(261 days)
No
The description focuses on traditional electrotherapy, ultrasound, laser, and biofeedback modalities with standard functionalities and validated software. There is no mention of AI or ML algorithms for data analysis, treatment optimization, or predictive capabilities.
Yes
The "Intended Use / Indications for Use" section lists numerous medical indications for the device, such as "Relaxation of muscle spasms," "Symptomatic relief or management of chronic, intractable pain," and "Stroke rehab by muscle re-education," which are therapeutic goals. The "Device Description" also refers to it as a "Clinical Therapy System."
Yes
The "Intended Use / Indications for Use" section explicitly states "For EMG - To determine the activation timing of muscles..." and "An indication of the force produced by muscle for control and maintenance of muscle contractions," which are diagnostic functions.
No
The device description explicitly states it is a "combination device" offering "muscle stimulation, ultrasound, laser and biofeedback modalities." These are hardware-based therapies, not solely software functions. The device also mentions a "therapy system cart," "leadwire management system," and compliance with hardware-related standards like IEC 60601-1.
Based on the provided information, the Vectra Neo Clinical Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Vectra Neo's Function: The Vectra Neo Clinical Therapy System is a physical therapy device that applies various forms of energy (electrical stimulation, ultrasound, laser) and biofeedback directly to the patient's body for therapeutic purposes. It is used for pain relief, muscle rehabilitation, increasing circulation, and other physical therapy applications.
- Intended Use: The stated intended uses clearly describe therapeutic applications on the patient's body, not the analysis of biological specimens.
- Device Description: The description details the different modalities (electrotherapy, ultrasound, laser, sEMG biofeedback) and their application to the patient.
- Lack of Specimen Handling: There is no mention of the device collecting, processing, or analyzing any biological specimens.
Therefore, the Vectra Neo Clinical Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Vectra Neo Clinical Therapy System is indicated for:
For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
. Relaxation of muscle spasms
. Prevention or retardation of disuse atrophy
Increasing local blood circulation .
. Muscle re-education
. Maintaining or increasing range of motion
. lmmediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN
Symptomatic relief or management of chronic, intractable pain .
Post-traumatic acute pain .
. Post-surgical acute pain
For DC Continuous Mode
Relaxation of muscle spasm
For FES
. Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For EMG triggered Stim
. Stroke rehab by muscle re-education
. Relaxation of muscle spasms
. Prevention or retardation of disuse atrophy
. Increase local blood circulation
. Muscle re-education
. Maintaining or increasing range of motion
For EMG
To determine the activation timing of muscles for: .
Retraining of muscle activation -
Coordinating of muscle activation -
. An indication of the force produced by muscle for control and maintenance of muscle contractions ·
Relaxation muscle training
Muscle re-education -
For Ultrasound
.
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
. Relief of pain, muscle spasms and joint contractures
Relief of pain, muscle spasms and joint contractures that may be associated with :
-Adhesive capsulitis
Bursitis with slight calcification l
-Myositis
Soft tissue injuries
Shortened tendons due to past injuries and scar tissues -
- Relief of sub-chronic and chronic pain and joint contractures resulting from: .
Capsular tightness -
Capsular scarring -
For Infrared Lamp (laser)
To provide topical heating for the following:
Temporary increase in local blood circulation .
Temporary relief of minor muscle and joint aches, pains and stiffness
. Relaxation of muscles
. Temporary relief of muscle spasms
. Temporary relief of minor pain and stiffness associated with arthritis
Product codes (comma separated list FDA assigned to the subject device)
ILY, IPF, IMG, GZJ, HCC, GZI, LIH
Device Description
The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package.
The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement.
The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use.
The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%.
The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis.
The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.
Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations.
Combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.
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
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)
Performance Testing:
- The device's software has been validated in accordance with the requirements set forth in . the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the software version meets its design requirements.
- . A Usability Study was conducted to validate the usability of the Vectra Neo Clinical Therapy System. The results of the Summative Validation support the instructions for successfully using the device as intended. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.
- . The Vectra Neo Clinical Therapy System was tested and found to comply with the following standards:
- . IEC 60601-1 for basic safety and essential performance
- . IEC 60601-1-2 for electromagnetic compatibility
- . IEC 60601-2-5 for safety of ultrasonic physiotherapy equipment
- . IEC 60601-2-10 for performance of nerve and muscle stimulators
- 트 IEC 60601-2-22 for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60601-2-57 for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (Radiology)
- . IEC 60825-1 for safety of laser products
Additionally, bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities.
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.
Vectra Genisys (K062354), Vectra Genisys Laser System (Intelect XT Laser System) (K040662)
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.
K874469, K852267, K970426, K955246
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
Image /page/0/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger font than the word "GLOBAL", and there is a trademark symbol next to the "O" in "DJO". The logo is black and white.
510(k) Summary
APR 1 0 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K132284
Submitted by:
DIO, LLC 1430 Decision Street Vista, CA 92081
Contact Person:
Lorri Trotter Regulatory Affairs Manager Phone: 760-734-3049 Fax: 760-734-5544 Email: lorri.trotter@djoglobal.com
Vectra Neo Clinical Therapy System
Vectra Neo Clinical Therapy System
Date Summary Prepared:
July 19, 2013
Trade Name:
Common/Usual Name:
Classification Name:
21 CFR 890.5500 Infrared lamp 21 CFR 890.5850 Powered muscle stimulator 21 CFR 890.5860 Ultrasound and Muscle stimulator 21 CFR 882.5890 TENS for pain relief 21 CFR 882.5050 Biofeedback device 21 CFR 882.5810 External functional neuromuscular stimulator Interferential current stimulator Unclassified
Product Code:
- ILY Infrared lamp
- IPF Powered muscle stimulator
- IMG Ultrasound and muscle stimulator
- Transcutaneous electrical nerve stimulator for pain relief GZJ
- HCC Biofeedback device
- GZI External functional neuromuscular stimulator
- LIH Interferential current therapy
1
Traditional 510(k): New Device Vectra Neo Clinical Therapy System
Image /page/1/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The globe is black and white and has a curved line running through it. The text "DJO" is in a bold, sans-serif font, and the text "GLOBAL" is in a smaller, sans-serif font below it.
| Regulatory Class: | Class II * |
|---|---|
| Panels: | 89 – Physical Medicine |
| 84 – Neurology | |
| Predicate Device(s): | Vectra Genisys Laser System (Intelect XT Laser System) |
| (K040662) |
Device Description:
The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package.
Vectra Genisys (K062354)
Clinicians have a variety of choices to best suit the needs of their individual practice. Below is an overview of the system choices/features.
The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement.
The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use.
The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%.
| Model
Number | Description | BNR
(FDA
method) | Standard
Deviation
(BNR) | ERA
(cm²) | ERA Limits
(cm²) | | Beam
Type
(Pattern) | Frequency
(MHz) | Number
of
Crystals | Max.
Output
Power
(W) |
|-----------------|-----------------------------------|------------------------|--------------------------------|--------------|---------------------|-----|---------------------------|--------------------|--------------------------|--------------------------------|
| 27333 | 1 cm²
ultrasound
applicator | 5:1 | 1 | 0.9 | 1 | 0.4 | Collimating | 3.3 | 1 | 1.5 |
| 27334 | 2 cm²
ultrasound
applicator | 5:1 | 1 | 1.8 | 2 | 1.4 | Collimating | 1.0 and
3.3 | 1 | 3.0 |
The following ultrasound applicators are provided with the Vectra Neo Clinical Therapy System:
2
Image /page/2/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The globe is black and white and appears to be divided into sections. The text "DJO" is in a bold, sans-serif font, and the text "GLOBAL" is in a smaller, sans-serif font below it.
| Model
Number | Description | BNR
(FDA
method) | Standard
Deviation
(BNR) | ERA
(cm²) | ERA Limits
(cm²) | | Beam
Type
(Pattern) | Frequency
(MHz) | Number
of
Crystals | Max.
Output
Power
(W) |
|-----------------|------------------------------------|------------------------|--------------------------------|--------------|---------------------|-----|---------------------------|--------------------|--------------------------|--------------------------------|
| | | | | | High | Low | | | | |
| 27335 | 5 cm²
ultrasound
applicator | 5:1 | 1 | 4.0 | 5 | 3 | Collimating | 1.0 and
3.3 | 1 | 6.0 |
| 27336 | 10 cm²
ultrasound
applicator | 5:1 | 1 | 8.5 | 10 | 7 | Collimating | 1.0 and
3.3 | 1 | 15.0 |
The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis.
The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.
Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations.
Combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.
Intended Use:
Vectra Neo Clinical Therapy System is indicated for:
For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- Increasing local blood circulation .
- . Muscle re-education
- . Maintaining or increasing range of motion
- . lmmediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HAN
- Symptomatic relief or management of chronic, intractable pain .
3
- Post-traumatic acute pain .
- . Post-surgical acute pain
For DC Continuous Mode
- Relaxation of muscle spasm �
For FES
- . Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For EMG triggered Stim
- . Stroke rehab by muscle re-education
- . Relaxation of muscle spasms
- . Prevention or retardation of disuse atrophy
- . Increase local blood circulation
- . Muscle re-education
- . Maintaining or increasing range of motion
For EMG
- To determine the activation timing of muscles for: .
- Retraining of muscle activation -
- Coordinating of muscle activation -
- . An indication of the force produced by muscle for control and maintenance of muscle contractions ·
- Relaxation muscle training ।
- Muscle re-education -
For Ultrasound
.
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- . Relief of pain, muscle spasms and joint contractures
- Relief of pain, muscle spasms and joint contractures that may be associated with :
- -Adhesive capsulitis
- Bursitis with slight calcification l
- -Myositis
- Soft tissue injuries ।
- Shortened tendons due to past injuries and scar tissues -
- Relief of pain, muscle spasms and joint contractures that may be associated with :
- Relief of sub-chronic and chronic pain and joint contractures resulting from: .
- Capsular tightness -
- Capsular scarring -
4
Image /page/4/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger font size than the word "GLOBAL". The logo is black and white.
For Infrared Lamp (laser)
To provide topical heating for the following:
- Temporary increase in local blood circulation .
- Temporary relief of minor muscle and joint aches, pains and stiffness
- . Relaxation of muscles
- . Temporary relief of muscle spasms
- . Temporary relief of minor pain and stiffness associated with arthritis
Indication for Use Comparison to Predicate Devices:
-
Vectra Genisys (K062354) primary predicate .
The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys for the following types of treatment: -
o VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
-
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, o Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), and Symmetrical Biphasic (TENS) and HAN
-
For FES 0
-
For DC Continuous Mode O
-
For EMG ಂ
-
For EMG triggered Stim ಂ
-
For Ultrasound ਼
-
Vectra Genisys Laser System (Intelect XT Laser System) (K040662) secondary predicate .
The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys Laser System (Intelect XT Laser System)
- For Infrared Lamp (laser) o
Technological Comparison to Predicate Devices:
The Vectra Neo Clinical Therapy System is technologically equivalent to Vectra Genisys (K062354) and Vectra Genisys Laser System (Intelect XT Laser System) (K040662) with respect to technical and performance characteristics.
The Vectra Neo Clinical Therapy System has the same indications for use and the same fundamental technology as the two predicate devices. It is intended to be used by the same target population and in the same clinical environments. The Vectra Neo Clinical Therapy System simply combines the functionality of the two predicates into one modular, adaptable device and has been upgraded with more modern components and has been engineered to meet FDA-recognized international consensus standards.
5
Image /page/5/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger font size than the word "GLOBAL", and there is a trademark symbol after the "O" in "DJO". The logo is black and white.
Some of the minor differences include: the user interface has been simplified from having 16 buttons to 2 buttons and a touchscreen, additional FDA recognized consensus standards have been conformed to, and some outputs have been modified slightly. These differences are minimal and do not affect the device's performance or efficacy. With respect to safety, these minor differences could only improve device safety. Additionally, bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities.
All differences noted above do not raise new issues of safety and effectiveness.
Performance Testing:
- The device's software has been validated in accordance with the requirements set forth in . the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005). The software validation tests demonstrated that the software version meets its design requirements.
- . A Usability Study was conducted to validate the usability of the Vectra Neo Clinical Therapy System. The results of the Summative Validation support the instructions for successfully using the device as intended. The result of the Human Factors and Usability Study substantiates the acceptability of the risks identified during the risk assessment activities.
- . The Vectra Neo Clinical Therapy System was tested and found to comply with the following standards:
- . IEC 60601-1 for basic safety and essential performance
- . IEC 60601-1-2 for electromagnetic compatibility
- . IEC 60601-2-5 for safety of ultrasonic physiotherapy equipment
- . IEC 60601-2-10 for performance of nerve and muscle stimulators
- 트 IEC 60601-2-22 for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60601-2-57 for basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use (Radiology)
- . IEC 60825-1 for safety of laser products
Biocompatibility:
The Vectra Neo Clinical Therapy System has no direct contact with the patient. The table below identifies accessories that have direct contact with the patient at the treatment site, the material in contact with the patient, reference to the predicateand if applicable, reference devices. For new accessories, evaluation for biocompatibility is in accordance ISO 10993-1:2009 – Annex C, Suggested Procedure for Literature Review. The conclusion of these evaluations , as well as reference to the predicate and any associated reference devices, indicate that all materials selected are considered safe and effective for the intended use.
6
.
Image /page/6/Picture/1 description: The image shows the logo for DJO Global. The logo consists of a stylized globe on the left and the text "DJO GLOBAL" on the right. The word "DJO" is in a larger, bolder font than the word "GLOBAL". The globe is made up of several curved lines and shapes.
| Accessory | Patient Contacting
Material | Predicate | Reference
Device | Biocompatibility Route |
|------------------------|------------------------------------------------------|-------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrodes | Hydrogel | Identical to predicate
(K062354) | Kaoosta
K874469
K852267
K970426 | n/a |
| Ultrasound Gel | Conductive gel | Identical to predicate
(K062354) | K955246 | n/a |
| Hivolt Probe | Cellulose Pad
Polyester | ldentical to predicate
(K062354) | n/a | n/a |
| Ultrasound Applicators | No direct patient
contact
(see Ultrasound Gel) | Identical to predicate
(K062354) | n/a | n/a |
| Laser Applicators | Aluminum
Chrome
Copper-Nickel
Polycarbonate | Identical to predicate
(K040662) | n/a | n/a |
| Laser Safety Glasses | Nylon | Identical to predicate
(K040662) | n/a | n/a |
| Patient Remote | Polycarbonate/ABS
Silicone | NEW | n/a | ISO 10993-1:2009 - Annex C,
Suggested Procedure for
Literature Review, which included
a comparison to the same patient
contacting materials used for the
predicate device (K062354)
remote |
Conclusion:
:
:
Based on the performance testing and the supporting documentation, it can be concluded that the Vectra Neo Clinical Therapy System is safe, effective and substantially equivalent to the predicate devices.
:
.
.
7
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2014
DIO, LLC Lorri Trotter Regulatory Affairs Manager 1430 Decision Street Vista, CA 92081
Re: K132284
Trade/Device Name: Vectra Neo Clinical Therapy System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF; IMG; GZJ; HCC; GZJ; LIH; ILY Dated: March 6, 2014 Received: March 7, 2014
Dear Ms. Trotter:
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 801); medical device reporting (reporting of medical
8
Page 2 - Ms. Lorri Trotter
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/ResourcesforYou/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/ReportaProblem/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
Carlos Peña, PhD, MS for
Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known) K132284
Device Name Vectra Neo Clinical Therapy System
Indications for Use (Describe) Vectra Neo Clinical Therapy System is indicated for:
For VMS-(Pulsed Mode, Burst Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), Symmetrical Biphasic (TENS), and HANS
· Symptomatic relief or management of chronic, intractable pain
- · Post-traumatic acute pain
- · Post-surgical acute pain
For DC Continuous Mode
- · Relaxation of muscle spasm
For FES
• Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of thus improve the patient's gait
For EMG triggered Stim
- · Stroke rehab by muscle re-education
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increase local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
For EMG
· To determine the activation timing of muscles for:
- Retraining of muscle activation -
- Coordinating of muscle activation ﮯ
- An indication of the force produced by muscle for control and maintenance of muscle contractions
- Relaxation muscle training •
- Muscle re-education -
For Ultrasound
1 of Unlabours
Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as: · Relief of pain, muscle spasms and joint contractures
See PRA Statement below.
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
10
| • Relief of pain, muscle spasms and joint contractures that may be associated with : | |
|---|---|
| - Adhesive capsulitis | |
| - Bursitis with slight calcification | |
| - Myositis | |
| - Soft tissue injuries | |
| - Shortened tendons due to past injuries and scar tissues | |
| • Relief of sub-chronic and chronic pain and joint contractures resulting from: | |
| - Capsular tightness | |
| - Capsular scarring |
For Infrared Lamp (laser)
To provide topical heating for the following:
| • Temporary increase in local blood circulation | |
|---|---|
| • Temporary relief of minor muscle and joint aches, pains and stiffness | |
| • Relaxation of muscles | |
| • Temporary relief of muscle spasms | |
| • Temporary relief of minor pain and stiffness associated with arthritis |
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------- |
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)
Felipe Aguel -S Date: 2014.04.10 15:34:06
Felipe Aguel -S Dato0'
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