(147 days)
BTL-703 is indicated to be used for 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.
The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office. The BTL-703 consists of the following main components: microprocessor-driven control unit, high-frequency energy generator, user interface with 15,6" HD touch screen, four-point applicator.
The acceptance criteria and study information for the BTL-703 device, based on the provided FDA 510(k) summary, are described below.
Please note: This document focuses on the regulatory submission information. For medical devices like the BTL-703 (Shortwave Diathermy), the "performance" in the context of a 510(k) submission primarily refers to meeting safety and fundamental operational requirements and demonstrating substantial equivalence to a predicate device. It typically does not involve the same kind of clinical trial efficacy metrics (sensitivity, specificity, etc.) as AI/software devices. The "acceptance criteria" here are therefore related to safety standards and the ability to achieve a therapeutic temperature range.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance Standards | Compliance with recognized medical device safety standards. Specifically: | - IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Complied) - IEC 60601-1-2: Collateral standard: Electromagnetic Disturbance – Requirements and tests (Complied) - IEC 62304: Medical device software – Software life cycle processes (Complied) - ISO 14971: Medical devices - Application of risk management to medical devices (Complied) - ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (Complied) - ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity (Complied) - ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization (Complied) |
| Ablity to achieve therapeutic temperature | The device should be able to maintain a therapeutic temperature range in vivo (in relevant body tissues). Specific target: approximately 40-45°C. | The study confirmed the ability of the BTL-703 device to maintain the temperature in the range of approx. 40-45°C in vivo. |
| Substantial Equivalence | Demonstration that the technological characteristics and indications for use are substantially equivalent to a legally marketed predicate device (K120093, BTL Elite), raising no new safety or effectiveness questions. | Comparison table provided showing similar indications for use, principle of action, clinical use, electrical protection, user interface, firmware control, type of energy, working frequency (27.12 MHz), therapy time (1-30 min), hands-free application, stop remote control, and applicator contact monitor. Differences (e.g., no pulsed mode, negative pressure applicator fixation, thermal stabilization system) were determined not to raise new safety or effectiveness questions. |
2. Sample size used for the test set and the data provenance
- Test Set (Animal Study): The document only mentions a "study in porcine model" for demonstrating temperature maintenance. It does not provide the specific sample size (number of animals or test points) used in this model.
- Data Provenance: The animal study was conducted in a porcine model. The country of origin for the data is not specified. This was a prospective study designed to specifically evaluate the device's ability to maintain temperature in vivo.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for the animal study was objective temperature measurement, not a subjective assessment by human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The animal study involved direct physical measurements (temperature), not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The BTL-703 is a physical therapy device that applies heat, not an AI/imaging diagnostic device. Therefore, MRMC studies and AI assistance improvements are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The BTL-703 is a physical medical device, not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study: The ground truth was based on objective temperature measurements within the porcine model.
- For demonstrating substantial equivalence: The ground truth was based on adherence to established medical device safety standards (e.g., IEC, ISO) and comparison of technical specifications and indications for use with the predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. The non-clinical testing involved rigorous testing against established standards.
9. How the ground truth for the training set was established
Not applicable (as it's not an AI/ML device with a training set). The "ground truth" for the non-clinical testing was established by internationally recognized and harmonized medical device safety and performance standards.
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January 24, 2019
BTL Industries, Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K182363
Trade/Device Name: BTL-703 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: IMJ Dated: December 20, 2018 Received: December 26, 2018
Dear David Chmel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, VivekJ. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182363
Device Name BTL-703
Indications for Use (Describe)
BTL-703 is indicated to be used for 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K182363
510(k) Summary
General Information
| Sponsor: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
|---|---|
| Applicant: | BTL Industries, Inc.362 Elm StreetMarlborough, MA 01752Tel: +1-866-285-1656Fax: +1-888-499-2502 |
| Contact Person: | David ChmelBTL Industries, Inc.chmel@btlnet.com |
| Summary PreparationDate: | January 21, 2019 |
Device Names
| Trade/Proprietary Name: | BTL-703 |
|---|---|
| Primary Classification Name: | Diathermy, Shortwave, For Use In ApplyingTherapeutic Deep Heat |
| Classification Regulation: | 890.5290 |
| Product Code: | IMJ |
Predicate Device
The BTL-703 is a state-of-the-art high-frequency energy device with accessory, and is substantially equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number:
- K120093, BTL Elite .
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Product Description
The BTL-703 is comprised of a device unit and applicator that deliver radiofrequency energy to the targeted tissue. The device is designed to enable hands-free treatment. Easyto-use color touch screen allows for maximum operator comfort. The main unit is placed in a specially designed cart, the shape of which provides maximum operator comfort and easy movement of the device in the office.
The BTL-703 consists of the following main components:
- microprocessor-driven control unit .
- . high-frequency energy generator
- user interface with 15,6" HD touch screen
- . four-point applicator
Indications for Use
BTL-703 is indicated to be used for 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.
Non-clinical Testing
The BTL-703 device has been thoroughly evaluated for its safety and performance. The device has been found to comply with applicable medical device safety standards:
| IEC 60601-1 | Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic Disturbance – Requirements and tests |
| IEC 62304 | Medical device software – Software life cycle processes |
| ISO 14971 | Medical devices - Application of risk management to medicaldevices |
| ISO 10993-1 | Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process |
| ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritationand skin sensitization |
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Animal Testing
In order to demonstrate the device is able to maintain temperature in the range of approx. 40-45°C in vivo, study in porcine model has been conducted. The results of this evaluation confirmed the ability of the BTL 703 device to maintain the temperature in the range of approx. 40-45°C in vivo.
Technological Characteristics
The BTL-703 device has similar technological characteristics compared to its predicate. Both devices comprised of a system console and applicator(s). The system console consists of the RF generator, computer, and the touch-screen control panel.
Both devices use high-frequency electromagnetic current for a purpose of deep heating of tissue. The BTL-703, compared to the predicate device, does not included pulsed mode of operation and inductive type of applicator. Output power of BTL-703 is divided into two outputs for more even energy distribution. Nevertheless, total maximum power output stays the same (200W) as by the predicted device. The working frequency is identical for both devices.
The BTL 703 is using neqative pressure for applicator fixation compared to the predicate device using mechanical arm. Negative pressure under silicone applicator sleeves ensures uniform coupling between the capacitive electrodes and patient. The BTL-703 device also differs in the shape and dimensions when compared to its predicate. Nevertheless, these differences does not rise any new safety or effectiveness questions compared to the predicate.
Therefore, the BTL-703 has similar technological characteristics compared to its predicate device. A device comparison table comparing characteristics of the BTL-703 with the BTL Elite including the indications for use, is provided below.
| 510(k) number | K182363 | K120093 |
|---|---|---|
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Product Codeand Regulation | Physical Medicine21 CFR 890.5290IMJ – Diathermy, Shortwave,For Use In Applying TherapeuticDeep Heat | Physical Medicine21 CFR 890.5290IMJ – Diathermy, Shortwave,For Use In Applying TherapeuticDeep Heat |
| 510(k) number | K182363 | K120093 |
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| Indications for Use | BTL-703 is indicated to be usedfor applying therapeutic deepheat in body tissues for thetreatment of selected medicalconditions such as: 1. Relievingpain; 2. Reducing musclespasm; 3. Increasing range ofmotion of contracted joints usingheat and stretch techniques; and4. Increasing blood flow totissues in the treatment area. | Indications for Use: Indicationsfor use in applying therapeuticdeep heat in body tissues forthe treatment of selectedmedical conditions such as:1. Relieving pain; 2. Reducingmuscle spasm; 3. Increasingrange of motion of contractedjoints using heat and stretchtechniques; and 4. Increasingblood flow to tissues in thetreatment area. |
| Principle of Action | Deep heating of tissue bytherapeutic application of radiofrequency electrical currents | Deep heating of tissue bytherapeutic application of radiofrequency electrical currents |
| Clinical Use | Prescription use | Prescription use |
| Electrical Protection | Class II, BF | Class I, BF |
| User Interface | Touch screen | Touch screen |
| Firmware Controlled | Yes | Yes |
| Type of Energy | High-frequency electromagneticcurrent | High-frequency electromagneticcurrent |
| Working frequency | 27.12 MHz | 27.12 MHz |
| Modes of operation | Continuous | ContinuousPulsed |
| Max Power Output | 2 x 100 W (continuous) | 200 W (continuous) |
| 510(k) number | K182363 | K120093 |
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| N/A | 400 W (pulsed) | |
| Therapy Time | 1 – 30 min | 1 – 30 min |
| Applicators type | Capacitive | CapacitiveInductive |
| CapacitiveApplicatorsSize | 100 mm | 42 mm85 mm130 mm |
| InductiveApplicatorsSize | N/A | 80 mm140 mm |
| Way of ApplicatorAttachment | Negative pressure | Mechanical arm lock |
| Applicator Sleeves | Yes | No |
| ThermalStabilization System | Yes | No |
| Arm control | Electrical / Mechanical | Mechanical |
| Hands-freeApplication | Yes | Yes |
| Stop RemoteControl | Yes | Yes |
| ApplicatorContactMonitor | Yes | Yes |
| System Dimensions(W×H×D) | 627x985x674 mm(24.7x38.8x26.5 in) | 560×980×560 mm(22.5×38.6×22.5 in) |
| Configuration | Cabinet-mounted with wheels | Cabinet-mounted with wheels |
| 510(k) number | K182363 | K120093 |
| Device name | BTL-703 | BTL Elite |
| Company name | BTL Industries, Inc. | BTL Industries, Inc. |
| EnvironmentalSpecifications | For indoor use only | For indoor use only |
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Image /page/6/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue squares nested inside each other, with the letters "BTL" inside the innermost square. To the right of the squares is the text "BTL Industries" in a gray sans-serif font.
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Image /page/7/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three interconnected blue squares, each containing the letters "BTL". To the right of the logo is the text "BTL Industries" in a dark gray sans-serif font. The logo is simple and modern, and the text is clear and easy to read.
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Substantial Equivalence
Based upon the indications for use and technical information provided in this pre-market notification, the BTL-703 device has been shown to be substantially equivalent to currently marketed predicate device.
Conclusions
Performance data demonstrate that the differences between the BTL-703 and the predicate do not raise any new question regarding the safety or effectiveness.
Based on the aforementioned information, the BTL-703 is substantially equivalent to the identified predicate device.
§ 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.