tel: 508-309-7948
Fax: 508-309-7956 |
| ------------ | ----------------------------------------------------------------------------------------------------------- |
|---|
- Contact Person: Marcy Moore MMP Regulatory Consultants, LLC for BTL Industries 131 Kelekent Lane Cary, NC 27518 919-363-2432 ph 919-651-1001 fax marcy@marcymoore.com
Summary Preparation Date: December 22, 2011
II. Device Information
| Trade Name: | BTL Elite |
|---|---|
| Common/Usual Name: | Shortwave Diathermy |
| Classification: | Class II |
| 21 CFR 890.5290 | |
| Product Code: | IMJ |
| Classification Name: | Shortwave Diathermy |
| Device Panel: | Physical Medicine |
1
III. Predicate Devices
| Device name | BTL Elite | Intelect SWD 100 | AutoTherm 395 |
|---|---|---|---|
| Company | |||
| name | BTL Industries Ltd | Chattanooga Group | Mettler Corp. Electronics |
| 510(k) | |||
| reference | K120093 | K083433 | K022458 |
| Device | |||
| description | Device consists of a | ||
| power supply that | |||
| provides power to an | |||
| electromagnetic energy | |||
| generator. | |||
| (27.12 MHz) | Device consists of a | ||
| power supply that | |||
| provides power to an | |||
| electromagnetic energy | |||
| generator. | |||
| (27.12 MHz) | Device consists of a | ||
| power supply that | |||
| provides power to an | |||
| electromagnetic energy | |||
| generator. | |||
| (27.12 MHz) | |||
| Class | II | II | II |
| Product Code | |||
| Indications for | |||
| use | IMJ | ||
| Indications for use in | |||
| applying therapeutic | |||
| deep heat in body | |||
| tissues for the | |||
| treatment of selected | |||
| medical conditions such | |||
| as: 1. Relieving pain; |
- Reducing muscle
spasm; 3. Increasing
range of motion of
contracted joints using
heat and stretch
techniques; and - Increasing blood flow
to tissues in the
treatment area. | IMJ
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. | IMJ
Indications for use -
Shortwave diathermy
delivers energy in the
radio band of
27.12 MHz to provide
deep heating
therapeutic effects to
body tissues. When
shortwave diathermy is
delivered to the body at
intensities capable of
generating a deep
tissue temperature
increase, it can be used
to treat selected
medical conditions such
as: 1. Relieving pain; 2.
Reducing muscle
spasm; 3. Increasing
range of motion of
contracted joints using
heat and stretch
techniques; and 4.
Increasing blood flow to
tissues in the treatment
area. |
| Mechanism
of
Action | Deep heating of tissue
by therapeutic
application of radio
frequency electrical
currents | Deep heating of tissue
by therapeutic
application of radio
frequency electrical
currents | Deep heating of tissue
by therapeutic
application of radio
frequency electrical
currents |
| Power | 400 W (pulsed)
200 W (continuous) | 200 W (pulsed)
100 W (continuous) | 400 W (pulsed)
200 W (continuous) |
| Dimensions
W x H x D | 560 x 980 x 560 mm | 420 x 1143 x 410 mm | 380 x 850 x 390 mm |
| Configuration | Cabinet-mounted with
wheels | Cabinet-mounted with
wheels | Cabinet-mounted with
wheels |
| Device
classification | Class II, IMJ, 890.5290 | Class II, IMJ, 890.5290 | Class II, IMJ, 890.5290 |
2
IV. Intended Use
The BTL Elite is intended 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.
V. Device Description
The BTL Elite is a shortwave diathermy system intended for the therapeutic application of deep heating. The control unit consists of the control system and the electronic system. The control system contains the main microprocessor and software for control of the entire equipment; the electronic system contains the complete electronics for electromagnetic field generation. The device is operated via a 5.7 inch color touch screen and graphic user interface that allows for maximum operator comfort. A large control knob is provided to increase and decrease output power.
A neon check light is provided to verify that radiofrequency energy is being transmitted between the capacitive applicators. If such energy is transmitted, the indicator illuminates. If the initial energy is set too low, the check light will not illuminate. The check light is not designed for the use with inductive applicators.
For therapeutic procedures, various capacitive and inductive applicators are available. Applicators of various size are available to accommodate different size treatment areas. Applicators are connected to the rear of the main unit using the connector cable and are affixed to the adjustable arm.
With the capacitive field method, the treated body part is located in the highfrequency electric field between two insulated electrodes. The body and the applicators together form a capacitor. The transformation of electromagnetic energy into heat occurs in tissues of low blood circulation. Thus, the major amount of heat is generated in areas near the surface. While contact application causes intensive warming of superficial tissues, contactless application causes deeper warming. The inductive field method produces high-frequency electric currents within the body tissue by means of induction. These currents increase with increasing electric conductivity of the corresponding tissue region. The danger of excessive heating of the outer layers of tissue is therefore significantly reduced.
Individual treatment parameters can be manually set and adjusted by the operator. All treatment parameters can be set and saved as a reference for future therapy sessions.
The BTL Elite control unit continuously monitors the output of the system for safe operation. In addition, output can be terminated at any time during a treatment session by the patient pulling the safety switch. If the therapy is stopped by pulling the safety switch, the applicator immediately stops emitting electromagnetic energy and the unit switches to a pause mode. Patient safety is assured through a number of ways including proper maintenance of the system, operator training, and adherence to the general safety precautions and instructions provided in the user manual.
3
VI. Performance Data
The review of the technical characteristics, indications for use, and verification and validation information provided in the 510(k) Premarket Notification demonstrates that the BTL Elite system is substantially equivalent to its predicate devices.
VII. Substantial Equivalence
The BTL Elite System is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the BTL Elite System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
BTL Industries, Incorporated % MMP Medical Associates, LLC Ms. Marcy Moore 131 Kelekent Lane Cary, NC 27518
OCT - 5 2012
Re: K120093
Trade/Device Name: BTL Elite Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class II Product Code: IMJ Dated: October 1, 2012 Received: October 5, 2012
Dear Ms. Moore:
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 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) 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Marcy Moore
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Mallekson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 4
INDICATIONS FOR USE STATEMENT
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: BTL Elite
Indications for Use: Indications for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions such as: 1. Relieving pain; 2. Reducing muscle spasm; 3. Increasing range of motion of contracted joints using heat and stretch techniques; and 4. Increasing blood flow to tissues in the treatment area.
Prescription Use ﻪ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ (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 Surgical, Orthopedic, and Restorative Devices
. 510(k) Number K120093