(24 days)
The Air Relax Pro Model AR-4.0 is intended for the temporary relief of minor muscle aches and for temporary increase in circulation to the treated areas in people who are in good health. The Air Relax Pro Model AR-4.0 simulates kneading and stroking of tissues by using an inflatable garment.
This submission is for the Diode Art Engineering Air Relax Pro Model AR-4.0. The Air Relax Pro Model AR-4.0 is a powered inflatable tube massager. It is intended to temporarily relieve minor muscle aches and pains, and to temporarily increase circulation to the treated areas. It simulates manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health.
The device is a Class II, type BF applied part that receives power a separately approved external IEC 60601-1 compliant power supply or optional battery pack.
The Air Relax Pro Model AR-4.0 consists of an air compressor unit with a control system, an inflatable "garment" (arms, legs and hips), plastic air tubing with a proprietary connector for connecting the device to the garment. A description of each of these components is provided below. The hip garment is also referred to as "shorts".
The user interface is a front panel display and buttons.
The Air Relax Pro Model AR-4.0 contains an air compressor with a system control that that allows the user to adjust the amount of air coming from the air compressor and going to the individual segments of the inflatable garment.
There is no electrical contact with the user and the device does not transfer or detect energy to or from the user.
The user interface of the Air Relax Pro Model AR-4.0 provides for starting and stopping the massage treatment, allows for adjusting time and intensity (pressure) of the treatment. The device also provide a proprietary keyed connector to the tubing which connects to the garment. The tubing connector at the garment is also proprietary. The proprietary connectors ensure that neither the device, tubing nor garment can be misconnected to any other device or garment.
Pressure selection is performed by pressing pressure button multiple times. Pressure level is selectable between 40 and 170 mmHg
There are four modes (Progressive, Sequential, Drain and Overlay) that determine the inflation sequence of the cells within the garments.
The provided text is a 510(k) Summary for the Air Relax Pro Model AR-4.0, a powered inflatable tube massager. It focuses on demonstrating substantial equivalence to a predicate device (Air Relax Model AR-3.0) rather than providing detailed acceptance criteria and a study proving those criteria for a novel device.
Therefore, much of the requested information regarding detailed acceptance criteria for specific performance metrics and a dedicated study to prove these against novel criteria is not present in the provided document. The document primarily highlights the similarities to a predicate device and relies on compliance with general medical device standards.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria for the Air Relax Pro Model AR-4.0's performance in terms of its intended therapeutic effect (e.g., specific thresholds for "temporary relief of minor muscle aches" or "temporary increase in circulation").
Instead, the document establishes "acceptance" by demonstrating substantial equivalence to a predicate device (Air Relax Model AR-3.0) through a comparative table (page 5). The criteria for acceptance are implicitly that the new device is as safe and effective as the predicate, meaning any differences do not raise new safety or efficacy concerns.
Here's a summary of the comparative performance and specifications, which serve as the implicit "acceptance criteria" through equivalence:
| Feature/Criteria | Air Relax Pro Model AR-4.0 (Subject Device) | Air Relax Plus Model AR-3.0 (Predicate Device) | Comment (Acceptance Status) |
|---|---|---|---|
| Indications for Use | Identical | Identical | Identical (Accepted) |
| OTC or Prescription | OTC | OTC | Identical (Accepted) |
| Environment of Use | Clinics, hospital, athlete training, home | Clinics, hospital, athlete training, home | Identical (Accepted) |
| Compliance with Standards | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Identical (Accepted) |
| Mode of Operation | Sequential/Peristaltic | Sequential/Peristaltic | Identical (Accepted) |
| Power | 100~240V, 50/60Hz | 100~240V, 50/60Hz | Identical (Accepted) |
| Device Pressure Range | 40 - 170 mmHg | 60 - 170 mmHg | Similar (Predicate has a higher minimum pressure). Comment: "Similar to predicate except low pressure, it does not affect safety and effectiveness." (Considered Acceptable) |
| Garments material | Nylon with a Polyurethane Laminate | Nylon with a Polyurethane Laminate | Identical (Accepted) |
| Leg Attachment Sizes | Size "2": 34 X 15.35, "3": 38.2 X 15.35, "4": 42 X 15.35 | Size "2": 34 X 15.35, "3": 38.2 X 15.35, "4": 42 X 15.35 | Identical in size and materials. "Number of Inflatable garment segments differs." (Considered Acceptable due to no impact on safety and effectiveness) |
| Arm Attachment Sizes | Size "1": 34 X 15.35, "2": 39.3 X 15.35 | Size "1": 34 X 15.35, "2": 39.3 X 15.35 | Identical in size and materials. "Number of Inflatable garment segments differs." (Considered Acceptable due to no impact on safety and effectiveness) |
| Shorts Attachment Sizes | Size "1": 20.8 X 32.5, "2": 24.6 X 32.5 | Size "1": 20.8 X 32.5, "2": 24.6 X 32.5 | Identical in size and materials. "Number of Inflatable garment segments differs." (Considered Acceptable due to no impact on safety and effectiveness) |
| Number of Inflatable Garment Segments | 6 | 4 | Different. Comment: "No impact on safety and effectiveness" (Considered Acceptable) |
| Weight | 2.2 kg (4.85 pounds) | 1.67kg (3.7 pounds) | Different. Comment: "Weight is different but it does not affect safety and effectiveness." (Considered Acceptable) |
| Dimensions (W x H x D) | 7.7" x 7.1" x 10.4" | 9.5" x 4.7" x 7.5" | Different. Comment: "Size is different but it does not affect safety and effectiveness." (Considered Acceptable) |
| Housing Materials and Constructions | Molded ABS enclosure | Molded ABS enclosure | Identical (Accepted) |
| Patient contact | Non-conductive garments | Non-conductive garments | Identical (Accepted) |
| Safety Features | Button at control unit allows stop/pause | Button at control unit allows stop/pause | Identical (Accepted) |
| Modes | "PROG", "SEQT", "OVLAY", "DRAIN" | "P", "S", "F", "Target" | Similar. Comment: "Similar to predicate. Differences do not affect safety and effectiveness." (Considered Acceptable) Note: "OVLAY" vs "F" seem functionally similar, "DRAIN" vs "Target" seem different but deemed not to affect safety/effectiveness. |
| Treatment Duration | 5-95 minutes | 15 or 30 minutes | Different. Comment: "Extended duration for subject device but predicate time can be re-enabled any number of times so no significant difference." (Considered Acceptable) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states:
- "No animal testing was performed" (page 8)
- "No clinical testing was performed" (page 9)
This indicates that there was no specific test set of patient data used to prove the device's performance against clinical acceptance criteria. The evaluation was primarily based on:
- Engineering bench testing (controls, indicators, performance)
- Compliance with recognized electrical and medical device safety standards (AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11).
- Demonstration of substantial equivalence to a legally marketed predicate device.
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)
Not applicable. Since no clinical test set was used, there was no need for experts to establish ground truth from patient data. The "ground truth" for substantial equivalence was established by the FDA's review process comparing the device to the predicate based on technical specifications and declared compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or human interpretation was involved that would require an adjudication method.
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 device is a physical therapy massager, not an AI-assisted diagnostic or therapeutic tool that involves human readers or interpretation of medical images. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical therapy massager, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the purpose of this 510(k), the "ground truth" for demonstrating safety and effectiveness relies on:
- Established performance of the predicate device: The predicate (Air Relax Model AR-3.0) is already legally marketed and presumed safe and effective for its indications.
- Compliance with recognized industry standards: The device's adherence to standards like IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), and IEC 60601-1-11 (home healthcare environment) provides "ground truth" for its electrical and mechanical safety and basic performance characteristics.
- Bench testing: Verifying the function of controls, indicators, and overall performance through engineering tests.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).