(136 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical functionality, with no mention of AI or ML algorithms for data analysis, decision-making, or image processing.
Yes
Explanation: The device is indicated for "Relief of minor muscle aches and pains," "Temporary increase in local blood circulation," and "Activation of connective tissue," which are all therapeutic benefits.
No
The "Intended Use / Indications for Use" section specifies the device's purposes as relief of aches, increased circulation, and activation of connective tissue, which are therapeutic and not diagnostic.
No
The device description clearly outlines hardware components such as a console, handpiece, applicator heads, and an integrated air compressor. The performance studies also detail testing of these physical components.
Based on the provided information, the DolorClast® Radial is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "Relief of minor muscle aches and pains," "Temporary increase in local blood circulation," and "Activation of connective tissue." These are therapeutic applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device description details a system that generates and applies physical pressure pulses to the body. This is a physical therapy or treatment device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the patient's body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The DolorClast® Radial does not fit this description.
N/A
Intended Use / Indications for Use
The DolorClast® Radial is indicated for:
- · Relief of minor muscle aches and pains
- · Temporary increase in local blood circulation
- · Activation of connective tissue
Product codes (comma separated list FDA assigned to the subject device)
ISA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Maximum penetration depth
- Energy flow density
- Positive and negative peak pressure amplitudes
- Derived focal acoustic pulse energy
- Derived pulse-intensity integral
- Rise time
- Compressional pulse duration
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
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
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.
1
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
2
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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3
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
Ch. de la Vuarpillière 31
1260 Nyon, Switzerland
Contact: Vivian Yee
Phone: +44 7305 232869
Email: vyee@ems-ch.com |
| ---- | ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- 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 ●
4
Comparison with Predicate Device H.
| Parameter | Proposed Device
(K220538) | Predicate Device
(K173692) | Comparison |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Device Trade Name | DolorClast® Radial | D-Actor® 200 Vibration Massage
System | N/A |
| Device Manufacturer | EMS Electro Medical System
SA | Storz Medical AG | N/A |
| 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 | The D-Actor® 200
Vibration Massage
System is intended for:
Relief of minor muscle
aches and pains
Temporary increase in local
●
blood circulation
Activation of connective
tissue | Same |
| Mode of Action | Radial pressure waves, or
extracorporeal pulse activation
respectively | Radial pressure waves, or
extracorporeal pulse activation
respectively | Same |
| Mechanism of action | Pneumatically generated
vibrations | Pneumatically generated
vibrations | Same |
| System components | Control console with integrated
air compressors to control
treatment parameters
Mains cable
Handpiece containing projectile
within guiding tube
Interchangeable applicators
Coupling gel
Cart (optional) | Control unit
Mains cable
Handpiece containing projectile
within guiding tube
Interchangeable applicators
Coupling gel
Footswitch (optional)
Tablet PC (optional) | Same except for
optional
accessories |
| Method of triggering
vibration pulses | Handpiece | Handpiece or optional
footswitch | Same except for
predicate
optionally can be
controlled using a
footswitch |
| Type of acoustic wave
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
applicators | 7 | 4 | Similar |
| Treatment applicator
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
applicator heads | 0.18 - 0.28 mm | 0.6 – 2.0 mm | Similar |
| Operating mode | Continuous vibration at a fixed
frequency | Continuous vibration at a fixed
frequency | Same |
| Parameter | Proposed Device
(K220538) | Predicate Device
(K173692) | Comparison |
| Maximum penetration
depth | 40 mm | 32.3 mm | Similar |
| Number of pulses per
treatment | Variable as set by operator
Max 5 000 pulses/treatment | Variable
Max not publicly available | Similar |
| Maximum energy flow
density | 0.29 mJ/mm² at 4 bar
0.14 mJ/mm² at 2.4 bar | 0.284 mJ/mm² at 5 bar
0.176 mJ/mm² at 3 bar | Similar |
| Maximum positive peak
pressure amplitude | 17 MPa at 4 bar
11.24 MPa at 2.4 bar | 18.5 MPa at 5 bar
13.4 MPa at 3 bar | Similar |
| Maximum negative peak
pressure amplitude | 10 MPa at 4 bar
7.2 MPa at 2.4 bar | 6.8 MPa at 5 bar
5.0 MPa at 3 bar | Similar |
| Derived focal acoustic
pulse energy | 5.9 mJ at 4 bar*
2.2 mJ at 2.4 bar* | 6.5 mJ at 5 bar
2.4 mJ at 3 bar | Similar |
| Derived pulse-intensity
integral (max), integrated
over total temporal
integration limits
(mJ/mm²) | 0.29 mJ/mm² at 4 bar
0.14 mJ/mm² at 2.4 bar | 0.284 mJ/mm² at 5 bar
0.176 mJ/mm² at 3 bar | Similar |
| Rise time | 3.2 µs | 2.5 µs | Similar |
| Compressional pulse
duration | 2.6 µs (1st peak)
62.7 µs (1st phase) | Ultrasonic pulse: 5.0 µs
Sonic pulse: 50 µs - 5.0 ms | Similar |
| Power supply | Mains power | Mains power | Same |
| Operating temperature
range | 10 °C - 30 °C | 10 °C - 40 °C | Similar |
| Control console
dimensions | 450 x 340 x 180 mm
17.7 x 13.4 x 7.1 inches | Not publicly available | - |
| Control console weight | 14.5kg | Not publicly available | - |
5
*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
6
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
7
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.