(165 days)
Not Found
No
The description focuses on traditional electrotherapy, ultrasound, and biofeedback modalities with pre-programmed protocols and data management features. There is no mention of adaptive learning, predictive capabilities, or other characteristics typically associated with AI/ML.
Yes.
The device's "Intended Use / Indications for Use" section explicitly lists various therapeutic applications for specific medical conditions, such as "Relaxation of Muscle Spasms," "Prevention or retardation of disuse atrophy," "Symptomatic relief or management of chronic, intractable pain," and "Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions." Additionally, the "Device Description" states that it offers "a modular design of muscle stimulation, ultrasound, and biofeedback modalities in one combination device" and is "used for the management of pain and muscle spasm."
Yes
The device includes an EMG modality, which is explicitly stated "To determination the activation timing of muscles" and "An indication of the force produced by muscle," indicating its use for diagnostic purposes related to muscle function.
No
The device description clearly outlines a physical device with multiple hardware components (electrotherapy module, ultrasound module, sEMG biofeedback module, display screen, hand held accessories, therapy system cart, ultrasound applicators). While it includes software features like clinical protocols and data management, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are all related to physical therapy and rehabilitation, focusing on muscle stimulation, pain relief, and improving physical function. These are applications performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The device description details modalities like electrotherapy, ultrasound, and biofeedback, all of which are used externally on the patient. There is no mention of analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: An IVD device is specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
The device is clearly intended for therapeutic and rehabilitative purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
For VMS-(Pulsed Mode, Burst Mode or FR 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), and Symmetrical Biphasic (TENS)
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
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 DC Continuous Mode
Relaxation of muscle spasm
For EMG
To determination the activation timing of muscles for:
- a) retraining of muscle activation
b) coordination 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 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 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:
a) Adhesive capsulitis
b) Bursitis with slight calcification
c) Myositis
d) Soft tissue injuries
e) Shortened tendons due to past injuries and scar tissues - Relief of sub-chronic and chronic pain and joint contractures resulting from:
a) Capsular tightness
b) Capsular scarring
Product codes (comma separated list FDA assigned to the subject device)
IPF, IMG, GZJ, HCC, GZI, LIH
Device Description
Vectra Genisys electrotherapy product lines offer clinicians a modular design of muscle stimulation, ultrasound, and biofeedback modalities in one combination device. These clinical product lines are designed to give the most treatment options in one compact and integrated package. The award winning design offers a 5 inch TFT LCD vibrant color display screen and hand held accessories.
Clinicians have a variety of choices to best suit the needs of the individual practice. Below is an overview of the system choices. The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by the FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides six concealed storage bins to conveniently house clinical essentials.
The electrotherapy module offers multiple waveforms; Interferrential, Premodulated, Asymmetrical Biphasic, Microcurrent, VMS-(Pulsed Mode, Burst Mode, and FR Mode), Russian, High Voltage Pulsed Current, Symmetrical Biphasic, Direct Current.
The dual frequency ultrasound module offers Pulsed and Continuous Duty Cycles (10%, 20%, 50%, and 100%), Low BNR (5:1), Four different size ultrasound applicators, 1cm², 2cm², and 10 cm².
The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto the sEMG Data Card. 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.
The online-guided assistance through Clinical Protocols and On-Board Indications to help guide therapy selections: electrotherapy waveform rationale, parameter selections, electrode placement images, ultrasound applicator recommendations.
The 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 Interferrential, Premodulated, Asymmetrical Biphasic, VMS-(Pulsed Mode, Burst Mode, ), 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
Clinicians
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.
Omnistim FX2 - K945509, Omnistim FX2 Pro - K945508
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
Summary - 510(k) # K062354
Chattanooga Group, SUBMITTER: A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37343
JAN 2 6 2007
EXTABLISHMENT 1022819 REGISTRATION:
CONTACT PERSON: Michael Treas Manager of Regulatory Affairs Phone: (423) 870-2281 Fax: (423) 870-7404
DATE PREPARED: October 20, 2006
DEVICE TRADE NAME: Vectra Genisys
CLASSIFICATION: Class II
PRODUCT CODES: IPF, IMG, GZJ, HCC, GZI, LIH
21 CFR 890.5850- Stimulator, Muscle, Powered REGULATION NUMBERS
21 CFR 890.5860- Ultrasound and muscle stimulator AND COMMON NAMES:
21 CFR 882.5890- Transcutaneous electrical nerve stimulator for pain relief
21 CFR 882.5050- Biofeedback device
21 CFR 882.5810- External functional neuromuscular stimulator
21 CFR 876.5320- Non-implantable electrical continence device
89- Physical Medicine, 84- Neurology & 78- Gastroenterology PANELS:
PREDICATE: Omnistim FX2 - K945509 Omnistim FX2 Pro - K945508
Page 1 of 3
1
Summary - 510(k) # K062354
Description: Vectra Genisys electrotherapy product lines offer clinicians a modular design of muscle stimulation, ultrasound, and biofeedback modalities in one combination device. These clinical product lines are designed to give the most treatment options in one compact and integrated package. The award winning design offers a 5 inch TFT LCD vibrant color display screen and hand held accessories.
Clinicians have a variety of choices to best suit the needs of the individual practice. Below is an overview of the system choices. The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by the FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides six concealed storage bins to conveniently house clinical essentials.
The electrotherapy module offers multiple waveforms; Interferrential, Premodulated, Asymmetrical Biphasic, Microcurrent, VMS-(Pulsed Mode, Burst Mode, and FR Mode), Russian, High Voltage Pulsed Current, Symmetrical Biphasic, Direct Current.
The dual frequency ultrasound module offers Pulsed and Continuous Duty Cycles (10%, 20%, 50%, and 100%), Low BNR (5:1), Four different size ultrasound applicators, 1cm², 2cm², and 10 cm².
The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto the sEMG Data Card. 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.
The online-guided assistance through Clinical Protocols and On-Board Indications to help guide therapy selections: electrotherapy waveform rationale, parameter selections, electrode placement images, ultrasound applicator recommendations.
The 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 Interferrential, Premodulated, Asymmetrical Biphasic, VMS-(Pulsed Mode, Burst Mode, ), and High Voltage Pulsed Current.
2
Summary - 510(k) # K062354
Declarations of Conformity
The Vectra Genisys devices are in compliance with the following FDA recognized consensus standards:
UL 60601-1: 2003, Standards for Medical Equipment Part 1: General Requirements for Safety, l $1 Edition
IEC 60601-1-2: 2001, Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition
Truthful and Accurate Statement
A statement attesting to the truthfulness and accuracy of the information was included in the submission.
Further Information
In the event that additional information is required, please contact:
Michael Treas Manager of Regulatory Affairs Chattanooga Group A Division of Encore Medical, L.P. 4717 Adams Road Hixson, TN 37343-0489 U.S.A. Telephone: (423) 870-2281 Fax: (423) 870-7404 E-mail: Michael Treas@ChattGroup.com
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
FEB 2 2 2007
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Encore Medical, L.P. Chattanooga Group c/o Mr. Michael Treas 4717 Adams Road Hixson, Tennessee 37343
Re: K062354
Trade Name: Vectra GENiSYS Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: IPF, GZJ, HCC, IMG, GZI Dated: January 26, 2007 Received: January 26, 2007
Dear Mr. Treas:
This letter corrects our substantially equivalent letter of January 26, 2007. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Mr. Michael Treas
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
5
| 510(k) Number | K062354 |
|---|---|
| Device Name: | Vectra Genisys |
Indications for Use: (Page 1 of 2)
For VMS-(Pulsed Mode, Burst Mode or FR 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), and Symmetrical Biphasic (TENS)
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
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 DC Continuous Mode
Relaxation of muscle spasm
For EMG
To determination the activation timing of muscles for:
- a) retraining of muscle activation
b) coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-)
Division of General. Restorative,
and Neurological Devices
Prescription Us510(k) Number K062354
(Per 21 CFR 801.109) Over-The-Counter Use
(Optional Forma
(Optional Format 1-2-96)
6
| 510(k) Number | K062354 |
|---|---|
| Device Name: | Vectra Genisys |
Indications for Use: (Page 2 of 2)
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 Ultrasound
| Application of therapeutic deep heat for the treatment of selected sub-chronic and | ||
|---|---|---|
| chronic medical conditions such as: | ||
| 1. Relief of pain, muscle spasms and joint contractures | ||
| 2. Relief of pain, muscle spasms and joint contractures that may be associated | ||
| with: | ||
| a) Adhesive capsulitis | ||
| b) Bursitis with slight calcification | ||
| c) Myositis | ||
| d) Soft tissue injuries | ||
| e) Shortened tendons due to past injuries and scar tissues | ||
| 3. Relief of sub-chronic and chronic pain and joint contractures resulting from: | ||
| a) Capsular tightness | ||
| b) Capsular scarring |
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Por 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Mark A. Milliman
(Division Sign. 47) (Division of General. Restorative, and Neurological Devices
510(k) Number K 06