(253 days)
Not Found
No
The description focuses on standard electrical stimulation therapy and temperature-based feedback for current level adjustment, without mentioning AI or ML algorithms.
Yes
The intended use section explicitly states the device is intended for the "symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain," which are therapeutic applications.
No
The provided text indicates that the device is intended for symptomatic relief of pain through electrical stimulation and Interferential Current Therapy. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the VT-300 device is comprised of hardware components including a PCBA, a lithium-ion battery, and a polycarbonate housing, in addition to the mobile application software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain" through electrical stimulation. This is a therapeutic use, not a diagnostic one.
- Device Description: The device delivers electrical current to the patient's body via electrodes. It measures temperature to adjust the therapy level. This is consistent with a therapeutic device, not a device that analyzes samples from the body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.
Product codes (comma separated list FDA assigned to the subject device)
LIH
Device Description
VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height. Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases. The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.
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
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)
VT-300 system and software verification & validation has been conducted to ensure design output meets the design input requirements. In addition, VT-300 complies with the following FDA recognized consensus standards: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2 Edition 4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. IEC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 8, 2024
Artaflex Inc. Gerry Iuliano Owner 181 Whitehall Drive Markham, Ontario L3T 9T1 Canada
Re: K231575
Trade/Device Name: Vecttor VT-300 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: LIH Dated: February 8, 2024 Received: February 8, 2024
Dear Gerry Iuliano:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Robert Kang -S
for Pamela Scott, MS 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
2
Indications for Use
510(k) Number (if known) K231575
Device Name Vecttor VT-300
Indications for Use (Describe)
Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
VECTTOR VT-300
Submitter's name, address, telephone number, a contact person:
Gerry Iuliano, Owner
Artaflex Inc. - 181 Whitehall Dr., Markham Ontario L3T 9T1 Canada.
TEL: 905.470.0109 | FAX: 905.470.0621
Date the summary was prepared;
February 6, 2024
Name of the device
Trade Name: VECTTOR VT-300 Common Name: Interferential Current Therapy Device Classification Name: Interferential Current Therapy Product Code: LIH
Identification of the legally marketed device to which the submitter claims equivalence.
K121662 VECTTOR VT-200
Description of the device
VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height.
Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases.
The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.
4
A statement of the intended use of the device
Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and/or management of post-traumatic or post-surgical pain.
Comparison of the technological characteristics with predicate device
Vecttor VT-300 represents a modified version of predicate device Vecttor VT-200 (K121662) implementing design changes requested by applicant of K121662 for VT-200 predicate device, Dr. Donald Rhodes:
- Modernized redesign including reduced size, wiring, and relocation of connection ports .
- . Change power supply to on-board battery
- Change thermistor temperature sensor to digital temperature sensor .
- Change SD card with cloud-based application for managing patient treatments and data .
- Change device display screen and tactile buttons interface to mobile device screen and . software application
VT-300 has the same intended use and similar technological characteristics and principles of operation as K121662 for VT-200 predicate device. Any differences in technological characteristics potentially raising questions of safety or effectiveness have been addressed through Bench Performance Testing and compliance with FDA recognized consensus standards.
5
| OUTPUT SPECIFICATIONS | |||
|---|---|---|---|
| # | Characteristics | Subject Device | Predicate Device |
| (K121662) | |||
| 0 | 510(k) Number | K231575 | K121662 |
| 1 | Waveform (e.g., pulsed | ||
| monophasic, biphasic) | Biphasic | Biphasic | |
| 2 | Shape (e.g., rectangular, | ||
| spike, rectified sinusoidal) | Pure Sinusoid | Pure Sinusoid | |
| 3 | Maximum Output Voltage | ||
| (volts p/p) | 4.36 @ 500 Ω | ||
| 6.72 @ 2 kΩ | |||
| 8.08 @10 kΩ | 4.36 @ 500 Ω | ||
| 6.72 @ 2 kΩ | |||
| 8.08 @10 kΩ | |||
| 4 | Maximum Output Current (mA | ||
| RMS) | 3.08 @ 500 Ω | ||
| 1.19 @ 2 kΩ | |||
| 0.29 @10 kΩ | 3.08 @ 500 Ω | ||
| 1.19 @ 2 kΩ | |||
| 0.29 @10 kΩ | |||
| 5 | Pulse Width (µsec) | Continuous Sine Wave | Continuous Sine Wave |
| 6 | Frequency (Hz) [or Rate (pps)] | 1500Hz – 1580Hz | |
| 2500Hz – 2580Hz | 1500Hz – 1580Hz | ||
| 2500Hz – 2580Hz | |||
| 7 | For interferential modes only: - | ||
| Beat Frequency (Hz) | 1000Hz | 1000Hz | |
| 8 | For multiphasic waveforms | ||
| only: - Symmetrical phases? | Yes | Yes | |
| 9 | - Phase Duration (include | ||
| units) (state range, if | |||
| applicable) (both phases, if | |||
| asymmetrical) | N/A | N/A | |
| 10 | Net Charge (mC per pulse) | 0 @ 500 Ω | |
| Outputs have no DC | |||
| output by means of DC | |||
| blocking capacitor and | |||
| isolation transformers at | |||
| outputs | 0 @ 500 Ω | ||
| Outputs have no DC | |||
| output by means of DC | |||
| blocking capacitor and | |||
| isolation transformers at | |||
| outputs | |||
| 11 | Maximum Phase Charge, (µC) | ||
| @500 Ω | 0.93 uC | 0.93 uC | |
| 12 | Maximum Current Density, | ||
| (mA/cm², r.m.s.) @500 Ω | 0.39 | 0.39 | |
| 13 | Maximum Power Density, | ||
| (W/cm²) using smallest | |||
| electrode conductive surface | |||
| area @500 Ω | 0.6 | 0.6 | |
| 14 | Burst Mode | N/A | N/A |
| 15 | ON Time (seconds) | 5 | 5 |
| 16 | OFF Time (seconds) | 1 | 1 |
| 17 | Average DC current through | ||
| electrodes when device is on | |||
| but no pulses are applied | Zero | Zero | |
| Mode or Program Name | 1 | 1 | |
| Duration of primary | |||
| (depolarizing) phase (msec) | N/A | N/A | |
| Maximum Average Current ( | |||
| average absolute value), mA | |||
| @500 Ω | 0 | ||
| (No DC contents | |||
| present) | 0 | ||
| (No DC contents | |||
| present) |
6
A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
VT-300 system and software verification & validation has been conducted to ensure design output meets the design input requirements. In addition, VT-300 complies with the following FDA recognized consensus standards:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- . IEC 60601-1-2 Edition 4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- EC 60601-1-11 Edition 2.0 2015-01 Medical electrical equipment Part 1-11: General . requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment Part 2-10: Particular . requirements for the basic safety and essential performance of nerve and muscle stimulators
- . IEEE ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence
7
A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence.
No clinical tests are being submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence
Conclusions
VT-300 has the same intended use as its predicate device. Any differences in technological characteristics potentially raising questions of safety or effectiveness have been addressed through Bench Performance Testing and compliance with FDA recognized consensus standards. In conclusion, VT-300 is substantially equivalent to VT-200.