(77 days)
Not Found
No
The device description and summary of performance studies focus on electrical stimulation parameters and comparison to predicate devices, with no mention of AI or ML.
Yes
The device is intended for use in applications that involve the symptomatic relief of pain, relaxation of muscle spasms, increasing range of motion, increasing blood circulation, prevention of venous thrombosis, prevention or retardation of disuse atrophy, and muscle re-education. These are all therapeutic applications.
No
This device is a therapeutic device that provides interferential and neuromuscular stimulation for pain relief, muscle relaxation, and prevention of disuse atrophy. It does not diagnose any conditions.
No
The device description explicitly states it is a "combination therapy device" and 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 for generating and delivering electrical stimulation, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Avid CT2, Model AV-CT20A is a combination therapy device that uses electrical stimulation applied to the skin. It directly interacts with the patient's body for therapeutic purposes (pain relief, muscle stimulation, etc.).
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens taken from the patient.
The device's function and intended use clearly fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Interferential Stimulation can be used 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
- Maintain or increase range of motion
- Increase local blood circulation
Neuromuscular Stimulation can be used in the following applications:
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
- Prevention or retardation of disuse atrophy
- Muscle-re-education
Product codes (comma separated list FDA assigned to the subject device)
IPF, LIH
Device Description
The Avid CT2, Model AV-CT20A is a combination therapy device. Like its predicate Avid IF2, it 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. The primary difference between the two devices is the addition of user-adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator.
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 (Part 21 CFR 801 Subpart D)
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
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11/16/2020
Vision Quest Industries Inc. Mohamed Ouerghi Director of QA/RA 1390 Decision Street. Suite A Vista, California 92081
Re: K202490
Trade/Device Name: Avid CT2 Neuromuscular and Interferential Stimulation System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, LIH Dated: October 2, 2020 Received: October 5, 2020
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
1
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,
Xiaorui Tang, Ph.D. Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices 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) K202490
Device Name
Avid CT2, Neuromuscular and Interferential Stimulation System, Model AV-CT20A
Indications for Use (Describe)
Interferential Stimulation can be used 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
- Maintain or increase range of motion
- Increase local blood circulation
Neuromuscular Stimulation can be used in the following applications:
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
- · Prevention or retardation of disuse atrophy
- · Muscle-re-education
| 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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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: | 8/26/2020 |
| Proprietary Name: | Avid CT2 Neuromuscular and
Interferential Stimulation System,
Model AV-CT20A |
| Device Name and Classification: | Neuromuscular and Interferential Stimulator, Class II,
21 CFR 882.5890, Product Code LIH and
21CFR 890.5850, Product Code IPF |
| Predicate Devices: | Surgi Stim/T.E.A.R. Tech by Vision Quest Industries, Inc.
K982388 and
Avid IF2 by Vision Quest Industries, Inc.K183692 |
| Device Description: | The Avid CT2, Model AV-CT20A is a combination therapy
device. Like its predicate Avid IF2, it 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. The primary
difference between the two devices is the addition of user-
adjustable parameters that allow the existing interferential
waveform to turn on and off within a small, preselected range to
provide necessary control for neuromuscular stimulation. This
same method of gating the interferential on and off was used in
VQ's previous Surgi Stim stimulator. |
4
Statement of Intended Use:
The Avid CT2 Neuromuscular and Interferential Stimulator, Model AV-CT20A. is indicated for use in the following applications:
Interferential Stimulation can be used 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
- · Maintain or increase range of motion
- Increase local blood circulation
Neuromuscular Stimulation can be used in the following applications:
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
- · Prevention or retardation of disuse atrophy
- Muscle-re-education
Substantial Equivalence
The Avid CT2 is a minor product enhancement to the Avid IF2. The primary difference between the two devices is the addition of user-adjustable parameters that allow the existing interferential waveform to turn on and off within a small, preselected range to provide necessary control for neuromuscular stimulation. This same method of gating the interferential on and off was used in VQ's previous Surgi Stim stimulator.
The Avid CT2 is equivalent to the Avid IF2 in all areas except these new user-adjustable parameters. For those parameters we are substantially equivalent to VO's Surgi Stim stimulator..
Indications for Use
The Avid CT2 has the same indications for use as the Avid IF2 when these are used in IF mode. The Avid CT2 has the additional indications for use as allowed by neuromuscular stimulators.
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 and CT2 Stimulator is self-contained and includes two non-removable, rechargeable lithium ion batteries and an external power supply like the predicates.
- The Avid IF2 and CT2 Stimulator also contain a single output jack for both output channels, and a user interface consisting of a touchscreen LCD for improved user experience. 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 Ouest 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.
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Device Characteristics and Output Specifications Equivalency
The Avid IF2 only has the IF mode whereas the Avid CT2 has an additional neuromuscular mode. The second 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 tables below compare the Avid CT2 to the two predicate devices.
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Device Characteristics Comparison
| 510(k) Number | K982388 | K183692 | Unassigned |
|---|---|---|---|
| Device Name | Surgi Stim /T.E.A.R. Tech | Avid IF2 | Avid CT2 |
| Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. |
| Power Source | 2 battery packs consisting of | ||
| 4 'AA' alkaline cells each or | |||
| external power supply | 2 internal, non-removable, | ||
| rechargeable Lithium-ion | |||
| batteries 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) |