(598 days)
Not Found
No
The device description focuses on standard electrical stimulation technology with user-controlled settings and a digital interface. There is no mention of AI, ML, or any adaptive or learning algorithms.
Yes
The device description and intended use clearly state that it is a transcutaneous electro-stimulation device for pain relief and management, which falls under the definition of a therapeutic device.
No
The device description clearly states its purpose as symptomatic relief and management of pain through transcutaneous electro-stimulation, not for diagnosing conditions.
No
The device description clearly states it is a "micro-current transcutaneous electro-stimulation device" that is "handheld, AA battery-operated portable device" with "electrodes" and "controls and visual indicators located on the upper side of the case and on the upper cover." This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Pro-Sport™ Function: The Pro-Sport™ device is a transcutaneous electro-stimulation device. It applies electrical currents to the body through electrodes placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use is for pain relief and management, which is achieved through direct electrical stimulation of the body, not through laboratory testing of samples.
The description clearly indicates it's a device that interacts directly with the body for therapeutic purposes, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Pro-Sport™ is indicated for:
- . symptomatic relief and management of chronic, intractable pain
- adjunctive treatment in the management of post-surgical and post-traumatic pain .
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.
The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can passively place the electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.
The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.
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
Home or clinic
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)
Not Found
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Avazzia, Inc
123096
510(k) Summary
Submitter's Identifications: Manufacturer and Sponsor:
Avazzia, Inc. 13140 Coit Road., Suite 515 Dallas, TX 75240 USA Establishment Registration # 3004839404 Official Contact Person: Tammy Lahutsky Date of Summary Preparation: April 2014
Classifications: TENS, Class II 21 CFR 882.5890 GZJ
Information of the 510(k) Cleared Devices (Predicate Device):
Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -- AV1™, (K062641) 4/30/2007, TENS, Class II 21 CFR 882.5890 GZJ
Intended Use:
Pro-Sport™ is indicated for:
- . symptomatic relief and management of chronic, intractable pain
- adjunctive treatment in the management of post-surgical and post-traumatic pain .
Trade Names of Candidate Devices: Best AV2 Pro Sport™ Device
Description of Candidate Devices:
Description of Candidate Devices as might be found in the labeling or promotional material: The candidate Pro-Sport Avazzia device is a micro-current transcutaneous electro-stimulation device. It is an easy-to-use, handheld, AA battery-operated portable device for use in the home or clinic.
Description of the Candidate Devices - How the devices work:
The device is a portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented.
The user can passively place the electrodes where indicated and apply stimulation for a period of time.
The user controls the output by selecting the preset mode and power setting. The device's controls and visual indicators are located on the upper side of the case and on the upper cover.
The Best-Pro 1™, Best-RSI™, Biomodulator™, Body-Stim™ devices have 4 pre-set modes.
Image /page/0/Picture/20 description: The image shows the word "AVAZIA" in a bold, sans-serif font. The letters are black, and there is a thick black line underlining the entire word. The letters are evenly spaced, and the word is centered in the image.
Patent(s) Pending
www.avazzia.com © Copyright 2014. AVAZZIA. Inc., All Rights Reserved. Avazzia, Inc., 13140 Coit Rd., Ste 515, Dallas, TX 75240 USA tel. 214-575-2820 fax 214-575-2824
MAY 2 3 2014
1
The Pro-Sport™ device incorporates a more sophisticated digital liquid crystal display user interface to help the user select the mode and see parameters like the power level, time, and other information and has one mode that allows practitioners to set up their own therapy signals.
Scientific Concepts that form the basis of the devices:
Various modes in the candidate device are suited for TENS applications.
Design Description: Significant physical and performance characteristics of the device including stimulation output specifications & Summary of the Technological Characteristics Compared to the Predicates are shown below:
Discussion of any different technological characteristics between the devices and the predicate devices:
The candidate device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device as summarized in the table of the technological characteristics.
The differences between the candidate device and the predicate device are:
- the Pro-Sport user-interface implements a menu system that allows the user to select from a ● list of preset modes beyond the 4 modes in the predicate devices
- . the Pro-Sport AVA mode allows the stimulation parameters to be programmed by the user
- . the Pro-Sport displays values in a digital display format instead of an LED that represents a range of values which allows values to be displayed in smaller incremental values
| Summary of Technical Characteristics | ||
|---|---|---|
| (i.e., design, material, chemical composition, energy source) | ||
| Parameter | Avazzia Candidate Device | Predicate Devices |
| Labeling Claims Indication | ||
| for Use | ||
| See Note 1 | TENS | TENS |
| Device Name and Model | Avazzia Pro Sport™ | Best-Pro 1, Best-RSI, |
| Biomodulator, and Body Stim | ||
| 510(k) Number | K123099 | K062641 |
| Manufacturer | Avazzia, Inc. | Avazzia, Inc. |
| Power Source(s): Number, | ||
| Size and Type of Batteries | 2 - 1.5 V | |
| AA batteries | 2 - 1.5 V | |
| AA batteries | ||
| Number of Output Modes | 24 | 4 models = 4 |
| Low Battery indication? | Yes | Yes |
| Timer Range (minutes) | 60 minutes | 60 minutes |
| Compliance with Voluntary | ||
| Standards? | Yes | Yes |
AVAZIA
Patent(s) Pending
© Copyright 2014, AVAZZIA, Inc., All Rights Reserved. www.avazzia.com Avazzia, Inc., 13140 Coit Rd., Ste 515, Dallas, TX 75240 USA tel. 214-575-2820 fax 214-575-2824
2
| Summary of Technical Characteristics
| (i.e., design, material, chemical composition, energy source) | ||||
|---|---|---|---|---|
| Parameter | Avazzia Candidate Device | Predicate Devices | ||
| Compliance with 21 CFR | ||||
| 898? | Yes | Yes | ||
| Weight (lbs., oz.) | 7oz | 7oz | ||
| Dimensions (in.) | ||||
| [W x H x D] | 2.6" X 1.35" X 4.7" | 2.6" X 1.35" X 4.7" | ||
| Housing Materials and | ||||
| Construction | Handheld ABS plastic housing | |||
| with a Polypac plastic nameplate | ||||
| and onboard electrodes | Handheld ABS plastic housing | |||
| with a Polypac plastic | ||||
| nameplate and onboard | ||||
| electrodes | ||||
| User Interface Display | LCD | LEDs | ||
| Design material | PCBs inside plastic case housing | PCBs inside plastic case | ||
| housing | ||||
| Energy type | Electro-stimulation | Electro-stimulation |
| Stimulation Output Specifications | ||
|---|---|---|
| Avazzia Candidate Device | Predicate Devices | |
| Pulse Duration | 0.1 - 1.15 mS | 0.1 - 1.15 mS |
| Pulse Frequency | 0.5 to 2500 Hz | 0.5 to 2500 Hz |
| Output Voltage | 20 – 650 V | 20 - 650 V |
| Current Amplitude TENS | 0 - 90mA | 0 - 90mA |
| Timeout | 60 minutes | 60 minutes |
| Waveform | Pulsed, damped, asymmetric | |
| biphasic sinusoidal | Pulsed, damped, asymmetric | |
| biphasic sinusoidal | ||
| Number of modes of | ||
| stimulation | 14 preset modes including AVA | |
| user programmable mode | 4 preset modes |
Summary of how the technological characteristics of your device compare to the predicate device:
- Do the candidate Devices have the same indications for use? Yes
- Do the candidate Devices have the same Technological Characteristics? Yes
- . Do the candidate devices pose any new questions regarding safety of effectiveness? No
- . Do the candidate devices have accepted scientific methods for evaluating safety and effectiveness? Yes
- . Do the candidate devices demonstrate no diminishment of performance? Yes
The Avazzia device technological specifications are the same; therefore, differences in user interface do not pose new questions regarding safety and effectiveness.
ΑνΑΖΙΑ Patent(s) Pending www.avazzia.com © Copyright 2014, AVAZZIA, Inc., All Rights Reserved. Avazzia, Inc., 13140 Coit Rd., Ste 515, Dallas, TX 75240 USA tel. 214-575-2820 fax 214-575-2824
3
Conclusions:
The devices have intended uses and technological characteristics that are substantially equivalent to the predicate devices Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 1™, Model BEST -A V ]™ (K062641), since their purpose, application, mechanism of action, utilized materials, basic technical characteristics, functionality and manufacturing processes are similar. Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices.
Accessories
Self-adhesive conductive electrode pads Finger electrode Cutaneous electrodes Soft tissue electrodes - Y electrodes Comb electrode Small Circular Electrode: Common name: Pencil electrode Lead wires
The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff -May 11, 2005.
The four candidates devices and accessories meet safety requirements IEC 60601-1 and requirements EMC:IEC 60601-1-2.
Conclusions:
The device has intended uses and technological characteristics that are substantially equivalent to the predicate devices Body-Stim™, Biomodulator™, Best-RSI™, Best-Pro 17M, Model BEST -AVI™ (K062641).
Image /page/3/Picture/10 description: The image shows the logo and contact information for Avazzia. The logo is in bold, and the website address is listed below it. The copyright information indicates that the image is copyrighted in 2014 by Avazzia, Inc., and all rights are reserved. The address is 13140 Coit Rd., Ste 515, Dallas, TX 75240 USA, and the phone number is 214-575-2820, with a fax number of 214-575-2824.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2014
Avazzia, Inc. c/o Tammy Lahutsky Regulatory Affairs 13140 Coit Road, Suite 515 Dallas. TX 75240
Re: K123099
Trade Name: Best AV2 Pro-Sport™ Regulation Number: 21 CFR 882.5950 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: May 14, 2014 Received: May 16, 2014
Dear Ms. Lahutsky:
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. Iisting 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 801); medical device reporting (reporting of medical
. , ,
5
Page 2 of 2 - Ms. Tammy Lahutsky
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K123099
Device Name Best AV2 Pro Sport™ Device
Indications for Use (Describe)
· symptomatic relief and management of chronic, intractable pain
· adjunctive treatment in the management of post-surgical and post-traumatic pain
.
. .
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
S Date: 2014.05.23 09:42:33 -04'00'
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