DolorClast Radial

K220538 · E.M.S Electro Medical Systems S.A · ISA · Jul 11, 2022 · Physical Medicine

Device Facts

• Record ID: K220538
• Device Name: DolorClast Radial
• Applicant: E.M.S Electro Medical Systems S.A
• Product Code: ISA · Physical Medicine
• Decision Date: Jul 11, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The DolorClast® Radial is indicated for: Relief of minor muscle aches and pains Temporary increase in local blood circulation Activation of connective tissue

Device Story

DolorClast® Radial is a portable radial pressure pulse device for therapeutic massage. System includes a console with integrated air compressor, handpiece, interchangeable stainless-steel applicator heads, and coupling gel. Practitioner operates device via handpiece trigger button. Console generates pneumatic pressure pulses; air drives internal projectile against applicator head. Applicator transmits radial pressure pulses to patient's skin via coupling gel. Device used in clinical settings to provide mechanical vibration. Output affects local blood circulation and connective tissue, providing relief for minor muscle aches and pains. Benefits include non-invasive therapeutic massage.

Clinical Evidence

Bench testing only. No clinical data. Testing included system functional performance (pressure output, console/handpiece operation), acoustic output characterization (displacement, penetration depth, energy flow density, peak pressure, pulse duration), lifetime testing (console, handpiece, applicators), biocompatibility (leveraging P050004), transportation testing (ISTA 2A/3A), and electrical safety/EMC (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Pneumatic/ballistic radial pressure pulse device. Materials: stainless-steel applicators. Energy source: mains-powered integrated air compressor. Dimensions: 450 x 340 x 180 mm. Weight: 14.5 kg. Operating frequency: 1-25 Hz. Pressure range: 1-4 bar. Software: moderate level of concern, compliant with IEC 62304. Standards: IEC 60601-1, IEC 60601-1-2, ISTA 2A/3A.

Indications for Use

Indicated for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue in patients requiring therapeutic massage.

Regulatory Classification

Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

Predicate Devices

• D-Actor® 200 Vibration Massage System (K173692)

Submission Summary (Full Text)

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7/11/22

EMS Electro Medical Systems SA % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002

Re: K220538

Trade/Device Name: DolorClast® Radial Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic massager Regulatory Class: Class I Product Code: ISA Dated: February 25, 2022 Received: February 25, 2022

Dear Sheila Hemeon-Heyer:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number (if known) K220538

Device Name

DolorClast® Radial

Indications for Use (Describe)

The DolorClast® Radial is indicated 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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# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

| A. | Submitter: | EMS Electro Medical SA<br>Ch. de la Vuarpillière 31<br>1260 Nyon, Switzerland<br>Contact: Vivian Yee<br>Phone: [phone]<br>Email: [e-mail] |
|----|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
|----|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|

- B. Date Prepared: July 7, 2022
#### Device Name and Classification Information: D.

| Trade name: | DolorClast® Radial |
|----------------------------|-------------------------------|
| Common/Usual Name: | Therapeutic Electric Massager |
| Classification name: | Therapeutic Massager |
| Review Panel | Physical Medicine |
| Classification regulation: | 21 CFR 890.5660 |
| Product code: | ISA |
| Class: | Class I |

#### E. Predicate Device(s): K173692, D-Actor® 200 Vibration Massage System

#### F. Device Description:

The DolorClast® Radial is a portable radial pressure pulse device with an integrated air compressor. The DolorClast® Radial system is composed of the DolorClast® Radial console, handpiece, interchangeable applicator heads, and optional cart. Swiss DolorClast® Gel, previously approved under P050004, is also provided for coupling the treatment applicator to the patient's skin.

The DolorClast® Radial console generates and controls the pressure pulse frequency and intensity. Air pressure from the console drives a projectile within the handpiece against the applicator head to generate the pressure pulses at the set frequency and intensity. Device activation is done by the practitioner via a trigger button on the handpiece. The applicator at the distal end of the handpiece transmits the radial pressure pulses to the targeted tissues via the coupling gel applied to the treated skin.

#### G. Indications for Use Statement

The DolorClast® Radial is indicated for:

- . Relief of minor muscle aches and pains
- Temporary increase in local blood circulation
- Activation of connective tissue ●

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#### Comparison with Predicate Device H.

| Parameter | Proposed Device<br>(K220538) | Predicate Device<br>(K173692) | Comparison |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Device Trade Name | DolorClast® Radial | D-Actor® 200 Vibration Massage<br>System | N/A |
| Device Manufacturer | EMS Electro Medical System<br>SA | Storz Medical AG | N/A |
| Indications for Use<br>Statement | The DolorClast® Radial<br>is indicated for:<br>Relief of minor muscle<br>●<br>aches and pains<br>Temporary increase in local<br>●<br>blood circulation<br>Activation of connective<br>●<br>tissue | The D-Actor® 200<br>Vibration Massage<br>System is intended for:<br>Relief of minor muscle<br>aches and pains<br>Temporary increase in local<br>●<br>blood circulation<br>Activation of connective<br>tissue | Same |
| Mode of Action | Radial pressure waves, or<br>extracorporeal pulse activation<br>respectively | Radial pressure waves, or<br>extracorporeal pulse activation<br>respectively | Same |
| Mechanism of action | Pneumatically generated<br>vibrations | Pneumatically generated<br>vibrations | Same |
| System components | Control console with integrated<br>air compressors to control<br>treatment parameters<br>Mains cable<br>Handpiece containing projectile<br>within guiding tube<br>Interchangeable applicators<br>Coupling gel<br>Cart (optional) | Control unit<br>Mains cable<br>Handpiece containing projectile<br>within guiding tube<br>Interchangeable applicators<br>Coupling gel<br>Footswitch (optional)<br>Tablet PC (optional) | Same except for<br>optional<br>accessories |
| Method of triggering<br>vibration pulses | Handpiece | Handpiece or optional<br>footswitch | Same except for<br>predicate<br>optionally can be<br>controlled using a<br>footswitch |
| Type of acoustic wave<br>generation | Pneumatic/ballistic | Pneumatic/ballistic | Same |
| Pressure setting range | 1-4 bar | 1-5 bar | Similar |
| Frequency setting range | 1-25 Hz | 1-21 Hz | Similar |
| Number of treatment<br>applicators | 7 | 4 | Similar |
| Treatment applicator<br>sizes | OD in mm: 5, 10, 15, 25, 40 | OD in mm: 6, 15, 20, 35 | Similar |
| Projectile mass (g) | 3.2 | 3 | Similar |
| Displacement of<br>applicator heads | 0.18 - 0.28 mm | 0.6 – 2.0 mm | Similar |
| Operating mode | Continuous vibration at a fixed<br>frequency | Continuous vibration at a fixed<br>frequency | Same |
| Parameter | Proposed Device<br>(K220538) | Predicate Device<br>(K173692) | Comparison |
| Maximum penetration<br>depth | 40 mm | 32.3 mm | Similar |
| Number of pulses per<br>treatment | Variable as set by operator<br>Max 5 000 pulses/treatment | Variable<br>Max not publicly available | Similar |
| Maximum energy flow<br>density | 0.29 mJ/mm² at 4 bar<br>0.14 mJ/mm² at 2.4 bar | 0.284 mJ/mm² at 5 bar<br>0.176 mJ/mm² at 3 bar | Similar |
| Maximum positive peak<br>pressure amplitude | 17 MPa at 4 bar<br>11.24 MPa at 2.4 bar | 18.5 MPa at 5 bar<br>13.4 MPa at 3 bar | Similar |
| Maximum negative peak<br>pressure amplitude | 10 MPa at 4 bar<br>7.2 MPa at 2.4 bar | 6.8 MPa at 5 bar<br>5.0 MPa at 3 bar | Similar |
| Derived focal acoustic<br>pulse energy | 5.9 mJ at 4 bar*<br>2.2 mJ at 2.4 bar* | 6.5 mJ at 5 bar<br>2.4 mJ at 3 bar | Similar |
| Derived pulse-intensity<br>integral (max), integrated<br>over total temporal<br>integration limits<br>(mJ/mm²) | 0.29 mJ/mm² at 4 bar<br>0.14 mJ/mm² at 2.4 bar | 0.284 mJ/mm² at 5 bar<br>0.176 mJ/mm² at 3 bar | Similar |
| Rise time | 3.2 µs | 2.5 µs | Similar |
| Compressional pulse<br>duration | 2.6 µs (1st peak)<br>62.7 µs (1st phase) | Ultrasonic pulse: 5.0 µs<br>Sonic pulse: 50 µs - 5.0 ms | Similar |
| Power supply | Mains power | Mains power | Same |
| Operating temperature<br>range | 10 °C - 30 °C | 10 °C - 40 °C | Similar |
| Control console<br>dimensions | 450 x 340 x 180 mm<br>17.7 x 13.4 x 7.1 inches | Not publicly available | - |
| Control console weight | 14.5kg | Not publicly available | - |

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*Averaged across all applicator sizes.

#### -Substantial Equivalence Discussion

The DolorClast® Radial has the same indications for use and mechanism of action as the predicate D- Actor® 200. Both use compressed air to drive a projectile against a stainless steel applicator in contact with the skin, transferring low-amplitude pressure pulses to the treatment target via standard coupling gel. Both devices are operated using a handpiece; however, the predicate device can also optionally be operated using a footswitch. There are minor differences in the technical characteristics of the pressure pulses. The maximum pulse pressure setting of the DolorClast® Radial is slightly lower than the D-Actor® 200 Vibration Massage System (4 bar vs 5 bar, respectively), while the maximum pulse frequency setting of the DolorClast® Radial is slightly higher than the D-Actor® 200 Vibration Massage System (25Hz vs 21Hz, respectively). The DolorClast® Radial has more options for applicators than the D-Actor® 200 Vibration Massage System (7 vs 4, respectively); however, the applicator size ranges for the two devices are very similar. The technical characteristics of the pressure pulses are very similar between the two devices. In particular, the maximum energy flux density is nearly identical at 0.29 mJ/mm² for the DolorClast® Radial and 0.28mJ/mm² for the D-Actor® 200 Vibration Massage System. The DolorClast® Radial applicator heads demonstrate less movement than the D-Actor® 200

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Vibration Massage System, ranging from 0.18 to 0.28 mm depending on applicator size for the DolorClast® Radial versus 0.6 to 2.0 mm for the D-Actor® 200 Vibration Massage System. However, the role of the applicator is to transfer the pressure pulse energy from the handpiece piston to the treatment site, which is independent of applicator movement. The technical differences do not present any new risks or raise any new questions of safety or effectiveness.

#### J. Summary of Data Submitted to Support Substantial Equivalence

The following testing was included in this 510(k) to support substantial equivalence:

### System functional performance testing

- The operation of the DolorClast® Radial air compressors was tested under an internal EMS protocol to confirm that the compressors were only activated when the handpiece trigger was pressed and to verify that the pressure output at each pressure setting met the pre - defined pressure setting tolerance. All tests were passed.
- . The operation of the DolorClast® Radial console was tested under an internal EMS protocol to confirm correct operation of the console at all treatment settings, including for the Smart Protocols and Special Modes. Testing included error conditions to verify correct device response. All tests were passed.
- . The operation of the DolorClast® Radial handpiece was tested under an internal EMS protocol to confirm correct operation of the handpiece including adjustment of the pressure, starting and stopping treatment, and recording piston use information. All tests were passed.
- Acoustic output testing was conducted to characterize the output pressure wave for each . of the system applicators on the following parameters:
- Displacement of applicator heads o
- O Maximum penetration depth
- Energy flow density O
- Positive and negative peak pressure amplitudes O
- Derived focal acoustic pulse energy o
- Derived pulse-intensity integral O
- Rise time O
- Compressional pulse duration o

### Lifetime Testing

Testing was conducted under internal EMS protocols to confirm that the DolorClast® Radial console, handpiece, and applicators continued to function and meet their performance specifications for the claimed useful lifetimes of:

- . Console: 7 years or 50,000,000 pulses
- . Handpiece: 2 years or 5,000,000 pulses
- . Applicators: 2 years or 5,000,000 pulses

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# Biocompatibility

The only components of the DolorClast® Radial system that come into contact with the patient are the applicator tips and the Swiss DolorClast® gel, both of which are in contact with intact skin for less than 24 hours. Cumulative use may exceed 24 hours for heavy users. The Swiss DolorClast® gel was previously approved under P050004 and has not changed since that time. The applicators are made of the same stainless-steel material as the applicators for the Swiss DolorClast® applicators, previously approved under P050004, and there have been no changes to the applicator material, manufacturing processes, or patient contact category since that time. Therefore, the prior biocompatibility testing conducted to support P050004 remains applicable for both the applicators and the gel, and no further biocompatibility testing was required to support the DolorClast® Radial 510(k) application.

# Transportation Testing

Transportation testing was conducted for the DolorClast® Radial system in accordance with the International Safe Transit Authority standards ISTA 2A and ISTA 3A. Packages were visually inspected after being subjected to environmental and mechanical conditioning. The device and device accessories were tested for functionality following the package conditioning. All tests were passed.

# Software Validation

The DolorClast® Radial software was evaluated as having a moderate level of concern. The 510(k) included software documentation commensurate with a moderate level of concern and compliant with IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes. The software was validated in both software testing and system level testing with the software integrated into the final device.

# Electrical Safety and EMC

The DolorClast was tested and demonstrated to comply with the following standards:

- . IEC 60601-1:2005 + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

#### K. Conclusion

The information presented in this 510(k) demonstrates that the DolorClast® Radial is substantially equivalent to the predicate device as a Class I therapeutic massager under 21 CFR 890.5660, Product Code ISA.