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510(k) Data Aggregation
(317 days)
This device is intended/ indicated for use for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction
Guardian Dysphagia dual channel NMES is a lightweight battery powered dual channel neuromuscular stimulation device used for treating patients suffering from dysphagia. It is a prescription device administered to patients by or under the direction of a licensed healthcare provider in hospitals, post acute care facilities, nursing homes and outpatient clinics. The intended patient outcome is to regain control of muscles used to swallow food and drink liquids without aspirating. It is to be used with Guardian 150 electrode or other compatible electrodes cleared for the same indications for use, as well as lead wires.
This document, K120922, is a 510(k) premarket notification for the Guardian Dysphagia dual channel NMES unit. It directly states that no clinical testing was required or performed to demonstrate substantial equivalence for this device. Therefore, the device performance is not proven through a study but rather through bench testing and a comparison to a predicate device.
Given this, I cannot provide detailed answers to many of your questions as they pertain to clinical studies and data. However, I can extract information related to the "acceptance criteria" (which in this context refers to the characteristics compared for substantial equivalence) and the "study" (which in this case means the non-clinical bench testing).
Here's the breakdown based on the provided document:
Device Acceptance Criteria and Performance (Based on Substantial Equivalence Claim)
The "acceptance criteria" for this device are implicitly the characteristics of the predicate device (K070425 Chattanooga VitalStim Experia) that the Guardian Dysphagia Dual Channel NMES unit must meet or be substantially equivalent to. The "reported device performance" is the Guardian's characteristics as measured during bench testing or as designed.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Predicate (K070425 Chattanooga VitalStim Experia) | K120922 (Guardian Dysphagia Dual Channel NMES) (Reported Performance/Characteristic) |
|---|---|---|
| Output Configuration | Dual Channel, electrically Isolated with miniature safety connectors | SAME |
| Output Waveform | AC Mode: Rectangular symmetrical biphasic with zero net DC | SAME |
| Regulated current or voltage | Constant current | Constant current |
| Patient Voltage (no load) | 100 Volts max | SAME |
| Automatic Overload Trip | For high resistance the circuit detects this and shuts off the current. The current indicator shows this by flashing "0". Trip point measured: 33 k ohm. Can withstand permanent short or open circuit | SAME. Trip point measured: 23 k ohm. Can withstand permanent short or open circuit |
| Intensity Control | Dual intensity potentiometers: 0-25 mA peak current output, adjustable current. Constant current regulation from 0 to 4000 ohms load minimum | SAME |
| Pulse Rate | Fixed, 80 Hz | SAME |
| Pulse Shape | Positive square wave of 300 µs width followed by an interphase interval of 100 µs followed by a negative square wave of 300 µs width symmetric in shape and amplitude to that of the positive square wave (and therefore charge balanced). | Positive square wave of 300 µs width followed by an interphase interval of 100 µs followed by a negative square wave of 300 µs width symmetric in shape and amplitude to that of the positive square wave (and therefore charge balanced). |
| Low Battery Indicator Display | LCD symbol | LCD Symbol: Triggers at 6.6 volts |
| Ramp down/ramp up and rest time | Down: 0.75 s. Up: 0.75 s. Off: 1.0 s | Down: 0.75 s. Up: 0.75 s. Off: 1.0 s |
| Rest Period | Each 57.5 seconds of operation, the unit will reduce power down to zero power for a period of 1 second. The power ramps down to zero and back up to the preset power over a total time of 2.5 seconds. | Each 57.5 seconds of operation, the unit will reduce power down to zero power for a period of 1 second. The power ramps down to zero and back up to the preset power over a total time of 2.5 seconds. |
| Distance between electrodes | 30 mm | 30 mm |
| Electrode Dimensions | Conductive area: 0.75" round. 19 mm x 2 contacts) | 105 x 55 mm with liner, 74 x 36 mm fabric, Conductive area: 0.875" diameter round, 2 contacts. (22.5 mm diameter) silver film/gel (round, x 2) (K083756) - Note: Larger electrode conductive area on Guardian vs. predicate |
| Electrode Conductive Surface Area | Surface area of 0.882 sq. In. for two electrodes | Surface area of 1.14 sq. In. for two electrodes - Note: Larger electrode conductive area on Guardian vs. predicate |
| Timer | 60 minutes | 60 minutes |
| Pulse Width | 300 µ sec | 300 µ sec |
| Pulse Current Range | 0-25 mA | 0-25 mA |
| Number of Independent Channels | 2 | 2 |
| Power Source | 2 AA cells | 9 Volt Alkaline battery - Note: Different power source, justified by equivalent functional performance. |
| Start up current | Not specified | Zero mA. |
Study Information (Non-Clinical Bench Testing)
As explicitly stated in the document: "9- Clinical test discussion: Not applicable/not required." Therefore, the "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated regarding "samples." Bench testing involves measuring characteristics of the device itself. It would typically be a single device or a small representative batch of devices.
- Data Provenance: The testing was "Bench testing consisted of:" which implies in-house testing by the manufacturer. No country of origin for data is stated beyond the manufacturer being located in Mount Vernon, Ohio, USA. The testing is
prospective(i.e., performed for this submission), not retrospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For bench testing of electrical safety, EMC, and oscillometric properties, "ground truth" is established by adherence to recognized engineering standards (IEC 60601-1, IEC 60601-1-2) and FDA recommendations. The "experts" would be the test engineers and the standards bodies themselves. No specific number of experts or their qualifications are mentioned as they would not be "establishing ground truth" in the way a clinical expert panel would for image review or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., medical image reading). For bench testing, results are quantitative measurements against defined standards.
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. This is a physical electronic device, not an AI or imaging device. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical electronic device, and performance relates to its electrical and mechanical characteristics, not an algorithm's diagnostic performance. The bench tests are "standalone" in the sense that they measure the device's intrinsic characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground truth for bench testing: Defined by international standards (IEC 60601-1, IEC 60601-1-2), FDA recommendations for electrical stimulators, and the manufacturer's design specifications. These are objective engineering and regulatory standards.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design specifications and characteristics of the predicate device served as the "target" or baseline for the substantial equivalence claim.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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