(74 days)
Neurodyn V2.0 Stimulators are intended for:
As a FES device:
- 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.
As a TENS device:
-
Symptomatic relief of chronic (long term) intractable pain
-
Symptomatic relief of post-traumatic acute pain and post-surgical pain
As an Interferential and Premodulated device: -
Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Russian device:
-
Temporary relaxation of muscle spasms - Prevention 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
-
Prevention or retardation of disuse atrophy in post-injury type conditions
-
Increase local blood circulation
-
Muscle re-education
-
Maintaining or increasing range of motion
-
Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain
As a DC/Polarized device: -Relaxation of Muscle Spasm
As a High Voltage Pulsed current device:
- Muscle re-education
- Relaxation of Muscle Spasms
- Maintaining or increasing range of motion
- Increasing local blood circulation
- Prevention or retardation of disuse atrophy
Neurodyn Aussie V2.0 Stimulators are intended for:
As a Burst Modulated Alternating 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
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
NEURODYN v2.0 is a transcutaneous neuromuscular stimulator of four channels with independent controls for treatments with: AUSSIE CURRENT (with Medium Frequency Current modulated in Burst), RUSSIAN CURRENT (Medium Frequency Current modulated in Burst), FES CURRENT (Functional Electrical Stimulation),TENS CURRENT(Transcutaneous Electrical Nerve Stimulation), INTERFERENTIAL CURRENT (IFC-T), PREMODULATED INTERFERENTIAL CURRENT (IFC-B) BIPOLAR (Medium Frequency Current modulated in Amplitude), and with two independent control channels for the treatments with: MICROCURRENT (Microcurrent Electrical Neuromuscular Stimulation), DIRECT CURRENT /POLARIZED CURRENT and HIGH VOLTAGE PULSED CURRENT (High Volt Pulsed Current).
NEURODYN AUSSIE V2.0 transcutaneous neuromuscular stimulator is a four-channel stimulator with independent controls for current therapy used in AUSSIE CURRENT (Burst Modulated Medium Frequency).
This FDA 510(k) summary for the Neurodyn V2.0 and Neurodyn Aussie V2.0 powered muscle stimulators focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is not directly available or applicable in the provided document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding device performance in the context of an effectiveness study. Instead, it provides a comparative table of technological characteristics between the new devices and their predicate devices. The "Performance" line in this table states "Identical" for both the new devices and the primary predicate (Neurodyn Multiwave; Neurodyn Aussie Sport), implying that the performance is considered equivalent due to identical technological characteristics for many modalities.
Key parameters from the "Technological Characteristics Comparison" considered for substantial equivalence, which implicitly act as performance criteria for the new device as compared to the predicates:
| Characteristic | Acceptance Criteria (based on predicate) | Reported Device Performance (Neurodyn V2.0/Aussie V2.0) |
|---|---|---|
| Technological Characteristics Medium-frequency alternating current (MFAC) | Identical to K131629 (Neurodyn Multiwave) | Identical |
| Number of Channels | Up to 4 (identical to K131629 & K031077) | Up to 4 |
| Temperature range during transport and storage | 41°F-122°F for K131629; 59°F-104°F for K031077 | 41°F-122°F (deemed "very similar" not affecting substantial equivalence) |
| Environment operating temperature range | 41°F-113°F for K131629; Not specified for K031077 | 41°F-113°F (deemed "very similar" not affecting substantial equivalence) |
| Performance | Identical to K131629 (Neurodyn Multiwave); Identical to K031077 (Vectra Genesis) | Identical |
| Biocompatibility | FDA cleared electrodes (identical to K131629 & K031077) | FDA cleared electrodes |
| Mechanical safety | Identical to K131629 & K031077 | Identical |
| Burst Modulated Alternating Current (Russian) | Yes (identical to K131629 & K031077) | Yes |
| Burst Modulated Alternating Current (Aussie) | Yes (identical to K131629); No for K031077 | Yes (predicate Neurodyn Multiwave contains Aussie current, supporting SE) |
| Interferential | Yes (identical to K131629 & K031077) | Yes |
| Microcurrent | Yes (identical to K131629 & K031077) | Yes |
| TENS | Yes (identical to K131629 & K031077) | Yes |
| FES | Yes (K131629); No (K031077) | NEURODYN_V2.0: Yes; NEURODYN AUSSIE_V2.0: No (predicate Neurodyn contains FES, supporting SE) |
| Premodulated | Yes (identical to K131629 & K031077) | Yes |
| High Volt | No (K131629); Yes (K031077) | Yes (Vectra contains HV current, supporting SE) |
| Patient leakage control - normal condition | K131629: 0.0508mA; K031077: 100µA | NEURODYN_V2.0: 0.0044 mA; NEURODYN AUSSIE_V2.0: 0.0134 mA (within standard acceptance range) |
| Patient leakage control - single fault condition | K131629: 0.0252mA; K031077: 500µA | NEURODYN_V2.0: 0.0124 mA; NEURODYN AUSSIE_V2.0: 0.0008 mA (within standard acceptance range) |
| Treatment timer auto shut off | 1-60 minutes (identical to K131629 & K031077) | 1-60 minutes |
| Voltage Input Range and Frequency | 100-240VAC, 50/60Hz (identical to K131629 & K031077) | 100-240VAC, 50/60Hz |
| Safety standards requirements biocompatibility | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, 21 CFR 898 (identical to K131629 & K031077) | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, 21 CFR 898 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No clinical test sets or human subject data were used or described in this 510(k) summary for performance evaluation. The substantial equivalence is based on engineering and performance characteristics comparison with predicate devices and compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth based on expert consensus was established as no clinical test set was utilized for demonstrating effectiveness.
4. Adjudication method for the test set:
Not applicable. No test set requiring adjudication was described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device. Its performance is compared based on physical and electrical characteristics to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of clinical performance data. The "ground truth" for substantial equivalence is primarily the established performance and safety profiles of the predicate devices and compliance with recognized industry standards.
8. The sample size for the training set:
Not applicable. No machine learning algorithm requiring a training set was mentioned.
9. How the ground truth for the training set was established:
Not applicable. No machine learning algorithm requiring a training set was mentioned.
Summary of Device Acceptance Approach:
The Neurodyn V2.0 and Neurodyn Aussie V2.0 gained FDA clearance (K210572) through the 510(k) premarket notification pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving independent safety and effectiveness through de novo clinical trials.
The study that "proves" the device meets acceptance criteria, in this context, is primarily a non-clinical engineering and performance characteristic comparison study against legally marketed predicate devices, coupled with compliance to recognized international safety and performance standards:
- Predicate Devices: K131629 (Neurodyn Multiwave; Neurodyn Aussie Sport) and K031077 (Vectra Genesis).
- Methodology: A detailed comparison of the new devices' indications for use and technological characteristics (e.g., number of channels, current types, output ranges, safety features, input voltage, and construction materials) against the predicate devices.
- Performance "Proof": The document explicitly states "Performance: Identical" when comparing key aspects to the predicate devices. Differences in current ranges (e.g., TENS 0 to 120mA (Ipp) vs. Tens 0 to 80 mA for a predicate) are deemed not to interfere with performance because "the intensity does not have fixed parameter, it is according to the sensorial of each patient." This indicates that these parameters are within acceptable safe and effective ranges as evidenced by the predicates.
- Standards Compliance: The devices comply with IEC 60601-1 (general requirements for basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), and IEC 60601-2-10 (particular requirements for nerve and muscle stimulators). Non-clinical testing was performed to demonstrate compliance with these standards.
Conclusion from the document: "The Neurodyn V2.0 device and the predicate devices are substantially equivalent when comparing the indications for use, and technological properties. The differences shown in the comparison do not affect the substantial equivalence."
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May 11, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Ibramed Equipamentos Medicos % Rodrigo Abreu Regulatory Specialist United Regulatory LLC 12343 NW 25th St Coral Springs, Florida 33065
Re: K210572
Trade/Device Name: Neurodyn V2.0, Neurodyn Aussie V2.0 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: IPF Dated: February 26, 2021 Received: February 26, 2021
Dear Rodrigo Abreu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak, PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210572
Device Name Neurodyn V2.0, Neurodyn Aussie V2.0
Indications for Use (Describe)
Neurodyn V2.0 Stimulators are intended for:
As a FES device:
- 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.
As a TENS device:
-
Symptomatic relief of chronic (long term) intractable pain
-
Symptomatic relief of post-traumatic acute pain and post-surgical pain
As an Interferential and Premodulated device: -
Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Russian device:
-
Temporary relaxation of muscle spasms - Prevention 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
-
Prevention or retardation of disuse atrophy in post-injury type conditions
-
Increase local blood circulation
-
Muscle re-education
-
Maintaining or increasing range of motion
-
Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain
As a DC/Polarized device: -Relaxation of Muscle Spasm
As a High Voltage Pulsed current device:
- Muscle re-education
- Relaxation of Muscle Spasms
- Maintaining or increasing range of motion
- Increasing local blood circulation
- Prevention or retardation of disuse atrophy
Neurodyn Aussie V2.0 Stimulators are intended for:
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
{3}------------------------------------------------
- Muscle re-education
- Maintaining or increasing range of motion
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is made up of four blue curved shapes, two on top and two on the bottom, with a black hourglass shape in the center. The word "IBRAMED" is written in a bold, sans-serif font.
Ibramed Fouinamentos Médicos Av. Dr. Carlos Burgos, 2800 - Jardim Itália, SP, 13901-080 Brazil 3817 9633
510(k) SUMMARY
May 10, 2021
- A) Submitter's Name: Ibramed Equipamentos Médicos
Owner / Operator Registration Number: 3010362721
Manufacture Registration Number: 3010362721
- B) Address: Av. Dr. Carlos Burgos, 2800 Jardim Itália, Amparo SP, 13901-080 Brazil
- C) Phone and Fax Numbers
Phone: + 55 19 3817 9633
- D) Contact Person:
Fábio Alexandre Pinto
Tel.: +55 19 3817-9636
- E) Preparation Date: May 10, 2021
- F) Classification Name: Powered Muscle Stimulator
Common / Usual Name: Powered Muscle Stimulator
Proprietary Name: Neurodyn V2.0; Neurodyn Aussie V2.0
Product Code: IPF
Class: Class II
Regulation: 21 CFR 890.5850
G) Device Description
NEURODYN v2.0 is a transcutaneous neuromuscular stimulator of four channels with independent controls for treatments with: AUSSIE CURRENT (with Medium Frequency Current modulated in Burst), RUSSIAN CURRENT (Medium Frequency Current modulated in Burst), FES CURRENT (Functional Electrical Stimulation),TENS CURRENT(Transcutaneous Electrical Nerve Stimulation), INTERFERENTIAL CURRENT (IFC-T), PREMODULATED INTERFERENTIAL CURRENT (IFC-B) BIPOLAR (Medium Frequency Current modulated in Amplitude), and with two independent control channels for the treatments with: MICROCURRENT (Microcurrent Electrical Neuromuscular Stimulation), DIRECT CURRENT /POLARIZED CURRENT and HIGH VOLTAGE PULSED CURRENT (High Volt Pulsed Current).
NEURODYN AUSSIE V2.0 transcutaneous neuromuscular stimulator is a four-channel stimulator with independent controls for current therapy used in AUSSIE CURRENT (Burst Modulated Medium Frequency).
H) Substantial Equivalence:
The Neurodyn V2.0 is equivalent with the following products:
| Predicatetype | 510(k)Number | Model | Company |
|---|---|---|---|
| Predicate | K131629 | Neurodyn Multiwave; Neurodyn Aussie Sport | Ibramed Equipamentos Médicos |
| SecondaryPredicate | K031077 | Vectra Genesis | Chattanooga |
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Image /page/5/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is made up of two blue curved shapes on the top and bottom, with a black hourglass shape in the middle. The word "IBRAMED" is written in a bold, sans-serif font.
Ibramed Equipamentos Médicos
Av. Dr. Carlos Burgos, 2800 - Jardim Itália,
Amparo - SP, 13901-080 Brazil
Ph: + 55 19 3817 9633
I) Indications for Use
1. Subject device: Neurodyn V2.0, Neurodyn Aussie V2.0
Neurodyn V2.0 Stimulators are intended for:
As a FES device:
- 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.
As a TENS device:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post-surgical pain
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic 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 - Muscle re-education - Maintaining or increasing range of motion
As a Burst Modulated Alternating 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
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain
As a DC/Polarized device:
-
-Relaxation of Muscle Spasm
As a High Voltage Pulsed current device: -
Muscle re-education
-
Relaxation of Muscle Spasms
-
Maintaining or increasing range of motion
-
Increasing local blood circulation
-
Prevention or retardation of disuse atrophy
Neurodyn Aussie V2.0 Stimulators are intended for:
As a Burst Modulated Alternating Current (Aussie) device:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for IBRAMED. The logo features a stylized symbol above the word "IBRAMED". The symbol consists of two blue shapes that resemble stylized wings or curved lines, positioned above and below a black hourglass shape. The word "IBRAMED" is written in a bold, sans-serif font, with the letters in black.
lardim Itália
-
Increase local blood circulatio
-
Muscle re-education
-
Maintaining or increasing range of motion
-
Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
2. Predicate: Neurodyn Multiwave; Neurodyn Aussie Sport
Neurodyn Multiwave-Indications for Use:
As a FES device:
- 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.
As a TENS device:
-
Symptomatic relief of chronic (long term) intractable pain
-
Symptomatic relief of post-traumatic acute pain and post surgical pain
As an Interferential and Premodulated device:
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic 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 - Muscle re-education
-
Maintaining or increasing range of motion
As a Burst Modulated Alternating 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
-
Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
As a Microcurrent device:
- Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain
As a DC/Polarized device: -Relaxation of Muscle Spasm
Aussie Sport- Indications for Use:
As a Burst Modulated Alternating 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
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black symbol above the word "IBRAMED" in black, bold letters. The symbol is composed of two blue shapes that resemble open books facing each other, connected by a black hourglass shape in the center.
Ibramed Equipamentos Médicos Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo - SP, 13901-080 Brazil Ph: + 55 19 3817 9633
- Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain
3. Secondary Predicate Device: Vectra Genesis
Indications for Use for High Voltage current device:
- Muscle re-education
- Relaxation of Muscle Spasms
- Maintaining or increasing range of motion
- Increasing local blood circulation
- Prevention or retardation of disuse atrophy
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for Ibramed. The logo consists of a stylized blue and black symbol to the left of the word "IBRAMED" in black, bold letters. To the right of the logo is the text "Ibramed Equip", "Av. Dr. Carlos", "Amparo - SP,", and "Ph: + 55 19 3".
Ibramed Equipamentos Médicos gos, 2800 - Jardim Itália, 1-080 Brazil
K) Technological Characteristics Comparison:
The predicate device used to establish squivalence for the Neurodyn Aussie V2.0 device is outlined below. This section of this submission will provide a comparison of dechnical specifications of the Neurodyn V2.0 to each of the predicate devices stratified by functional modality.
| Device name | Neurodyn_V2.0;Neurodyn Aussie_V2.0 | Neurodyn Multiwave;Neurodyn Aussie Sport | Vectra Genesis | SE Discussion of thedifferences |
|---|---|---|---|---|
| K Number | K210572 | K131629 | K031077 | N/A |
| Manufacturer | Ibramed | Ibramed | Chattanooga | N/A |
| Population target | Patients must be at least12 years of age andPatients must weigh atleast 35 kg. | Patients must be at least12 years of age andPatients must weigh atleast 35 kg. | Not stated in the Manual | Identical when comparedwith Neurodyn |
| Environment | Hospitals, Clinics, omedical environment | Hospitals, Clinics, omedical environment | Hospitals, Clinics, omedical environment | Identical |
| Technologicalcharacteristics Medium-frequency alternatingcurrent (MFAC) | Identical | Identical | Similar | N/A |
| Housing Material | ABS plastic panel LCDdisplay | ABS plastic panel LCDdisplay | Not stated in the Manual | N/A |
| Dimensions W x H x D(in) | Neurodyn V2.0 14.6 x 4.9x 12.4Aussie: 10.6 x 4.9 x 10.4 | 6.8 x 4.9 x 12.4 | 11.38 x 8.75 x 12.75 | N/A |
| Weight | 5Lb | 5Lb | 7Lb | N/A |
| Number of Channels | Up to 4 | Up to 4 | Up to 4 | Identical |
| Temperature rangeduring transport andstorage | 41°F-122°F | 41°F-122°F | 59° F and 104° F | The ranges are verysimilar not affecting thesubstantial equivalence. |
| Environment operatingtemperature range | 41°f-113°f | 41°F-113°F | No specified | The ranges are verysimilar not affecting thesubstantial equivalence. |
| Performance | Identical | Identical | Identical | Identical |
| Biocompatibility | FDA cleared electrodes | FDA cleared electrodes | FDA cleared electrode | Identical |
| Mechanical safety | Identical | Identical | Identical | Identical |
| Anatomical Sites | Identical | Identical | Similar | N/A |
| Burst ModulatedAlternating Current( Russian ) | Yes | Yes | Yes | Identical |
| Burst ModulatedAlternating Current(Aussie) | Yes | Yes | No | Vectra does not have theAussie current but theNeurodyn contains,supporting thesubstantial equivalence. |
| Interferential | Yes | Yes | Yes | Identical |
| Microcurrent | Yes | Yes | Yes | Identical |
| TENS | Yes | Yes | Yes | Identical |
| FES | NEURODYN_V2.0: YesNEURODYN AUSSIE_V2.0:No | Yes | No | Vectra does not have theFES current but theNeurodyn contains,supporting thesubstantial equivalence. |
| Premodulated | Yes | Yes | Yes | Identical |
| High Volt | Yes | No | Yes | Neurodyn does not havethe HV current but theVectra contains, |
| supporting thesubstantial equivalence. | ||||
| Method of currentisolation | Double Isolation | Double Isolation | Double Isolation | Identical |
| Patient leakage control-normal condition | NEURODYN_V2.0: 0.0044mANEURODYN AUSSIE_V2.0:0.0134 mA | 0.0508mA | 100µA | It is between thestandard acceptancerange, supporting thesubstantial equivalence. |
| Patient leakage control-single fault condition | NEURODYN_V2.0: 0.0124mANEURODYN AUSSIE_V2.0:0.0008 mA | 0.0252mA | 500µA | It is between thestandard acceptancerange, supporting thesubstantial equivalence. |
| Number of output mode | NEURODYN_V2.0: 8NEURODYN AUSSIE_V2.0:1 | 7 | 10 | Number of modalitiesthat the equipmentprovides, the modalitiesare independent and donot need each other tocarry out the treatment,limiting only the numberof treatments performedaccording to the suppliedcurrents. |
| Synchronous orAlternating? | Synchronous | Synchronous | Synchronous | Identical |
| Method of Channelisolation | Output transformation withisolation to 1000V | Output transformationwith isolation to 1000V | Not Stated in the Manual | Identical when comparedwith Neurodyn |
| Regulated current orregulated voltage? | Only Current | Only Current | Optional | Circuit regulated incurrent or voltage does |
| Current or Voltage | not interfere inperformance, but circuitregulated in current ismore common. | |||
| Software Microprocessor | Yes | Yes | Yes | Identical |
| Automatic overload trip | No | No | Not Stated in the Manual | Identical when comparedwith Neurodyn |
| Automatic no-load trip | No | No | Not Stated in the Manual | Identical when comparedwith Neurodyn |
| Automatic shut off | Yes | Yes | Yes | Identical |
| Patient override control? | Yes | Yes | Yes | Identical |
| Indicator DisplayOn/off Status? | Yes | Yes | Yes | Identical |
| Indicator DisplayVoltage/Current Level? | NEURODYN_V2.0: Aussie 0to 120mA (Ipp)NEURODYN AUSSIE_V2.0:Aussie 0 to 120mA (Ipp) | Aussie 0 to 120mA (Ipp) | No | Identical when comparedwith Neurodyn |
| NEURODYN_V2.0: Russa 0to 120mA (Ipp) | Russa 0 to 120mA (Ipp) | Russian 0 to 100 mA | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does nothave fixed parameter, itis according to thesensorial of each patient. | |
| NEURODYN_V2.0: TENS 0to 120mA (Ipp) | TENS 0 to 120mA (Ipp) | Tens 0 to 80 mA | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does not | |
| NEURODYN_V2.0: FES 0 to120mA (Ipp) | FES 0 to 120mA (Ipp) | No | have fixed parameter, itis according to thesensorial of each patient.Identical when comparedwith Neurodyn | |
| NEURODYN_V2.0:Interferential TP 0 to120mA (Ipp) | Interferential TP 0 to120mA (Ipp) | Interferential 0 to 100mA | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does nothave fixed parameter, itis according to thesensorial of each patient. | |
| NEURODYN_V2.0:Interferential BP 0 to120mA (Ipp) | Interferential BP 0 to120mA (Ipp) | Interferential 0 to 100mA | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does nothave fixed parameter, itis according to thesensorial of each patient. | |
| NEURODYN_V2.0: MicroCurrent 0 to 990μA (Ip) | Micro Current 0 to 990µA(Ip) | Micro Current 0 to 100 µA | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does nothave fixed parameter, itis according to thesensorial of each patient. | |
| NEURODYN_V2.0:Polarized/ Direct Current 0to 30 mA (Ip) | Polarized/ Direct Current0 to 30 mA (Ip) | Direct Current 0 to 4 mA | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does nothave fixed parameter, itis according to the | |
| is according to thesensorial of each patient. | ||||
| High Volt 0 to 400 V | High Volt 0 to 500V | Characteristics of thecircuit, does not interferein the performance, sincethe intensity does nothave fixed parameter, itis according to thesensorial of each patient. | ||
| Locking feature | Keyboard lock safetyfeature | Keyboard lock safetyfeature | Keyboard lock safetyfeature | Identical |
| Treatment timer | Treatment timer with autoshut off 1-60 minutes | Treatment timer with autoshut off 1-60 minutes | Treatment timer with autoshut off 1-60 minutes | Identical |
| Voltage Input Range andFrequency | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz | Identical |
| Safety standardsrequirementsbiocompatibility | IEC 60601-1IEC 60601-1-2IEC 60601-2-1021 CFR 898 | IEC 60601-1IEC 60601-1-2IEC 60601-2-1021 CFR 898 | IEC 60601-1IEC 60601-1-2IEC 60601-2-1021 CFR 898 | Identical |
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Image /page/9/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol in black, resembling two connected hourglass shapes, positioned above the text "IBRAMED" in a bold, sans-serif font. The symbol is flanked by two blue shapes that curve inward, creating a symmetrical design. The overall impression is modern and professional.
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Image /page/10/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized symbol above the word "IBRAMED". The symbol is composed of three blue shapes on the top and three blue shapes on the bottom, with a black shape in the middle. The word "IBRAMED" is in a bold, sans-serif font.
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Image /page/11/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black graphic above the word "IBRAMED" in black, sans-serif font. The graphic resembles a bow tie or a stylized hourglass shape, with three horizontal blue bars on the top and bottom, and a black vertical bar in the center.
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Image /page/12/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black design above the word "IBRAMED" in black, bold letters. The design features two sets of curved blue shapes on the top and bottom, with a black hourglass shape in the center.
Ibramed Equipamentos Médicos
Av. Dr. Carlos Burgos, 2800 - Jardim Itália,
Amparo - SP, 13901-080 Brazil
Ph: + 55 19 3817 9633
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Image /page/13/Picture/0 description: The image shows the logo for IBRAMED. The logo consists of a stylized blue and black graphic above the word "IBRAMED" in black, sans-serif font. The graphic resembles a bow tie or a stylized hourglass shape, with three horizontal blue bars on the top and bottom, and a black vertical bar in the center.
Conclusion: The Neurodyn V2.0 device and the predicate devices are substantially equivalent when comparing the indications for use, and technological properties. The differences shown in the comparison do not affect the substantial equivalence.
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Image /page/14/Picture/0 description: The image shows the logo for Ibramed. The logo consists of a stylized blue and black symbol to the left of the word "IBRAMED" in blue. To the right of the logo is the text "Ibramed" followed by an address and phone number, beginning with "Ph: + 55".
bramed Equipamentos Médicos Carlos Burgos, 2800 - Jardim Itália, 3901-080 Brazil า: + 55 19 3817 9633
L) Applicable Standards:
Neurodyn V2.0 was developed, as well produced in compliance with recognized international regulations and standards for the medical device industry.
IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Conclusion:
Based on compliance with the international standard and regulation mentioned above, the device Neurodyn V2.0 demonstrate substantial equivalence to the predicates above.
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Image /page/15/Picture/0 description: The image shows the logo and contact information for Ibramed Equipamentos Médicos. The logo features a stylized blue and black design with the word "BRAMED" underneath. The contact information includes the address "Av. Dr. Carlos Burgos, 2800 - Jardim Itália, Amparo - SP, 13901-080 Brazil" and the phone number "Ph: + 55 19 3817 9633".
M) Non-clinical Testing:
In order to study the performance of the product, pre-clinical tests were performed according to the table below.
Test Performance
IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-2-10 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Conclusion: Based on compliance with the international standard and regulation mentioned above, the device Neurodyn V2.0 demonstrates equivalency to the predicate device.
§ 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).