(163 days)
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No
The document describes a standard electrical stimulator with adjustable parameters and protocol selection, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is indicated for symptomatic relief of pain, relaxation of muscle spasms, maintaining and increasing range of motion, and increasing local blood circulation, which are all therapeutic applications.
No
The device is an Interferential Stimulator used for therapeutic purposes such as pain relief, muscle relaxation, and increasing range of motion. Its intended use and functions (producing electrical current for stimulation) do not involve assessing, diagnosing, or monitoring a patient's condition.
No
The device description explicitly states it is an "Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin". This indicates the device includes hardware components (stimulator, lead wires, electrodes) that deliver electrical current, making it a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to therapeutic applications (pain relief, muscle relaxation, increasing range of motion, increasing blood circulation). IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The device is an electrical stimulator that applies current to the skin. This is a physical therapy or pain management device, not a device that analyzes biological samples.
- Lack of Diagnostic Information: The document does not mention any analysis of biological samples, diagnostic results, or information used for diagnosis.
The device is clearly described as an Interferential Stimulator used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:
- Symptomatic relief of post-surgical and/or post traumatic acute pain
- Symptomatic relief of chronic intractable pain
- Relaxation of muscle spasms
- Maintaining and increasing range of motion
- Increases local blood circulation
Product codes (comma separated list FDA assigned to the subject device)
LIH
Device Description
The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.
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
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Intended User / Care Setting
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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.)
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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.
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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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
June 12, 2019
Vision Quest Industries, Inc. Mohamed Ouerghi Director of QA/RA 1390 Decision Street, Suite A Vista, California 92081
Re: K183692
Trade/Device Name: Avid IF2 Interferential Stimulator, Model AV-IF19A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: LIH Dated: March 12, 2019 Received: March 14, 2019
Dear Mohamed Ouerghi:
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.
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
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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 (OS) 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 mediation-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 Carlos Pena, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183692
Device Name
Avid IF2 Interferential Stimulator, Model AV-IF19A
Indications for Use (Describe)
The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:
- -Symptomatic relief of post-surgical and/or post traumatic acute pain
- -Symptomatic relief of chronic intractable pain
-Relaxation of muscle spasms
-Maintaining and increasing range of motion
-Increases local blood circulation
| 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) |
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510(k) SUMMARY
| 510(k) Owner: | Vision Quest Industries, Inc.
18011 Mitchell South,
Irvine, CA, 92614 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mohamed Ouerghi
Director of QA/RA
Vision Quest Industries, Inc.
Phone 760-477-8201
Mobile 760-691-0168
Fax 760-727-5950
mouerghi@vqorthocare.com |
| Date Summary Prepared: | 12/24/ 2018 |
| Proprietary Name: | Avid IF2 Interferential Stimulator,
Model AV-IF19A |
| Device Name and Classification: | Interferential Current Therapy Stimulator, Class II,
21 CFR 882.5890, Product Code LIH |
| Predicate Devices: | T.E.A.R. Tech3 by Vision Quest Industries, Inc.
K030507 and K090532 |
| Device Description: | The Avid IF2, Model AV-IF19A is an Interferential
Stimulator that produces a low electrical current that
is transmitted via lead wires to electrodes placed on
the skin in the area predetermined by a clinician.
Operating parameters can be adjusted throughout
their range by a trained clinician but the end-user is
limited to protocol selection and amplitude. The user
interface consists of an LCD display and a keypad. |
| Statement of Intended Use: | The Avid IF2 Interferential Stimulator, Model AV-
IF19A, is indicated for use in the following
applications:
☐ Symptomatic relief of post-surgical and/or
post traumatic acute pain
☐ Symptomatic relief of chronic intractable
pain
☐ Relaxation of muscle spasms
☐ Maintaining and increasing range of motion
☐ Increases local blood circulation |
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Substantial Equivalence
The Avid IF2 is a generation design improvement to the company's previous device, the T.E.A.R. Tech3 IF/Muscle Stimulator. The company's previous models combined many stimulation modes in one device. The Avid IF2 only has the IF mode. Therefore, as far as modes of stimulation is concerned the equivalency will be established by focusing on the IF mode.
Indications for Use
The Avid IF2 has the same indications for use as the predicate devices when these are used in IF mode.
Device Functionality Equivalency
- Like the predicate devices, the new device uses a microcontroller and LCD ● display to create a user friendly interface.
- The Avid IF2 Stimulator is self-contained and includes two non-removable, rechargeable lithium ion batteries and an external power supply like the predicates.
- The Avid IF2 Stimulator also contains a single output jack for both output channels, and a user interface consisting of a touchscreen LCD for improved user experience. The device software contains self-tests for proper function and readiness. The electrodes used for stimulation are the same used with the predicates. The lead wires are of proprietary design.
- The user is able to select presets on the device for the desired treatment and waveform output based upon prescriptions from the treating clinician. This is accomplished by displayed menu items and selection through the device interface. If desired. the user will be able to upload data stored on the device to Vision Quest Industries, Inc. (via wired interface or wirelessly). The device has the ability to move from preset to preset without patient interaction. This allows for easy use of physician prescribed protocols.
Device Characteristics and Output Specifications Equivalency
The Avid IF2 only has the IF mode. The first predicate device from Vision Quest Industries, Inc. has three modes of stimulation: High Volt Pulsed Current (HVPC), Interferential (IF), and a Neuromuscular Electrical Stimulation (NMES) mode. The second predicate device from Vision Quest Industries, Inc. has four modes of stimulation: High Volt Pulsed Current (HVPC), Interferential (IF), Neuromuscular Electrical Stimulation (NMES) mode, and Pulsed Direct Current (PDC).
The next two tables compare the Avid IF 2 to its predicates.
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| 510(k) Number | K030507 | K090532 | Unassigned |
|---|---|---|---|
| Device Name | T.E.A.R. Tech3 | T.E.A.R. Tech3 | Avid IF2 |
| Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. |
| Power Source | 1 battery pack consisting of a | ||
| Lithium-ion battery or | |||
| 2 battery packs consisting of 3 | |||
| 'AA' alkaline cells each or | |||
| external power supply | 1 battery pack consisting of a | ||
| Lithium-ion battery or 2 | |||
| battery packs consisting of 3 | |||
| 'AA' alkaline cells each or | |||
| external power supply | 2 internal, non-removable, | ||
| rechargeable Lithium-ion | |||
| batteries or external power | |||
| supply | |||
| -Method of Line Current | |||
| Isolation | Use of UL2601-1 approved | ||
| external power supply | Use of UL2601-1 approved | ||
| external power supply | Use of UL2601-1 approved | ||
| external power supply | |||
| -Patient Leakage Current | |||
| -Normal Condition | |||
| (μΑ) |