K120093 · BTL Industries, Inc. · IMJ · Oct 5, 2012 · Physical Medicine
Device Facts
Record ID
K120093
Device Name
BTL ELITE
Applicant
BTL Industries, Inc.
Product Code
IMJ · Physical Medicine
Decision Date
Oct 5, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.5290
Device Class
Class 2
Attributes
Therapeutic
Indications for 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.
Device Story
BTL Elite is a shortwave diathermy system delivering 27.12 MHz electromagnetic energy to generate deep tissue heat. System comprises a power supply, electromagnetic generator, control unit with 5.7-inch touch screen, and various capacitive/inductive applicators. Operated by clinicians in a clinical setting. Capacitive method uses high-frequency electric field between insulated electrodes; inductive method uses induction to create high-frequency currents in tissue. Operator manually sets and saves treatment parameters. Safety features include a neon check light for capacitive energy verification, continuous output monitoring, and a patient-operated safety switch to terminate energy emission. Device aims to provide therapeutic deep heating for pain relief, muscle spasm reduction, and increased joint mobility.
Clinical Evidence
No clinical data provided; substantial equivalence is based on bench testing and comparison of technical characteristics to predicate devices.
Technological Characteristics
Shortwave diathermy system; 27.12 MHz RF energy source. Capacitive and inductive applicator configurations. Cabinet-mounted with wheels. 5.7-inch color touch screen interface. Microprocessor-controlled output. Continuous and pulsed modes (up to 400W pulsed, 200W continuous).
Indications for Use
Indicated for applying therapeutic deep heat to body tissues to relieve pain, reduce muscle spasms, increase range of motion of contracted joints via heat and stretch techniques, and increase blood flow to treatment areas.
Regulatory Classification
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.
Special Controls
*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.
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# 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.<br>47 Loring Drive<br>Framingham, MA 01702<br>Tel: 508-309-7948<br>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 |
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#### III. Predicate Devices
| Device name | BTL Elite | Intelect SWD 100 | AutoTherm 395 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company<br>name | BTL Industries Ltd | Chattanooga Group | Mettler Corp. Electronics |
| 510(k)<br>reference | K120093 | K083433 | K022458 |
| Device<br>description | Device consists of a<br>power supply that<br>provides power to an<br>electromagnetic energy<br>generator.<br>(27.12 MHz) | Device consists of a<br>power supply that<br>provides power to an<br>electromagnetic energy<br>generator.<br>(27.12 MHz) | Device consists of a<br>power supply that<br>provides power to an<br>electromagnetic energy<br>generator.<br>(27.12 MHz) |
| Class | II | II | II |
| Product Code<br>Indications for<br>use | IMJ<br>Indications for use in<br>applying therapeutic<br>deep heat in body<br>tissues for the<br>treatment of selected<br>medical conditions such<br>as: 1. Relieving pain;<br>2. Reducing muscle<br>spasm; 3. Increasing<br>range of motion of<br>contracted joints using<br>heat and stretch<br>techniques; and<br>4. Increasing blood flow<br>to tissues in the<br>treatment area. | IMJ<br>Indications for use in<br>applying therapeutic<br>deep heat in body<br>tissues for the<br>treatment of selected<br>medical conditions such<br>as disorders of the<br>musculoskeletal<br>system, muscle spasm,<br>joint stiffness,<br>contractures, and<br>chronic inflammatory or<br>infective conditions<br>such as tenosynovitis,<br>bursitis, synovitis<br>and chronic<br>inflammatory pelvic<br>diseases. | IMJ<br>Indications for use -<br>Shortwave diathermy<br>delivers energy in the<br>radio band of<br>27.12 MHz to provide<br>deep heating<br>therapeutic effects to<br>body tissues. When<br>shortwave diathermy is<br>delivered to the body at<br>intensities capable of<br>generating a deep<br>tissue temperature<br>increase, it can be used<br>to treat selected<br>medical conditions such<br>as: 1. Relieving pain; 2.<br>Reducing muscle<br>spasm; 3. Increasing<br>range of motion of<br>contracted joints using<br>heat and stretch<br>techniques; and 4.<br>Increasing blood flow to<br>tissues in the treatment<br>area. |
| Mechanism<br>of<br>Action | Deep heating of tissue<br>by therapeutic<br>application of radio<br>frequency electrical<br>currents | Deep heating of tissue<br>by therapeutic<br>application of radio<br>frequency electrical<br>currents | Deep heating of tissue<br>by therapeutic<br>application of radio<br>frequency electrical<br>currents |
| Power | 400 W (pulsed)<br>200 W (continuous) | 200 W (pulsed)<br>100 W (continuous) | 400 W (pulsed)<br>200 W (continuous) |
| Dimensions<br>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<br>wheels | Cabinet-mounted with<br>wheels | Cabinet-mounted with<br>wheels |
| Device<br>classification | Class II, IMJ, 890.5290 | Class II, IMJ, 890.5290 | Class II, IMJ, 890.5290 |
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### 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.
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#### 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.
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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
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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
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# 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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
