(226 days)
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
Muscle re-education
Maintaining or increasing range of motion
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
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.
The provided text details a 510(k) summary for the Neurodyn and Neurodyn Aussie Powered Muscle Stimulators, seeking substantial equivalence to the Chattanooga Vectra Genisys K031077. The document outlines essential performance metrics and demonstrates equivalency through non-clinical testing and comparison of device characteristics.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the typical sense of quantitative performance thresholds. Instead, it demonstrates substantial equivalence to a predicate device (Chattanooga Vectra Genisys K031077) by showing that the Neurodyn and Neurodyn Aussie devices share identical or very similar technological characteristics, intended uses, indications for use, safety, and effectiveness.
Therefore, the "acceptance criteria" are implicitly met by demonstrating this substantial equivalence through a detailed comparison, rather than by achieving specific numerical performance targets against a predefined standard.
| Feature | Acceptance Criteria (Implied: Substantial Equivalence to Predicate) | Reported Device Performance (Neurodyn / Neurodyn Aussie) | Predicate Device Performance (Vectra Genisys K031077) |
|---|---|---|---|
| Intended Use | Identical to predicate | Identical | |
| Indications for Use | Identical to predicate | Identical | |
| Target Population | Identical to predicate | Identical | |
| Human Factors | Identical to predicate | Identical | |
| Contraindications | Identical to predicate | Identical | |
| Technological Characteristics | Identical (or very similar) to predicate | Identical (e.g., MFAC, materials, software) | Identical |
| Device Material | Similar to predicate | ABS plastic panel, LCD display | ABS plastic panel, LCD display |
| Width (in) | Comparable to predicate | Neurodyn Aussie: 10.6, Neurodyn: 14.6 | 9.75 |
| Height (in) | Comparable to predicate | Neurodyn Aussie: 4.9, Neurodyn: 4.9 | 8.75 |
| Depth (in) | Comparable to predicate | Neurodyn Aussie: 10.4, Neurodyn: 12.4 | 12.75 |
| Weight (lbs) | Comparable to predicate | Neurodyn Aussie: 4.08, Neurodyn: 5.5 | 6 |
| Performance | Identical to predicate | Identical | Identical |
| Biocompatibility | Uses FDA cleared electrodes | FDA cleared electrodes | FDA cleared electrodes |
| Mechanical Safety | Identical to predicate | Identical | Identical |
| Anatomical Sites | Identical to predicate | Identical | Identical |
| Number of Channels | Comparable to predicate | Neurodyn Aussie: 4, Neurodyn: 4 | 2/4 |
| Current Types (Russian, Aussie, Interferential, Microcurrent, TENS, Premodulated) | Similar array of current types to predicate | Varies between Neurodyn and Neurodyn Aussie, but comparable to predicate's offerings. | Vectra Genisys offers all listed. Specific Neurodyn models offer subsets. |
| Voltage Input | Identical to predicate | 100/240V, 50/60Hz Bivolt | 100/240V, 50/60Hz, 1.0A |
| Output | Identical to predicate | +24V 7.3A | +24V 7.3A |
| Electrical Class | Identical to predicate | II | II |
| Electrical Type | Identical to predicate | BF Type | BF Type |
| Method of line current isolation | Comparable to predicate | Double Isolation | Fuse-Two 5.6A Time Lag |
| Patient leakage control (normal condition) | Comparable to predicate (within acceptable limits) | 0.0508mA | 69μA |
| Patient leakage control (single fault condition) | Comparable to predicate (within acceptable limits) | 0.0252mA | 31μA |
| Software Microprocessor | Yes | Yes | Yes |
| Automatic overload trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| Temperature range (transport/storage) | Comparable to predicate | 41°F-122°F | 59°F-104°F |
| Environment operating temperature range | Comparable to predicate | 41°F-113°F | 59°F-104°F |
| Locking feature | Yes | Keyboard lock safety feature | Keyboard lock safety feature |
| Treatment timer with auto shut off | Yes | Yes | Yes |
| Auto test and repeat treatment | Yes | Yes | Yes |
| Safety standards requirements | ISO 13485, IEC 60601-1, IEC 60601-2, IEC 60602-10, CE | Same standards (Vectra Genisys also UL 60602) | ISO 13485, IEC 60601-1, IEC 60601-2, IEC 60602-10, UL 60602 |
| Electromagnetic compatibility | IEC 60601-1-2001/A:2004 | Identical Standard | IEC 60601-1-2001/A:2004 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a non-clinical test design focused on demonstrating substantial equivalence to a predicate device. This typically involves performance verification against a known, cleared device, rather than a test on a patient sample. The data provenance is derived from engineering and design specifications and testing performed by Ibramed, a company based in Brazil (Amparo - Sao Paulo - Brasil). The document does not specify whether this was a retrospective or prospective comparison, but the data itself (device specifications) would inherently be current/prospective for the new devices and historical/retrospective for the predicate device's cleared specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this submission. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (Chattanooga Vectra Genisys K031077). The assessment is based on comparison of technical specifications and performance against recognized standards, not on expert consensus regarding patient outcomes or diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "adjudication" in the sense of resolving discrepancies between expert readings or interpretations. The comparison is between documented technical specifications and results of non-clinical engineering tests.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which is not the nature of a powered muscle stimulator. The submission focuses on demonstrating substantial equivalence of a therapeutic device based on its functional characteristics and safety.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. These are powered muscle stimulator devices, not algorithmic diagnostic tools. Their performance is inherent in their electrical output and physical characteristics, and they are operated by a human user (clinician or patient) as part of a therapeutic regimen.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is the established safety and effectiveness of the legally marketed predicate device (Chattanooga Vectra Genisys K031077) and compliance with relevant international and national electrical safety and medical device standards (e.g., ISO 13485, IEC 60601 series). No clinical outcomes data or pathology samples were used as ground truth for this 510(k) submission.
8. The sample size for the training set
This is not applicable. As a medical device submission based on substantial equivalence to a predicate device and non-clinical testing, there is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are likely informed by prior engineering knowledge and regulatory standards, but not a specific "training set" of data for an algorithm.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set mentioned or implied in the context of this 510(k) submission.
§ 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).