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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)

• 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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