(133 days)
Not Found
No
The description focuses on mechanical and software features for controlling the device and managing patient data, with no mention of AI or ML algorithms for analysis, prediction, or adaptation.
Yes
The device is described as a "Vibration Massage System" intended for "Relief of minor muscle aches and pains," "Temporary increase in local blood circulation," and "Activation of connective tissue." These are therapeutic claims.
No
The device description and intended use indicate that the D-ACTOR® 200 Vibration Massage System is used for therapeutic purposes (relief of pain, increased circulation, activation of connective tissue) and not for identifying or investigating a disease, injury, or other condition.
No
The device description clearly outlines multiple hardware components including a handpiece, control unit, mains cable, and optional foot switch and tablet PC. While it includes software, it is not solely software.
Based on the provided information, the D-ACTOR® 200 Vibration Massage System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the relief of muscle aches and pains, increasing local blood circulation, and activating connective tissue. These are therapeutic and physical effects applied directly to the body.
- Device Description: The device works by generating pressure pulses that are applied to the skin. This is a physical mechanism of action.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. The D-ACTOR® 200 does not fit this description.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
ISA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Various muscle groups
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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.
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|__ | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 |
4
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.
5
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.
6
Substantial Equivalence Comparison
| Product Characteristic | D-Actor® 200 | AW Module of Predicates
Dermablate & TattooStar |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | *Relief of minor muscle aches and pains
*Temporary increase in local blood circulation
*Activation of connective tissue | Same |
| Modes of Action | Radial pressure waves, or extracorporeal pulse
activation respectively | Same |
| Mechanisms of Action | Pneumatically generated vibrations | Same |
| Maximum and Minimum intensity
settings | 1-5bar | 1-5bar and 1-3bar |
| Number and size of treatment
applicator heads | 4: 6mmOD, 15mmOD, 20mmOD, 35mmOD | 3: 6mmOD, 15mmOD, 20mmOD
and
2: 20mmOD, 35mmOD |
| Maximum and minimum
displacements of applicator heads | 0.6 – 2.0mm | 0.6 – 2.0mm and 2.0mm |
| Type of application (e.g.,
continuous vibration at a fixed
frequency); | Continuous vibration at a fixed frequency | Same |
| Maximum and minimum vibration
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:
5bar/0.284mJ/mm²
3bar/0.176mJ/mm² | Value of ultrasonic pulse:
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
generation | Pneumatic/ballistic | Same |
| Positive peak pressure
amplitude (MPa) | Values of ultrasonic pulse:
5bar/18.5MPa
3bar/13.4MPa | Value of ultrasonic pulse:
3bar/13.4MPa |
| Negative peak pressure amplitude
(MPa) | Values of ultrasonic pulse:
5bar/6.8MPa
3bar/5.0MPa | Value of ultrasonic pulse:
3bar/5.0MPa |
| Derived focal acoustic pulse
energy (mJ) | Values of ultrasonic pulse:
5bar/6.5mJ
3bar/2.4mJ | Value of ultrasonic pulse:
3bar/2.4mJ |
| Derived pulse-intensity
integral, integrated over
total temporal integration limits
(mJ/mm2) | Values of ultrasonic pulse:
5bar/0.284mJ/mm²
3bar/0.176mJ/mm² | Value of ultrasonic pulse:
3bar/0.176mJ/mm² |
| Rise time (ns) | Ultrasonic pulse: 2.5µs
Sonic pulse: 25µs - 2.5ms | Same |
| Compressional pulse
duration (us) | Ultrasonic pulse: 5.0µs
Sonic pulse: 50µs - 5.0ms | Same |