D-Actor 200 Vibration Massage System

K173692 · Storz Medical AG · ISA · Apr 13, 2018 · Physical Medicine

Device Facts

• Record ID: K173692
• Device Name: D-Actor 200 Vibration Massage System
• Applicant: Storz Medical AG
• Product Code: ISA · Physical Medicine
• Decision Date: Apr 13, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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

Device Story

D-ACTOR 200 is a therapeutic vibration massage system using pneumatically generated radial pressure waves. System comprises control unit, handpiece, and optional tablet PC. Operation involves pressurized air pulses accelerating a projectile within a tube to impact a skin-contacting steel activator; dampened by O-rings and vibration absorber. Coupling gel is applied to skin to facilitate pulse transmission. Operator adjusts energy level, frequency, and pulse count via GUI. Software includes patient management, treatment program editing, and 3D musculature visualization for marking treatment regions. Used in clinical settings by trained operators to deliver continuous vibration. Output provides mechanical stimulation to muscle groups, intended to increase local circulation and relieve minor aches. Benefits include non-invasive muscle therapy and progress tracking via saved images/videos.

Clinical Evidence

Bench testing only. In-vitro testing evaluated applicator displacement, force, and penetration depth, confirming equivalence to predicate AW modules. Ultrasonic energy output (approx. 5% of total) was measured per modified IEC 61846 protocols, showing energy flow densities of 0.176mJ/mm2 at 3 bar and 0.284mJ/mm2 at 5 bar. Biocompatibility testing conformed to ISO 10993-1:2003. Electrical safety and EMC testing confirmed compliance with IEC 60601-1:2012 and IEC 60601-1-2:2007.

Technological Characteristics

Pneumatic/ballistic radial pressure wave generator. Materials: steel activator, elastic O-rings. Energy source: pressurized air (1-5 bar). Frequency: 1-21 Hz. Connectivity: optional tablet PC for GUI. Software: IEC 62304 compliant. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 14971 (risk management).

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

• Dermablate Effect (K081541)
• TattooStar Effect Y (K112669)

Submission Summary (Full Text)

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April 13, 2018

Storz Medical AG % Michael Dayton President Biomed Research, Inc. 3959 Van Dyke Road Suite 245 Lutz, Florida 33558

Re: K173692

Trade/Device Name: D-Actor 200 Vibration Massage System Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: April 5, 2018 Received: April 9, 2018

Dear Mr. Dayton:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K173692

Device Name

D-ACTOR® 200 Vibration Massage System

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

|__ | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(k) Summary

# Storz Medical AG

## D-ACTOR® 200 Vibration Massage System

#### 1. SPONSOR

Storz Medical AG Lohstampfestr. 8 CH-8274 Tägerwilen Switzerland

| Contact Person: | Pavel Novak, Ph.D. |
|-----------------|---------------------|
| Telephone: | 41 (0) 71 677 45 13 |
| FAX: | 41 (0) 71 677 45 05 |

Date Prepared: April 5, 2018

#### DEVICE NAME 2.

| Proprietary Name: | D-ACTOR® 200 Vibration Massage System |
|----------------------|----------------------------------------|
| Common/Usual Name: | Therapeutic Electric Massager/Vibrator |
| Classification Name: | Massager, Therapeutic, Electric |
| Review Panel: | Physical Medicine |
| Regulations Number: | 890.5660 |
| Product Code: | ISA |
| Device Class: | 1 |

#### 3. PREDICATE DEVICES

Equivalence claimed to the Acoustic Wave (AW) module component (i.e., D-Actor Vibration Massage System provided OEM) of the Dermablate Effect, submission number K081541 and the TattooStar Effect Y, submission number K112669.

AW Module (D-Actor provided OEM):

| Classification Name: | Massager, Therapeutic, Electric |
|----------------------|---------------------------------|
| Product Code: | ISA |
| Device Class: | 1 |

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#### 4. DEVICE DESCRIPTION

The D-ACTOR® handpiece uses pressurized air pulses to accelerate a projectile within a guiding tube. The accelerated projectile hits a skin-contacting steel activator which is dampened by elastic O-rings that affix it to the distal end of the handpiece and a vibration absorber at proximal end of the handpiece. When the projectile impacts the activator, slow-rising, low-amplitude pressure pulses are generated. Standard coupling gel is typically used to reduce the loss of pulse amplitude to surrounding air. The D-ACTOR 200 System consists of a Control Unit, Handpiece, Mains Cable, Commercially available coupling gel, Foot switch (optional), and Tablet PC (optional). The password protected GUI interface software allows the operator to create, save and edit treatment programs for application to various muscle groups, and permits the operator to create, edit and save individual patient treatment program routines and progress notes. Various software features permit the operator to: (1) adjust energy level, number of pulses, frequency and total pulses delivered, (2) display and adjust skin contact intensity of the applicator, (3) save treatment images/videos to track progress, and (4) utilize Visible Body® interactive 3D musculature to allow the operator to "mark" and save treatment regions to patient records.

#### 5. INTENDED USE

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

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The technological characteristics of the D-ACTOR® 200 device and the predicate devices are substantially equivalent in that each device is designed to use pressurized air pulses to accelerate a projectile within a guiding tube that hits a skin-contacting steel activator. When the projectile impacts the activator, slowrising, low-amplitude pressure pulses are generated. Standard coupling gel is used to reduce the loss of pulse amplitude to surrounding air. The D-ACTOR® 200 and the predicate devices employ the same principles of operation. The D-ACTOR® 200 is substantially equivalent in function, purpose and design to the predicate devices and other legally marketed therapeutic massagers and vibrators.

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#### 7. PERFORMANCE TESTING

Verification and validation testing was performed and demonstrated that the D-ACTOR® 200 meets the design specifications and is safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed.

The D-ACTOR® 200 software was validated and demonstrated to be of a Moderate level of concern; while hazard analysis / risk management was performed and demonstrated that all risks are mitigated to an acceptable level. The skin contacting component was tested for biocompatibility and found to conform to elements of ISO 10993-1:2003. The D-ACTOR® 200 was tested and demonstrated to conform to the general safety requirements of IEC 60601-1:2012 (Ed. 3.1); as well as the electromagnetic compatibility requirements of IEC 60601-1-2:2007 (3rd Ed.).

In-vitro testing was performed to determine applicator displacement, force and penetration depth and was demonstrated to be equivalent to the AW module (i.e., D-ACTOR provided as OEM) of the predicate devices. Ultrasonic energy comprises approximately 5% of D-ACTOR® 200 total output and this parameter was evaluated by employing modified protocols from IEC 61846. Those tests demonstrated energy flow densities (ED) of 0.176mJ/mm2 at 3 bar pressure (same ED as the predicates) and 0.284mJ/mm2 at 5 bar pressure.

There are no performance standards applicable to the D-ACTOR device adopted under Section 514 of the Act. However, in addition to the international consensus standards cited above, the D-ACTOR® 200 also complies with the applicable requirements of the following international standards:

- ISO 14971:2000/A1:2003: Medical devices: Application of risk management ● to medical devices.
- IEC 62304:2006: Medical Device Software Software Life Cycle Process. ●
- IEC 61000-3-2:2000: Electromagnetic compatibility (EMC): Limits Limits ● for harmonic current emission.
- . IEC 61000-3-3:2000: Electromagnetic compatibility (EMC): Limits -Limitation of voltage changes, voltage fluctuations and flicker in public lowvoltage supply systems.

The performance testing demonstrated that the D-ACTOR® 200 is substantially equivalent to the predicate devices and that it is safe and effective for its intended use. The table below compares D-Actor® 200 characteristics to the predicate devices.

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### Substantial Equivalence Comparison

| Product Characteristic | D-Actor® 200 | AW Module of Predicates<br>Dermablate & TattooStar |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | *Relief of minor muscle aches and pains<br>*Temporary increase in local blood circulation<br>*Activation of connective tissue | Same |
| Modes of Action | Radial pressure waves, or extracorporeal pulse<br>activation respectively | Same |
| Mechanisms of Action | Pneumatically generated vibrations | Same |
| Maximum and Minimum intensity<br>settings | 1-5bar | 1-5bar and 1-3bar |
| Number and size of treatment<br>applicator heads | 4: 6mmOD, 15mmOD, 20mmOD, 35mmOD | 3: 6mmOD, 15mmOD, 20mmOD<br>and<br>2: 20mmOD, 35mmOD |
| Maximum and minimum<br>displacements of applicator heads | 0.6 – 2.0mm | 0.6 – 2.0mm and 2.0mm |
| Type of application (e.g.,<br>continuous vibration at a fixed<br>frequency); | Continuous vibration at a fixed frequency | Same |
| Maximum and minimum vibration<br>frequency | 1-21Hz | 0.5-21Hz and 0.5-3Hz |
| Driving Power | 1-5bar | 1-5bar and 1-3bar |
| Power Supply | 500VA | Same |
| Maximum penetration depth | 32.3mm | 17mm and 32.3mm |
| Energy flow density | Values of ultrasonic pulse:<br>5bar/0.284mJ/mm²<br>3bar/0.176mJ/mm² | Value of ultrasonic pulse:<br>3bar/0.176mJ/mm² |
| Operating mode | Continuous | Same |
| Projectile mass (g) | 3 | Same |
| Pulse repeat rate (1/s) | 1-21Hz | 0.5-21Hz and 0.5-3Hz |
| Number of pulses (min and max) | Variable | Same |
| Maximum operating temperature | 10-40°C | Same |
| Type of acoustic wave<br>generation | Pneumatic/ballistic | Same |
| Positive peak pressure<br>amplitude (MPa) | Values of ultrasonic pulse:<br>5bar/18.5MPa<br>3bar/13.4MPa | Value of ultrasonic pulse:<br>3bar/13.4MPa |
| Negative peak pressure amplitude<br>(MPa) | Values of ultrasonic pulse:<br>5bar/6.8MPa<br>3bar/5.0MPa | Value of ultrasonic pulse:<br>3bar/5.0MPa |
| Derived focal acoustic pulse<br>energy (mJ) | Values of ultrasonic pulse:<br>5bar/6.5mJ<br>3bar/2.4mJ | Value of ultrasonic pulse:<br>3bar/2.4mJ |
| Derived pulse-intensity<br>integral, integrated over<br>total temporal integration limits<br>(mJ/mm2) | Values of ultrasonic pulse:<br>5bar/0.284mJ/mm²<br>3bar/0.176mJ/mm² | Value of ultrasonic pulse:<br>3bar/0.176mJ/mm² |
| Rise time (ns) | Ultrasonic pulse: 2.5µs<br>Sonic pulse: 25µs - 2.5ms | Same |
| Compressional pulse<br>duration (us) | Ultrasonic pulse: 5.0µs<br>Sonic pulse: 50µs - 5.0ms | Same |