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.

AI/ML Overview

This document is an FDA 510(k) summary for a medical device (DolorClast® Radial), which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance. Therefore, many of the requested elements (e.g., sample sizes for training/test sets, ground truth establishment for AI, MRMC studies, expert qualifications) are not applicable or not present in this type of regulatory submission.

However, based on the provided text, I can extract information related to the device's functional performance testing against internal protocols.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several functional performance tests and generally states that "All tests were passed," indicating the device met internal EMS protocols. Specific numerical acceptance criteria are generally not provided in this summary, but the reported performance is that the device met those criteria.

Acceptance Criterion (Internal EMS Protocol)	Reported Device Performance
System Functional Performance Testing
Compressor activation only when handpiece trigger pressed	All tests were passed (confirming activation met pre-defined tolerance).
Pressure output at each pressure setting met pre-defined pressure setting tolerance	All tests were passed (confirming pressure output met pre-defined tolerance).
Correct operation of console at all treatment settings (including Smart Protocols and Special Modes)	All tests were passed (confirming correct operation).
Correct device response to error conditions	All tests were passed (verifying correct device response).
Correct operation of handpiece (pressure adjustment, starting/stopping treatment, recording piston use)	All tests were passed (confirming correct operation).
Acoustic output characterization (Displacement of applicator heads)	Displacement of applicator heads: 0.18 - 0.28 mm
Acoustic output characterization (Maximum penetration depth)	Maximum penetration depth: 40 mm
Acoustic output characterization (Energy flow density)	0.29 mJ/mm² at 4 bar; 0.14 mJ/mm² at 2.4 bar
Acoustic output characterization (Positive peak pressure amplitudes)	17 MPa at 4 bar; 11.24 MPa at 2.4 bar
Acoustic output characterization (Negative peak pressure amplitudes)	10 MPa at 4 bar; 7.2 MPa at 2.4 bar
Acoustic output characterization (Derived focal acoustic pulse energy)	5.9 mJ at 4 bar; 2.2 mJ at 2.4 bar
Acoustic output characterization (Derived pulse-intensity integral (max))	0.29 mJ/mm² at 4 bar; 0.14 mJ/mm² at 2.4 bar
Acoustic output characterization (Rise time)	3.2 µs
Acoustic output characterization (Compressional pulse duration)	2.6 µs (1st peak); 62.7 µs (1st phase)
Lifetime Testing
Console functions and meets specs for 7 years or 50,000,000 pulses	All tests were passed (confirming specified useful lifetime).
Handpiece functions and meets specs for 2 years or 5,000,000 pulses	All tests were passed (confirming specified useful lifetime).
Applicators function and meet specs for 2 years or 5,000,000 pulses	All tests were passed (confirming specified useful lifetime).
Biocompatibility (Applicator tips and gel)	Previously approved under P050004; no changes to material/manufacturing.
Transportation Testing (ISTA 2A and ISTA 3A)	All tests were passed (devices and accessories functional after conditioning).
Software Validation (IEC 62304 Ed 1.1)	Software validated in software testing and system level testing.
Electrical Safety and EMC (IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014)	Demonstrated to comply with stated standards.

Note: The document states "Averaged across all applicator sizes" for derived focal acoustic pulse energy.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for any of the performance tests. The testing described appears to be engineering verification and validation, likely involving a limited number of test units or prototypes.
Data Provenance: The origin of the data is stated as "internal EMS protocols" and "internal EMS testing." It is prospective testing conducted specifically for this regulatory submission on the device itself. No mention of geographical data origin (e.g., country) is made as it's not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts. The "ground truth" for these tests refers to engineering specifications and regulatory standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert interpretations.

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. This 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. This device is a physical therapeutic device, not an algorithm. Its performance is inherent in its physical operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" effectively used for this regulatory submission is adherence to engineering specifications, internal EMS protocols, and recognized industry standards (e.g., IEC 60601-1, IEC 60601-1-2, ISTA 2A/3A). For biocompatibility, the "ground truth" was established by prior approval (P050004) of identical materials.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 SACh. de la Vuarpillière 311260 Nyon, SwitzerlandContact: Vivian YeePhone: +44 7305 232869Email: vyee@ems-ch.com
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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 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(K220538)	Predicate Device(K173692)	Comparison
Device Trade Name	DolorClast® Radial	D-Actor® 200 Vibration MassageSystem	N/A
Device Manufacturer	EMS Electro Medical SystemSA	Storz Medical AG	N/A
Indications for UseStatement	The DolorClast® Radialis indicated for:Relief of minor muscle●aches and painsTemporary increase in local●blood circulationActivation of connective●tissue	The D-Actor® 200Vibration MassageSystem is intended for:Relief of minor muscleaches and painsTemporary increase in local●blood circulationActivation of connectivetissue	Same
Mode of Action	Radial pressure waves, orextracorporeal pulse activationrespectively	Radial pressure waves, orextracorporeal pulse activationrespectively	Same
Mechanism of action	Pneumatically generatedvibrations	Pneumatically generatedvibrations	Same
System components	Control console with integratedair compressors to controltreatment parametersMains cableHandpiece containing projectilewithin guiding tubeInterchangeable applicatorsCoupling gelCart (optional)	Control unitMains cableHandpiece containing projectilewithin guiding tubeInterchangeable applicatorsCoupling gelFootswitch (optional)Tablet PC (optional)	Same except foroptionalaccessories
Method of triggeringvibration pulses	Handpiece	Handpiece or optionalfootswitch	Same except forpredicateoptionally can becontrolled using afootswitch
Type of acoustic wavegeneration	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 treatmentapplicators	7	4	Similar
Treatment applicatorsizes	OD in mm: 5, 10, 15, 25, 40	OD in mm: 6, 15, 20, 35	Similar
Projectile mass (g)	3.2	3	Similar
Displacement ofapplicator heads	0.18 - 0.28 mm	0.6 – 2.0 mm	Similar
Operating mode	Continuous vibration at a fixedfrequency	Continuous vibration at a fixedfrequency	Same
Parameter	Proposed Device(K220538)	Predicate Device(K173692)	Comparison
Maximum penetrationdepth	40 mm	32.3 mm	Similar
Number of pulses pertreatment	Variable as set by operatorMax 5 000 pulses/treatment	VariableMax not publicly available	Similar
Maximum energy flowdensity	0.29 mJ/mm² at 4 bar0.14 mJ/mm² at 2.4 bar	0.284 mJ/mm² at 5 bar0.176 mJ/mm² at 3 bar	Similar
Maximum positive peakpressure amplitude	17 MPa at 4 bar11.24 MPa at 2.4 bar	18.5 MPa at 5 bar13.4 MPa at 3 bar	Similar
Maximum negative peakpressure amplitude	10 MPa at 4 bar7.2 MPa at 2.4 bar	6.8 MPa at 5 bar5.0 MPa at 3 bar	Similar
Derived focal acousticpulse energy	5.9 mJ at 4 bar2.2 mJ at 2.4 bar	6.5 mJ at 5 bar2.4 mJ at 3 bar	Similar
Derived pulse-intensityintegral (max), integratedover total temporalintegration limits(mJ/mm²)	0.29 mJ/mm² at 4 bar0.14 mJ/mm² at 2.4 bar	0.284 mJ/mm² at 5 bar0.176 mJ/mm² at 3 bar	Similar
Rise time	3.2 µs	2.5 µs	Similar
Compressional pulseduration	2.6 µs (1st peak)62.7 µs (1st phase)	Ultrasonic pulse: 5.0 µsSonic pulse: 50 µs - 5.0 ms	Similar
Power supply	Mains power	Mains power	Same
Operating temperaturerange	10 °C - 30 °C	10 °C - 40 °C	Similar
Control consoledimensions	450 x 340 x 180 mm17.7 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.

Regulation Number and Section

§ 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.