(291 days)
BTL-094 is indicated to be used for:
- Relief of minor muscle aches and pains.
- Temporary increase in local blood circulation.
- Activation of connective tissue.
The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.
The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.
The main unit is equipped with a color touch screen, which considerably simplifies its operation. The onscreen information guides the user step through the entire therapy process. A secondary screen is placed on the applicator for the presentation of the actual state of main therapy parameters. The therapeutic parameters are adjustable via touch-screen, buttons and knob. The user is able to set following therapy parameters: intensity, frequency and number of shocks.
The provided text describes a 510(k) premarket notification for the BTL-094 therapeutic massager, which is a Class I device. The focus of the document is to demonstrate "substantial equivalence" to legally marketed predicate devices, rather than establishing new performance criteria through a clinical study. Therefore, a direct 'acceptance criteria' and 'reported device performance' based on a clinical study for the BTL-094 device itself are not applicable as per the document.
The document explicitly states: "Clinical Testing: Not applicable" on page 5. This indicates that no clinical study was performed or required for this 510(k) submission to assess the device's performance against specific acceptance criteria.
Instead of a clinical study, the submission relies on demonstrating that the BTL-094 device has "technological characteristics" (on pages 6-11) that are substantially equivalent to those of two predicate devices: D-Actor 200 (K173692) and DolorClast® Radial (K220538). The "acceptance criteria" in this context are implicitly that the technological characteristics of the BTL-094 are comparable enough to the predicates that they do not raise new questions of safety or effectiveness.
Here's an analysis based on the information provided, addressing your points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was conducted for the BTL-094 to establish new acceptance criteria and measure its performance against them, a direct table for this is not available in the document. The acceptance for this submission is based on the comparison of the BTL-094's technological characteristics to those of the predicate devices. The table below summarizes key comparative information presented in the document, which serves as the basis for the declaration of substantial equivalence.
Comparison of BTL-094 to Predicate Devices (Basis for Substantial Equivalence)
| Characteristic | BTL-094 Performance/Description | Predicate Device (D-Actor 200 / DolorClast® Radial) Performance/Description | Assessment in Document (Implicit "Acceptance") |
|---|---|---|---|
| Indications for Use | - Relief of minor muscle aches and pains. - Temporary increase in local blood circulation. - Activation of connective tissue. | - Relief of minor muscle aches and pains. - Temporary increase in local blood circulation. - Activation of connective tissue. | Same - "None" (meaning no difference identified, thus accepted as equivalent). |
| Modes of Action | Extracorporeally induced pressure waves. | Radial pressure waves, or extracorporeal pulse activation respectively. | Not Significantly different - "The technology used in BTL-094 device differs from the predicate device. Nevertheless, the technology creates the same type of acoustic pressure delivered to the tissue." (page 9) |
| Mechanisms of Action | Vibrations generated by electroacoustic technology. | Pneumatically generated vibrations. | Not Significantly different - "Differences are caused by alternative technology of the pressure wave generation." (page 6), but "creates the same type of acoustic pressure delivered to the tissue." (page 9) |
| Max & Min Intensity Settings | 5-30% alternative output power setting scale. | D-Actor 200: 1-5bar; DolorClast® Radial: 1-4bar. | Not Significantly different - "Differences are caused by alternative technology of the pressure wave generation." (page 6). BTL-094 is limited to 30% max power for comparability. (page 9) |
| Number & Size of Applicator Heads | 2; L Pad - 12.2 cm², U Pad - 7.3 cm². | D-Actor 200: 4 (6mmOD, 15mmOD, 20mmOD, 35mmOD); DolorClast® Radial: 7 (5mm OD, 10 mm OD, 15 mm OD, 25 mm OD, 40 mm OD). | Not Significantly different - "The application area of the pads in contact with the patient is within the set range of the predicate devices." (page 6). |
| Max & Min Vibration Frequency | 1-25 Hz. | D-Actor 200: 1-21Hz; DolorClast® Radial: 1-25 Hz. | Not Significantly different - Differs from one predicate (D-Actor 200) by up to 4Hz higher max frequency, but same range as the other (DolorClast® Radial). (page 6, 9) |
| Maximum Penetration Depth | 35 mm. | D-Actor 200: 32.3mm; DolorClast® Radial: 40 mm. | Not Significantly different - "comparable within setting range of predicate devices." (page 7, 10) |
| Energy Flow Density | In the range of 0.01 - 0.11 mJ/mm². | D-Actor 200: 5bar/0.284mJ/mm², 3bar/0.176mJ/mm²; DolorClast® Radial: 0.29 mJ/mm² at 4 bar, 0.14 mJ/mm² at 2.4 bar. | Not Significantly different - EFD of BTL-094 "differs from the predicates but it is lower or within setting range of predicat devices." (page 7, 9). |
| Positive Peak Pressure Amplitude | In the range of 3 - 10 MPa. | D-Actor 200: 5bar/18.5MPa, 3bar/13.4MPa; DolorClast® Radial: 17 MPa at 4 bar, 11.24 MPa at 2.4 bar. | Not Significantly different - "fits with output parameters within or bellow setting range of predicat devices" due to 30% max output power limitation. (page 7, 10) |
| Negative Peak Pressure Amplitude | In the range of 3 - 10 MPa. | D-Actor 200: 5bar/6.8MPa, 3bar/5.0MPa; DolorClast® Radial: 10 MPa at 4 bar, 7.2 MPa at 2.4 bar. | Not Significantly different - "fits with output parameters within or bellow setting range of predicat devices" due to 30% max output power limitation. (page 7, 10) |
| Derived Focal Acoustic Pulse Energy | In the range of 0.1 – 1.4 mJ. | D-Actor 200: 5bar/6.5mJ, 3bar/2.4mJ; DolorClast® Radial: 5.9 mJ at 4 bar, 2.2 mJ at 2.4 bar. | Not Significantly different - "fits with output parameters within or bellow setting range of predicat devices" due to 30% max output power limitation. (page 7, 10) |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-36, IEC 62304, ISO 14971, ISO 10993-1, ISO 10993-5, ISO 10993-10. | Not explicitly listed for predicates in this document, but predicate devices are assumed to be compliant with applicable standards. | Compliant - "The BTL-094 device has been thoroughly evaluated for electrical safety." (page 5). |
2. Sample size used for the test set and the data provenance
Not Applicable. As stated, "Clinical Testing: Not applicable." No test set of patient data was used for a clinical study to prove the device meets acceptance criteria. The submission relies on non-clinical testing (safety and performance standards, biocompatibility) and a comparison of technological characteristics to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. No clinical test set requiring expert ground truth establishment was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. No clinical test set requiring adjudication was used.
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 device is a therapeutic massager, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is a physical therapeutic massager, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not Applicable. No clinical performance study was conducted that would require a ground truth based on patient data. The "ground truth" for this 510(k) submission, in a broad sense, is the demonstration of adherence to recognized safety standards and the established safety and effectiveness profiles of the legally marketed predicate devices through a comparison of technological attributes.
8. The sample size for the training set
Not Applicable. No training set of data was used, as no artificial intelligence or machine learning component is described for this device.
9. How the ground truth for the training set was established
Not Applicable. There was no training set mentioned in the provided document.
In summary, the provided document is a 510(k) premarket notification that demonstrates substantial equivalence based on non-clinical testing (compliance with recognized safety and performance standards like IEC 60601 series and ISO 14971/10993 for electrical safety, EMC, usability, and biocompatibility) and a detailed comparison of the device's technological characteristics to those of two legally marketed predicate devices. The absence of clinical testing is explicitly stated, indicating that the FDA determined it was not necessary for this type of device and submission pathway.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 14, 2023
BTL Industries Inc. David Chmel VP of Operations 362 Elm Street Marlborough, Massachusetts 01752
Re: K221865
Trade/Device Name: BTL-094 Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: March 20, 2023 Received: March 20, 2023
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber T. Ballard -S
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221865
Device Name BTL-094
Indications for Use (Describe) BTL-094 is indicated to be used for:
- Relief of minor muscle aches and pains.
- Temporary increase in local blood circulation.
- Activation of connective tissue.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each nested inside the other.
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: | April 14, 2023 |
Device Name
| Trade/Proprietary Name: | BTL-094 |
|---|---|
| Primary Classification Name: | Therapeutic Massager |
| Common/Usual Name: | Therapeutic Massager |
| Classification Regulation: | 21 CFR 890.5660, Class I |
| Classification Product Code: | ISA |
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Legally Marketed Predicate Device
The BTL-094 is a state-of-the-art device substantially equivalent to the following products, which are already cleared for distribution in the USA under the following 510(k) Premarket Notification number:
Product Description
The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.
The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.
The main unit is equipped with a color touch screen, which considerably simplifies its operation. The onscreen information guides the user step through the entire therapy process. A secondary screen is placed on the applicator for the presentation of the actual state of main therapy parameters. The therapeutic parameters are adjustable via touch-screen, buttons and knob. The user is able to set following therapy parameters: intensity, frequency and number of shocks.
The mechanism of action and technological similarities and differences between the BTL-094 device and the predicate devices are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
Indications For Use
BTL-094 is indicated to be used for:
- Relief of minor muscle aches and pains.
- Temporary increase in local blood circulation.
- Activation of connective tissue.
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Image /page/5/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a blue geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each containing the letters "B", "T", and "L" respectively.
Non-clinical Testing
The BTL-094 device has been thoroughly evaluated for electrical safety. The device has been found to comply with the following applicable medical device safety standards:
| IEC 60601-1:2005/A1:2012FR Recognition Number: 19-4 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
|---|---|
| IEC 60601-1-2:2014FR Recognition Number: 19-8 | Medical electrical equipment – Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| IEC 60601-1-6:2010/A1:2013FR Recognition Number: 5-89 | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| IEC 60601-2-36:2014FR Recognition Number: 9-119 | Medical electrical equipment - Part 2-36: Particular requirements forthe basic safety and essential performance of equipment forextracorporeally induced lithotripsy |
| IEC 62304:2006/A1:2015FR Recognition Number: 13-79 | Medical device software – Software lifecycle processes |
| ISO 14971:2019FR Recognition Number: 5-125 | Medical devices - Application of risk management to medicaldevices |
| ISO 10993-1:2018FR Recognition Number: 2-258 | Biological evaluation of medical devices – Part 1: Evaluation andtesting within a risk management process |
| ISO 10993-5:2009FR Recognition Number: 2-245 | Biological evaluation of medical devices - Part 5: Tests for in vitrocytotoxicity |
| ISO 10993-10:2010FR Recognition Number: 2-174 | Biological evaluation of medical devices – Part 10: Tests forirritation and skin sensitization |
Clinical Testing
Not aplicable
Technological Characteristics
The BTL-094 is a non-invasive therapeutic device, which uses acoustic waves in order to stimulate a local biological response in the treated tissue.
The BTL-094 generates extracorporeally induced massage pulses to stimulate a local biological response in the treated tissue. The main source of acoustic waves is a piezo transducer inside the applicator. The energy transfer from the piezo transducer to the treated tissue is realized via coupling pad.
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The mechanism of action and technological similarities and differences between the BTL-094 device and the predicate devices are described below in the comparison table. The differences do not raise any new types of safety or effectiveness questions.
| Comparison with the Predicate Device | |||
|---|---|---|---|
| -------------------------------------- | -- | -- | -- |
| 510(k)number | K221865 | K173692 | K220538 | |
|---|---|---|---|---|
| Device name | BTL-094 | D-Actor 200 | DolorClast®Radial | |
| Companyname | BTL Industries Inc. | Storz Medical | EMS ElectroMedical SA | |
| Indications forUse | Relief of minormuscle aches andpainsTemporary increasein local bloodcirculationActivation ofconnective tissue | *Relief of minormuscle aches andpains*Temporary increasein local bloodcirculation*Activation ofconnective tissue | - Relief of minormuscle aches andpains.- Temporaryincrease in localblood circulation.- Activation ofconnective tissue. | None |
| Product CodeandRegulation | 21 CFR890.5660ISA | 21 CFR890.5660ISA | 21 CFR890.5660ISA | None |
| Modes ofAction | Extracorporeallyinduced pressurewaves. | Radial pressurewaves, orextracorporeal pulseactivationrespectively | Radial pressurewaves, orextracorporealpulse activationrespectively | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Mechanisms ofAction | Vibrations generatedby electroacoustictechnology. | Pneumaticallygenerated vibrations | Pneumaticallygeneratedvibrations | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Maximum andMinimumintensitysettings | 5-30%alternative outputpower setting scale | 1-5bar | 1-4bar | Not SignificantlydifferentDifferences arecaused byalternativetechnology of thepressure wavegeneration. |
| Number andsize oftreatmentapplicatorheads | 2;L Pad - 12.2 cm²U Pad - 7.3 cm² | 4;6mmOD, 15mmOD,20mmOD, 35mmOD | 7;5mm OD, 10 mmOD, 15 mm OD, 25mm OD, 40 mm OD | Not SignificantlydifferentThe applicationarea of the pads incontact with thepatient is within theset range of thepredicate devices.All materials incontact with thepatient have beenassessed forbiocompatibility |
| Maximum andminimumdisplacementsof applicatorheads | N/A | 0.6 - 2.0mm | 0.18 - 0.28 mm | N/AThe BTL-094applicator does nothave any movingparts that come incontact with thepatient. |
| Type ofapplication(e.g.,continuousvibration at afixedfrequency); | Continuous vibrationat a fixed frequencyand single pulsemode | Continuous vibrationat a fixed frequency | Continuousvibration at a fixedfrequency | None |
| Maximum andminimumvibrationfrequency | 1-25 Hz | 1-21Hz | 1-25 Hz | Not Significantlydifferent |
| Power Supply | 100 V to 240 V AC50 - 60 Hz150VA | 500VA | Mains power | None |
| Maximumpenetrationdepth | 35 mm | 32.3mm | 40 mm | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Energy flowdensity | In the range of0.01 - 0.11 mJ/mm2 | Values of ultrasonicpulse:5bar/0.284mJ/mm23bar/0.176mJ/mm2 | 0.29 mJ/mm2 at 4bar0.14 mJ/mm2 at 2.4bar | Not Significantlydifferent |
| Operatingmode | Continuous | Continuous | Continuous | None |
| Projectilemass (g) | N/A | 3 | 3.2 | Not applicableThe BTL-094applicator does notcontain a projectile. |
| Pulse repeatrate (1/s) | 1-25 Hz | 1-21Hz | 1-25 Hz | Not Significantlydifferent |
| Number ofpulses (minand max) | Variable in range0 – 9999 | Variable | Variable,Max5000/treatment | Not Significantlydifferent |
| Maximumoperatingtemperature | 10 - 35 °C | 10-40°C | 10 - 30 °C | Not Significantlydifferent |
| Type ofacoustic wavegeneration | Electroacoustictechnology withelectroacoustic lenssystem | Pneumatic/ballistic | Pneumatic/ballistic | Not SignificantlydifferentDifferences arecaused byalternativetechnology of thepressure wavegeneration. |
| Positive peakpressureamplitude(MPa) | In the range of3 - 10 MPa | Values of ultrasonicpulse: 5bar/18.5MPa3bar/13.4MPa | 17 MPa at 4 bar11.24 MPa at 2.4bar | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Negative peakpressureamplitude(MPa) | In the range of3 - 10 MPa | Values of ultrasonicpulse: 5bar/6.8MPa3bar/5.0MPa | 10 MPa at 4 bar7.2 MPa at 2.4 bar | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Derived focalacoustic pulseenergy (mJ) | In the range of0.1 – 1.4 mJ | Values of ultrasonicpulse: 5bar/6.5mJ3bar/2.4mJ | 5.9 mJ at 4 bar*2.2 mJ at 2.4 bar**Averaged acrossall applicator sizes. | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Derivedpulse-intensityintegral,integrated overtotal temporalintegrationlimits(mJ/mm2) | In the range of0.01 - 0.11 mJ/mm2 | Values of ultrasonicpulse:5bar/0.284mJ/mm23bar/0.176mJ/mm2 | 0.29 mJ/mm2 at 4bar0.14 mJ/mm2 at 2.4bar | Not SignificantlydifferentPlease see thediscussion andconclusion below. |
| Rise time (ns) | 10 ns | Ultrasonic pulse:2.5µs | 3.2 µs | Not Significantlydifferent |
| Sonic pulse: 25µs –2.5ms | Differences arecaused byalternativetechnology of theenergy generation. | |||
| Compressionalpulse duration(μs) | 2µs | Ultrasonic pulse:5.0µs Sonic pulse:50µs – 5.0ms | 2.6 µs (1st peak)62.7 µs (1st phase) | Not Significantlydifferent |
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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 with the letters "BTL" inside. To the right of the logo, the words "BTL Industries" are written in a modern, sans-serif font. The text is in a dark gray color.
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Image /page/8/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three nested squares with the letters "BTL" inside the innermost square. To the right of the logo is the text "BTL Industries" in a sans-serif font.
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Image /page/9/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" in white inside the innermost square. To the right of the square logo is the text "BTL Industries" in a gray sans-serif font.
Modes of Action, Mechanisms of Action
The technology used in BTL-094 device differs from the predicate device. Nevertheless, the technology creates the same type of acoustic pressure delivered to the tissue. Similar devices that generate a pressure wave based on a different technological principle but with the same or very comparable mechanism of action have already been recognised as substantially equivalent in this device category.
Maximum and Minimum intensity settings
BTL-094 has an alternative type of technology from the predicate device and therefore the BTL-094 device has an alternative power setting scale - in percentage and not in bars as a comparative device has. In addition, for comparability with the predicate devices the BTL-094 device intended for the US market is limited to a maximum power level of 30% of maximum driving power.
Number and size of treatment applicator heads
The number of application pads are different from predicate device but the area of the subjected device pads that is in contact with the patient is comparable within a set range to the contact area of application tips of predicate devices. Additionally all materials in contact with patient have been assessed for biocompatibility and the maximal depth of pressure wave penetration is comparable to the predicate.
Maximum and minimum displacements of applicator heads
The predicate device is generating the pressure wave by the head displacement. Due to an alternative type of technology used for pressure wave generation the BTL-094 device does not have the ability of displacements of applicator heads/pads.
Maximum and minimum vibration frequency
BTL-094 device differs from one predicate device in the value of the maximum frequency, where the frequency value of the BTL-094 device can be up to 4Hz higher than the predicate device, but has available the same frequency range as its second predicate device.
Driving Power
BTL-094 device has an alternative type of technology from the predicate device and therefore the driving power parameter is not applicable. In addition, for comparability with the predicate devices the BTL-094 device intended for the US market is limited to a maximum power level of 30% of maximum driving power.
Energy flow density
BTL-094 device uses alternative technology and is able to better pulse targeting, a maximum driving power of the device has been limited at a maximum power level of 30%. The EFD of our device differs from the predicates but it is lower or within setting range of predicat devices.
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Image /page/10/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of a geometric design on the left and the text "BTL Industries" on the right. The geometric design is made up of three squares, each rotated 45 degrees and nested inside the other. The text "BTL Industries" is written in a sans-serif font.
Operating mode
The BTL-094 device has two modes of operation: single therapy mode or sequence mode. The two modes differ based on repetition of therapy sections and settings that can be done during the running therapy. Nevertheless, both the modes have a character of continual therapy.
Maximum penetration depth
The BTL-094 device is equipped with two different coupling pad sizes, which allow it to reach up to 35 mm depth. This penetration depth is comparable within setting range of predicate devices.
Pulse repeat rate (1/s)
BTL-094 device differs from one predicate device in the value of the maximum frequency, where the frequency value of the BTL-094 device can be up to 4Hz higher than the predicate device, but has available the same frequency range as its second predicate device.
Number of pulses (min and max)
BTL-094 device allows to set a variable number of pulses according to the user's needs. This parameter is similar as for the predicate device.
Type of acoustic wave generation
The subject device provides the therapy by the application of extracorporeally induced acoustic pressure waves that are generated by means of piezoelectric principle. The device is designed with planar piezoelement and acoustic lens quiding the waves. The generated wave is coupled to biological tissue via the coupling gel pads of the applicator.
This technology creates the same type of acoustic pressure wave with comparable parameters therefore it reach the same mechanism of action as the predicate devices.
Positive peak pressure amplitude (MPa)
A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power fits with output parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.
Negative peak pressure amplitude (MPa)
A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power fits with output parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.
Derived focal acoustic pulse energy (mJ)
A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power fits with output parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.
Derived pulse- intensity integrated over total temporal integration limits (m.J/mm2)
A maximum driving power of the BTL-094 has been limited at a maximum power level of 30%. The device with this limitation in maximal output power parameters within or bellow setting range of predicat devices and is not significantly different from the predicate devices.
Rise time (ns)
BTL-094 has an alternative type of technology from the predicate device and therefore the BTL-094 device is able to reach a faster rise time and shorter compressional pulse duration.
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Image /page/11/Picture/0 description: The image shows the logo for BTL Industries. The logo consists of three blue interlocking squares on the left, with the letters "BTL" inside the squares. To the right of the squares is the text "BTL Industries" in a gray sans-serif font. The logo is simple and modern, and the use of blue and gray gives it a professional look.
Compressional pulse duration (µs)
BTL-094 has an alternative type of technology from the predicate device and therefore the BTL-094 device is able to reach a faster rise time and shorter compressional pulse duration.
Substantial Equivalence
The BTL-094 is substantially equivalent to the predicate devices D-Actor (K173692) and DolorClast® Radial (K220538). The subject device is safe and effective for its intended use.
Any differences between the predicate devices and BTL-094 have no significant influence on the safety or effectiveness of the subject device. Therefore, the BTL-094 is substantially equivalent to the predicate devices.
Conclusion
Based upon the intended use and known technical information provided in this pre-market notification, the BTL-094 device has been shown to be substantially equivalent to the currently marketed predicate device.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.