(226 days)
Not Found
No
The description focuses on standard electrical stimulation modalities and programmable settings, with no mention of AI or ML.
Yes
This device is designed to provide symptomatic relief for various types of pain and to address muscle-related conditions, which are therapeutic applications.
No
The device description and intended uses clearly state that it is a neuromuscular stimulator for pain relief and muscle rehabilitation, not for diagnosing conditions.
No
The device description explicitly states it is a "Neuromuscular Stimulator" and describes hardware components like output channels and current generation, indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to therapeutic applications, specifically pain relief and muscle stimulation. IVDs are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that generates electrical currents for direct application to the body. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device described is a neuromuscular stimulator used for physical therapy and pain management.
N/A
Intended Use / Indications for Use
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain l
- Symptomatic relief of post-traumatic acute pain and post-surgical acute pain -
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post traumatic surqical pain
As a Russian device: - Temporary relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy in post-injury type conditions -
- Increase local blood circulation -
- Muscle re-education
- Maintaining or increasing range of motion -
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms ー
- Prevention or retardation of disuse atrophy in post-injury type conditions ।
- Increase local blood circulation .
- Muscle re-education l
- Maintaining or increasing range of motion
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain
- Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IPF, LIH, GZI
Device Description
Neurodyn and Neurodyn Aussie Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the predicate the Vectra Genisys K031077. The Neurodyn Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user protocols. The user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Neurodyn Aussie Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current (MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Identical
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)
Non-Clinical Tests Submitted:
The Ibramed Powered Muscle Stimulators have been tested in accordance with the applicable standards for medical device electrical safety, electromagnetic compatibility and the particular requirements for stimulator nerve and muscle safety.
The comparison chart shows that all three devices (Neurodyn Aussie, Neurodyn, Vectra Genisys) are similar in every aspect regarding intended use, indications for use, contraindications, target population and human factors, technological characteristics, voltages, inputs, outputs, sizes, weight, types of materials, patient cable construction, software construction, user interface, control parameters, level of concern (software), waveforms, treatment times and the results of each treatment.
Key results: The Neurodyn and the Neurodyn Aussie are as safe and effective as the Vectra Genisys. The Ibramed devices deliver the same currents for the same intended uses as the Vectra Genisys. Thus, they were found to be substantially equivalent.
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.
Chattanooga Vectra Genisys K031077
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 shows a logo for IBRAMED. The logo consists of the word "IBRAMED" in a bold, sans-serif font, with a stylized symbol above it. The symbol is composed of horizontal lines and a vertical element that resembles the letter "I" with extensions on either side. The entire logo is in black against a white background.
SECTION 9
510(k) Summary
Neurodyn Powered Muscle Stimulator Neurodyn Aussie Muscle Stimulator
510 (k) Number: K121369
Date of Submission December 13, 2012
Submitter:
IBRAMED EQUIPAMENTOS MEDICOS Avenida Dr. Carlos Burgos 2800 Amparo - Sao Paulo - Brasil
TEL - 5519-3817-9633 FAX - 5519-7816-7980
Official Contact:
Lilian Llull TechLink International Consulting 18851 NE 29th Avenue Suite 720 Aventura, FL 33180
TEL - (305) 206-6777 FAX - (305) 377-0088
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510 (k) premarket notification is in accordance with 21 CFR 807.87.
| Common (Standard) Name: | Powered Muscle Stimulator |
|---|---|
| Trade Name: | Neurodyn Powered Muscle Stimulator |
| Neurodyn Aussie Powered Muscle Stimulator |
Regulation Number & Product Codes:
GZJ - 21 CFR 882.5890-Transcutaneous electrical nerve stimulator for pain relief
IPF - 21 CFR 890.5850-Powered muscle stimulator
LIH - Interferential Current Therapy-Pre-amendment
GZI- 21 CFR 882.5810-External functional neuromuscular stimulator
1
K12/369
Image /page/1/Picture/1 description: The image shows a logo for IBRAMED DEVICE CLASS II. The logo is black and white and features a stylized symbol above the word "IBRAMED". Below the word "IBRAMED" is the text "DEVICE CLASS II". The symbol above the word "IBRAMED" appears to be a stylized letter "I".
Specifications - Both devices were designed according to Existing Technical Standards for the Development of Medical Devices (NBR NBR IEC 60601-1 IEC 60601-1-2 and IEC 60601-2-10 NBR). Predicate Device Identification:
Chattanooga Vectra Genisys K031077
Predicate devices had been submitted and cleared by 510(k) for the same intended uses and indications.
Device Description
Neurodyn and Neurodyn Aussie Neuromuscular Stimulators are intended for the treatment of, relief of chronic (long term) intractable pain as adjunctive treatment of post-surgical and post-traumatic acute pain. Both devices have the same intended uses and incorporate the same technologies as the predicate the Vectra Genisys K031077. The Neurodyn Muscle Stimulator is a programmable device. It comes equipped with 5 preset clinical programs along with 10 user protocols. The user programs are adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings.
The Neurodyn Aussie Muscle Stimulator has four output channels with independent intensity controls. Thus, four different areas can be stimulated separately or together during a therapy session. It is adjustable and can be changed according to the patient's needs, doctor's recommendations and prescription settings. It generates the medium frequency alternate current (MFAC), burst modulated alternating current (Aussie)- type of sinusoidal current with a frequency carrying 1,000 Hz or 4,000 Hz and a burst duration of 4 ms or 2 ms, modulated in pulse trains (bursts) with a variable frequency from 1 to 120Hz. ·
Indications for Use
As a TENS device:
Symptomatic relief of chronic (long term) intractable pain Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
As an Interferential and Premodulated device:
Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
As a Russian device: Temporary relaxation of muscle spasms Prevention or retardation of disuse atrophy in post-injury type conditions Increase local blood circulation
2
1512/369
Image /page/2/Picture/1 description: The image shows the logo for IBRAMED. Below the logo is the text "Muscle re-education" and "Maintaining or increasing range of motion". The logo is black and white and features a stylized "I" shape.
As an Burst modulated alternaing current (Aussie) device: Temporary relaxation of muscle spasms Prevention or retardation of disuse atrophy in post-injury type conditions Increase local blood circulation Muscle re-education Maintaining or increasing range of motion
As a Microcurrent device: Symptomatic relief of chronic intractable pain Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Essential Performance
Neurodyn Muscle Stimulator produces the following currents: Russian / Aussie / Interferential / Tens / Premodulated / Microcurrent
Neurodyn Aussie Muscle Stimulator produces the burst modulated alternating current (Aussie) medium frequency alternate current. The current intensity required for treatment depends on the patient's sensitivity. The treatment should be started with minimum levels of intensity .with gradual increase until the patient achieves the full effect of the treatment.
Electrodes
Electrodes used are Axelgaard K970426. The minimal size of the electrode that can used with the Neurodyn and Neurodyn Aussie is 25cm².
Patient Cables
Utilizes shrouded connectors to meet Lead Wire Connectors Safety Requirements IEC-60601-1 Sub clause 66-3 -c -according to 21 CFR 898. They are designed to be 4.5 feet (1.5 meters) away from the patient. The connector cables are designed to comply with subclause 56.3 ( c ) of the following standard: International Electrotechnical Commission (IEC) 60601-1: Medical Electrical Equipment 60601-1 (1988) Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995)
Declaration of Conformity
This device has been assessed and found compliant. It upholds the highest safety and effectiveness standards.
3
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Image /page/3/Picture/1 description: The image shows a logo for IBRAMED. The logo is black and white and features the word "IBRAMED" in a bold, sans-serif font. Above the word is a stylized graphic that resembles a capital "I" with horizontal lines extending from the top and bottom. The logo is simple and modern.
Summary of Safety and Effectiveness
-
The Neurodyn and Neurodyn Aussie Muscle Stimulators are substantially equivalent to the Vetra Genisys K031077 manufactured by Chattanooga. All three devices claim similar Indications for Use and Device Characteristics in technological design and materials.
-
The Neurodyn and Neurodyn Aussie Muscle Stimulators do not raise any new issues of Safety and Effectiveness based on their similarities.
-
The devices have continually proven to be safe and effective and demonstrate intended product performance.
Non-Clinical Tests Submitted:
The Ibramed Powered Muscle Stimulators have been tested in accordance with the applicable standards for medical device electrical safety, electromagnetic compatibility and the particular requirements for stimulator nerve and muscle safety.
| EMC
| l | l est |
|---|---|
| Device Name | Neurodyn Aussie | Neurodyn | Vectra Genisys |
|---|---|---|---|
| K number | 121369 | 121369 | 031077 |
| Manufacturer | Ibramed | Ibramed | Ibramed |
| Intended use | Identical | Identical | Identical |
| Indications for use | Identical | Identical | Identical |
| Target population | Identical | Identical | Identical |
| Human factors | Identical | Identical | Identical |
| Contraindication | Identical | Identical | Identical |
| Device Name | Neurodyn Aussie | Neurodyn | Vectra Genisys |
| K number | --- | --- | K031077 |
| Manufacturer | Ibramed | Ibramed | Chattanooga |
| Technological | |||
| characteristics | Identical | Identical | Identical |
| Medium- | |||
| frequency | |||
| alternating current | |||
| (MFAC) | |||
| Device Material | ABS plastic panel | ||
| LCD display | ABS plastic panel | ||
| LCD display | ABS plastic panel | ||
| LCD display | |||
| Width (in) | 10.6 | 14.6 | 9.75 |
| Height (in) | 4.9 | 4.9 | 8.75 |
| Depth (in) | 10.4 | 12.4 | 12.75 |
| Weight (lbs) | 4.08 | 5.5 | 6 |
| Performance | Identical | Identical | Identical |
| Biocompatibility | FDA cleared | ||
| electrodes | FDA cleared | ||
| electrodes | FDA cleared | ||
| electrodes | |||
| Mechanical safety | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Identical |
| Number of | |||
| channels | 4 | 4 | 2/4 |
| Russian | No | Yes | Yes |
| Burst Modulated | |||
| Alternating | |||
| Current (Aussie) | Yes | Yes | Yes |
| Interferential | No | Yes | Yes |
| Microcurrent | No | Yes | Yes |
| TENS | No | Yes | Yes |
| Premodulated | No | Yes | Yes |
| Voltage Input | 100/240V | ||
| 50/60Hz | |||
| Bivolt | 100/240V | ||
| 50/60Hz | |||
| Bivolt | 100/240V | ||
| 50/60Hz | |||
| 1.0A | |||
| Output | +24V | ||
| 7.3A+24V | |||
| 7.3A | +24V | ||
| 7.3A+24V | |||
| 7.3A | +24V | ||
| 7.3A+24V | |||
| 7.3A | |||
| Electrical Class | II | II | II |
| Electrical Type | BF Type | BF Type | BF Type |
| Method of line | |||
| current isolation | Double Isolation | Double Isolation | Fuse-Two 5.6A |
| Time Lag | |||
| Patient leakage | |||
| control-normal | |||
| condition | 0.0508mA | 0.0508mA | 69μA |
| Patient leakage | |||
| control-single fault | |||
| condition | 0.0252mA | 0.0252mA | 31μA |
The above comparison chart shows that all four devices are identical in every aspect regarding intended use, indications for use, contraindications, target population and human factors
4
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ﻟﻤﻌﺘﻤﺪ | C |
| -- | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | ---------------------------------- | --- |
|---|
| Software
| Microprocessor | Yes | Yes | Yes |
|---|---|---|---|
| Automatic | |||
| overload trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| Temperature | |||
| range during | |||
| transport and | |||
| storage | 41°F-122°F | 41°F-122°F | 59°F-104°F |
| Environment | |||
| operating | |||
| temperature | |||
| range | 41°F-113°F | 41°F-113°F | 59°F-104°F |
| Locking feature | Keyboard lock | ||
| safety feature | Keyboard lock | ||
| safety feature | Keyboard lock | ||
| safety feature | |||
| Treatment timer | Treatment timer | ||
| with auto shut off | Treatment timer | ||
| with auto shut off | Treatment timer | ||
| with auto shut off | |||
| Auto test and | |||
| repeat | Automatic setting | ||
| and repeat | |||
| treatment | Automatic setting | ||
| and repeat | |||
| treatment | Automatic setting | ||
| and repeat | |||
| treatment | |||
| Safety standards | |||
| requirements | ISO 13485 | ||
| IEC 60601-1 | |||
| IEC 60601-2 | |||
| IEC 60602-10 | |||
| CE | ISO 13485 | ||
| IEC 60601-1 | |||
| IEC 60601-2 | |||
| IEC 60602-10 | |||
| CE | ISO 13485 | ||
| IEC 60601-1 | |||
| IEC 60601-2 | |||
| IEC 60602-10 | |||
| UL 60602 | |||
| Electromagnetic | |||
| compatibility | IEC 60601-1- | ||
| 2001/A:2004 | IEC 60601-1- | ||
| 2001/A:2004 | IEC 60601-1- | ||
| 2001/A:2004 |
The preceding comparison chart shows that all three devices are similar in every aspect. We assessed the indications for use, intended use, technological characteristics, voltages, inputs, outputs, sizes, weight, types of materials, patient cable construction, software construction, user interface, control parameters, level of concern (software), waveforms, treatment times and the results of each treatment.
We have concluded that the Neurodyn and the Neurodyn Aussie are as safe and effective as the Vectra Genisys. The Ibramed devices deliver the same currents for the same intended uses as the Vectra Genisys. Thus, we found them to be substantially equivalent.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The text is in all caps and is oriented to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
December 19, 2012
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ibramed Equipamentos Medicos % Ms. Lilian Llull Ibramed U.S. Agent TechLink International 18851 NE 29th Avenue 720 Aventura. FL 33180
K121369 Re:
Trade/Device Name: Neurodyn/Neurodyn Aussie Powered Muscle Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ, IPF, LIH, GZI Dated: November 29, 2012 Received: December 5, 2012
Dear Ms. Llull:
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.
7
Page 2 - Ms. Lillian Llull
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
Neurodyn Series: Neurodyn/ Neurodyn Aussie
510(k) Number: K121369
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain l
- Symptomatic relief of post-traumatic acute pain and post-surgical acute pain -
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post traumatic surqical pain
As a Russian device:
- Temporary relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy in post-injury type conditions -
- Increase local blood circulation -
- Muscle re-education
- Maintaining or increasing range of motion -
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms ー
- Prevention or retardation of disuse atrophy in post-injury type conditions ।
- Increase local blood circulation .
- Muscle re-education l
- Maintaining or increasing range of motion
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain
- Symptomatic relief of post-traumatic acute pain and post-surgical acute pain
Prescription Use ____________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation
(ODE) Page 1 of 1
Division of Neurological and I Medicine Devices 510(k) Number